[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Page 26396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP), NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Request for 
Data on the Use of Topical Anesthetics and Systemic Analgesics for In 
Vivo Eye Irritation Testing

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

ACTION: Request for data on the use of topical anesthetics and systemic 
analgesics for in vivo ocular irritation testing.

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SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and NICEATM request the submission of data 
and information on the use of topical anesthetics and systemic 
analgesics for alleviating pain and distress in rabbits during eye 
irritation testing. They also request the submission of information 
about other procedures and strategies that may reduce or eliminate pain 
and distress associated with in vivo eye irritation methods.

DATES: Data should be received by June 25, 2007.

ADDRESSES: Data should be sent by mail, fax, or e-mail to Dr. William 
S. Stokes, Director, NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research 
Triangle Park, NC, 27709, (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, NICEATM 
Director, (phone) 919-541-2384 or [email protected].

SUPPLEMENTARY INFORMATION

Background

    The U.S. Environmental Protection Agency (EPA) nominated to ICCVAM 
several activities relevant to reducing, replacing, or refining the use 
of rabbits in the current in vivo eye irritation test method (Federal 
Register Vol. 69, No. 57, pages 13859-13861, March 24, 2004). One 
activity is to review ways to alleviate pain and suffering that might 
arise from current in vivo eye irritation testing. ICCVAM endorsed this 
activity with a high priority and recommended that NICEATM review the 
data currently available on the use of topical anesthetics and/or 
systemic analgesics to reduce animal pain and distress.
    As part of this review, NICEATM requests the submission of data 
from completed studies on the use of topical anesthetics and/or 
systemic analgesics for in vivo ocular irritancy testing. These data 
will be used to evaluate the validation status of the use of topical 
anesthetics and/or analgesics to reduce pain and distress for in vivo 
testing situations. ICCVAM and NICEATM also request the submission of 
information and data from in vivo methods, procedures, and/or 
strategies that may reduce or eliminate the pain and suffering 
associated with current in vivo eye irritation methods.

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 (42 U.S.C. 285l-3) 
established ICCVAM as a permanent interagency committee of the NIEHS 
under NICEATM. NICEATM administers the ICCVAM and provides scientific 
and operational support for ICCVAM-related activities. Additional 
information about NICEATM and ICCVAM can be found at the following Web 
site: http://iccvam.niehs.nih.gov.

    Dated: April 30, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E7-8898 Filed 5-8-07; 8:45 am]
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