[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 (http://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 (http://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