[Federal Register Volume 65, Number 32 (Wednesday, February 16, 2000)]
[Notices]
[Pages 7878-7879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Meeting of the 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 National Toxicological Program (NTP) Advisory Committee on 
Alternative Toxicological Methods, U.S. Public Health Service. The 
meeting will be held from 1:00 p.m. to 5:00 p.m. on March 7, 2000 and 
from 8:45 a.m. to 4:15 p.m. on March 8, 2000 in the Conference Center, 
Building 101, South Campus, NIEHS, 111 Alexander Drive, Research 
Triangle Park, North Carolina, 27709. The entire meeting is open to the 
public and time is planned for persons who would like to make public 
comments. Preregistration is not required and attendance is limited 
only by the space available. Individuals who plan to attend and need 
special assistance, such as sign language interpretation or other 
reasonable accommodations are asked to notify the contact person listed 
below in advance of the meeting.

Background

    Under authority of 42 U.S.C. 217a, Section 222 of the Public Health 
Service Act, as amended, the Department of Health and Human Services 
has established an Advisory Committee on Alternative Toxicological 
Methods. The Committee functions to provide advice on the activities 
and priorities of the National Toxicological Program (NTP) Interagency 
Center for the Evaluation of Alternative Toxicological Methods (Center) 
and the Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and to provide advice on ways to foster 
partnership activities and productive interactions among all 
stakeholders. The Advisory Committee is composed of knowledgeable 
representatives drawn from academia, industry, public interest 
organizations, other state and Federal agencies, and the international 
community.
    The NTP established the Center and ICCVAM to fulfill specific 
mandates provides to the National Institutes of Environmental Health 
Sciences (NIEHS) by Public Law 103-43, Section 1301. The NIEHS was 
directed to (1) develop and validate toxicological testing methods 
including alternative methods that can reduce or eliminate the use of 
animals in acute or chronic toxicity testing, (2) establish criteria 
for the validation and regulatory acceptance of alternative testing 
methods, and (3) recommend a process through which scientifically 
validated alternative methods can be accepted for regulatory use. 
Criteria and processes for validation and regulatory acceptance were 
developed in conjunction with 14 other Federal agencies and programs 
with broad input from the public. These are described in the document 
Validation and Regulatory Acceptance of Toxicological Test Methods: A 
Report of the Ad Hoc Interagency Coordinating Committee on the 
Validation of Alternative Methods NIH Publication No. 97-3981, March 
1997, that is available on the internet at http://ntp-server.niehs.nih.gov/htdocs/ICCVAM/iccvam.html or by request to the 
Center at the address provided below.
    As a standing committee, ICCVAM was subsequently established as a 
collaborative effort by the NIEHS and 13 Federal regulatory and 
research agencies and programs. The ICCVAM provides cross-agency 
coordination and communications on issues relating to validation, 
acceptance, and national/international harmonization of toxicological 
test methods. The ICCVAM works with the Center to carry out the 
scientific review of proposed methods of multi-agency interest and 
provides recommendations regarding their usefulness to appropriate 
agencies. The ICCVAM also provides a mechanism for interagency 
communication with stakeholders throughout the process of test method 
development and validation. The following Federal regulatory and 
research agencies and organizations are participating in this effort:

Consumer Product Safety Commission
Department of Defense
Department of Energy
Department of Health and Human Services
    Agency for Toxic Substances and Disease Registry
    Food and Drug Administration
    National Institute for Occupational Safety and Health/Centers for 
Disease Control and Prevention
    National Institutes of Health
    Nationl Cancer Institute
    National Institute of Environmental Health Sciences
    National Library of Medicine
Department of the Interior
Department of Labor
    Occupational Safety and Health Administration
Department of Transportation
    Research and Special Programs Administration
Environmental Protection Agency

    The Center was established to provide operational support for the 
ICCVAM and to assist Federal agencies by coordinating and facilitating 
(1) the interagency review and adoption of toxicolical test methods of 
multi-agency interest and (2) the participation and communication with 
other stakeholders throughout the process of test method development 
and validation. The Center organizes, in collaboration with ICCVAM, 
independent scientific peer reviews and workshops for test methods of 
interest to Federal agencies. Peer review panels are convened to 
develop scientific consensus on the usefulness of test methods and to 
generate information for specific human health and/or ecological risk 
assessment purposes. Expert workshops and panel meetings are convened 
to evaluate the adequacy of current test methods for assessing specific 
toxicities, to identify areas in need of improved or new methods, to 
evaluate proposed validation studies, to evaluate the status of methods 
at various stages of validation, and to develop recommendations and 
priorities for related test method research, development, and 
validation. The Center provides an opportunity for partnerships with 
other agencies and organizations to facilitate the development, 
validation, and review of alternative testing methods. The Center and 
ICCVAM seek to promote the scientific validation and regulatory 
acceptance of toxicological test methods that will enhance agencies' 
ability to assist risks and make decisions and that

[[Page 7879]]

will refine, reduce, and replace animal use whenever possible. The 
Center's office is located at the NIEHS and can be contacted by 
telephone: 919-541-3398, FAX: 919-541-0947, or email: 
[email protected].

