National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Announcement of an Independent Scientific Peer Review Meeting on the Use of In Vitro Pyrogenicity Testing Methods; Request for Comments, 74533-74534 [E6-21038]
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Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices
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[FR Doc. E6–21042 Filed 12–11–06; 8:45 am]
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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); Announcement
of an Independent Scientific Peer
Review Meeting on the Use of In Vitro
Pyrogenicity Testing Methods;
Request for Comments
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Meeting announcement and
request for comments.
jlentini on PROD1PC65 with NOTICES
AGENCY:
Background
SUMMARY: NICEATM in collaboration
with the Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM)
announces an independent scientific
peer review meeting to evaluate the
validation status of five in vitro
pyrogenicity test methods: (1) Human
PBMC/IL–6 in vitro pyrogen test
(PBMC/IL–6), (2) human whole blood/
IL–1 in vitro pyrogen test (WB/IL–1), (3)
human whole blood/IL–1 in vitro
pyrogen test: application of
cryopreserved human whole blood (cryo
WB/IL–1), (4) the human whole blood/
IL–6 in vitro pyrogen test (WB/IL–6),
and (5) an alternative in vitro pyrogen
test using the human monocytoid cell
line MONO MAC–6 (MM6/IL6). These
five in vitro test methods are proposed
as replacements for the in vivo rabbit
pyrogen test (RPT). At this meeting, a
scientific panel will peer review the
draft background review document
(BRD) on each test method, evaluate the
extent that the BRD addresses
established validation and acceptance
criteria for each test method, and
provide comment on draft ICCVAM
recommendations on the proposed use
of these test methods, draft test method
protocols, and draft performance
standards. NICEATM invites public
comments on the draft BRDs, draft
ICCVAM test method recommendations,
VerDate Aug<31>2005
18:00 Dec 11, 2006
Jkt 211001
draft test method protocols, and draft
performance standards.
DATES: The meeting will be held on
February 6, 2007, from 8:30 a.m. to 5
p.m. The meeting is open to the public
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 January 23, 2007, via the
ICCVAM/NICEATM Web site
(https://iccvam.niehs.nih.gov).
Comments should be sent by mail, fax,
or email to the address given below by
January 26, 2007.
ADDRESSES: The meeting will be held at
the National Institutes of Health (NIH),
Natcher Conference Center, 45 Center
Drive, Bethesda, MD 20892.
FOR FURTHER INFORMATION CONTACT: Dr.
William S. Stokes, Director of
NICEATM, 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:
The European Centre for the
Validation of Alternative Methods
(ECVAM) conducted a validation study
to independently evaluate the
usefulness and limitations of five in
vitro pyrogenicity test methods (PBMC/
IL–6, WB/IL–1, cryo WB/IL–1, WB/IL–6,
and MM6/IL6). In June 2005, ECVAM
submitted BRDs for these five methods
to NICEATM for consideration as
replacements for the currently required
test, the RPT. ICCVAM and NICEATM
reviewed the BRDs for completeness
and concluded that these five in vitro
test methods appear to have
considerable potential for pyrogenicity
testing, but that the sponsor needed to
provide additional information prior to
a formal scientific review by an expert
panel. In anticipation of proceeding
with an evaluation of these test
methods, ICCVAM and NICEATM
requested public comments as to the
appropriateness and relative priority of
a panel review activity and the
nomination of scientists with relevant
knowledge and experience to
potentially serve on the panel (Federal
Register Vol. 70, No. 241, pp. 74833–4,
December 16, 2005). NICEATM also
requested submission of data using the
standard in vivo rabbit pyrogen test, the
bacterial endotoxin test (BET), and in
vitro pyrogenicity tests. These requests
were sent directly to over 100 interested
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
74533
stakeholders; no additional data were
received.
In March 2006, ECVAM responded to
the ICCVAM/NICEATM request for
information by providing a revised BRD
for each test method. ICCVAM and
NICEATM drafted a BRD that combines
all of the available information on the
five in vitro pyrogenicity test methods
into a single document and includes
each of the ECVAM BRDs as an
appendix. Based on this information,
ICCVAM developed draft test method
recommendations regarding the
proposed usefulness, limitations, and
validation status of these test methods.
ICCVAM subsequently recommended
that an independent scientific panel be
convened to (1) peer review the draft
BRD for the test methods and (2)
determine whether the data and
analyses in the draft BRDs support the
draft ICCVAM test method
recommendations. The panel will also
be asked to comment on the adequacy
of the draft recommended performance
standards, proposed future validation
studies, draft standardized test method
protocols, and recommended reference
substances. In making their conclusions
and recommendations, NICEATM will
ask the panel to consider all available
information including the scientific
studies cited in the draft BRD, public
comments, and any new information
identified during the peer review.
