[Federal Register Volume 71, Number 159 (Thursday, August 17, 2006)]
[Notices]
[Pages 47505-47506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP), NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM): Scientific 
Workshop on Alternative Methods To Refine, Reduce, or Replace the Mouse 
LD50 Assay for Botulinum Toxin Testing; Request for In Vivo and In 
Vitro Data

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH), Department of Health and Human 
Services.

ACTION: Workshop announcement and data request.

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SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and NICEATM announce an upcoming ``ICCVAM/
NICEATM/ECVAM Scientific Workshop on Alternative Methods to Refine, 
Reduce, or Replace the Mouse LD50 Assay for Botulinum Toxin 
Testing.'' The workshop is being co-organized by ICCVAM, NICEATM, and 
the European Centre for the Validation of Alternative Methods (ECVAM). 
This workshop is open to the public with attendance limited only by the 
space available. ICCVAM and NICEATM also invite the submission of (1) 
data from botulinum toxin test methods and (2) abstracts for scientific 
posters for display at the workshop (discussed more under 
``Supplemental Information'').

DATES: The workshop will be held on November 13 and 14, 2006. Sessions 
for both days will begin at approximately 8:30 a.m. and end at 
approximately 5 p.m. The deadline for submission of an abstract is 
September 29, 2006. The deadline for submission of data is October 20, 
2006.
    Individuals who plan to attend the workshop are strongly encouraged 
to register in advance (by October 30, 2006) with NICEATM. Registration 
information, an agenda, and additional information will be available on 
the workshop Web site (http://iccvam.niehs.nih.gov/methods/biolodocs/biolowkshp/wkshpinfo.htm) and upon request from NICEATM (see ``FOR 
FURTHER INFORMATION CONTACT'' above).

ADDRESSES: The workshop will be held at the Crowne Plaza Hotel, 8777 
Georgia Avenue, Silver Spring, MD 20910. 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 [email protected]. Requests should 
be made at least 7 days in advance of the event.

FOR FURTHER INFORMATION CONTACT: Correspondence should be addressed to 
Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box 12233, MD EC-
17, Research Triangle Park, NC 27709, (phone) 919-541-2384, (fax) 919-
541-0947, (e-mail) [email protected].

SUPPLEMENTARY INFORMATION: 

Background

    In October 2005, the Humane Society of the United States (HSUS) 
submitted a nomination to NICEATM to organize a workshop to evaluate 
the state-of-the-science for potential alternatives to the mouse 
LD50 assay for botulinum toxin potency testing. The HSUS 
nomination is available at http://iccvam.niehs.nih.gov. See 
``Nominations and Submissions.'' ICCVAM considered the nomination and 
supported, with a high priority, the concept of a workshop to discuss 
alternative methods and approaches that might reduce, refine, or 
replace the use of animals for botulinum toxin potency testing. The 
Scientific Advisory Committee on Alternative Toxicological Methods 
(SACATM) discussed this nomination at its meeting on December 12, 2005, 
and concurred with ICCVAM. The goals of the workshop are to (1) review 
the state-of-the-science and current status of alternative methods that 
may refine (less pain and distress), reduce, or replace the use of mice 
for botulinum toxin testing and (2) identify priorities for research, 
development, and validation efforts needed to advance the use of 
alternative methods for botulinum toxicity testing.

Preliminary Workshop Agenda

Day 1 Monday, November 13, 2006

     Welcome and Introduction of Workshop Goals and Objectives.
     Session 1 Overview of Public Health Needs for Botulinum 
Toxin Testing and Regulatory Requirements.
     Session 2 Current Understanding and Knowledge Gaps for 
Botulinum Toxin.
     Session 3 Potential Replacement of Animal Use for 
Botulinum Toxin Potency Testing.

Day 2 Tuesday, November 14, 2006

     Session 4 Refinement (Less Pain and Distress) of Animal 
Use for Botulinum Toxin Potency Testing.
     Session 5 Reduction of Animal Use For In Vivo Botulinum 
Testing.
     Session 6 Wrap-up of Panel Discussions.

Call for Abstracts

    ICCVAM and NICEATM invite the submission of abstracts for 
scientific posters to be displayed during the workshop. Posters should 
address current developments and/or the validation status of 
alternative test methods for in vivo botulinum toxin tests and their 
potential to reduce, refine, or replace the use of the mouse 
LD50 assay. The body of the abstract is limited to 400 words 
or less and 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 in at 
least 12-point font and all margins for the document should be no 
smaller than one inch. Title information should include the names of 
all authors and their affiliations. The name and contact

[[Page 47506]]

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 from the senior author certifying that 
all animal use was carried out in accordance with applicable laws, 
regulations, and guidelines, and that the appropriate Institutional 
Animal Care and Use Committee approved the studies. All abstracts that 
involve studies using humans should be accompanied by a statement from 
the senior author certifying that all human use was conducted in 
accordance with applicable laws, regulations, and guidelines, and that 
the appropriate Institutional Review Board approved the studies.
    Abstracts should be submitted by e-mail to [email protected]. 
The deadline for abstract submission is close of business on September 
29, 2006. ICCVAM and NICEATM will review the submitted abstracts. The 
corresponding author will be notified of the abstract's acceptance, 
along with guidelines for the poster format, approximately five weeks 
prior to the workshop.

Request for Data

    NICEATM invites the submission of data and information from in vivo 
botulinum toxin testing and ex vivo and in vitro test methods being 
used or evaluated as potential alternatives to the mouse assay for 
botulinum toxin testing. The deadline for data submission is October 
20, 2006. These data will be provided to the workshop participants and 
workshop panels for their review and consideration during workshop 
discussions. A similar request for data was announced previously 
(Federal Register, Vol. 71, No. 18, pp. 4603-4604, January 27, 2006, 
available at http://iccvam.niehs.nih.gov/).
    When submitting chemical and protocol information/test data, please 
reference this Federal Register notice and provide appropriate contact 
information (name, affiliation, mailing address, phone, fax, e-mail, 
and sponsoring organization, as applicable). NICEATM prefers data to be 
submitted as copies of pages from study notebooks and/or study reports, 
if available. Raw data and analyses available in electronic format may 
also be submitted. Each submission should preferably include the 
following information, as appropriate:
     Specific type of botulinum neurotoxin tested (e.g., 
Clostridium botulinum neurotoxin type A).
     In vivo potency test protocol used and test results.
     Individual animal responses, including time of onset of 
specific clinical signs and death.
     Alternative ex vivo or in vitro test protocol used and 
test results.
     The extent to which the study complied with national or 
international Good Laboratory Practice guidelines.
     Date of the study.
     The organization that conducted the study

Background Information on ICCVAM, NICEATM, and SACATM

    ICCVAM is an interagency committee composed of representatives from 
15 U.S. Federal regulatory and research agencies that 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 that more accurately assess the safety and 
hazards of chemicals and products and that refine, reduce, or replace 
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 2851-2, 
2851-5 [2000]) established ICCVAM as a permanent interagency committee 
of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides 
scientific and operational support for ICCVAM-related activities. 
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 can be found at the 
ICCVAM-NICEATM Web site (http://iccvam.niehs.nih.gov).
    SACATM provides external advice to the Director of the NIEHS, 
ICCVAM, and NICEATM regarding statutorily mandated duties of ICCVAM and 
activities of NICEATM. Additional information about SACATM, including 
the charter, roster, and records of past meetings can be found at 
http://ntp.niehs.nih.gov/go/167.

    Dated: August 7, 2006.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and 
National Toxicology Program.
 [FR Doc. E6-13525 Filed 8-16-06; 8:45 am]
BILLING CODE 4140-01-P