National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Announcement of an Independent Scientific Peer Review Panel Meeting on the Murine Local Lymph Node Assay; Availability of Draft Background Review Documents; Request for Comments, 1360-1362 [E7-25553]
Download as PDF
<![CDATA[
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Federal Register / Vol. 73, No. 5 / Tuesday, January 8, 2008 / Notices
and Radiological Health (HFZ–300),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–0243.
SUPPLEMENTARY INFORMATION:
pwalker on PROD1PC71 with NOTICES
I. Background
On October 26, 2002, the Medical
Device User Fee and Modernization Act
of 2002 (MDUFMA) (Public Law 107–
250) was signed into law. Among other
things, MDUMFA authorized the
collection of user fees to improve the
performance and predictability of FDA’s
device review program, including
premarket approval applications
(PMAs). One such goal included a
commitment to improve the scheduling
and timeliness of PMA preapproval
inspections. A portion of the user fees
collected under MDUFMA will be used
to help to cover the costs associated
with the bioresearch monitoring (BIMO)
program review of a PMA and the
performance of any related clinical or
nonclinical inspections. This final
guidance document supersedes the
corresponding draft guidance entitled
‘‘The Review and Inspection of
Premarket Approval Applications Under
the Bioresearch Monitoring Program,’’
which was announced in the Federal
Register on June 20, 2006 (71 FR 35436
through 35437).
The comment period for the draft
guidance closed on September 18, 2006.
During this time, FDA received one set
of comments from a device
manufacturer concerning the draft
guidance. Some of the comments
suggested combining the BIMO and
manufacturing preapproval inspections.
FDA did not make changes in response
to these comments because preapproval
BIMO and manufacturing inspections
can not be performed at the same time.
Compared to the preapproval
manufacturing inspection program, the
BIMO program has different objectives,
usually involves inspections of different
sites, and FDA investigators with
different expertise. FDA did modify the
guidance to respond to comments that
requested further information about
criteria for selecting inspection sites and
determining when followup actions are
necessary.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on ‘‘The Review and
Inspection of Premarket Approval
Applications Under the Bioresearch
Monitoring Program.’’ It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
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17:32 Jan 07, 2008
Jkt 214001
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. To receive ‘‘The Review and
Inspection of Premarket Approval
Applications Under the Bioresearch
Monitoring Program,’’ you may either
send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 240–276–3151 to receive
a hard copy. Please use the document
number 1602 to identify the guidance
you are requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 USC 3501–
3520). The collections of information in
21 CFR part 814 have been approved
under OMB Control Number 0910–0231.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one copy.
Comments are to be identified with the
docket number found in brackets in the
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heading of this document. Received
comments received may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: December 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–143 Filed 1–7–08; 8:45 am]
BILLING CODE 4160–01–S
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 an Independent Scientific Peer
Review Panel Meeting on the Murine
Local Lymph Node Assay; Availability
of Draft Background Review
Documents; Request for Comments
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Meeting announcement and
request for comments.
AGENCY:
SUMMARY: NICEATM in collaboration
with the Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM)
announces an independent scientific
peer review panel meeting to evaluate
modifications and new applications for
the Murine Local Lymph Node Assay
(LLNA). The LLNA is an alternative test
method that can be used to determine
the allergic contact dermatitis potential
of chemicals and products. The panel
will review the following:
• The validation status of three
modified LLNA test method protocols
that use non-radioactive probe
chemicals.
• The validation status of a LLNA
limit dose procedure.
• The use of the LLNA to test
mixtures, aqueous solutions, and metals
(applicability domain for the LLNA).
• The use of the LLNA to determine
potency (potential for causing allergic
contact dermatitis).
• Revised draft recommended
performance standards for the LLNA.
