[Federal Register Volume 70, Number 211 (Wednesday, November 2, 2005)]
[Notices]
[Page 66451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21830]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP), NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Availability 
of a Second Expert Panel Request on the Evaluation of the Current 
Validation Status of In Vitro Test Methods for Identifying Ocular 
Corrosives and Severe Irritants

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

ACTION: Report availability and request for comments.

-----------------------------------------------------------------------

SUMMARY: NICEATM announces availability of the report ``The Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM) Expert Panel Evaluation of the draft Background Review 
Document Addendum for In Vitro Test Methods For Identifying Ocular 
Corrosives And Severe Irritants.'' NICEATM invites public comment on 
the expert panel report. Copies of the expert panel report may be 
obtained on the ICCVAM/NICEATM Web site at http://iccvam.niehs.nih.gov, 
or by contacting NICEATM at the address given below.

DATES: Comments should be sent by mail, fax, or e-mail to the address 
given below by December 2, 2005.

FOR FURTHER INFORMATION CONTACT: Dr. Raymond Tice at NICEATM, NIEHS, 
P.O. Box 12233, MD EC-17, Research Triangle Park, NC, 27709, (phone) 
919-541-4482, (fax) 919-541-0947, (e-mail) [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On November 3, 2004, NICEATM released draft background review 
documents (BRDs) that provided information about the current validation 
status of four in vitro test methods for detecting ocular corrosives 
and severe irritants (Federal Register, Vol. 69, No. 212, pp. 64081-
64082, November 3, 2004). In conjunction with ICCVAM, NICEATM convened 
an expert panel meeting on January 11-12, 2005, to independently assess 
the validation status of the four in vitro test methods. The expert 
panel report from the January 2005 meeting (``first expert panel 
report'') was released in March 2005 and is available at http://iccvam.niehs.nih.gov/methods/eyeirrit.htm. Public comments at the 
meeting indicated that additional data could be made available that had 
not been provided in response to earlier requests for data announced in 
the Federal Register in March (Vol. 69, No. 57, pp. 13859-13861, March 
24, 2004) and November 2004. The expert panel recommended that NICEATM 
conduct a reanalysis of the accuracy and reliability of each test 
method that would include these data. In response to this 
recommendation, NICEATM published a notice in the Federal Register 
(Vol. 70, No. 38, pp. 9661-9662, February 28, 2005) requesting 
additional in vitro data on these four in vitro ocular irritancy test 
methods, corresponding in vivo rabbit eye test method data, as well as 
any human ocular exposure/injury data (either from human studies or 
accidental exposure). Subsequently, NICEATM received additional in 
vitro and in vivo data that were used for the revised accuracy and 
reliability analyses and considered in revising the list of proposed 
reference substances.
    NICEATM released the revised accuracy and reliability analyses and 
the revised list of proposed reference substances as an addendum to the 
draft BRDs and announced its availability in the Federal Register (Vol. 
70, No. 142, pg. 43149, July 26, 2005). NICEATM subsequently announced 
a second meeting of an expert panel by teleconference on September 19, 
2005 in the Federal Register (Vol. 70, No. 174, pg. 53676, September 9, 
2005). The second expert panel report is a product of the 
teleconference meeting and is being made available for public comment. 
ICCVAM will consider the first and second expert panel reports, other 
relevant background materials, and all comments received from the 
public and the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM) on this topic in finalizing ICCVAM test 
method recommendations for these methods.

Request for Comments

    NICEATM invites the submission of written comments on the second 
expert panel report. When submitting written comments please include 
appropriate contact information (name, affiliation, mailing address, 
phone, fax, e-mail and sponsoring organization, if applicable). All 
written comments received by the deadline listed above will be posted 
on the ICCVAM/NICEATM Web site and made available to ICCVAM agency 
representatives for their consideration prior to the development of 
final ICCVAM recommendations on these test methods.
    An ICCVAM test method evaluation report, which includes the ICCVAM 
test method recommendations, will be forwarded to appropriate Federal 
agencies for their consideration. This report also will be available to 
the public on the ICCVAM/NICEATM Web site and by request to NICEATM.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
fifteen Federal regulatory and research agencies that use or gerate 
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/PLI06545.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://www.iccvam.niehs.nih.gov.

    Dated: October 25, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-21830 Filed 11-1-05; 8:45 am]
BILLING CODE 4140-01-M