Agenda

    The agenda for the March 7th session will consist of presentations 
and discussions about new emerging technologies that are being 
developed and their potential usefulness in toxicological assessments. 
The Committee will also discuss issues and recommendations relevant to 
the validation of new and revised test methods that may incorporate 
these technologies. On March 8, the Committee will hear presentations 
and discuss issues relating to processes, priorities, and recent and 
proposed activities of the NTP Center and ICCVAM. The revised 
publication, Evaluation of the Validation Status of Toxicological 
Methods: General Guidelines for Submissions to ICCVAM (revised October 
20, 1999), is available on the internet at http://iccvam.niehs.nih.gov/doc1.htm.

Tentative Agenda

National Toxicology Program Advisory Committee on Alternative 
Toxicological Methods

Conference Center, Building 101, South Campus, NIEHS, 111 Alexander 
Drive, Research Triangle Park, North Carolina, 27709

Tuesday, March 7

1:00 p.m.  Call to Order and Introductions
1:05 p.m.  Welcome

Application of Emerging Technologies to Toxicology Testing: Gene 
Expression Assays

1:10 p.m. Introduction and Overview of Gene Expression Assays and 
Microarray Technology; Application of Gene Expression Patterns to In 
Vitro and In Vivo Toxicological Assessments
     Discussion (15')
2:05 p.m. Application of Gene Expression Technology to Drug Development
     Discussion (10')
2:45 p.m. Break
3:00 p.m. Real Time and Quantitive PCR
     Discussion (10')
3:30 Proteomics
     Discussion (10')
4:00 p.m. Bioinformatics
     Discussion (10')
4:30 p.m.  Committee Discussion: Validation Issues for New Technologies
5:00 p.m.  Public Comments

Wednesday March 8, 2000

8:45 a.m.  Call to Order and Introductions
8:55 a.m. Welcome from the NTP
9:05 a.m. Update on NTP Center and ICCVAM Activities
     Discussion (25')
10:00 a.m. Break
10:15 a.m. Regulatory Acceptance Status of ICCVAM Recommended Methods:
      EPA
      FDA
      OSHA
      CPSC
11:00 a.m. Summary of Revisions to ICCVAM Test Methods Submission 
Guidelines
11:30 a.m. Committee Discussion/Recommendations on Submission 
Guidelines
12:00 p.m. Public Comments
12:15 p.m. Lunch Break

Development and Validation of New Test Methods

1:15 p.m. Introduction to Session
1:25 p.m. Current ICCVAM/NICEATM Role in Test Method Development and 
Validation
      Discussion (15')
1:55 p.m.  Current NIEHS External Activities for Support of Test 
Method/Model Development and Validation
2:40 p.m.  Break
3:00 p.m.  Open Discussion: Future Directions
4:00 p.m.  Public Comments
4:15 p.m.  Adjourn

    A detail agenda with meeting schedule and the Committee roster will 
be available prior to the meeting on the NTP web site (http://ntp-server.niehs.nih.gov) and by contacting the NTP Executive Secretary, 
Environmental Toxicology Program, P.O. Box 12233, A3-07, NIEHS, 
Research Triangle Park, North Carolina 27709, telephone: 919-541-3971 
and FAX: 919-541-0295. Summary minutes will also be available 
subsequent to the meeting by contacting the address above.

Solicitation of Public Comment

    The Advisory Committee on Alternative Toxicological Methods meeting 
is open to the public, and time is reserved on both days for any 
interested member of the public to give oral comments on the 
activities, directions, or priorities of the Center and/or on any of 
the agenda items discussed at the meeting. In order to facilitate 
planning for the meeting, persons wishing to make an oral presentation 
are asked to notify the Executive Secretary prior to the meeting at the 
address given above; however, registration for public comments will 
also be available on-site at the meeting. A person registering to make 
comments will be asked to provide his/her name, affiliation, mailing 
address, phone, fax, e-mail and supporting organization (if any).
    Written comments can accompany or be provided in lieu of making 
oral comments. All comments must include name, affiliation, mailing 
address, phone, fax, e-mail and sponsoring organization (if any) and 
should be sent to the Executive Secretary at the address given above.

    Dated: February 7, 2000.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 00-3590 Filed 2-15-00; 8:45 am]
BILLING CODE 4140-01-M