[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37405-37406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences (NIEHS); 
Notice of Meeting to Review the Murine Local Lymph Node Assay (LLNA) as 
an Alternative Test Method for Contact Hypersensitivity; Request for 
Comments

Summary: Pursuant to Public Law 103-43, notice is hereby given of a 
public meeting sponsored by the NIEHS and the National Toxicology 
Program (NTP), and coordinated by the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM) and the NTP 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NTP Center). The agenda topic is the scientific peer review of 
the murine local lymph node assay (LLNA), which is proposed as an 
alternative toxicological test method for assessing contact 
hypersensitivity (allergic contact dermatitis) potential of chemicals 
and products. The meeting will be held on September 17, 1998, at the 
Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, Maryland. The 
meeting will take place from 8:30 a.m. to 4:30 p.m. and is open to the 
public.

Background

    Public Law 103-43 directed the NIEHS to develop and validate 
alternative methods that can reduce or eliminate the use of animals in 
acute or chronic toxicity testing, establish criteria for the 
validation and regulatory acceptance of alternative testing methods, 
and recommend a process through which scientifically validated 
alternative methods can be accepted for regulatory use. Criteria and 
processes for validation and regulatory acceptance were developed in 
conjunction with 13 other Federal agencies and programs

[[Page 37406]]

with broad input from the public. These are described in the document 
``Validation and Regulatory Acceptance of Toxicological Test Methods: A 
Report of the Ad Hoc Interagency Coordinating Committee on the 
Validation of Alternative Methods'' NIH publication 97-3981, March 
1997, which is available on the internet at http://ntp-
server.niehs.nih.gov/htdocs/ICCVAM/ICCVAM htm. An Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM) was subsequently established in a collaborative effort by 
NIEHS and 13 other Federal regulatory and research agencies and 
programs. The Committee's functions include the coordination of 
interagency reviews of toxicological test methods and communication 
with stakeholders throughout the process of test method development and 
validation. The following Federal regulatory and research agencies and 
organizations are participating in this effort:

Consumer Product Safety Commission
Department of Defense
Department of Energy
Department of Health and Human Services
    Agency for Toxic Substances and Disease Registry
    Food and Drug Administration
    National Institute for Occupational Safety and Health/CDC
    National Institutes of Health
    National Cancer Institute
    National Institute of Environmental Health Sciences
    National Library of Medicine
Department of the Interior
Department of Labor
    Occupational Safety and Health Administration
Department of Transportation
    Research and Special Programs Administration
Environmental Protection Agency

    The LLNA was proposed to the ICCVAM for consideration as a stand-
alone test to identify chemicals that have a potential to cause contact 
hypersensitivity (allergic contact dermatitis). An ICCVAM 
Immunotoxicity Working Group composed of Federal employees determined 
that there was sufficient information available to merit an independent 
scientific peer review of the LLNA test method. Peer review has been 
determined to be an essential prerequisite for consideration of a 
method for regulatory acceptance. The peer review panel will be charged 
with developing a scientific consensus on the usefulness of the test 
method to generate information for various human health risk assessment 
purposes. Following evaluation at this peer review meeting, the 
proposed test method and results of the peer review will be forwarded 
by ICCVAM to Federal agencies for consideration. Federal agencies will 
determine the regulatory acceptability of a method according to their 
mandates.

Agenda

    There will be a brief orientation on the ICCVAM and the ICCVAM 
review process, followed by peer review of the proposed LLNA test 
method and supporting information. The peer review panel will discuss 
the usefulness of the LLNA as an alternative to test methods currently 
accepted by government regulatory authorities for the assessment of the 
contact hypersensitivity potential of chemicals and products. Copies of 
the proposed LLNA Test Method Protocol and supporting documentation may 
be obtained from the NTP Center for the Evaluation of Alternative 
Toxicological Methods, MD EC-17, P.O. Box 12233, Research Triangle 
Park, NC, 27709 (919-541-3398), FAX (919-541-0947), e-mail: 
[email protected]. The LLNA test method documents and copies of 
written public comments can also be viewed at the Documents Management 
Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
Rockville, MD, 20852 on Monday through Friday from 9:00 a.m. to 4:00 
p.m.

Public Comment

    The NTP Center invites the submission of written comments on the 
proposed LLNA test method, and other available information regarding 
the usefulness of the LLNA, including information about completed, 
ongoing, or planned studies. Written comments and additional 
information should be sent by mail, fax, or e-mail to the NTP Center at 
the address listed above by August 14th. Written comments will be made 
available to the peer review panel members, ICCVAM agency 
representatives and experts, and will be made available for attendees 
at the meeting. Members of the public who wish to present oral 
statements at the meeting should also contact the NTP Center as soon as 
possible, but not later than September 11, 1998. Speakers will be 
assigned on a first-come, first-serve basis and will be limited to a 
maximum of five minutes in presentation length. Written comments 
accompanying the oral statement should be submitted in advance so that 
copies can be made and distributed to the peer panel members.
    The NTP Center will furnish an agenda and a roster of peer review 
panel members just prior to the meeting. Summary minutes and a final 
report of the LLNA peer review meeting will be available subsequent to 
the meeting upon request to the Center. Persons needing special 
assistance, such as sign language interpretation or other special 
accommodations should contact the NTP Center as described above.

    Dated: June 30, 1998.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 98-18320 Filed 7-9-98; 8:45 am]
BILLING CODE 4140-01-M