National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review Panel Report on Five In Vitro Pyrogen Test Methods: Availability and Request for Public Comments, 26395-26396 [E7-8896]
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Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices
SUPPLEMENTARY INFORMATION
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 Five In Vitro Pyrogen
Test Methods: Availability and Request
for Public Comments
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
AGENCY:
ACTION:
Request for comments.
SUMMARY: NICEATM in collaboration
with the Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM)
convened an independent scientific
peer review panel meeting on February
6, 2007, to evaluate the validation status
of five in vitro pyrogen test methods
proposed as replacements for the Rabbit
Pyrogen Test (RPT). 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 (https://
iccvam.niehs.nih.gov/methods/pyrogen/
pyrogen.htm) or by contacting
NICEATM (see FOR FURTHER
INFORMATION CONTACT below).
Written comments on the Panel
report should be received by June 25,
2007.
DATES:
Comments should
preferably be submitted electronically
via the NICEATM/ICCVAM Web site:
https://iccvam.niehs.nih.gov/contact/
FR_pubcomment.htm. Comments can
also be submitted by e-mail to
niceatm@niehs.nih.gov. Written
comments can be sent by mail or fax to
Dr. William S. Stokes, NICEATM
Director, NIH/NIEHS, P.O. Box 12233,
MD EC–17, Research Triangle Park, NC
27709, (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.
sroberts on PROD1PC70 with NOTICES
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Other correspondence should be
directed to Dr. William S. Stokes,
NICEATM Director (919–541–2384 or
niceatm@niehs.nih.gov).
VerDate Aug<31>2005
18:12 May 08, 2007
Jkt 211001
Background
The European Centre for the
Validation of Alternative Methods
(ECVAM) submitted five in vitro
pyrogen test methods to ICCVAM for
evaluation in 2006. The proposed test
methods include:
1. The Human Whole Blood
(WB)/IL–1 In Vitro Pyrogen Test:
Application of Cryopreserved Human
WB
2. The Monocytoid Cell Line Mono
Mac 6 (MM6)/IL–6 In Vitro Pyrogen Test
3. The Human PBMC/IL–6 In Vitro
Pyrogen Test
4. The Human WB/IL–1 In Vitro
Pyrogen Test
5. The Human WB/IL–6 In Vitro
Pyrogen Test
These test methods are based on the
measurement of proinflammatory
cytokines released from either fresh or
cryopreserved human blood cells or a
human monocytoid line in response to
the presence of Gram-negative
endotoxin in parenteral
pharmaceuticals. NICEATM and
ICCVAM prepared a comprehensive
background review document (BRD)
that included the available data for the
five test methods and a separate
document containing ICCVAM test
method recommendations. At the peer
review meeting, the Panel reviewed the
BRD and evaluated the extent to which
the ICCVAM criteria for validation and
acceptance had been adequately
addressed for the intended purpose of
these test methods. The Panel also
provided comments on the ICCVAM
draft test method recommendations
regarding the proposed usefulness and
limitations, standardized protocols,
performance standards, and future
studies. The Panel’s conclusions and
recommendations on the five in vitro
pyrogen test methods are described in
the Peer Review Panel Final Report: Five
In Vitro Pyrogen Test Methods (available
at: https://iccvam.niehs.nih.gov/
methods/pyrogen/pyrogen.htm). The
draft BRD and the draft test method
recommendations are available at https://
iccvam.niehs.nih.gov/methods/pyrogen/
pyrogen.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, email, and
sponsoring organization, if applicable).
All comments received by the deadline
listed above will be placed on the
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
26395
NICEATM/ICCVAM Web site (https://
ntp-apps.niehs.nih.gov/iccvampb/
searchPubCom.cfm) and made available
to ICCVAM. In addition, there will be an
opportunity for oral public comments
on the Panel’s report during a meeting
of the Scientific Advisory Committee on
Alternative Toxicological Methods
(SACATM) scheduled for June 12, 2007.
Information concerning the SACATM
meeting will be published in a separate
Federal Register notice and available on
the SACATM website: (https://
ntp.niehs.nih.gov/go/7441). Any written
comments on the Panel report received
prior to June 7, 2007, will be distributed
to SACATM.
ICCVAM will consider the Panel
report along with the SACATM and
public comments as it finalizes
recommendations for the five in vitro
pyrogen test methods. An ICCVAM test
method evaluation report, which
includes the ICCVAM final
recommendations, will be forwarded to
appropriate federal agencies for their
consideration. This report will also be
available to the public on the
NICEATM/ICCVAM Web site and by
request from NICEATM.
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 and regulatory
acceptance 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
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 can be found at the ICCVAM/
NICEATM Web site (https://
iccvam.niehs.nih.gov).