At this meeting, the panel will peer
review the draft background review
documents and revised draft LLNA
performance standards for each topic
and evaluate the extent that established
validation and acceptance criteria have
been appropriately addressed. The
panel will also comment on the extent
E:\FR\FM\08JAN1.SGM
08JAN1
Federal Register / Vol. 73, No. 5 / Tuesday, January 8, 2008 / Notices
pwalker on PROD1PC71 with NOTICES
that the review documents support draft
ICCVAM recommendations on proposed
test method protocols, proposed uses of
the LLNA, and the revised draft LLNA
performance standards.
NICEATM invites public comments
on the draft background review
documents, draft ICCVAM test
recommendations, draft test method
protocols, and revised draft LLNA
performance standards. All documents
will be available on the NICEATM–
ICCVAM Web site at https://
iccvam.niehs.nih.gov/methods/
immunotox/immunotox.htm by January
8, 2008.
DATES: The meeting is scheduled for
March 4–6, 2008, from 8:30 a.m. to 5
p.m. each day. The meeting is open to
the public free of charge, with
attendance limited only by the space
available. In order to facilitate planning
for this meeting, persons wishing to
attend are asked to register by February
20, 2008, via the NICEATM–ICCVAM
Web site (https://iccvam.niehs.nih.gov/
contact/reg_LLNAPanel.htm). The
deadline for written comments is
February 22, 2008.
ADDRESSES: The meeting will be held at
the U.S. Consumer Product Safety
Commission (CPSC) Headquarters,
Bethesda Towers Bldg., 4330 East West
Highway, Bethesda, MD.
FOR FURTHER INFORMATION CONTACT:
Comments may also be submitted via
the NICEATM–ICCVAM Web site at
https://iccvam.niehs.nih.gov/contact/FR_
pubcomment.htm. Comments or other
correspondence can be sent to Dr.
William S. Stokes, NICEATM Director,
NIEHS, P.O. Box 12233, MD EC–17,
Research Triangle Park, NC, 27709,
(phone) 919–541–2384, (fax) 919–541–
0947, (e-mail) niceatm@niehs.nih.gov.
Courier address: NICEATM, 79 T.W.
Alexander Drive, Building 4401, Room
3128, Research Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
The LLNA is a reduction and
refinement alternative test method for
skin sensitization testing because it
reduces the number of animals needed
and can substantially reduce or avoid
pain and distress compared to
traditional guinea pig testing methods
for sensitization. The LLNA was the first
alternative test method evaluated and
recommended by ICCVAM (NIH
Publication No. 99–4494, available at:
https://iccvam.niehs.nih.gov/docs/
immunotox_docs/llna/llnarep.pdf).
Based on the recommendations of
ICCVAM and an independent scientific
peer review panel, U.S. and
international regulatory authorities have
VerDate Aug<31>2005
17:32 Jan 07, 2008
Jkt 214001
accepted the LLNA as an alternative to
the guinea pig maximization test and
Buehler test for assessing allergic
contact dermatitis (ISO 2002; OECD
2002; EPA 2003). This review will
evaluate the potential for broader use of
the LLNA for regulatory testing of
chemicals and products for allergic
contact dermatitis potential, enabling
further reduction and refinement (less
pain and suffering) of animal use for
this purpose. In January 2007, the CPSC
submitted a nomination requesting that
NICEATM and ICCVAM assess the
validation status of (1) the LLNA as a
stand-alone assay for potency
determination for hazard classification
purposes; (2) modified LLNA protocols;
(3) the LLNA limit test; (4) the use of the
LLNA to test mixtures, aqueous
solutions, and metals; and (5) the
applicability domain for 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 (Federal Register: Vol. 72, No.
95, pages 27815–27817, May 17, 2007).
After considering these inputs, ICCVAM
endorsed these activities as high
priorities. ICCVAM is also developing
performance standards to facilitate
evaluation of modified LLNA protocols
compared to the traditional LLNA.
Although ICCVAM has routinely
developed performance standards for
test methods since 2003, they were not
developed as part of the ICCVAM
evaluation of the LLNA in 1998. These
draft performance standards for the
LLNA were made public and comments
were requested via the Federal Register
(Vol. 72, No. 176, pages 52130–52131,
Sept. 12, 2007). The May 2007 Federal
Register notice requested data from
studies using the LLNA or modified
versions of the LLNA.