Peer Review Panel Meeting
The purpose of this meeting is the
scientific peer review evaluation of the
validation status of five in vitro
pyrogenicity test methods as
replacements for the RPT. First, the
panel will review the draft BRD on the
current status of five in vitro test
methods for the detection of
pyrogenicity and evaluate the extent
that established validation and
acceptance criteria are addressed for
each test method (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, https://
iccvam.niehs.nih.gov). Next, the panel
will comment on the extent to which
the ICCVAM recommendations are
supported by the information provided
in the BRD and on the proposed use of
these test methods, draft test method
protocols, draft performance standards,
and any proposed validation studies.
Information about the panel meeting,
including a roster of the panel members
and the draft agenda, will be made
available two weeks prior to the meeting
on the ICCVAM/NICEATM Web site
(https://iccvam.niehs.nih.gov) or can be
E:\FR\FM\12DEN1.SGM
12DEN1
74534
Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices
obtained after that date by contacting
NICEATM (see FOR FURTHER
INFORMATION CONTACT above).
Attendance and Registration
This public meeting will take place
February 6, 2007, at the NIH Campus,
Natcher Conference Center, Bethesda,
MD (a map of the NIH campus and other
visitor information are available at
https://www.nih.gov/about/visitor/
index.htm). The meeting begins at 8:30
a.m. and will conclude at approximately
5 p.m. Persons needing special
assistance, such as sign language
interpretation or other reasonable
accommodation in order to attend,
should contact 919–541–2475 (voice),
919–541–4644 TTY (text telephone),
through the Federal TTY Relay System
at 800–877–8339, or by e-mail to
niehsoeeo@niehs.nih.gov. Requests
should be made at least seven business
days in advance of the event.
jlentini on PROD1PC65 with NOTICES
Availability of the BRD and Draft
ICCVAM Recommendations
NICEATM prepared a BRD on five in
vitro pyrogenicity test methods that
describes the current validation status of
the in vitro test methods and contains
all of the data and analyses supporting
this validation status. The draft BRDs,
draft ICCVAM test method
recommendations, draft test method
protocols, and draft test method
performance standards are available
from the ICCVAM/NICETAM Web site
(https://iccvam.niehs.nih.gov) or by
contacting NICEATM (see FOR FURTHER
INFORMATION CONTACT above).
Request for Comments
NICEATM invites the submission of
written comments on the BRDs, draft
ICCVAM test method recommendations,
draft test method protocols, and draft
test method performance standards.
When submitting written comments, it
is important to 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 should be sent by
mail, fax, or e-mail to Dr. William
Stokes, Director of NICEATM, at the
address listed above, not later than
January 26, 2007. All comments
received will be placed on the ICCVAM/
NICEATM Web site (https://
iccvam.niehs.nih.gov), 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 public oral comments at
designated times during the peer
review. Members of the public who
VerDate Aug<31>2005
18:00 Dec 11, 2006
Jkt 211001
wish to present oral statements at the
meeting (one speaker per organization)
should contact NICEATM (see FOR
FURTHER INFORMATION CONTACT above) no
later than January 26, 2007. Speakers
will be assigned on a consecutive basis
and up to seven minutes will be allotted
per speaker. Persons registering to make
comments are asked to provide
NICEATM a written copy of their
statement by January 26, 2007, so that
copies can be distributed to the panel
prior to the meeting or if this is not
possible to bring 40 copies to the
meeting. Written statements can
supplement and expand the oral
presentation. Each speaker is asked to
provide contact information (name,
affiliation, mailing address, phone, fax,
e-mail, and sponsoring organization, if
applicable) when registering to make
oral comments.
Summary minutes and the panel’s
final report will be available following
the meeting on the ICCVAM/NICEATM
Web site (https://iccvam.niehs.nih.gov).
ICCVAM will consider the panel’s
conclusions and recommendations and
any public comments received in
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, and replace animal use.
The ICCVAM Authorization Act of 2000
(42 U.S.C. 285l–3, available at
https://iccvam.niehs.nih.gov/about/
PL106545.htm) establishes ICCVAM as a
permanent interagency committee of the
NIEHS under the 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 following Web site:
https://iccvam.niehs.nih.gov.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Dated: November 27, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E6–21038 Filed 12–11–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Center for the Evaluation of Risks to
Human Reproduction (CERHR);
Availability of the Draft Expert Panel
Report on Bisphenol A and Request
for Public Comment on the Draft
Report; Announcement of the
Bisphenol A Expert Panel Meeting
National Institute of
Environmental Health Sciences
(NIEHS); National Institutes of Health
(NIH).
