National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report: Validation Status of Five In Vitro, 71003-71004 [E8-27790]
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Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood Safety and Availability
Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
AGENCY:
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Advisory Committee on Blood Safety
and Availability (ACBSA) will hold a
meeting. The meeting will be open to
the public on both Tuesday December
16 and Wednesday December 17, 2008.
DATES: The meeting will take place
Tuesday December 16 and Wednesday
December 17, 2008 from 9 a.m. to 5 p.m.
ADDRESSES: The Hilton Rockville Hotel,
1750 Rockville Pike, Rockville, MD
20852, Phone: (301) 468–1100.
Jerry
A. Holmberg, PhD, Executive Secretary,
Advisory Committee on Blood Safety
and Availability, Office of Public Health
and Science, Department of Health and
Human Services, 1101 Wootton
Parkway, Suite 250, Rockville, MD
20852, (240) 453–8803, FAX (240) 453–
8456, e-mail ACBSA@hhs.gov.
SUPPLEMENTARY INFORMATION:
Blood and plasma donations are
critical to provide blood products
necessary for maintaining health
delivery. Over the years the safety of the
blood and plasma supply has increased
through vigilant review of processes and
adherence to layers of safeguards. While
safety and availability is paramount to
the intended recipient of blood and
plasma products, the pre and post
donation care of the donor is also
important. Commitment to donor health
as well as to transfusion recipient is
necessary to build a robust and healthy
donor based nationally.
The Nation’s potential donor
population is approximately 37% of
those medically eligible to donate.
Approximately 16 million units of blood
were collected in 2006 which exceeded
demand by 7.8%. First time whole
blood donors represented approximately
28.5% of the donors, while the
remaining 71.5% of the donors had
given previously an equivalent of 1.7
whole blood donations in the year. As
the American population ages,
dependence on the younger generation
is more critical. In some states, donors
may be 16-years-old to be eligible.
Donor selection processes have the
potential to detect health abnormalities
or risks which could affect the donor
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FOR FURTHER INFORMATION CONTACT:
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19:32 Nov 21, 2008
Jkt 217001
and even public health. Adverse events
to the donor either as a result of the
process of donating blood (e.g. injury,
syncope, or loss of iron) or discovery of
abnormal screening results can impact
the donor’s health. For example, iron
loss can be from 220 to 290 mg in whole
blood donations and from 20 to 25 mg
in plasmapheresis.
Informed consent is required by FDA
regulation or recommended in guidance
for apheresis procedures (source plasma
and platelet collections) prior to
donations to include the donation
procedure, the risk of the procedure,
and laboratory screenings performed to
reduce the risk of transmission of
infectious diseases to the recipient. A
written statement of understanding for
whole blood donations is proposed in
the Food and Drug Administration’s
Requirements for Human Blood and
Blood Components Intended for
Transfusion or for Further
Manufacturing Use, November 2007.
During the December 2008 meeting of
the ACBSA, the Committee will be
asked to comment on the responsibility
of blood and plasma centers to donor
and public health. Public comment will
be solicited on both December 16 and
17, 2008. Comments will be limited to
five minutes per speaker and must be
pertinent to the discussion. Anyone
planning to comment is encouraged to
contact the Executive Secretary at his/
her earliest convenience. Those who
wish to have printed material
distributed to Advisory Committee
members should submit thirty (30)
copies to the Executive Secretary prior
to close of business December 12, 2008.
Likewise, those who wish to utilize
electronic data projection to the
Committee must submit their materials
to the Executive Secretary prior to close
of business December 12, 2008.
Dated: November 18, 2008.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on
Blood Safety and Availability.
[FR Doc. E8–27852 Filed 11–21–08; 8:45 am]
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71003
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Availability of the
Interagency Coordinating Committee
on the Validation of Alternative
Methods (ICCVAM) Test Method
Evaluation Report: Validation Status of
Five In Vitro Test Methods Proposed
for Assessing Potential Pyrogenicity of
Pharmaceuticals and Other Products
and Final Background Review
Document: Validation Status of Five In
Vitro Test Methods Proposed for
Assessing Potential Pyrogenicity of
Pharmaceuticals and Other Products;
Notice of Transmittal of ICCVAM Test
Method Recommendations to Federal
Agencies
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH)
ACTION: Availability of the ICCVAM Test
Method Evaluation Report and Final
Background Review Document.