Drawing on the submitted data and
literature sources, ICCVAM and
NICEATM drafted background review
documents for each of the modifications
and new applications of the LLNA.
ICCVAM has also developed draft test
method recommendations regarding the
proposed usefulness, limitations, and
validation status of these test methods.
ICCVAM will convene an independent
scientific panel to peer review the draft
background review documents for the
test methods and determine whether the
data and analyses in the draft
documents support the draft ICCVAM
test method recommendations. The
panel will also be asked to comment on
the adequacy of the revised draft
performance standards, proposed future
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Fmt 4703
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1361
studies, draft standardized test method
protocols, and recommended reference
substances. NICEATM will ask the
panel to consider all available
information, including the scientific
studies cited in the draft review
documents, public comments, and any
new information identified during the
peer review, for developing their
conclusions and recommendations.
Peer Review Panel Meeting
The purpose of this meeting is to
conduct a scientific peer review of the
revised draft performance standards and
an evaluation of modifications and new
applications for the LLNA. The LLNA is
an alternative test method that can be
used to determine the allergic contact
dermatitis potential of chemicals and
products. The panel will review the
following:
• The LLNA as a stand-alone assay
for potency determination for hazard
classification purposes
• Modified LLNA protocols
• The LLNA limit test
• The use of the LLNA to test
mixtures, aqueous solutions, and metals
(applicability domain for the LLNA)
• The use of the LLNA to determine
potency (potential for causing allergic
contact dermatitis).
The panel will consider the draft
background review documents for each
of these methods and evaluate the
extent that established validation and
acceptance criteria are appropriately
addressed for each test method (as
described in the ICCVAM 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
No. 97–981, available at https://
iccvam.niehs.nih.gov/docs/about_docs/
validate.pdf). The panel will then
comment on the extent to which the
draft ICCVAM recommendations are
supported by the information provided
in the background review document for
each topic. It is anticipated that the
panel will address the topics in the
following order:
1. The LLNA limit test.
2. The applicability domain of the
LLNA including its suitability for
mixtures, aqueous solutions, and
metals.
3. The LLNA as a stand-alone assay
for potency determination for hazard
classification.
4. The revised draft performance
standards for the LLNA.
5. The modified LLNA test method
protocols using non-radioactive
materials.
E:\FR\FM\08JAN1.SGM
08JAN1
1362
Federal Register / Vol. 73, No. 5 / Tuesday, January 8, 2008 / Notices
Additional information about the
meeting, including a roster of the panel
members and the draft agenda, will be
made available two weeks prior to the
meeting on the NICEATM-ICCVAM Web
site (https://iccvam.niehs.nih.gov). This
information will also be available after
that date by contacting NICEATM (see
FOR FURTHER INFORMATION CONTACT
above).
Attendance and Registration
This public meeting will take place
March 4–6, 2008, at the CPSC
Headquarters, Bethesda Towers Bldg.,
4330 East West Highway, Bethesda, MD
(an area map, driving directions, and
CPSC contact information are available
at https://www.cpsc.gov/about/
contact.html). The meeting will begin at
8:30 a.m. and is scheduled to conclude
at approximately 5 p.m. each day,
although adjournment on March 6 may
occur earlier or later depending upon
the time needed for the expert panel to
complete its work. It is also possible
that the panel may conclude its
deliberations on March 5 and not need
to meet on March 6. Persons needing
special assistance in order to attend,
such as sign language interpretation or
other reasonable accommodation,
should contact 919–541–2475 (voice),
919–541–4644 TTY (text telephone,
through the Federal TTY Relay System
at 800–877–8339), or e-mail
niehsoeeo@niehs.nih.gov. Requests
should be made at least seven days in
advance of the event.
