International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning the Way Forward, 50221-50223 [2011-20540]
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Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices
Background Information on ICCVAM,
NICEATM, and SACATM
mstockstill on DSK4VPTVN1PROD with NOTICES
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, generate, or
disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
with regulatory applicability and
promotes the scientific validation and
regulatory acceptance of toxicological
and safety testing methods that more
accurately assess the safety and hazards
of chemicals and products and that
reduce, refine (decrease or eliminate
pain and distress), or replace animal
use. The ICCVAM Authorization Act of
2000 (42 U.S.C. 285l–3) established
ICCVAM as a permanent interagency
committee of the NIEHS under
NICEATM. NICEATM administers
ICCVAM, provides scientific and
operational support for ICCVAM-related
activities, and conducts independent
validation studies to assess the
usefulness and limitations of new,
revised, and alternative test methods
and strategies. NICEATM and ICCVAM
welcome the public nomination of new,
revised, and alternative test methods
and strategies for validation studies and
technical evaluations. Additional
information about NICEATM and
ICCVAM can be found on the
NICEATM–ICCVAM Web site (https://
iccvam.niehs.nih.gov).
SACATM was established in response
to the ICCVAM Authorization Act
[Section 285l–3(d)] and is composed of
scientists from the public and private
sectors. SACATM advises ICCVAM,
NICEATM, and the Director of the
NIEHS and NTP regarding statutorily
mandated duties of ICCVAM and
activities of NICEATM. SACATM
provides advice on priorities and
activities related to the development,
validation, scientific review, regulatory
acceptance, implementation, and
national and international
harmonization of new, revised, and
alternative toxicological test methods.
Additional information about SACATM,
including the charter, roster, and
records of past meetings, can be found
at https://ntp.niehs.nih.gov/go/167.
References
AWA. 2010. Animal Welfare Act. 7 U.S.C.
2131 et seq. Public Law 89–544. Available:
https://www.aphis.usda.gov/
animal_welfare/downloads/awa/awa.pdf.
CPSC. 2010. Hazardous Substances and
Articles; Administration and Enforcement
Regulations. 16 CFR part 1500. Available:
https://www.gpo.gov/fdsys/pkg/CFR-2010-
VerDate Mar<15>2010
16:37 Aug 11, 2011
Jkt 223001
title16-vol2/xml/CFR-2010-title16-vol2part1500.xml.
EPA. 1998. Health Effects Test Guideline,
OPPTS 870.2400 Acute Eye Irritation.
Washington, DC: U.S. Environmental
Protection Agency. Available: https://
iccvam.niehs.nih.gov/SuppDocs/FedDocs/
EPA/EPA_870_2400.pdf.
FHSA. 2008. 15 U.S.C. 1261–1278. Public
Law 86–613. Available: https://
www.cpsc.gov/businfo/fhsa.pdf.
Haseman JK, Allen DG, Lipscomb EA, Truax
JF, Stokes WS. 2011. Using fewer animals
to identify chemical eye hazards: Revised
criteria necessary to maintain equivalent
hazard classification [published online
ahead of print]. Regul Toxicol Pharmacol.
Available: https://dx.doi.org/10.1016/
j.yrtph.2011.06.006.
OECD. 2002. Test No. 405: Acute Eye
Irritation/Corrosion. In: OECD Guidelines
for the Testing of Chemicals, Section 4:
Health Effects. Paris:OECD Publishing.
Available: https://www.oecd-ilibrary.org/
content/book/9789264070646-en.
PHS. 2002. Public Health Service Policy on
Humane Care and Use of Laboratory
Animals. Bethesda, MD: Office of
Laboratory Animal Welfare, National
Institutes of Health. Available: https://
grants.nih.gov/grants/olaw/references/
phspol.htm.
Dated: August 3, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–20537 Filed 8–11–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
International Workshop on Alternative
Methods for Human and Veterinary
Rabies Vaccine Testing: State of the
Science and Planning the Way Forward
Division of the National
Toxicology Program (DNTP), National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH), HHS.
ACTION: Announcement of a Workshop;
Call for Abstract Submissions.