Additional information about
SACATM, including the charter, roster,
and records of past meetings, can be
found at https://ntp.niehs.nih.gov/go/
167.
E:\FR\FM\09MYN1.SGM
09MYN1
26396
Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices
Dated: April 30, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E7–8896 Filed 5–8–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP),
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Request for Data
on the Use of Topical Anesthetics and
Systemic Analgesics for In Vivo Eye
Irritation Testing
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Request for data on the use of
topical anesthetics and systemic
analgesics for in vivo ocular irritation
testing.
AGENCY:
SUMMARY: The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM) and
NICEATM request the submission of
data and information on the use of
topical anesthetics and systemic
analgesics for alleviating pain and
distress in rabbits during eye irritation
testing. They also request the
submission of information about other
procedures and strategies that may
reduce or eliminate pain and distress
associated with in vivo eye irritation
methods.
Data should be received by June
25, 2007.
ADDRESSES: Data should be sent by mail,
fax, or e-mail to Dr. William S. Stokes,
Director, NICEATM, NIEHS, P.O. Box
12233, MD EC–17, Research Triangle
Park, NC, 27709, (fax) 919–541–0947, (email) niceatm@niehs.nih.gov. 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, NICEATM Director,
(phone) 919–541–2384 or
niceatm@niehs.nih.gov.
DATES:
SUPPLEMENTARY INFORMATION
sroberts on PROD1PC70 with NOTICES
Background
The U.S. Environmental Protection
Agency (EPA) nominated to ICCVAM
several activities relevant to reducing,
replacing, or refining the use of rabbits
in the current in vivo eye irritation test
method (Federal Register Vol. 69, No.
57, pages 13859–13861, March 24,
VerDate Aug<31>2005
18:12 May 08, 2007
Jkt 211001
2004). One activity is to review ways to
alleviate pain and suffering that might
arise from current in vivo eye irritation
testing. ICCVAM endorsed this activity
with a high priority and recommended
that NICEATM review the data currently
available on the use of topical
anesthetics and/or systemic analgesics
to reduce animal pain and distress.
As part of this review, NICEATM
requests the submission of data from
completed studies on the use of topical
anesthetics and/or systemic analgesics
for in vivo ocular irritancy testing. These
data will be used to evaluate the
validation status of the use of topical
anesthetics and/or analgesics to reduce
pain and distress for in vivo testing
situations. ICCVAM and NICEATM also
request the submission of information
and data from in vivo methods,
procedures, and/or strategies that may
reduce or eliminate the pain and
suffering associated with current in vivo
eye irritation 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) established ICCVAM
as a permanent interagency committee
of the NIEHS under NICEATM.
NICEATM administers the ICCVAM and
provides scientific and operational
support for ICCVAM-related activities.
Additional information about NICEATM
and ICCVAM can be found at the
following Web site: https://
iccvam.niehs.nih.gov.
Dated: April 30, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E7–8898 Filed 5–8–07; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Aging
Purpose of Notice: Availability of
Funding Opportunity Announcement
Funding Opportunity Title/Program
Name: Aging and Disability Resource
Center Initiative: Integrating Access to
Long-Term Care.
Announcement Type: Initial.
Funding Opportunity Number: HHS–
2007–AoA–DR–0707.
Statutory Authority: The Older
Americans Act of 2006, Public Law
109–365.
Catalog of Federal Domestic
Assistance (CFDA) Number: 93.048,
Title IV and Title II, Discretionary
Projects.
Dates: The deadline date for the
submission of applications is June 29,
2007.
I. Funding Opportunity Description
In FY 2003, the Administration on
Aging (AoA) and the Centers for
Medicare & Medicaid Services (CMS)
formed a historic partnership to launch
the Aging and Disability Resource
Center (ADRC) demonstration grant
initiative. The goal of the ADRC
program is to empower individuals to
make informed choices and to
streamline access to long term support
services. AoA and CMS share a vision
to have Resource Centers in every
community serving as highly visible and
trusted places where people of all ages
can turn for information on the full
range of long term support options and
a single point of entry to public long
term support programs and benefits.
ADRCs are a resource for both public
and private-pay individuals. They serve
older adults, younger individuals with
disabilities, family caregivers, as well as
persons planning for future long term
support needs. ADRCs are also a
resource for health and long term
support professionals and others who
provide services to older adults and to
people with disabilities. Since FY 2003,
43 states have received three year grants
from AoA and CMS to design and
implement ADRC demonstrations
serving the elderly and at least one other
target population of adults with
disabilities in at least one community.
An ADRC Program Announcement
published in FY 2003 resulted in the
funding of twelve states that year with
an additional twelve states funded to
develop ADRC programs in FY 2004.