pwalker on PROD1PC71 with NOTICES
Availability of the Draft Background
Review Documents and Draft ICCVAM
Recommendations
NICEATM prepared draft background
review documents on each of these
modifications or applications of the
LLNA that describe the current
validation status of the modified test
methods and applications and contain
all of the data and analyses supporting
this proposed validation status. The
draft background review documents,
draft ICCVAM test method
recommendations, draft test method
protocols, and revised draft test method
performance standards are available
from the NICEATM–ICCVAM Web site
(https://iccvam.niehs.nih.gov/methods/
immunotox/immunotox.htm) or by
contacting NICEATM (see FOR FURTHER
INFORMATION CONTACT above).
Request for Public Comments
NICEATM invites the submission of
written comments on the draft
background review documents, draft
ICCVAM test method recommendations,
draft test method protocols, and revised
draft test method performance
VerDate Aug<31>2005
17:32 Jan 07, 2008
Jkt 214001
standards. Written comments should be
submitted preferably electronically via
the NICEATM–ICCVAM Web site or by
e-mail (niceatm@niehs.nih.gov); the
deadline for submission of written
comments is February 22, 2008. 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). Written
comments may also be sent by mail, fax,
or e-mail to Dr. William Stokes (see FOR
FURTHER INFORMATION CONTACT above).
All comments received will be placed
on the NICEATM–ICCVAM Web site
(https://iccvam.niehs.nih.gov) and
identified by the individual’s name and
affiliation or sponsoring organization (if
applicable). Comments will also be sent
to the panel and ICCVAM agency
representatives and made available at
the meeting.
This meeting is open to the public,
and time will be provided for the
presentation of oral comments by the
public at designated times during the
peer review. Members of the public who
wish to present oral statements at the
meeting should contact NICEATM (see
FOR FURTHER INFORMATION CONTACT
above) no later than February 20, 2008,
and provide contact information (name,
affiliation, mailing address, phone, fax,
e-mail, and sponsoring organization, if
applicable). Up to seven minutes will be
allotted per speaker, one speaker per
organization. Persons registering to
make comments are asked to provide
NICEATM a written copy of their
statement by February 27, 2008, so that
copies can be distributed to the panel
prior to the meeting. If this is not
possible, please bring 40 copies of your
comments to the meeting for
distribution and to supplement the
record. Written statements can
supplement and expand the oral
presentation.
Summary minutes and the panel’s
final report will be available following
the meeting on the NICEATM–ICCVAM
Web site (https://iccvam.niehs.nih.gov).
ICCVAM will consider the panel’s
conclusions and recommendations and
any public comments received when
finalizing their test method
recommendations and performance
standards for these methods.
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,
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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, or replace
animal use. The ICCVAM Authorization
Act of 2000 (42 U.S.C. 285l–3, available
at https://iccvam.niehs.nih.gov/docs/
about_docs/PL106545.pdf) establishes
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 is available on the
NICEATM–ICCVAM Web site at https://
iccvam.niehs.nih.gov.
References
EPA. 2003. EPA OPPTS 870.2600 Test
Guideline—Skin Sensitization. Available:
https://www.epa.gov/opptsfrs/publications/
OPPTS_Harmonized/870_Health_Effects_
Test_Guidelines/Drafts/870–2600.pdf.
ISO. 2002. ISO 10993–10 Biological
evaluation of medical devices—Part 10:
Tests for irritation and delayed-type
hypersensitivity. Geneva: International
Organization for Standardization.
OECD. 2002. OECD Guideline for the Testing
of Chemicals—Test Guideline 429: Skin
Sensitization: Local Lymph Node Assay
(adopted 24 April 2002). Paris:
Organisation for Economic Co-operation
and Development.
Dated: December 19, 2007.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E7–25553 Filed 1–7–08; 2:42 pm]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2007–0197]
Area Maritime Security Advisory
Committee Detroit; Vacancies
Coast Guard, DHS.
Request for applications.