AGENCY:
The NTP Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM)
announces an ‘‘International Workshop
on Alternative Methods for Human and
Veterinary Rabies Vaccine Testing: State
of the Science and Planning The Way
Forward.’’ This workshop will bring
together scientists from government,
industry, and academia to review the
current state of the science and
validation status of methods and
approaches that may reduce, refine, or
replace animal use in human and
veterinary rabies vaccine potency
testing, and to develop an
SUMMARY:
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50221
implementation strategy to achieve
global acceptance and use of these
alternatives. Attendance is open to the
public at no charge and limited only by
the available space. Abstracts for
scientific posters for display at the
workshop are also invited (see
SUPPLEMENTARY INFORMATION).
DATES: The workshop is scheduled for
October 11–13, 2011. Sessions will
begin at 8:30 a.m. each day and end at
approximately 6 p.m. on October 11 and
12 and at 12 p.m. on October 13. The
deadline for registration is September
30, 2011. Due to U.S. Department of
Agriculture (USDA) security
requirements, onsite registration at the
workshop will not be available. The
deadline for submission of poster
abstracts is September 16, 2011.
ADDRESSES: The workshop will be held
at the Center for Veterinary Biologics at
the USDA National Centers for Animal
Health, 1920 Dayton Avenue, Ames,
Iowa 50010. Individuals with
disabilities who need accommodation to
participate in this event should contact
Ms. Debbie McCarley at voice
telephone: 919–541–2384 or e-mail:
mccarley@niehs.nih.gov. TTY users
should contact the Federal TTY Relay
Service at 800–877–8339. Requests
should be made at least 5 business days
in advance of the event.
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
Rabies is one of the oldest known
zoonotic diseases and is responsible for
at least 55,000 human deaths worldwide
each year (World Health Organization
[WHO], 2010). Rabies vaccines serve a
vital role in preventing further deaths
and controlling the disease in certain
animal populations. An estimated 15
million people receive post-exposure
vaccine prophylaxis each year due to
actual or suspected exposures to the
rabies virus. In the United States and
other developed countries, rabies
vaccines have effectively eliminated
domestic rabies virus strains. Prior to
the release of each production lot of
vaccine, regulatory authorities require
demonstration of potency and safety.
Potency and safety testing of rabies
vaccines requires large numbers of
laboratory animals and involves
significant pain and distress. New
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12AUN1
50222
Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices
methods and approaches are sought that
(1) are more humane and use fewer or
no animals; (2) are faster, less
expensive, and more accurate; and (3)
are safer for laboratory workers.
A recent international workshop
organized by NICEATM, the Interagency
Coordinating Committee on the
Validation of Alternative Methods
(ICCVAM), and its international
partners identified rabies vaccines as
one of the three highest priorities for
future research, development, and
validation of alternative test methods
that could further reduce, refine, and
ultimately replace animal use for
potency and safety testing. Organizing
an international workshop to assess the
current state of the science and way
forward for alternative methods for
rabies vaccine potency testing was
identified as a high priority. Based on
recent scientific and technological
advances, several alternative approaches
to rabies vaccine potency testing have
been proposed or are currently
available. This international workshop
will bring together scientific experts
from government, industry, and
academia to review these methods and
to define efforts necessary to achieve
global acceptance and implementation.
The workshop is organized by
NICEATM, ICCVAM, the European
Centre for the Validation of Alternative
Methods (ECVAM), the Japanese Center
for the Validation of Alternative
Methods (JaCVAM), and Health Canada.
