[Federal Register: November 2, 2005 (Volume 70, Number 211)]
[Notices]
[Page 66451]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no05-114]
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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); 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.
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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]
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