AGENCY:
ACTION:
SUMMARY: The Coast Guard seeks
applications for membership in the Area
Maritime Security Committee (AMSC)
Detroit. The Committee assists the
Captain of the Port, Detroit, in
developing, reviewing, and updating the
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[Federal Register Volume 73, Number 5 (Tuesday, January 8, 2008)]
[Notices]
[Pages 1360-1362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25553]
-----------------------------------------------------------------------
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 an Independent Scientific Peer Review Panel Meeting on the Murine
Local Lymph Node Assay; Availability of Draft Background Review
Documents; Request for Comments
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Meeting announcement and request for comments.
-----------------------------------------------------------------------
SUMMARY: NICEATM in collaboration with the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM) announces
an independent scientific peer review panel meeting to evaluate
modifications and new applications for the Murine Local Lymph Node
Assay (LLNA). The LLNA is an alternative test method that can be used
to determine the allergic contact dermatitis potential of chemicals and
products. The panel will review the following:
The validation status of three modified LLNA test method
protocols that use non-radioactive probe chemicals.
The validation status of a LLNA limit dose procedure.
The use of the LLNA to test mixtures, aqueous solutions,
and metals (applicability domain for the LLNA).
The use of the LLNA to determine potency (potential for
causing allergic contact dermatitis).
Revised draft recommended performance standards for the
LLNA.
At this meeting, the panel will peer review the draft background
review documents and revised draft LLNA performance standards for each
topic and evaluate the extent that established validation and
acceptance criteria have been appropriately addressed. The panel will
also comment on the extent
[[Page 1361]]
that the review documents support draft ICCVAM recommendations on
proposed test method protocols, proposed uses of the LLNA, and the
revised draft LLNA performance standards.
NICEATM invites public comments on the draft background review
documents, draft ICCVAM test recommendations, draft test method
protocols, and revised draft LLNA performance standards. All documents
will be available on the NICEATM-ICCVAM Web site at https://
iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm by January 8,
2008.
DATES: The meeting is scheduled for March 4-6, 2008, from 8:30 a.m. to
5 p.m. each day. The meeting is open to the public free of charge, with
attendance limited only by the space available. In order to facilitate
planning for this meeting, persons wishing to attend are asked to
register by February 20, 2008, via the NICEATM-ICCVAM Web site (https://
iccvam.niehs.nih.gov/contact/reg_LLNAPanel.htm). The deadline for
written comments is February 22, 2008.
ADDRESSES: The meeting will be held at the U.S. Consumer Product Safety
Commission (CPSC) Headquarters, Bethesda Towers Bldg., 4330 East West
Highway, Bethesda, MD.
FOR FURTHER INFORMATION CONTACT: Comments may also be submitted via the
NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/contact/FR_
pubcomment.htm. Comments or other correspondence can be sent to Dr.
William S. Stokes, NICEATM Director, NIEHS, P.O. Box 12233, MD EC-17,
Research Triangle Park, NC, 27709, (phone) 919-541-2384, (fax) 919-541-
0947, (e-mail) niceatm@niehs.nih.gov. Courier address: NICEATM, 79 T.W.
Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC
27709.
SUPPLEMENTARY INFORMATION:
Background
The LLNA is a reduction and refinement alternative test method for
skin sensitization testing because it reduces the number of animals
needed and can substantially reduce or avoid pain and distress compared
to traditional guinea pig testing methods for sensitization. The LLNA
was the first alternative test method evaluated and recommended by
ICCVAM (NIH Publication No. 99-4494, available at: https://
iccvam.niehs.nih.gov/docs/immunotox_docs/llna/llnarep.pdf). Based on
the recommendations of ICCVAM and an independent scientific peer review
panel, U.S. and international regulatory authorities have accepted the
LLNA as an alternative to the guinea pig maximization test and Buehler
test for assessing allergic contact dermatitis (ISO 2002; OECD 2002;
EPA 2003). This review will evaluate the potential for broader use of
the LLNA for regulatory testing of chemicals and products for allergic
contact dermatitis potential, enabling further reduction and refinement
(less pain and suffering) of animal use for this purpose. In January
2007, the CPSC submitted a nomination requesting that NICEATM and
ICCVAM assess the validation status of (1) the LLNA as a stand-alone
assay for potency determination for hazard classification purposes; (2)
modified LLNA protocols; (3) the LLNA limit test; (4) the use of the
LLNA to test mixtures, aqueous solutions, and metals; and (5) the
applicability domain for 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
(Federal Register: Vol. 72, No. 95, pages 27815-27817, May 17, 2007).