mstockstill on DSK4VPTVN1PROD with NOTICES
Preliminary Workshop Agenda
Day 1 Tuesday, October 11, 2011
• Welcome and Overview of
Workshop Goals and Objectives
• Rabies Vaccines for Humans and
Animals: Public Health Perspectives
• Current Requirements and
Guidance on Product-Specific
Validation of Alternatives for Veterinary
Rabies Vaccine Potency Testing
• Current Requirements and
Guidance on Product-Specific
Validation of Alternatives for Human
Rabies Vaccine Potency Testing
• International Guidelines for Rabies
Vaccine Potency Testing
Æ WHO
Æ World Organisation for Animal
Health (OIE)
• Incorporating Reduction,
Refinement, and Replacement (the
‘‘3Rs’’) Into Human and Veterinary
Rabies Vaccine Potency Testing: An
Industry Perspective
• Critical Analysis of the In Vivo
Potency Challenge Test for Inactivated
Rabies Vaccines
• Serological Methods for Human and
Veterinary Rabies Vaccine Potency
Testing: Overview and Validation Status
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Jkt 223001
• In Vitro Antigen Quantification
Assays for Rabies Vaccine Potency
Testing
• Application of Consistency
Parameters and Integrated Approaches
to Reduce and Replace Animal Use for
Rabies Vaccine Potency Testing
• Vaccine Adjuvants and their Impact
on Antigen Quantification Methods
• Current NIH Research on Improved
Rabies Vaccines
Day 2 Wednesday, October 12, 2011
• Breakout Session #1: Serologic
Methods for Rabies Vaccine Potency
Testing
• Breakout Session #2: Non-Animal
Approaches to Rabies Vaccine Potency
Testing: Antigen Quantification and
Integrated Approaches
Day 3 Thursday, October 13, 2011
• Breakout Session #2 (continued):
Non-Animal Approaches to Rabies
Vaccine Potency Testing: Antigen
Quantification and Integrated
Approaches
• Breakout Session #3: The In Vivo
Potency Challenge Test for Inactivated
Rabies Vaccines: Refinement and
Reduction Opportunities
• Closing Session: Review of
Workshop Conclusions and
Recommendations
Registration
Registration information, tentative
agenda, and additional meeting
information are available on the
workshop Web site (https://
iccvam.niehs.nih.gov/meetings/
RabiesVaccWksp-2011/
RabiesVaccWksp.htm) and upon request
from NICEATM (see FOR FURTHER
INFORMATION CONTACT).
Call for Abstracts
NICEATM and ICCVAM 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
for human or veterinary rabies vaccine
potency testing. The body of the abstract
is not to exceed 400 words. 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 12point font and all margins for the
document should be no less than one
inch. Title information should include
the names of all authors and associated
institutions. The name, address, phone
number, fax number, and email address
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Fmt 4703
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for the corresponding or senior author
should be provided at the end of the
abstract.
Abstracts must include the following
information, when applicable: (1) A
statement indicating whether animals or
humans were used in studies, (2) a
statement by the senior author certifying
that use of animals or animal tissues
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, and (3) 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.
Abstracts must be submitted by e-mail
to niceatm@niehs.nih.gov. The deadline
for abstract submission is September 16,
2011. The corresponding author will be
notified regarding the abstract’s
acceptance within 10 working days of
the submission deadline. Guidelines for
poster presentations will be sent to the
corresponding authors.
Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, generate, or
disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
with regulatory applicability and
promotes the scientific validation and
regulatory acceptance of toxicological
and safety testing methods that more
accurately assess the safety and hazards
of chemicals and products and that
reduce, refine (decrease or eliminate
pain and distress), or replace animal
use. The ICCVAM Authorization Act of
2000 (42 U.S.C. 285l–3) established
ICCVAM as a permanent interagency
committee of the NIEHS under
NICEATM. NICEATM administers
ICCVAM, provides scientific and
operational support for ICCVAM-related
activities, and conducts independent
validation studies to assess the
usefulness and limitations of new,
revised, and alternative test methods
and strategies. NICEATM and ICCVAM
welcome the public nomination of new,
revised, and alternative test methods
and strategies applicable to the needs of
U.S. Federal agencies. Additional
information about ICCVAM and
NICEATM can be found on the
E:\FR\FM\12AUN1.SGM
12AUN1
Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices
NICEATM–ICCVAM Web site (https://
iccvam.niehs.nih.gov).
Application Selection Process
References
WHO. 2010. Rabies vaccines: WHO
Position paper. Weekly Epidemiological
Record 85(32):309–320.
Dated: August 3, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–20540 Filed 8–11–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice To Change Catalog of Federal
Domestic Assistance (CFDA) Number
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice provides public
announcement of CDC’s intent to award
two awards to eligible applicants of
State or Territorial Public Health
Newborn Bloodspot Screening
Programs. These activities are proposed
by the above-mentioned grantees in
their FY 2011 applications submitted
under funding opportunity CDC–RFA–
EH11–001, ‘‘Program to Support New
Implementation of State or Territorial
Public Health Laboratory Capacity for
Newborn Bloodspot Screening of Severe
Combined Immune Deficiency (SCID)
(U01), ’’ Catalog of Federal Domestic
Assistance Number (CFDA): 93.070.
