[Federal Register Volume 68, Number 136 (Wednesday, July 16, 2003)]
[Notices]
[Pages 42066-42067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


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 August 12-13, 2003, in the Rodbell Auditorium, Rall 
Building at the National Institute of Environmental Health Sciences, 
Research Triangle Park, NC. The meeting begins each day at 8:30 a.m.

Agenda

    The meeting is being held on August 12-13, 2003 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 (NTP Liaison and 
Scientific Review Office, NIEHS, P.O. Box 12233, Research Triangle 
Park, NC 27709; telephone: 919-541-0530; facsimile: 919-541-0295 or 
wolfe.niehs.nih.gov). The names of those registered will be given to 
the NIEHS Security Office in order to gain access to the campus. 
Persons attending who have not pre-registered may be asked to provide 
pertinent information about the meeting, i.e., title or host of meeting 
before gaining access to the campus. All visitors (whether or not you 
are pre-registered) will need to be prepared to show 2 forms of 
identification (ID, e.g., driver's license, government ID).
    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). Plans 
are underway for making this meeting available for viewing on the 
Internet (http://www.niehs.nih.gov/external/video.htm).
    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) or 
available upon request to the NTP Executive Secretary (contact 
information provided above). Following the meeting, summary minutes 
will be prepared and available through the NICEATM/ICCVAM Web site 
(http://iccvam.niehs.nih.gov) and upon request to the NTP Liaison and 
Scientific Review Office (contact information above).

Preliminary Agenda

Scientific Advisory Committee on Alternative Toxicological Methods 
August 12-13, 2003

Rodbell Auditorium, Rall Building, National Institute of Environmental 
Health Sciences (NIEHS), Research Triangle Park, NC 27709

August 12, 2003
8:30 a.m.--Call to Order and Introductions
    Welcome from the NIEHS Director
    National Toxicology Program Update
    Update on Activities of the NTP Center for the Evaluation of 
Alternative Toxicological Methods and the Interagency Coordinating 
Committee on the Validation of Alternative Methods
    Update on Activities of the European Centre for the Validation of 
Alternative Methods
    U.S. Federal Agency Efforts in Test Method Development and 
Validation
    [sbull] Environmental Protection Agency
    [sbull] National Center for Toxicological Research of the Food and 
Drug Administration
11:50 a.m.--Lunch Break (on your own)
1 p.m.
    [sbull] U.S. Department of Agriculture
    [sbull] National Institutes of Health, Office of the Director
    [sbull] National Cancer Institute
    [sbull] National Institute of Environmental Health Sciences and the 
NTP
    Public Comments
5 p.m.--Adjourn
August 13, 2003
8:30 a.m.--Introductions and Call to Order

[[Page 42067]]

    Application of GLPs to In Vitro Test Methods
    [sbull] ICCVAM/ECVAM Proposal for Development of International 
Guidance
    [sbull] ECVAM Guidelines for Good Cell Culture Practices
    [sbull] Public Comments
    Minimum Performance Standards for Test Methods
    [sbull] MPS for In Vitro Corrosivity Methods
    [sbull] Public Comments
    In Vitro Endocrine Binding and Transcriptional Activation Assays: 
Minimum Procedural Standards and Reference Chemicals
    [sbull] Public Comments
12:05 p.m.--Lunch (on your own)
1 p.m.--Overview of ILSI/HESI Work Group's Activities on Identification 
of Biomarkers of Toxicity and Summary of First Meeting
    Validation of Genetically Modified Mouse Models
    [sbull] Public Comments
2:45 p.m.--Adjourn

Public Comment Welcome

    [sbull] 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 
August 4, 2003, 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 then 
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 August 4, 2003, 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).
    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 August 4, 2003, 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 chartered 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 and is available in hard copy upon 
request from the NTP Executive Secretary (contact information above).

    Dated: July 9, 2003.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 03-18012 Filed 7-15-03; 8:45 am]
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