After considering these inputs, ICCVAM endorsed these activities as
high priorities. ICCVAM is also developing performance standards to
facilitate evaluation of modified LLNA protocols compared to the
traditional LLNA. Although ICCVAM has routinely developed performance
standards for test methods since 2003, they were not developed as part
of the ICCVAM evaluation of the LLNA in 1998. These draft performance
standards for the LLNA were made public and comments were requested via
the Federal Register (Vol. 72, No. 176, pages 52130-52131, Sept. 12,
2007). The May 2007 Federal Register notice requested data from studies
using the LLNA or modified versions of the LLNA.
Drawing on the submitted data and literature sources, ICCVAM and
NICEATM drafted background review documents for each of the
modifications and new applications of the LLNA. ICCVAM has also
developed draft test method recommendations regarding the proposed
usefulness, limitations, and validation status of these test methods.
ICCVAM will convene an independent scientific panel to peer review the
draft background review documents for the test methods and determine
whether the data and analyses in the draft documents support the draft
ICCVAM test method recommendations. The panel will also be asked to
comment on the adequacy of the revised draft performance standards,
proposed future studies, draft standardized test method protocols, and
recommended reference substances. NICEATM will ask the panel to
consider all available information, including the scientific studies
cited in the draft review documents, public comments, and any new
information identified during the peer review, for developing their
conclusions and recommendations.
Peer Review Panel Meeting
The purpose of this meeting is to conduct a scientific peer review
of the revised draft performance standards and an evaluation of
modifications and new applications for the LLNA. The LLNA is an
alternative test method that can be used to determine the allergic
contact dermatitis potential of chemicals and products. The panel will
review the following:
The LLNA as a stand-alone assay for potency determination
for hazard classification purposes
Modified LLNA protocols
The LLNA limit test
The use of the LLNA to test mixtures, aqueous solutions,
and metals (applicability domain for the LLNA)
The use of the LLNA to determine potency (potential for
causing allergic contact dermatitis).
The panel will consider the draft background review documents for
each of these methods and evaluate the extent that established
validation and acceptance criteria are appropriately addressed for each
test method (as described in the ICCVAM 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 No. 97-981, available at https://
iccvam.niehs.nih.gov/docs/about_docs/validate.pdf). The panel will
then comment on the extent to which the draft ICCVAM recommendations
are supported by the information provided in the background review
document for each topic. It is anticipated that the panel will address
the topics in the following order:
1. The LLNA limit test.
2. The applicability domain of the LLNA including its suitability
for mixtures, aqueous solutions, and metals.
3. The LLNA as a stand-alone assay for potency determination for
hazard classification.
4. The revised draft performance standards for the LLNA.
5. The modified LLNA test method protocols using non-radioactive
materials.
[[Page 1362]]
Additional information about the meeting, including a roster of the
panel members and the draft agenda, will be made available two weeks
prior to the meeting on the NICEATM-ICCVAM Web site (https://
iccvam.niehs.nih.gov). This information will also be available after
that date by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT
above).
