[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]
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