[Federal Register: July 16, 2003 (Volume 68, Number 136)]
[Notices]
[Page 42066-42067]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy03-102]
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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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