[Federal Register Volume 71, Number 132 (Tuesday, July 11, 2006)]
[Notices]
[Pages 39121-39122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP), Liaison and Scientific Review 
Office; Meeting of the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM)

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH), HHS.

ACTION: Meeting announcement and request for comment.

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SUMMARY: 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 
teleconference meeting of the SACATM on August 3, 2006. The 
teleconference is scheduled from 1 p.m. to 4 p.m. and is open to the 
public. At the teleconference, SACATM will discuss the conclusions of a 
peer review panel that met on May 23, 2006 to evaluate the validation 
status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral 
red uptake (NRU) basal cytotoxicity test methods (see ``Background'' 
for more detail). The public is invited to participate in the 
teleconference and will be provided with an opportunity to make oral 
comments during the public comment period. Participation is limited 
only by the number of phone lines available.

DATES: In order to facilitate planning for this meeting, persons 
wishing to make an oral presentation are asked to notify Dr. Kristina 
Thayer via phone or e-mail by July 25, 2006, (see ADDRESSES below). 
Please note that a request for written comments on the peer review 
report is being announced in a separate Federal Register notice 
(available at http://ntp.niehs.nih.gov/go/frn).

ADDRESSES: Correspondence should be directed to Dr. Kristina Thayer, 
Executive Secretary for SACATM (NTP Liaison and Scientific Review 
Office, NIEHS, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 
27709; telephone: 919-541-5021, fax: 919-541-0295; or e-mail: 
[email protected]). Persons needing special assistance to 
participate should contact 919-541-2475 voice, 919-541-4644 TTY (text 
telephone), through the Federal TTY Relay System at 800-877-8339, or by 
e-mail to [email protected]. Requests should be made at least 7 
days in advance of the event.

SUPPLEMENTARY INFORMATION: 

Background

    The National Toxicology Program (NTP) Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM), in 
collaboration with the Interagency Coordinating Committee on the 
Validation of Alternative Methods (ICCVAM), organized an independent, 
scientific peer review meeting on May 23, 2006, to evaluate the 
validation status of the in vitro 3T3 and normal human keratinocyte 
(NHK) neutral red uptake (NRU) basal cytotoxicity test methods. These 
two in vitro cytotoxicity test methods are proposed as adjuncts (for 
the purpose of determining the starting dose) to in vivo acute oral 
toxicity tests. The peer review panel prepared a report that contains 
(1) a summary of the peer review evaluation and (2) the peer review 
panel's conclusions on the draft ICCVAM test method recommendations 
regarding the proposed usefulness, limitations, and validation status 
of the 3T3 and NHK cytotoxicity test methods. The availability of the 
report, entitled Peer Review Panel Evaluation of the Use of In Vitro 
Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute 
Oral Systemic Toxicity Testing, and a request for written public 
comments on the peer review panel's conclusions regarding the draft 
ICCVAM test method recommendations are announced in a separate Federal 
Register notice (available at http://ntp.niehs.nih.gov/go/frn). Copies 
of the report may be obtained on the ICCVAM/NICEATM Web site at http://iccvam.niehs.nih.gov or by contacting the Dr. Kristina Thayer (see 
ADDRESSES above).
    At the teleconference, SACATM will discuss peer review panel's 
report, focusing on the panel's conclusions regarding the draft ICCVAM 
recommendations for the proposed use of these test methods, draft test 
method protocols, draft performance standards, and draft recommended 
future studies. ICCVAM will consider the peer review report, SACATM 
comments, and any written public comments received on that report as it 
prepares final ICCVAM recommendations for the two in vitro basal 
cytotoxicity test methods. An ICCVAM test method evaluation report, 
which will include the final ICCVAM recommendations, will be forwarded 
to the appropriate federal agencies for their consideration and made 
available to the public.

Request for Comments

    Public input at the SACATM teleconference is invited and time is 
set aside for the presentation of public

[[Page 39122]]

comments. Each organization is allowed one time slot per public comment 
period. At least 7 minutes will be allotted to each speaker, and if 
time permits, may be extended to 10 minutes. Persons registering to 
make oral comments are asked, if possible, to send a copy of their 
statement to Dr. Kristina Thayer by July 25, 2006, to enable review by 
SACATM and NTP staff prior to the meeting. Please not that this 
teleconference provides an additional opportunity for the public to 
provide comment on the peer review panel's conclusions regarding the 
draft ICCVAM test method recommendations. Written comments submitted to 
NICEATM in response to a NICEATM notice published in this issue of the 
Federal Register do not need to be resubmitted. Any written comments on 
the peer review report received prior to July 25, 2006, will be 
distributed to SACATM.

Background Information on ICCVAM, NICEATM, and SACATM

    The SACATM was established January 9, 2002, to fulfill section 3(d) 
of 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 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 http://ntp.niehs.nih.gov/go/167. Information about NICEATM and ICCVAM 
activities can be found at the NICEATM/ICCVAM Web site (http://iccvam.niehs.nih.gov) or by contacting the Director of NICEATM, Dr. 
William Stokes (telephone: 919-541-2384, or e-mail: 
[email protected]).

    Dated: June 30, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E6-10790 Filed 7-10-06; 8:45 am]
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