[Federal Register Volume 70, Number 54 (Tuesday, March 22, 2005)]
[Notices]
[Pages 14473-14474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program; National Toxicology Program (NTP) 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NICEATM); Request for Nominations for an Independent Peer 
Review Panel To Evaluate In Vitro Testing Methods for Estimating Acute 
Oral Systemic Toxicity and Request for In Vivo and In Vitro Data

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

ACTION: Request for nominations for an independent peer review panel 
and request for in vivo and in vitro data.

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SUMMARY: The NTP Interagency Center for Evaluation of Alternative 
Toxicological Methods (NICEATM) in collaboration with the Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM) is planning to convene an independent peer review panel 
(hereafter, Panel) to evaluate the validation status of two in vitro 
cytotoxicity assays for estimating in vivo acute oral toxicity. The 
Panel will evaluate the usefulness, limitations, accuracy, and 
reliability of these test methods for their intended purpose. NICEATM 
requests nominations of expert scientists for consideration as 
potential Panel members. ICCVAM will consider the conclusions and 
recommendations from the Panel in developing test method 
recommendations and performance standards for these test methods. Data 
from standard in vivo acute oral toxicity testing and in vitro 
cytotoxicity testing also is requested.

DATES: Nominations and data should be received by noon on May 6, 2005.

ADDRESSES: Nominations and data should be sent by mail, fax, or e-mail 
to Dr. William S. Stokes, Director of NICEATM, at NICEATM, NIEHS, P.O. 
Box 12233, MD EC-17, Research Triangle Park, NC 27709, (phone) 919-541-
2384, (fax) 919-541-0947, (e-mail) [email protected]. Courier 
address: NICEATM, 79 T.W. Alexander Drive,

[[Page 14474]]

Building 4401, Room 3128, Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: NICEATM, NIEHS, P.O. Box 12233, MD EC-
17, Research Triangle Park, NC 27709, (phone) 919-541-2384, (fax) 919-
541-0947, (e-mail) [email protected].

SUPPLEMENTARY INFORMATION:

Background

    NICEATM and the European Committee on the Validation of Alternative 
Methods (ECVAM) conducted a collaborative validation study to 
independently evaluate the usefulness of two in vitro basal 
cytotoxicity assays proposed for estimating in vivo rat acute oral 
toxicity. Neutral red uptake assays using both a mouse cell line (i.e., 
BALB/c 3T3 fibroblasts) and a primary human cell type (i.e., normal 
human epithelial keratinocytes) were evaluated in a multi-laboratory 
validation study. Cytotoxicity results are proposed for use in 
predicting starting doses for in vivo acute oral lethality assays, 
which may reduce the number of animals required for such 
determinations.
    NICEATM is preparing Background Review Documents on the two in 
vitro test methods that will contain comprehensive summaries of 
available data, an analysis of the accuracy and reliability of 
standardized test method protocols, and related information 
characterizing the current validation status of these assays. Once 
completed, the Background Review Documents will be provided to the 
Panel and made available to the public. Meeting information, including 
date and location, and public availability of the Background Review 
Documents will be announced in a future Federal Register notice and 
posted on the ICCVAM/NICEATM Web site (http://iccvam.niehs.nih.gov).

Request for the Nomination of Scientists for the Peer Review Panel

    NICEATM invites nominations of scientists with relevant knowledge 
and experience to serve on the Panel. Areas of relevant expertise 
include, but are not limited to: physiology and pharmacology, acute 
systemic toxicity testing in animals, evaluation and treatment of acute 
toxicity in humans, development and use of in vitro methodologies, 
biostatistical data analysis, knowledge of chemical data sets useful 
for validation of acute toxicity studies, and hazard classification of 
chemicals and products. Each nomination should include the person's 
name, affiliation, contact information (i.e. mailing address, e-mail 
address, telephone and fax numbers), and a brief summary of relevant 
experience and qualifications. Nominations should be sent to NICEATM by 
mail, fax, or e-mail within 45 days of the publication of this notice. 
Correspondence should be directed to Dr. William Stokes, Director, 
NICEATM, at the address given above.

Request for Data

    NICEATM invites the submission of data from standard in vivo acute 
oral toxicity testing and in vitro cytotoxicity testing. Two previous 
requests for existing in vivo and in vitro acute toxicity data have 
been made (Federal Register, Vol. 69, No. 201, pp. 61504-5, October 19, 
2004 and Vol. 65, No. 115, pp. 37400-3, June 14, 2000). In vivo and in 
vitro acute toxicity testing data for chemicals or products should be 
sent to NICEATM by mail, fax, or e-mail to the address given above. 
Data submitted by the deadline listed in this notice will be considered 
during an evaluation of the validation status of the two cytotoxicity 
methods, anticipated in late 2005; however, data will be accepted at 
any time. Chemical and protocol information/test data submitted in 
response to this notice may be incorporated in future NICEATM and 
ICCVAM reports and publications as appropriate.
    When submitting chemical and protocol information/test data, please 
reference this Federal Register notice and provide appropriate contact 
information (name, affiliation, mailing address, phone, fax, e-mail, 
and sponsoring organization, as applicable).
    NICEATM prefers data to be submitted as copies of pages from study 
notebooks and/or study reports, if available. Raw data and analyses 
available in electronic format may also be submitted. Each submission 
for a chemical should preferably include the following information, as 
appropriate:
     Common and trade name.
     Chemical Abstracts Service Registry Number (CASRN).
     Chemical class.
     Product class.
     Commercial source.
     In vitro basal cytotoxicity test protocol used.
     In vitro cytotoxicity test results.
     In vivo acute oral toxicity test protocol used.
     Individual animal responses at each observation time (if 
available).
     The extent to which the study complied with national or 
international Good Laboratory Practice (GLP) guidelines.
     Date and testing organization.
    Those persons submitting data on chemicals tested for in vitro 
basal cytotoxicity are referred to the standard test-reporting template 
recommended for the High Production Volume (HPV) program at http://www.epa.gov/chemrtk/toxprtow.htm or at http://iccvam.niehs.nih.gov/methods/invitro.htm. In vivo data for the same chemicals should be 
reported as recommended in the test reporting section of the current 
Environmental Protection Agency (EPA) guideline for acute oral toxicity 
(EPA, 2002).
    Submitted data will be used to further evaluate the usefulness and 
limitations of in vitro cytotoxicity data for estimating acute oral 
toxicity and will be included in a database to support the 
investigation of other test methods necessary to improve the accuracy 
of in vitro assessments of acute systemic toxicity.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use or generate 
toxicological information. ICCVAM conducts technical evaluations of 
new, revised, and alternative methods with regulatory applicability and 
promotes the scientific validation and regulatory acceptance of 
toxicological test methods that more accurately assess the safety and 
hazards of chemicals and products and that refine, reduce, and replace 
animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106-545, 
available at http://iccvam.niehs.nih.gov/about/PL106545.htm) 
establishes ICCVAM as a permanent interagency committee of the NIEHS 
under the NICEATM. NICEATM administers the ICCVAM and provides 
scientific and operational support for ICCVAM-related activities. 
NICEATM and ICCVAM work collaboratively to evaluate new and improved 
test methods applicable to the needs of Federal agencies. Additional 
information about ICCVAM and NICEATM can be found at the following Web 
site: http://iccvam.niehs.nih.gov.

    Dated: March 11, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-5564 Filed 3-21-05; 8:45 am]
BILLING CODE 4140-01-P