[Federal Register Volume 75, Number 89 (Monday, May 10, 2010)]
[Notices]
[Pages 25867-25869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10958]


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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.

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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 
<a href="/cdn-cgi/l/email-protection#ea84838f8299858f8f85aa84838f8299c4848382c48d859c"><span class="__cf_email__" data-cfemail="9ef0f7fbf6edf1fbfbf1def0f7fbf6edb0f0f7f6b0f9f1e8">[email protected]</span></a>. 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) <a href="/cdn-cgi/l/email-protection#3f51565c5a5e4b527f51565a574c1151565711585049"><span class="__cf_email__" data-cfemail="1d73747e787c69705d737478756e33737475337a726b">[email protected]</span></a>.

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

    <bullet> Welcome and Introduction of Workshop Goals and Objectives
    <bullet> Overview of Public Health Needs and Regulatory 
Requirements for Vaccine Safety and Potency Testing
    <bullet> Replacement Methods for Vaccine Potency Testing: Current 
State of the Science
    <bullet> Breakout Groups: Non-animal Replacement Methods for 
Vaccine Potency Testing
    <bullet> Human Vaccines
    <bullet> Veterinary Vaccines

Day 2 Wednesday, September 15, 2010

    <bullet> Refinement Alternatives: Using Serological Methods to 
Avoid Challenge Testing
    <bullet> Refinement Alternatives: Using Earlier Humane Endpoints to 
Avoid or Minimize Animal Pain and Distress in Vaccine Potency Challenge 
Testing
    <bullet> Reduction Alternatives: Strategies to Further Reduce 
Animal Numbers for Vaccine Potency Testing
    <bullet> Breakout Groups: Refinement and Reduction of Animal Use 
for Vaccine Potency Testing
     <bullet> Human Vaccines
     <bullet> Veterinary Vaccines

Day 3 Thursday, September 16, 2010

    <bullet> Vaccine Post-licensing Safety Testing: Reduction, 
Refinement and Replacement Methods and Strategies
    <bullet> Breakout Groups: Post-license Vaccine Safety Testing: 
Alternative Strategies for the Replacement, Refinement, and Reduction 
of Animals
     <bullet> Human Vaccines
     <bullet> Veterinary Vaccines
    <bullet> Closing Comments

Registration

    Registration information, tentative agenda, and additional meeting 
information are available on the workshop Web site (http://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 <a href="/cdn-cgi/l/email-protection#127c7b717773667f527c7b777a613c7c7b7a3c757d64"><span class="__cf_email__" data-cfemail="c5abaca6a0a4b1a885abaca0adb6ebabacadeba2aab3">[email protected]</span></a>. 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

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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 http://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 http://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


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