Approximately $900,000 in funding will
be awarded to the grantees for the
implementation of newborn screening
for SCID.
Accordingly, CDC adds the following
information to the previously published
funding opportunity announcement of
EH11–001:
SUMMARY:
Authority: Authorized under Section 301
of the Public Health Service Act, [42 U.S.C.
241], as amended.
CFDA #: 93.070 Environmental Public
Health Emergency Response.
mstockstill on DSK4VPTVN1PROD with NOTICES
Award Information
Type of Award: New Competing
Cooperative Agreement.
Approximate Total Current Fiscal
Year ACA Funding: $900,000.
Anticipated Number of Awards: 2.
Fiscal Year Funds: 2011.
Anticipated Award Date: September
1, 2011.
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16:37 Aug 11, 2011
Jkt 223001
Funding will be awarded to
applicants based on results from the
peer review panel ranking
recommendations.
Funding Authority
CDC will add the authority to that
which is reflected in the published
Funding Opportunity CDC–RFA–EH11–
001. The revised funding authority
language will read:
—Authorized under Section 301 of the
Public Health Service Act, [42 U.S.C.
241], as amended.
DATES: The effective date for this action
is the date of publication of this Notice
and remains in effect until the
expiration of the project period of the
funded applications.
FOR FURTHER INFORMATION CONTACT: Beth
Gardner, Extramural Team Lead,
National Center for Environmental
Health, Centers for Disease Control and
Prevention, 4770 Buford Hwy., Atlanta,
GA 30341, telephone (770) 488–0572, email Bgardner@cdc.gov.
SUPPLEMENTARY INFORMATION: None.
Dated: August 3, 2011.
James Stephens,
Director of the Office of Science Quality,
Centers for Disease Control and Prevention.
[FR Doc. 2011–20507 Filed 8–11–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 76 FR 47189–47190,
dated August 4, 2011) is amended to
reflect the reorganization of the Center
for Global Health, Centers for Disease
Control and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows: After the title and functional
statements for the Division of Global
Disease Detection and Emergency
Response (CWJ), insert the following:
Global Immunization Division (CWK).
The Global Immunization Division
(GID) protects the health of Americans
and global citizens by preventing
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50223
disease, disability, and death worldwide
from vaccine-preventable diseases. In
carrying out its mission, GID: (1)
Provides national leadership and
coordination of the CGH efforts to
eradicate polio, control or eliminate
measles, strengthen routine
immunization programs, introduce new
and under-utilized vaccines, and
promote safe injection practices, in
collaboration with international
organizations and CDC Centers/
Institute/Offices; (2) provides short- and
long-term consultation and technical
assistance to the WHO, UNICEF, and
foreign countries involved in global
immunization activities and participates
in international advisory group
meetings on immunization issues; (3)
administers grants to WHO, Pan
American Health Organization (PAHO),
UNICEF, and other international
partners as appropriate for the provision
of technical, programmatic, and
laboratory support, and vaccine
procurement for initiatives to support
global immunization targets; (4) designs
and participates in international
research, monitoring, and evaluation
projects to increase the effectiveness of
immunization strategies as may be
developed; (5) develops strategies to
improve the technical skills and
problem-solving abilities of program
managers and health care workers in
other countries; (6) refines strategies
developed for the eradication or control
of vaccine-preventable diseases in the
Western Hemisphere for
implementation in other parts of the
world; (7) assists other countries, WHO,
and other partners to improve
surveillance for polio, measles, and
other vaccine preventable diseases
(VPDs); (8) prepares articles based on
findings for publication in international
professional journals and presentation
at international conferences; (9)
collaborates with other countries, WHO,
UNICEF, and advocacy groups to ensure
the availability of sufficient funds to
purchase an adequate supply of polio,
measles, and other vaccines, and funds
for technical support for use in
eradication and control efforts; and (10)
provides technical and operational
leadership for CDC’s activities in
support of the immunization initiatives
such as Global Alliance for Vaccines
and Immunization and the Global
Immunization Vision and Strategies.
