[Federal Register Volume 73, Number 98 (Tuesday, May 20, 2008)]
[Notices]
[Pages 29136-29137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11195]


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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); Peer Review 
Panel Report on the Validation Status of New Versions and Applications 
of the Murine Local Lymph Node Assay (LLNA): A Test Method for 
Assessing the Allergic Contact Dermatitis Potential of Chemicals and 
Products: Notice of Availability and Request for Public Comments

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

ACTION: Request for comments.

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SUMMARY: NICEATM, in collaboration with the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM), convened 
an independent international scientific peer review panel on March 4-6, 
2008 to evaluate new versions and applications of the LLNA for 
assessing the allergic contact dermatitis potential of chemicals and 
products. The peer review panel (``the Panel'') report from this 
meeting is now available. The report contains (1) the Panel's 
evaluation of the validation status of the methods and (2) the Panel's 
comments and conclusions on draft ICCVAM test method recommendations. 
NICEATM invites public comment on the Panel's report. The report is 
available on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/methods/immunotox/llna_PeerPanel.htm or by 
contacting NICEATM at the address given below.

DATES: Written comments on the Panel report should be received by July 
7, 2008.

ADDRESSES: Comments should be submitted preferably electronically via 
the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm. Comments can also be submitted by e-mail to 
[email protected]. Written comments can be sent by mail or fax to 
Dr. William S. Stokes, Director, NICEATM, NIH/NIEHS, P.O. Box 12233, MD 
EC-17, Research Triangle Park, NC 27709, (phone) 919-541-2384, (fax) 
919-541-0947. 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, Director, 
NICEATM (919-541-2384 or [email protected]).

SUPPLEMENTARY INFORMATION: 

Background

    In January 2007, the Consumer Product Safety Commission submitted a 
nomination to NICEATM and ICCVAM to assess the validation status of (1) 
The use of the LLNA to determine potency for hazard classification 
purposes; (2) LLNA protocols using non-radioactive procedures; (3) the 
LLNA limit dose procedure; and (4) the use of the LLNA to test 
mixtures, aqueous solutions, and metals (i.e., an updated assessment of 
the applicability domain of the LLNA). In June 2007, the Scientific 
Advisory Committee on Alternative Toxicological Methods (SACATM) 
endorsed these activities as high priorities for ICCVAM. NICEATM, on 
behalf of ICCVAM, also sought input from the public on these activities 
and requested data from studies using the LLNA or modified versions of 
the LLNA (Federal Register Vol. 72, No. 95, pages 27815-27817, May 17, 
2007). After considering all comments received, ICCVAM endorsed 
carrying out these activities as high priorities. ICCVAM also developed 
draft LLNA performance standards to facilitate evaluation of modified 
LLNA protocols that are functionally and mechanistically similar to the 
traditional LLNA. These draft LLNA performance standards were made 
public and comments were requested via the Federal Register (Vol. 72, 
No. 176, pages 52130-52131, Sept. 12, 2007).
    ICCVAM and NICEATM prepared draft background review documents 
(BRDs) that provided comprehensive reviews of available data and 
relevant information for each of the modifications and new applications 
of the LLNA. ICCVAM also developed draft test method recommendations 
regarding the proposed usefulness and limitations, standardized 
protocols, and future studies. Both the draft BRDs and draft 
recommendations were made available for public comment, and a public 
peer review meeting was announced in the Federal Register (Vol. 73, No. 
5, pages 1360-1362, Jan. 8, 2008).
    The Panel met in public session on March 4-6, 2008. The Panel 
reviewed the draft ICCVAM BRDs for completeness, errors, and omissions 
of any existing relevant data or information. The Panel evaluated the 
information in the BRDs to determine the extent to which each of the 
applicable criteria for validation and acceptance of toxicological test 
methods (ICCVAM, 2003) had been appropriately addressed. The Panel then 
considered the ICCVAM draft test method

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recommendations (i.e., proposed test method uses, proposed recommended 
standardized protocol, proposed test method performance standards, and 
proposed additional studies) and commented on whether the 
recommendations were supported by the information provided in the draft 
BRDs.
    The Panel's conclusions and recommendations are detailed in the 
Peer Review Panel Final Report: Validation Status of New Versions and 
Applications of the Murine Local Lymph Node Assay (LLNA): A Test Method 
for Assessing the Allergic Contact Dermatitis Potential of Chemicals 
and Products (available at http://iccvam.niehs.nih.gov/methods/immunotox/llna_PeerPanel.htm). The draft BRDs, draft ICCVAM test 
method recommendations, and the draft LLNA Performance Standards are 
available at http://iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm.

Request for Comments

    NICEATM invites the submission of written comments on the Panel's 
report. When submitting written comments, please refer to this Federal 
Register notice and include appropriate contact information (name, 
affiliation, mailing address, phone, fax, e-mail, and sponsoring 
organization, if applicable). All comments received will be made 
publicly available on the NICEATM-ICCVAM Web site at http://ntp-apps.niehs.nih.gov/iccvampb/searchPubCom.cfm. In addition, there will 
be an opportunity for oral public comments on the Panel's report during 
an upcoming meeting of SACATM scheduled for June 18-19, 2008. 
Information concerning the SACATM meeting will be published in a 
separate Federal Register notice and available on the SACATM Web site 
at http://ntp.niehs.nih.gov/go/7441.
    ICCVAM will consider the Panel report along with SACATM and public 
comments when finalizing test method recommendations. An ICCVAM test 
method evaluation report, which will include the final ICCVAM 
recommendations, will be forwarded to relevant Federal agencies for 
their consideration. The evaluation report will also be available to 
the public on the NICEATM-ICCVAM Web site and by request from NICEATM 
(see ADDRESSES above).

Background Information on ICCVAM, NICEATM, and SACATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use, generate, or 
disseminate toxicological information. ICCVAM conducts technical 
evaluations of new, revised, and alternative methods with regulatory 
applicability and promotes scientific validation, regulatory 
acceptance, and national and international harmonization of 
toxicological test methods that more accurately assess safety and 
hazards of chemicals and products and that refine, reduce, and replace 
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3, 
available at http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) 
established ICCVAM as a permanent interagency committee of the NIEHS 
under NICEATM. NICEATM administers 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 NICEATM-ICCVAM Web site 
(http://iccvam.niehs.nih.gov).
    Additional information about SACATM, including the charter, roster, 
and records of past meetings, can be found at http://ntp.niehs.nih.gov/go/167.

References

    ICCVAM, 2003, ICCVAM Guidelines for the Nomination and 
Submission of New, Revised, and Alternative Test Methods. NIH 
Publication No. 03-4508. Research Triangle Park, NC: NIEHS. 
Available at: http://iccvam.niehs.nih.gov.

    Dated: May 8, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
[FR Doc. E8-11195 Filed 5-19-08; 8:45 am]
BILLING CODE 4140-01-P