Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 66451 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 25, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21829 Filed 11–1–05; 8:45 am] 

BILLING CODE 4140–01–M 

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) 

niceatm@niehs.nih.gov. 

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