Office of the Director (CWK1). (1)
Provides leadership, management, and
oversight for all division activities; (2)
provides coordination of budgeting and
liaison with CGH, and FMO on budget
and spending; (3) provides coordination
and oversight of the division’s
E:\FR\FM\12AUN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50221-50223]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20540]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
International Workshop on Alternative Methods for Human and
Veterinary Rabies Vaccine Testing: State of the Science and Planning
the Way Forward
AGENCY: Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS), National Institutes
of Health (NIH), HHS.
ACTION: Announcement of a Workshop; Call for Abstract Submissions.
-----------------------------------------------------------------------
SUMMARY: The NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM) announces an ``International Workshop
on Alternative Methods for Human and Veterinary Rabies Vaccine Testing:
State of the Science and Planning The Way Forward.'' This workshop will
bring together scientists from government, industry, and academia to
review the current state of the science and validation status of
methods and approaches that may reduce, refine, or replace animal use
in human and veterinary rabies vaccine potency testing, and to develop
an implementation strategy to achieve global acceptance and use of
these alternatives. Attendance is open to the public at no charge and
limited only by the available space. Abstracts for scientific posters
for display at the workshop are also invited (see SUPPLEMENTARY
INFORMATION).
DATES: The workshop is scheduled for October 11-13, 2011. Sessions will
begin at 8:30 a.m. each day and end at approximately 6 p.m. on October
11 and 12 and at 12 p.m. on October 13. The deadline for registration
is September 30, 2011. Due to U.S. Department of Agriculture (USDA)
security requirements, onsite registration at the workshop will not be
available. The deadline for submission of poster abstracts is September
16, 2011.
ADDRESSES: The workshop will be held at the Center for Veterinary
Biologics at the USDA National Centers for Animal Health, 1920 Dayton
Avenue, Ames, Iowa 50010. Individuals with disabilities who need
accommodation to participate in this event should contact Ms. Debbie
McCarley at voice telephone: 919-541-2384 or e-mail:
mccarley@niehs.nih.gov. TTY users should contact the Federal TTY Relay
Service at 800-877-8339. Requests should be made at least 5 business
days in advance of the event.
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
Rabies is one of the oldest known zoonotic diseases and is
responsible for at least 55,000 human deaths worldwide each year (World
Health Organization [WHO], 2010). Rabies vaccines serve a vital role in
preventing further deaths and controlling the disease in certain animal
populations. An estimated 15 million people receive post-exposure
vaccine prophylaxis each year due to actual or suspected exposures to
the rabies virus. In the United States and other developed countries,
rabies vaccines have effectively eliminated domestic rabies virus
strains. Prior to the release of each production lot of vaccine,
regulatory authorities require demonstration of potency and safety.
Potency and safety testing of rabies vaccines requires large numbers of
laboratory animals and involves significant pain and distress. New
[[Page 50222]]
methods and approaches are sought that (1) are more humane and use
fewer or no animals; (2) are faster, less expensive, and more accurate;
and (3) are safer for laboratory workers.
A recent international workshop organized by NICEATM, the
Interagency Coordinating Committee on the Validation of Alternative
Methods (ICCVAM), and its international partners identified rabies
vaccines as one of the three highest priorities for future research,
development, and validation of alternative test methods that could
further reduce, refine, and ultimately replace animal use for potency
and safety testing. Organizing an international workshop to assess the
current state of the science and way forward for alternative methods
for rabies vaccine potency testing was identified as a high priority.
Based on recent scientific and technological advances, several
alternative approaches to rabies vaccine potency testing have been
proposed or are currently available. This international workshop will
bring together scientific experts from government, industry, and
academia to review these methods and to define efforts necessary to
achieve global acceptance and implementation. The workshop is organized
by NICEATM, ICCVAM, the European Centre for the Validation of
Alternative Methods (ECVAM), the Japanese Center for the Validation of
Alternative Methods (JaCVAM), and Health Canada.
