[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43827-43828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


International Workshop on Alternative Methods for Leptospira 
Vaccine Potency Testing: State of the Science and 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 Leptospira Vaccine Potency Testing: State of 
the Science and the Way Forward.'' This workshop, the second in a 
series of specialized vaccine workshops, will review recent advances 
and innovations in science and technology that can be applied to 
Leptospira vaccine potency testing. The goal is to promote development 
of innovative testing methods and approaches that may provide improved 
accuracy, efficiency, and worker safety and that are more humane and 
use fewer or no animals. The workshop will also address global 
acceptance and implementation of scientifically valid alternative 
methods.
    The workshop is open to the public at no charge with attendance 
limited only by the available space; however, advance registration is 
required (see DATES). NICEATM also invites submission of abstracts for 
scientific posters for display at the workshop (see SUPPLEMENTARY 
INFORMATION).

DATES: The workshop is scheduled for September 19-21, 2012. Sessions 
will begin at 1:00 p.m. CDT on September 19 and 8:00 a.m. on September 
20 and 21. Sessions will end at approximately 6:00 p.m. on September 19 
and 20 and at 1:00 p.m. on September 21. The deadline for registration 
is September 7, 2012. 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 August 
13, 2012.

ADDRESSES: The workshop will be held at the USDA Center for Veterinary 
Biologics at the 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 email: [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, (email) 
[email protected]. Courier address: NICEATM, NIEHS, Room 2034, 530 
Davis Drive Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:

Background

    Leptospirosis is an emerging and widespread bacterial zoonotic 
disease caused by spirochetes of the genus Leptospira. An estimated 
500,000 human cases of leptospirosis occur worldwide each year, with a 
fatality rate of up to 25% in some regions. Designated a Neglected 
Tropical Disease by the NIH and a Neglected Zoonotic Disease by the 
World Health Organization, leptospirosis is a global research and 
public health priority.
    Leptospirosis affects numerous animal species including livestock, 
pets, and wildlife. Vaccines have been developed for most susceptible 
livestock and domestic pet species and are widely used in the U.S. and 
other countries. Human Leptospira vaccines that protect against region-
specific serovars are also available for workers in high-risk 
professions in selected countries, although none are currently approved 
for use in the United States.
    Regulatory authorities require potency testing prior to release of 
each production lot of Leptospira vaccine to ensure that it will be 
effective. However, the current testing methods require the use of 
large numbers of laboratory animals that experience significant 
unrelieved pain and distress, accounting for over one-third of the 
animals reported to the USDA in this pain category. A recent 
international workshop, organized by NICEATM, the Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM), and their international partners, identified Leptospira 
vaccines as one of the three highest priorities for future research, 
development, and validation of alternative test methods that could 
further reduce, refine (enhance animal well-being and lessen or avoid 
pain and distress), or replace animal use for vaccine potency testing 
(Stokes et al., 2011). The USDA has developed and validated in vitro 
enzyme-linked immunosorbent assay (ELISA) antigen quantification 
methods for potency determination of vaccines for several Leptospira 
serovars (i.e., Leptospira interrogans serovars pomona, canicola, 
icterohaemorrhagiae, and Leptospira kirschneri serovar grippotyphosa 
[Kulpa-Eddy, 2012; USDA, 2009a, 2009b, 2009c, 2011]).
    This workshop, the second in a series of specialized vaccine 
workshops, will review recent advances and innovations in science and 
technology that can be applied to the development of new methods and 
approaches for Leptospira vaccine potency testing. These new methods 
and approaches may provide improved accuracy, efficiency, and worker 
safety, and would be more humane and use fewer or no animals. 
Participants will develop a strategy to achieve global acceptance and 
implementation of scientifically valid alternative methods.

[[Page 43828]]

    NICEATM and ICCVAM are organizing the workshop in collaboration 
with partner organizations in the International Cooperation on 
Alternative Test Methods (ICATM): the European Union Reference 
Laboratory for Alternatives to Animal Testing (EURL ECVAM), the 
Japanese Center for the Validation of Alternative Methods, the Korean 
Center for the Validation of Alternative Methods, and Health Canada. 
Cosponsors include EURL ECVAM, the Animal Health Institute, the 
International Alliance for Biological Standardization, and the USDA 
Center for Veterinary Biologics.

Preliminary Workshop Agenda and Registration

    Registration information, draft agenda, and additional meeting 
information are available on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/meetings/LeptoVaccWksp-2012/LeptoVaccWksp.htm) and 
upon request from NICEATM (see FOR FURTHER INFORMATION CONTACT).

Call for Abstract Submissions

    NICEATM and ICCVAM invite the submission of abstracts for 
scientific posters to be displayed during this workshop. Guidelines for 
the submission of abstracts are available at http://iccvam.niehs.nih.gov/meetings/LeptoVaccWksp-2012/LeptoWksp-AbstractSubmit-508.pdf. Abstracts must be submitted by email to 
[email protected]. The deadline for abstract submission is August 
13, 2012. The corresponding author will be notified regarding the 
abstract's acceptance within 7 working days of the submission deadline. 
Guidelines for poster presentations will be sent to the corresponding 
authors with notification of acceptances.

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. 
ICCVAM conducts technical evaluations of new, revised, and alternative 
safety testing methods and integrated testing strategies with 
regulatory applicability and promotes the scientific validation and 
regulatory acceptance of testing methods that more accurately assess 
the safety and hazards of chemicals and products and that reduce, 
refine, 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 NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).

References

    Kulpa-Eddy J. 2012. Successful Development and Validation of an 
In Vitro Replacement Assay for Leptospira Vaccine Potency Tests. In: 
Proceedings of an International Scientific Workshop on Potency 
Testing of Veterinary Vaccines for Animals: The Way from In Vivo to 
In Vitro; Langen, Germany; 1-3 December 2010 (Jungb[auml]ck, C, 
ed.). Basel: Karger.
    USDA. 2009a. SAM 624: Supplemental Assay Method for In Vitro 
Potency Testing of Leptospira interrogans Serovar pomona Bacterins. 
Washington, DC:USDA Animal and Plant Health Inspection Service. 
Available: http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    USDA. 2009b. SAM 625: Supplemental Assay Method for In Vitro 
Potency Testing of Leptospira interrogans Serovar canicola 
Bacterins. Washington, DC:USDA Animal and Plant Health Inspection 
Service. Available: http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    USDA. 2009c. SAM 627: Supplemental Assay Method for In Vitro 
Potency Testing of Leptospira interrogans Serovar 
icterohaemorrhagiaea Bacterins. Washington, DC:USDA Animal and Plant 
Health Inspection Service. Available: http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    USDA. 2011. SAM 626: Supplemental Assay Method for In Vitro 
Potency Testing of Leptospira kirschneri serogroup grippotyphosa 
Bacterins. Washington, DC:USDA Animal and Plant Health Inspection 
Service. Available: http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    Stokes WS, Kulpa-Eddy J, McFarland R. 2011. The International 
Workshop on Alternative Methods to Reduce, Refine, and Replace the 
Use of Animals in Vaccine Potency and Safety Testing: introduction 
and summary. In: 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 
(Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 1-
15.

    Dated: July 19, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-18294 Filed 7-25-12; 8:45 am]
BILLING CODE 4140-01-P