[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50221-50223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20540]


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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.

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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: 
[email protected]. 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) 
[email protected]. 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 [email protected]. 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

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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