Attendance and Registration
This public meeting will take place March 4-6, 2008, at the CPSC
Headquarters, Bethesda Towers Bldg., 4330 East West Highway, Bethesda,
MD (an area map, driving directions, and CPSC contact information are
available at https://www.cpsc.gov/about/contact.html). The meeting will
begin at 8:30 a.m. and is scheduled to conclude at approximately 5 p.m.
each day, although adjournment on March 6 may occur earlier or later
depending upon the time needed for the expert panel to complete its
work. It is also possible that the panel may conclude its deliberations
on March 5 and not need to meet on March 6. Persons needing special
assistance in order to attend, such as sign language interpretation or
other reasonable accommodation, should contact 919-541-2475 (voice),
919-541-4644 TTY (text telephone, through the Federal TTY Relay System
at 800-877-8339), or e-mail niehsoeeo@niehs.nih.gov. Requests should be
made at least seven days in advance of the event.
Availability of the Draft Background Review Documents and Draft ICCVAM
Recommendations
NICEATM prepared draft background review documents on each of these
modifications or applications of the LLNA that describe the current
validation status of the modified test methods and applications and
contain all of the data and analyses supporting this proposed
validation status. The draft background review documents, draft ICCVAM
test method recommendations, draft test method protocols, and revised
draft test method performance standards are available from the NICEATM-
ICCVAM Web site (https://iccvam.niehs.nih.gov/methods/immunotox/
immunotox.htm) or by contacting NICEATM (see FOR FURTHER INFORMATION
CONTACT above).
Request for Public Comments
NICEATM invites the submission of written comments on the draft
background review documents, draft ICCVAM test method recommendations,
draft test method protocols, and revised draft test method performance
standards. Written comments should be submitted preferably
electronically via the NICEATM-ICCVAM Web site or by e-mail
(niceatm@niehs.nih.gov); the deadline for submission of written
comments is February 22, 2008. 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). Written comments may also
be sent by mail, fax, or e-mail to Dr. William Stokes (see FOR FURTHER
INFORMATION CONTACT above). All comments received will be placed on the
NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov) and identified by
the individual's name and affiliation or sponsoring organization (if
applicable). Comments will also be sent to the panel and ICCVAM agency
representatives and made available at the meeting.
This meeting is open to the public, and time will be provided for
the presentation of oral comments by the public at designated times
during the peer review. Members of the public who wish to present oral
statements at the meeting should contact NICEATM (see FOR FURTHER
INFORMATION CONTACT above) no later than February 20, 2008, and provide
contact information (name, affiliation, mailing address, phone, fax, e-
mail, and sponsoring organization, if applicable). Up to seven minutes
will be allotted per speaker, one speaker per organization. Persons
registering to make comments are asked to provide NICEATM a written
copy of their statement by February 27, 2008, so that copies can be
distributed to the panel prior to the meeting. If this is not possible,
please bring 40 copies of your comments to the meeting for distribution
and to supplement the record. Written statements can supplement and
expand the oral presentation.
Summary minutes and the panel's final report will be available
following the meeting on the NICEATM-ICCVAM Web site (https://
iccvam.niehs.nih.gov). ICCVAM will consider the panel's conclusions and
recommendations and any public comments received when finalizing their
test method recommendations and performance standards for these
methods.
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, or replace
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3,
available at https://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf)
establishes 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 is available on the NICEATM-ICCVAM Web site at
https://iccvam.niehs.nih.gov.
References
EPA. 2003. EPA OPPTS 870.2600 Test Guideline--Skin Sensitization.
Available: https://www.epa.gov/opptsfrs/publications/OPPTS_
Harmonized/870_Health_Effects_Test_Guidelines/Drafts/870-
2600.pdf.
ISO. 2002. ISO 10993-10 Biological evaluation of medical devices--
Part 10: Tests for irritation and delayed-type hypersensitivity.
Geneva: International Organization for Standardization.
OECD. 2002. OECD Guideline for the Testing of Chemicals--Test
Guideline 429: Skin Sensitization: Local Lymph Node Assay (adopted
24 April 2002). Paris: Organisation for Economic Co-operation and
Development.
Dated: December 19, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E7-25553 Filed 1-7-08; 2:42 pm]
BILLING CODE 4140-01-P
