[Federal Register Volume 70, Number 53 (Monday, March 21, 2005)]
[Notices]
[Pages 13512-13513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5471]


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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 Data on Non-Animal Methods and 
Approaches for Determining Skin and Eye Irritation Potential of 
Antimicrobial Cleaning Product Formulations; Request for Nominations 
for an Independent Expert Panel

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

ACTION: Request for data and nomination of panelists.

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SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and NICEATM are requesting the submission 
of data that would assist in evaluating the validation status of non-
animal methods and approaches used for determining the skin and eye 
irritation potential of antimicrobial cleaning product formulations to 
meet regulatory hazard classification and labeling purposes. 
Additionally, NICEATM is also requesting the nomination of scientists 
for consideration as potential members of an independent scientific 
expert panel (``Panel'') to evaluate the proposed methods and 
approaches. The ICCVAM will consider the conclusions and 
recommendations from the Panel in developing its recommendations on the 
validation status of these methods.

DATES: Nominations and data should be received by noon on May 5, 2005.

ADDRESSES: Nominations and data should be sent by mail, fax, or email 
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, Building 4401, Room 3128, 
Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director of 
NICEATM, (phone) 919-541-2384, (fax) 919-541-0947, (email) 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    In June 2004, the Environmental Protection Agency (EPA) asked 
ICCVAM to evaluate the validation status of proposed non-animal 
approaches for determining the skin and eye irritation potential of 
antimicrobial cleaning product formulations for meeting regulatory 
hazard classification and labeling requirements. ICCVAM considered the 
EPA's request and recommended that the evaluation of these non-animal 
approaches proceed as a high priority. ICCVAM agreed to work with the 
EPA and representatives of its Pesticide Program Dialogue Committee 
(PPDC) to help assure that the submission provided to ICCVAM contains 
all relevant information, data, and appropriate analyses as described 
in the ``ICCVAM Guidelines for the Nomination and Submission of New, 
Revised, and Alternative Test Methods'' (NIH publication 03-4508). The 
NICEATM on behalf of ICCVAM plans to convene an independent scientific 
expert panel to review the submission, develop conclusions on the 
validation status of these methods, and make recommendations about the 
usefulness and limitations of these methods for their intended purpose. 
The date for the expert panel meeting has not been determined but will 
be announced in a future Federal Register notice.

Request for Data

    Data, the nomination of experts, and other information submitted in 
response to this notice should be sent to NICEATM at the address given 
above. Data received by the deadline will be made available on the 
ICCVAM/NICEATM Web site at http://iccvam.niehs.nih.gov and considered 
by the Panel and ICCVAM.
    When submitting data or information on protocols, 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 the 
submission of raw untransformed data in addition to any summary data 
including the submission of copies of pages from applicable study 
notebooks and/or study reports, if available. In vivo and in vitro data 
for each substance are preferred. Post-marketing surveillance data, 
ethical human studies, and accidental exposure reports also are sought 
when available and applicable. Each submission for a chemical or 
product should preferably include the following information when 
available:
     Common and trade name.
     Chemical Abstracts Service Registry Number (CASRN) for 
each ingredient of a formulation, and the percent composition of each 
ingredient.
     Chemical structure.
     Chemical class.
     Product class.
     Commercial source.
     Test protocol used for either in vivo or in vitro testing.
     The extent to which the study complies with national/
international Good Laboratory Practice (GLP) guidelines.
     Date and testing organization.

Request for the Nomination of Scientists for the Expert Panel

    NICEATM invites the nomination of scientists with relevant 
knowledge and experience that can serve on the Panel to evaluate in 
vitro dermal and ocular toxicity test methods. Areas of relevant 
expertise include, but are not limited to: human and animal 
dermatotoxicology/ophthalmology with an emphasis on evaluation and 
treatment of chemical injuries, in vivo dermal/ocular toxicity testing, 
in vitro dermal/ocular toxicology, test method validation, and 
biostatistics. Each nomination should include the person's name, 
affiliation, contact information (i.e., mailing address, e-mail 
address, telephone and fax numbers), a brief summary of relevant 
experience and qualifications, and curriculum vitae, if possible. 
NICEATM and ICCVAM will also consider nominations previously submitted 
in response to a request for scientific experts for the evaluation of 
in vitro ocular test methods (Federal Register, Vol. 69, No. 57, pp. 
13859-13861, March 24, 2004, available at http://iccvam.niehs.nih.gov/) 
and do not need to be resubmitted.

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, or replace 
animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106-545, 
available at http://iccvam.niehs.nih.gov/about/

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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 9, 2005.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-5471 Filed 3-18-05; 8:45 am]
BILLING CODE 4140-01-P