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, 47505-47506 [E6-13525]

Download as PDF Federal Register / Vol. 71, No. 159 / Thursday, August 17, 2006 / Notices Contact Person: Yvonne T. Maddox, PhD, Deputy Director, National Institute of Child Health and Human Development, NIH, 9000 Rockville Pike MSC 7510, Building 31, Room 2A03, Bethesda, MD 20892, (301) 496–1848. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: https:// www.nichd.nih.gov/about/nachhd.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: August 8, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–6965 Filed 8–16–06; 8:45 am] BILLING CODE 4140–01–M 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 National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Department of Health and Human Services. ACTION: Workshop announcement and data request. rwilkins on PROD1PC63 with NOTICES AGENCY: 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 VerDate Aug<31>2005 16:36 Aug 16, 2006 Jkt 208001 Refine, Reduce, or Replace the Mouse LD50 Assay for Botulinum Toxin Testing.’’ The workshop is being coorganized 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’’). 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 (https:// iccvam.niehs.nih.gov/methods/ biolodocs/biolowkshp/wkshpinfo.htm) and upon request from NICEATM (see ‘‘FOR FURTHER INFORMATION CONTACT’’ above). DATES: 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 email to niehsoeeo@niehs.nih.gov. 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) niceatm@niehs.nih.gov. ADDRESSES: 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-thescience for potential alternatives to the mouse LD50 assay for botulinum toxin potency testing. The HSUS nomination is available at https:// PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 47505 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-ofthe-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 12point 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 E:\FR\FM\17AUN1.SGM 17AUN1 47506 Federal Register / Vol. 71, No. 159 / Thursday, August 17, 2006 / Notices rwilkins on PROD1PC63 with NOTICES 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 email to niceatm@niehs.nih.gov. 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 https://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: VerDate Aug<31>2005 16:36 Aug 16, 2006 Jkt 208001 • 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 (https:// 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 https:// 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; A CaseControl Study of ACL Risk Factors. Date: August 16, 2006. Time: 11:30 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jo Pelham, BA, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4102, MSC 7814, Bethesda, MD 20892, (301) 435–1786, pelhamj@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Prognosis and Predictions of ACL Reconstruction. Date: August 21, 2006. Time: 11:30 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jo Pelham, BA, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4102, MSC 7814, Bethesda, MD 20892, (301) 435–1786, pelhamj@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Influenza Vaccine Development. Date: August 22, 2006. Time: 1 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\17AUN1.SGM 17AUN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 (https://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 niehsoeeo@niehs.nih.gov. 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) niceatm@niehs.nih.gov.

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 https://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 niceatm@niehs.nih.gov. 
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 https://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 (https://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 
https://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

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