[Federal Register Volume 63, Number 144 (Tuesday, July 28, 1998)]
[Notices]
[Page 40303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences; National 
Toxicology Program; Request for Comments on Test Methods Undergoing 
Review by the Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and the National Toxicology Program 
Interagency Center for the Evaluation of Alternative Methods

Background

    The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM), with participation by 14 Federal 
regulatory and research agencies and programs, was established in 1997 
to facilitate cross-agency communication and coordination on issues 
relating to validation, acceptance, and national/international 
harmonization of toxicological test methods. The Committee seeks to 
promote the scientific validation and regulatory acceptance of 
toxicological test methods that will enhance agencies's ability to 
assess risks and make decision, and that will refine, reduce, and 
replace animal use whenever possible. The National Toxicology Program 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (Center), in collaboration with ICCVAM, carries out related 
activities such as independent 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 to generate information for specific human heath and/or 
ecological risk assessment purposes. Expert workshops are convened as 
needed to evaluate the adequacy of current methods for assessing 
specific toxicities, to identify areas in need of improved or new 
methods, to evaluate proposed validation studies, and to evaluate the 
validation status of methods. Following the peer review of proposed 
test methods, the ICCVAM forwards recommendations regarding their 
usefulness to appropriate agencies for their consideration. Federal 
agencies then determine the regulatory acceptability of a method 
according to their mandates.
    Additional information on the activities and functions of the 
ICCVAM can be found in the publication: Validation on Regulatory 
Acceptance of Toxicological Test Methods, a Report of the ad hoc 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (NIH Publication 97-3981, March 1997). This report was prepared 
in response to the National Institutes of Health (NIH) Revitalization 
Act of 1993 (Pub. L. 103-43), which required the NIEHS to develop 
criteria and recommended processes for the validation and regulatory 
acceptance of alternative toxicological test methods. The report is 
available on the internet at http://ntp-server.niehs.nih.gov/htdocs/
ICCVAM/ICCVAM html, or may be requested from the NTP Center address 
listed below.

Request for Comments

    Interested parties are encouraged to submit information and data 
that would be helpful in evaluating the usefulness of two test methods 
for which upcoming independent scientific peer review meetings are 
being planned. The methods are: (1) Corrositex, an in vitro 
method proposed for assessing the dermal corrosivity potential of 
chemicals and products; and (2) the Frog Embryo Teratogeneisis Assay in 
Xenopus (FETAX), a method for demonstrating developmental toxicity. 
Potential regulatory applications of FETAX to human health 
developmental toxicity assessments include screening and prioritizing 
compounds for further testing, evaluating complex mixtures in 
environmental samples, and as supplemental information in a weight-of-
evidence evaluation of human developmental toxicity hazards.
    The Center would welcome receiving information and data from 
completed, ongoing, or planned studies using or evaluating these test 
methods. Data and information submitted should address one or more of 
the criteria for validation and regulatory acceptance as provided in 
NIH publication 97-3981, ``Validation and Regulatory Acceptance of 
Toxicological Test Methods: A Report of the AD Hoc Interagency 
Coordinating Committee on the Validation of Alternative Methods''. 
Where possible, data and information should adhere to the guidance 
provided in the document ``Evaluation of the Validation Status of 
Toxicological Methods: General Guidelines for Submissions to ICCVAM'', 
which is available on request from the NTP Center at the address 
provided below. Relevant information submitted in response to this 
request will be used to prepare test methods background review 
documents for use by peer review and expert panels. Peer review 
meetings and/or workshops for these methods will be announced in future 
notices as they are scheduled.
    Information on these test methods should sent by mail, fax, or e-
mail to the NTP Interagency Center for the Evaluation of Alternative 
Toxicological Methods within 45 days of the appearance of this notice. 
The NTP Center mailing address, phone, fax, and e-mail are as follows: 
MD EC-17, P.O. Box 12233, Research Triangle Park, NC 27709; 919-541-
3398 (phone); 919-541-0947 (FAX); ICCVAM@niehs. nih.gov (e-mail). 
Additional information can be obtained from: Dr. William S. Stokes, NTP 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods, Environmental Toxicology Program, NIEHS/NTP, P.O. Box 12233, 
Research Triangle Park, North Carolina 27709, telephone (919) 541-3398, 
FAX (919) 541-0947, [email protected].

    Dated: July 17, 1998.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 98-20040 Filed 7-27-98; 8:45 am]
BILLING CODE 4140-01-M