ACTION: Announcement of a meeting and
request public comment.
AGENCY:
SUMMARY: The CERHR announces the
availability of the draft expert panel
report for bisphenol A on December 15,
2006, from the CERHR Web site
(https://cerhr.niehs.nih.gov) or in printed
text from CERHR (see FOR FURTHER
INFORMATION CONTACT below). The
CERHR invites the submission of public
comments on sections 1–4 of the draft
expert panel report (see SUPPLEMENTARY
INFORMATION below). The expert panel
will meet on March 5–7, 2007, at the
Radisson Hotel Old Town in
Alexandria, Virginia to review and
revise the draft expert panel report and
reach conclusions regarding whether
exposure to bisphenol A is a hazard to
human development or reproduction.
The expert panel will also identify data
gaps and research needs. CERHR expert
panel meetings are open to the public
with time scheduled for oral public
comment. Attendance is limited only by
the available meeting room space.
Following the expert panel meeting and
completion of the expert panel report,
the CERHR will post the final report on
its Web site and solicit public comment
on it through a Federal Register notice.
DATES: The expert panel meeting for
bisphenol A will be held on March 5–
7, 2007. Sections 1–4 of the draft expert
panel report will be available for public
comment on December 15, 2006.
Written public comments on the draft
report must be received by February 2,
2007. Time is set-aside at the expert
panel meeting on March 5, 2007 for oral
public comments. Individuals wishing
to make oral public comments are asked
to contact Dr. Michael D. Shelby,
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Notices]
[Pages 74533-74534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21038]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP), NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Announcement
of an Independent Scientific Peer Review Meeting on the Use of In Vitro
Pyrogenicity Testing Methods; 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 meeting to evaluate the
validation status of five in vitro pyrogenicity test methods: (1) Human
PBMC/IL-6 in vitro pyrogen test (PBMC/IL-6), (2) human whole blood/IL-1
in vitro pyrogen test (WB/IL-1), (3) human whole blood/IL-1 in vitro
pyrogen test: application of cryopreserved human whole blood (cryo WB/
IL-1), (4) the human whole blood/IL-6 in vitro pyrogen test (WB/IL-6),
and (5) an alternative in vitro pyrogen test using the human monocytoid
cell line MONO MAC-6 (MM6/IL6). These five in vitro test methods are
proposed as replacements for the in vivo rabbit pyrogen test (RPT). At
this meeting, a scientific panel will peer review the draft background
review document (BRD) on each test method, evaluate the extent that the
BRD addresses established validation and acceptance criteria for each
test method, and provide comment on draft ICCVAM recommendations on the
proposed use of these test methods, draft test method protocols, and
draft performance standards. NICEATM invites public comments on the
draft BRDs, draft ICCVAM test method recommendations, draft test method
protocols, and draft performance standards.
DATES: The meeting will be held on February 6, 2007, from 8:30 a.m. to
5 p.m. The meeting is open to the public 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 January 23,
2007, via the ICCVAM/NICEATM Web site (https://iccvam.niehs.nih.gov).
Comments should be sent by mail, fax, or email to the address given
below by January 26, 2007.
ADDRESSES: The meeting will be held at the National Institutes of
Health (NIH), Natcher Conference Center, 45 Center Drive, Bethesda, MD
20892.
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director of
NICEATM, 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 European Centre for the Validation of Alternative Methods
(ECVAM) conducted a validation study to independently evaluate the
usefulness and limitations of five in vitro pyrogenicity test methods
(PBMC/IL-6, WB/IL-1, cryo WB/IL-1, WB/IL-6, and MM6/IL6). In June 2005,
ECVAM submitted BRDs for these five methods to NICEATM for
consideration as replacements for the currently required test, the RPT.
ICCVAM and NICEATM reviewed the BRDs for completeness and concluded
that these five in vitro test methods appear to have considerable
potential for pyrogenicity testing, but that the sponsor needed to
provide additional information prior to a formal scientific review by
an expert panel. In anticipation of proceeding with an evaluation of
these test methods, ICCVAM and NICEATM requested public comments as to
the appropriateness and relative priority of a panel review activity
and the nomination of scientists with relevant knowledge and experience
to potentially serve on the panel (Federal Register Vol. 70, No. 241,
pp. 74833-4, December 16, 2005). NICEATM also requested submission of
data using the standard in vivo rabbit pyrogen test, the bacterial
endotoxin test (BET), and in vitro pyrogenicity tests. These requests
were sent directly to over 100 interested stakeholders; no additional
data were received.
