[Federal Register Volume 69, Number 28 (Wednesday, February 11, 2004)]
[Notices]
[Pages 6674-6675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2931]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; Notice of a 
Meeting of the Scientific Advisory Committee on Alternative 
Toxicological Methods

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of 
the Scientific Advisory Committee on Alternative Toxicological Methods 
(SACATM) on March 10-11, 2004, in the Hyatt Regency Hotel, One Bethesda 
Metro Center, Bethesda, MD (301-657-1234 or 800-233-1234). The meeting 
begins each day at 8:30 a.m. The SACATM provides advise on the 
statutorily mandated duties of the Interagency Coordinating Committee 
on the Validation of Alternative Methods (ICCVAM) and the activities of 
the NTP Center for the Evaluation of Alternative Toxicological Methods 
(NICEATM).

Agenda

    The meeting is being held on March 10-11, 2004 from 8:30 a.m. until 
adjournment and is open to the public with attendance limited only by 
the space available. Individuals who plan to attend are asked to 
register with the NTP Executive Secretary (Dr. Kristina Thayer at the 
NTP Liaison and Scientific Review Office, NIEHS, P.O. Box 12233, 
Research Triangle Park, NC 27709; telephone: 919-541-5021; facsimile: 
919-541-0295; or E-mail: thayer.niehs.nih.gov).
    Persons needing special assistance, such as sign language 
interpretation or other reasonable accommodation in order to attend, 
are asked to notify the NTP Executive Secretary at least seven business 
days in advance of the meeting (see contact information above).
    A preliminary agenda is provided below. A copy of the agenda, 
committee roster, and any additional information, when available, will 
be posted on the NTP Web site (http://ntp-server.niehs.nih.gov) under 
``What's New'' or available upon request to the NTP Executive Secretary 
(contact information provided above). Additional information about 
SACATM is available through the NICEATM/ICCVAM Web site (http://iccvam.niehs.nih.gov) under ``Advisory Committee''. Following the 
meeting, summary minutes will be prepared and available at this Web 
site and upon request to the NTP Liaison and Scientific Review Office 
(contact information above). Information about NICEATM and ICCVAM 
activities can also be found at the NICEATM/ICCVAM Web site (http://iccvam.niehs.nih.gov) or by contacting the Director of NICEATM, Dr. 
William Stokes ( 919-541-2384, or e-mail: [email protected]).

Preliminary Agenda

Scientific Advisory Committee on Alternative Toxicological Methods--
March 10-11, 2004

    Hyatt Regency Hotel, 301-657-1234 or 800-233-1234, One Bethesda 
Metro Center, Bethesda, MD 20814.

March 10, 2004

8:30 a.m.
    1. Call to Order and Introductions
    2. Welcome and Remarks from NIEHS/NTP
    3. Welcome and Remarks from ICCVAM Chair
    4. Update on Activities of the NTP Center for the Evaluation of 
Alternative Toxicological Methods (NICEATM) and the Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM)
    5. Update on Activities of the European Centre for the Validation 
of Alternative Methods (ECVAM)
    6. Toxicology in the 21st Century: The Role of the National 
Toxicology Program
    a. Public Comment
    7. Update on Animal Use

[[Page 6675]]

12 p.m.
    Lunch Break (on your own)
1 p.m.
    8. ICCVAM Strategic Planning Process
    a. Public Comment
    9. ICCVAM Recommended Performance Standards for In Vitro Dermal 
Corrosivity Methods
    a. Public Comment
    10. Evaluation of the Predictivity of In Vivo Dermal Corrosivity 
Test Methods
    a. Public Comment
    11. Overview of ILSI/HESI Subcommittee's Activities on 
Identification of Biomarkers of Toxicity and Summary of First Meeting
    12. Validation of Genetically Modified Mouse Models
    a. Public Comment
5 p.m.
    Adjourn

March 11, 2004

8:30 a.m.
    1. Introductions and Call to Order
    2. ICCVAM-NICEATM-ECVAM Workshop on Validation of Toxicogenomics-
Based Test Systems
    a. Public Comment
    3. In Progress Test Method Evaluation Nomination: In Vitro Test 
Methods for Identifying Substances Causing Irreversible Ocular Damage
    4. New Test Method Nominations: EPA Test Method Nomination for Test 
Methods to Identify Negative, Mild, and Moderate Ocular Irritants (i.e. 
Those With Reversible or No Effect)
    a. Public Comment
11:30 p.m.
    Lunch (on your own)
12:30 p.m.
    New Test Method Nominations continued: In Vitro Vaccine Potency 
Tests for Veterinary Leptospira Vaccines
    a. Public Comment
    6. Report on the ECVAM Workshop on In Vitro Replacements for Acute 
Systemic Toxicity
    a. Public Comment
2:45 p.m.
    7. Other Issues
3:15 p.m.
    Adjourn

Public Comment Welcome

    Public input at this meeting is invited and time is set aside for 
the presentation of public comments on any agenda topic. Each 
organization is allowed one time slot per agenda topic. At least 7 
minutes will be allotted to each speaker, and if time permits, may be 
extended to 10 minutes. In order to facilitate planning for this 
meeting, persons wishing to make an oral presentation are asked to 
notify the NTP Executive Secretary (contact information above) by March 
1, 2004, and to provide their name, affiliation, mailing address, 
phone, fax, e-mail, and sponsoring organization (if any). Registration 
for oral comments will also be available on-site, although time allowed 
for presentation by on-site registrants may be less than that for pre-
registered speakers and will be determined by the number of persons who 
register at the meeting.
    Persons registering to make oral comments are asked, if possible, 
to provide a copy of their statement to the NTP Executive Secretary 
(contact information above) by March 1, 2004, to enable review by the 
SACATM and NIEHS/NTP staff prior to the meeting. Written statements can 
supplement and may expand the oral presentation. If registering on-site 
and reading from written text, please bring 40 copies of the statement 
for distribution to the SACATM and NIEHS/NTP staff and to supplement 
the record. Written comments received in response to this notice will 
be posted on the NTP Web site (http://ntp-server.niehs.nih.gov) under 
``What's New''.
    Persons may also submit written comments in lieu of making oral 
comments. Written comments should be sent to the NTP Executive 
Secretary and should be received by March 1, 2004, to enable review by 
the SACATM and NIEHS/NIH prior to the meeting. Persons submitting 
written comments should include their name, affiliation, mailing 
address, phone, fax, e-mail, and sponsoring organization (if any) with 
the document.

Background

    The SACATM was established January 9, 2002 to fulfill section 3(d) 
of Public Law 106-545, the ICCVAM Authorization Act of 2000 [42 U.S.C. 
285l-3(d)] and is composed of scientists from the public and private 
sectors (Federal Register: March 13, 2002: Vol. 67, No. 49, page 
11358). The SACATM provides advice to the Director of the National 
Institute of Environmental Health Sciences (NIEHS), the Interagency 
Coordinating Committee on the Validation of Alternative Toxicological 
Methods (ICCVAM), and the National Toxicology Program (NTP) Interagency 
Center for the Evaluation of Alternative Toxicological Methods 
(NICEATM) regarding statutorily mandated duties of the ICCVAM and 
activities of the NICEATM. The committee's charter is posted on the Web 
at http://iccvam.niehs.nih.gov under ``Advisory Committee'' and is 
available in hard copy upon request from the NTP Executive Secretary 
(contact information above).

    Dated: February 2, 2004.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-2931 Filed 2-10-04; 8:45 am]
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