[Federal Register Volume 70, Number 174 (Friday, September 9, 2005)]
[Notices]
[Pages 53676-53677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17939]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP); NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Announcement 
of Expert Panel Meeting To Evaluate Revised Analyses and Proposed 
Reference Substances for In Vitro Test Methods for Identifying Ocular 
Corrosives and Severe Irritants

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH), Department of Health and Human 
Services (HHS).

ACTION: Meeting announcement and opportunity for public comment.

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

SUMMARY: NICEATM announces a second meeting of an expert panel by 
teleconference on September 19, 2005, to evaluate (1) revised accuracy 
and reliability analyses of four in vitro test methods proposed for 
detecting ocular corrosives and severe irritants and (2) a revised list 
of proposed reference substances for validation studies on in vitro 
test methods for identifying ocular corrosives and severe irritants. 
The four in vitro test methods under consideration are the (1) Bovine 
Corneal Opacity and Permeability (BCOP) assay, (2) Hen's Egg Test--
Chorion Allantoic Membrane (HET-CAM), (3) Isolated Rabbit Eye (IRE) 
assay, and (4) Isolated Chicken Eye (ICE) assay. The revised analyses 
and revised list of proposed reference substances are available in an 
addendum to the draft Background Review Documents (BRDs) for the four 
methods (available at http://iccvam.niehs.nih.gov/methods/ocudocs/reanalysis.htm). A previous Federal Register notice solicited public 
comment on the revised analyses and revised list of proposed reference 
substances (Vol. 70, No. 142, pg. 43149, July 26, 2005). Comments 
submitted in response to the July 26, 2005 Federal Register notice will 
be considered at the expert panel meeting and do not need to be 
resubmitted. The public is invited to attend the teleconference and 
will be provided with an opportunity to make oral comments during the 
public comment period. Interested individuals can attend the meeting 
via a phone line or in person at the NIEHS campus (see ADDRESSES 
below). Participation is limited only by the number of phone lines 
available and by the number of available seats at the teleconference 
site. Additional meeting information may be obtained on the ICCVAM/
NICEATM Web site (http://iccvam.niehs.nih.gov) or by contacting NICEATM 
(see ADDRESSES below).

DATES: The expert panel meeting will be held via teleconference on 
Monday, September 19, 2005, beginning at 9 a.m. eastern daylight time 
(e.d.t.) and continuing until adjournment (approximately 12 p.m. 
e.d.t.).
    Requests to attend the meeting via the telephone or in person must 
be received no later than September 12, 2005, to ensure access (see 
ADDRESSES below). We encourage all individuals who plan to attend this 
meeting to register online at the NICEATM Web site (http://iccvam.niehs.nih.gov/), but requests may also be submitted by e-mail, 
telephone, fax, or through hand delivery/courier (see ADDRESSES below).
    Persons wishing to make oral comments during the teleconference 
must notify NICEATM no later than September 12, 2005 (see ADDRESSES 
below). In lieu of oral comments, individuals may provide written 
comments for distribution to the expert panel prior to the meeting. 
Written comments should be received by September 15, 2005, in order to 
enable consideration by the expert panel prior to the meeting.
    Persons with disabilities, such as those who need sign language 
interpreters and/or other reasonable accommodation to participate in 
this meeting at NIEHS, are asked to notify NICEATM by September 8, 
2005.

ADDRESSES: The teleconference will originate from Room 3162, 3rd Floor, 
NIEHS, 79 T.W. Alexander Drive, Bldg. 4401, Research Triangle Park, NC. 
A government-approved photo ID is required to access the meeting.
    Correspondence should be sent by mail, fax, e-mail, or through hand 
delivery/courier to Dr. Raymond Tice at NICEATM, NIEHS, PO Box 12233, 
MD EC-17, Research Triangle Park, NC 27709, (phone) 919-541-4482, (fax) 
919-541-0947, (e-mail) [email protected]. Courier address: 
NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3129, Research 
Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION:

Background

    On November 3, 2004, NICEATM released draft BRDs that provided 
information about the current validation status of the 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 and 
background information for this meeting are 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 ethical human 
studies or accidental exposure). Subsequently, NICEATM received 
additional in vitro and in vivo data that were used for the

[[Page 53677]]

revised accuracy and reliability analyses and considered in revising 
the list of proposed reference substances.
    In preparation for this teleconference, 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 July 26, 2006 Federal Register 
notice. Following the expert panel teleconference, a second expert 
panel report will be published and made available for public comment. 
ICCVAM will consider both 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 recommendations for these 
test methods.

Opportunity for Public Comment

    Public comments may be made on the revised accuracy and reliability 
analyses for BCOP, HET-CAM, ICE, and IRE and on the proposed list of 
reference substances. In lieu of oral comments, individuals may provide 
written comments for distribution to the expert panel prior to the 
meeting. Written comments should be received no later than September 
15, 2005, to enable consideration by the expert panel prior to the 
meeting. Written comments received in response to the July 26, 2005 
Federal Register notice announcing availability of the addendum to the 
draft BRDs do not need to be resubmitted. If written comments are 
submitted, appropriate contact information (name, affiliation, mailing 
address, phone, fax, email and sponsoring organization, if applicable) 
should be included. Written comments will be posted on the NICEATM/
ICCVAM Web site and made available to the expert panel and the ICCVAM. 
Persons wishing to make oral comments during the teleconference (one 
speaker per organization) must notify NICEATM by no later than 
September 12, 2005. Speakers will be assigned on a consecutive basis 
and comments will be limited to no more than four minutes per speaker. 
Due to logistical issues it may not be possible for persons who do not 
pre-register to make oral comments.

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

    Dated: August 30, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-17939 Filed 9-8-05; 8:45 am]
BILLING CODE 4140-01-P