In March 2006, ECVAM responded to the ICCVAM/NICEATM request for
information by providing a revised BRD for each test method. ICCVAM and
NICEATM drafted a BRD that combines all of the available information on
the five in vitro pyrogenicity test methods into a single document and
includes each of the ECVAM BRDs as an appendix. Based on this
information, ICCVAM developed draft test method recommendations
regarding the proposed usefulness, limitations, and validation status
of these test methods. ICCVAM subsequently recommended that an
independent scientific panel be convened to (1) peer review the draft
BRD for the test methods and (2) determine whether the data and
analyses in the draft BRDs support the draft ICCVAM test method
recommendations. The panel will also be asked to comment on the
adequacy of the draft recommended performance standards, proposed
future validation studies, draft standardized test method protocols,
and recommended reference substances. In making their conclusions and
recommendations, NICEATM will ask the panel to consider all available
information including the scientific studies cited in the draft BRD,
public comments, and any new information identified during the peer
review.
Peer Review Panel Meeting
The purpose of this meeting is the scientific peer review
evaluation of the validation status of five in vitro pyrogenicity test
methods as replacements for the RPT. First, the panel will review the
draft BRD on the current status of five in vitro test methods for the
detection of pyrogenicity and evaluate the extent that established
validation and acceptance criteria are addressed for each test method
(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, https://
iccvam.niehs.nih.gov). Next, the panel will comment on the extent to
which the ICCVAM recommendations are supported by the information
provided in the BRD and on the proposed use of these test methods,
draft test method protocols, draft performance standards, and any
proposed validation studies.
Information about the panel meeting, including a roster of the
panel members and the draft agenda, will be made available two weeks
prior to the meeting on the ICCVAM/NICEATM Web site (https://
iccvam.niehs.nih.gov) or can be
[[Page 74534]]
obtained after that date by contacting NICEATM (see FOR FURTHER
INFORMATION CONTACT above).
Attendance and Registration
This public meeting will take place February 6, 2007, at the NIH
Campus, Natcher Conference Center, Bethesda, MD (a map of the NIH
campus and other visitor information are available at https://
www.nih.gov/about/visitor/index.htm). The meeting begins at 8:30 a.m.
and will conclude at approximately 5 p.m. Persons needing special
assistance, such as sign language interpretation or other reasonable
accommodation in order to attend, should contact 919-541-2475 (voice),
919-541-4644 TTY (text telephone), through the Federal TTY Relay System
at 800-877-8339, or by e-mail to niehsoeeo@niehs.nih.gov. Requests
should be made at least seven business days in advance of the event.
Availability of the BRD and Draft ICCVAM Recommendations
NICEATM prepared a BRD on five in vitro pyrogenicity test methods
that describes the current validation status of the in vitro test
methods and contains all of the data and analyses supporting this
validation status. The draft BRDs, draft ICCVAM test method
recommendations, draft test method protocols, and draft test method
performance standards are available from the ICCVAM/NICETAM Web site
(https://iccvam.niehs.nih.gov) or by contacting NICEATM (see FOR FURTHER
INFORMATION CONTACT above).
Request for Comments
NICEATM invites the submission of written comments on the BRDs,
draft ICCVAM test method recommendations, draft test method protocols,
and draft test method performance standards. When submitting written
comments, it is important to 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 should be sent by mail, fax, or e-mail to
Dr. William Stokes, Director of NICEATM, at the address listed above,
not later than January 26, 2007. All comments received will be placed
on the ICCVAM/NICEATM Web site (https://iccvam.niehs.nih.gov), 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 public oral comments at designated times during the
peer review. Members of the public who wish to present oral statements
at the meeting (one speaker per organization) should contact NICEATM
(see FOR FURTHER INFORMATION CONTACT above) no later than January 26,
2007. Speakers will be assigned on a consecutive basis and up to seven
minutes will be allotted per speaker. Persons registering to make
comments are asked to provide NICEATM a written copy of their statement
by January 26, 2007, so that copies can be distributed to the panel
prior to the meeting or if this is not possible to bring 40 copies to
the meeting. Written statements can supplement and expand the oral
presentation. Each speaker is asked to provide contact information
(name, affiliation, mailing address, phone, fax, e-mail, and sponsoring
organization, if applicable) when registering to make oral comments.
Summary minutes and the panel's final report will be available
following the meeting on the ICCVAM/NICEATM Web site (https://
iccvam.niehs.nih.gov). ICCVAM will consider the panel's conclusions and
recommendations and any public comments received in 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, and replace
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3,
available at https://iccvam.niehs.nih.gov/about/PL106545.htm)
establishes ICCVAM as a permanent interagency committee of the NIEHS
under the 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 following Web site: http:/
/iccvam.niehs.nih.gov.
Dated: November 27, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E6-21038 Filed 12-11-06; 8:45 am]
BILLING CODE 4140-01-P