Nineteen additional states were funded
to develop ADRC programs based on a
Program Announcement published in
E:\FR\FM\09MYN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Pages 26395-26396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8896]
[[Page 26395]]
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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 Five In Vitro Pyrogen Test Methods: Availability and
Request for Public Comments
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Request for comments.
-----------------------------------------------------------------------
SUMMARY: NICEATM in collaboration with the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM) convened an
independent scientific peer review panel meeting on February 6, 2007,
to evaluate the validation status of five in vitro pyrogen test methods
proposed as replacements for the Rabbit Pyrogen Test (RPT). 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 (https://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm) or by
contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below).
DATES: Written comments on the Panel report should be received by June
25, 2007.
ADDRESSES: Comments should preferably be submitted electronically via
the NICEATM/ICCVAM Web site: https://iccvam.niehs.nih.gov/contact/FR_
pubcomment.htm. Comments can also be submitted by e-mail to
niceatm@niehs.nih.gov. Written comments can be sent by mail or fax to
Dr. William S. Stokes, NICEATM Director, NIH/NIEHS, P.O. Box 12233, MD
EC-17, Research Triangle Park, NC 27709, (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.
FOR FURTHER INFORMATION CONTACT: Other correspondence should be
directed to Dr. William S. Stokes, NICEATM Director (919-541-2384 or
niceatm@niehs.nih.gov).
SUPPLEMENTARY INFORMATION
Background
The European Centre for the Validation of Alternative Methods
(ECVAM) submitted five in vitro pyrogen test methods to ICCVAM for
evaluation in 2006. The proposed test methods include:
1. The Human Whole Blood (WB)/IL-1 In Vitro Pyrogen Test:
Application of Cryopreserved Human WB
2. The Monocytoid Cell Line Mono Mac 6 (MM6)/IL-6 In Vitro Pyrogen
Test
3. The Human PBMC/IL-6 In Vitro Pyrogen Test
4. The Human WB/IL-1 In Vitro Pyrogen Test
5. The Human WB/IL-6 In Vitro Pyrogen Test
These test methods are based on the measurement of proinflammatory
cytokines released from either fresh or cryopreserved human blood cells
or a human monocytoid line in response to the presence of Gram-negative
endotoxin in parenteral pharmaceuticals. NICEATM and ICCVAM prepared a
comprehensive background review document (BRD) that included the
available data for the five test methods and a separate document
containing ICCVAM test method recommendations. At the peer review
meeting, the Panel reviewed the BRD and evaluated the extent to which
the ICCVAM criteria for validation and acceptance had been adequately
addressed for the intended purpose of these test methods. The Panel
also provided comments on the ICCVAM draft test method recommendations
regarding the proposed usefulness and limitations, standardized
protocols, performance standards, and future studies. The Panel's
conclusions and recommendations on the five in vitro pyrogen test
methods are described in the Peer Review Panel Final Report: Five In
Vitro Pyrogen Test Methods (available at: https://iccvam.niehs.nih.gov/
methods/pyrogen/pyrogen.htm). The draft BRD and the draft test method
recommendations are available at https://iccvam.niehs.nih.gov/methods/
pyrogen/pyrogen.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, email, and sponsoring
organization, if applicable). All comments received by the deadline
listed above will be placed on the NICEATM/ICCVAM Web site (https://ntp-
apps.niehs.nih.gov/iccvampb/searchPubCom.cfm) and made available to
ICCVAM. In addition, there will be an opportunity for oral public
comments on the Panel's report during a meeting of the Scientific
Advisory Committee on Alternative Toxicological Methods (SACATM)
scheduled for June 12, 2007. Information concerning the SACATM meeting
will be published in a separate Federal Register notice and available
on the SACATM website: (https://ntp.niehs.nih.gov/go/7441). Any written
comments on the Panel report received prior to June 7, 2007, will be
distributed to SACATM.
ICCVAM will consider the Panel report along with the SACATM and
public comments as it finalizes recommendations for the five in vitro
pyrogen test methods. An ICCVAM test method evaluation report, which
includes the ICCVAM final recommendations, will be forwarded to
appropriate federal agencies for their consideration. This report will
also be available to the public on the NICEATM/ICCVAM Web site and by
request from NICEATM.
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 and regulatory
acceptance 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 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 can be found at the ICCVAM/NICEATM
Web site (https://iccvam.niehs.nih.gov).
Additional information about SACATM, including the charter, roster,
and records of past meetings, can be found at https://ntp.niehs.nih.gov/
go/167.
[[Page 26396]]
Dated: April 30, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E7-8896 Filed 5-8-07; 8:45 am]
BILLING CODE 4140-01-P