Preliminary Workshop Agenda
Day 1 Tuesday, October 11, 2011
Welcome and Overview of Workshop Goals and Objectives
Rabies Vaccines for Humans and Animals: Public Health
Perspectives
Current Requirements and Guidance on Product-Specific
Validation of Alternatives for Veterinary Rabies Vaccine Potency
Testing
Current Requirements and Guidance on Product-Specific
Validation of Alternatives for Human Rabies Vaccine Potency Testing
International Guidelines for Rabies Vaccine Potency
Testing
[cir] WHO
[cir] World Organisation for Animal Health (OIE)
Incorporating Reduction, Refinement, and Replacement (the
``3Rs'') Into Human and Veterinary Rabies Vaccine Potency Testing: An
Industry Perspective
Critical Analysis of the In Vivo Potency Challenge Test
for Inactivated Rabies Vaccines
Serological Methods for Human and Veterinary Rabies
Vaccine Potency Testing: Overview and Validation Status
In Vitro Antigen Quantification Assays for Rabies Vaccine
Potency Testing
Application of Consistency Parameters and Integrated
Approaches to Reduce and Replace Animal Use for Rabies Vaccine Potency
Testing
Vaccine Adjuvants and their Impact on Antigen
Quantification Methods
Current NIH Research on Improved Rabies Vaccines
Day 2 Wednesday, October 12, 2011
Breakout Session 1: Serologic Methods for Rabies
Vaccine Potency Testing
Breakout Session 2: Non-Animal Approaches to
Rabies Vaccine Potency Testing: Antigen Quantification and Integrated
Approaches
Day 3 Thursday, October 13, 2011
Breakout Session 2 (continued): Non-Animal
Approaches to Rabies Vaccine Potency Testing: Antigen Quantification
and Integrated Approaches
Breakout Session 3: The In Vivo Potency Challenge
Test for Inactivated Rabies Vaccines: Refinement and Reduction
Opportunities
Closing Session: Review of Workshop Conclusions and
Recommendations
Registration
Registration information, tentative agenda, and additional meeting
information are available on the workshop Web site (https://iccvam.niehs.nih.gov/meetings/RabiesVaccWksp-2011/RabiesVaccWksp.htm)
and upon request from NICEATM (see FOR FURTHER INFORMATION CONTACT).
Call for Abstracts
NICEATM and ICCVAM 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 for human or veterinary rabies vaccine
potency testing. The body of the abstract is not to exceed 400 words.
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 the names of all authors and
associated institutions. The name, address, phone number, fax number,
and email address for the corresponding or senior author should be
provided at the end of the abstract.
Abstracts must include the following information, when applicable:
(1) A statement indicating whether animals or humans were used in
studies, (2) a statement by the senior author certifying that use of
animals or animal tissues 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, and (3) 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.
Abstracts must be submitted by e-mail to niceatm@niehs.nih.gov. The
deadline for abstract submission is September 16, 2011. The
corresponding author will be notified regarding the abstract's
acceptance within 10 working days of the submission deadline.
Guidelines for poster presentations will be sent to the corresponding
authors.
Background Information on ICCVAM and NICEATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that require, use,
generate, or disseminate toxicological and safety testing information.
ICCVAM conducts technical evaluations of new, revised, and alternative
safety testing methods with regulatory applicability and promotes the
scientific validation and regulatory acceptance of toxicological and
safety testing methods that more accurately assess the safety and
hazards of chemicals and products and that reduce, refine (decrease or
eliminate pain and distress), or replace animal use. The ICCVAM
Authorization Act of 2000 (42 U.S.C. 285l-3) established ICCVAM as a
permanent interagency committee of the NIEHS under NICEATM. NICEATM
administers ICCVAM, provides scientific and operational support for
ICCVAM-related activities, and conducts independent validation studies
to assess the usefulness and limitations of new, revised, and
alternative test methods and strategies. NICEATM and ICCVAM welcome the
public nomination of new, revised, and alternative test methods and
strategies applicable to the needs of U.S. Federal agencies. Additional
information about ICCVAM and NICEATM can be found on the
[[Page 50223]]
NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov).
References
WHO. 2010. Rabies vaccines: WHO Position paper. Weekly
Epidemiological Record 85(32):309-320.
Dated: August 3, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-20540 Filed 8-11-11; 8:45 am]
BILLING CODE 4140-01-P