AGENCY:
SUMMARY: NICEATM announces
availability of the ICCVAM Test Method
Evaluation Report: Validation Status of
Five In Vitro Test Methods Proposed for
Assessing Potential Pyrogenicity of
Pharmaceuticals and Other Products
(NIH Publication 08–6392). The test
method evaluation report (TMER)
describes five in vitro pyrogen test
methods that can be used for detecting
Gram-negative endotoxin in human
parenteral pharmaceuticals. The report
includes ICCVAM’s (a)
Recommendations on uses and
limitations for each test method, (b)
recommendations for standardized
protocols, (c) recommendations for
future studies, and (d) recommendations
for the development of performance
standards.
ICCVAM concludes that none of these
test methods can be considered as a
complete replacement for the rabbit
pyrogen test (RPT) for all testing
situations for the detection of Gramnegative endotoxin. However, ICCVAM
recommends that they can be
considered for use on a case-by-case
basis to detect Gram-negative endotoxin
in human parenteral drugs, subject to
product-specific validation to
demonstrate equivalence to the RPT, in
accordance with applicable U.S. Food
and Drug Administration regulations.
When used in this manner, these
methods can reduce the number of
animals needed for pyrogenicity testing.
The report also recommends that these
E:\FR\FM\24NON1.SGM
24NON1
71004
Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices
sroberts on PROD1PC70 with NOTICES
and other in vitro alternative test
methods be considered prior to in vivo
pyrogenicity testing, where determined
appropriate for a specific testing
situation.
NICEATM also announces availability
of the final ICCVAM Background Review
Document: Validation Status of Five In
Vitro Test Methods Proposed for
Assessing Potential Pyrogenicity of
Pharmaceuticals and Other Products
(NIH Publication 08–6391). The final
background review document (BRD)
provides the data and analyses used to
assess the current validation status of
these five in vitro test methods.
The ICCVAM TMER and supporting
BRDs have been forwarded to U.S.
Federal agencies for regulatory and
other acceptance consideration, where
applicable. Responses received will be
posted on the NICEATM–ICCVAM Web
site.
ADDRESSES: Electronic copies of the
ICCVAM TMER and final BRD are
available from the NICEATM–ICCVAM
Web site at https://iccvam.niehs.nih.gov
or by contacting NICEATM (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Dr.
William S. Stokes, Director, NICEATM,
NIEHS, P.O. Box 12233, MD EC–17,
Research Triangle Park, NC 27709,
(telephone) 919–541–2384, (fax) 919–
541–0947, (e-mail)
niceatm@niehs.nih.gov Courier address:
NICEATM, NIEHS, 79 T.W. Alexander
Drive, Building 4401, Room 3128,
Research Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
In 2005, the European Centre for the
Validation of Alternative Methods
(ECVAM), a unit of the Institute for
Health and Consumer Protection at the
European Commission’s Joint Research
Centre, submitted BRDs for five in vitro
pyrogen test methods proposed as
replacements for the RPT to ICCVAM
for formal evaluation of their scientific
validity for regulatory testing purposes.
ICCVAM unanimously agreed that the
five submitted in vitro pyrogen test
methods should have high priority for
evaluation. On December 16, 2005,
NICEATM published a Federal Register
notice (Vol. 70, No. 241, pages 74833–
74834), requesting public comments on
the appropriateness and relative priority
of convening an independent peer
review panel (Panel) to evaluate the
validation status of the five in vitro
pyrogen test methods, the nomination of
scientists to serve on the Panel, and the
submission of data from in vivo and in
vitro pyrogenicity testing. Based on the
ECVAM BRDs as well as data and
VerDate Aug<31>2005
19:32 Nov 21, 2008
Jkt 217001
information submitted in response to
the aforementioned Federal Register
notice, NICEATM subsequently
compiled a comprehensive draft BRD on
the five in vitro pyrogen test methods
and released it for public comment on
December 12, 2006 (Vol. 71, No. 238,
pages 74533–74534).
On February 6, 2007, NICEATM and
ICCVAM convened a Panel to review
the ICCVAM draft BRD for errors and
omissions and to evaluate the validation
status of the five in vitro pyrogen test
methods. The Panel also reviewed the
extent that the information contained in
the ICCVAM draft BRD supported the
ICCVAM draft test method
recommendations for proposed test
method uses, standardized protocols,
test method performance standards, and
additional studies. The Panel
considered public comments made at
the Panel meeting, as well as public
comments submitted in advance of the
meeting, before concluding their
deliberations. NICEATM made the
Panel’s report available in May 2007
(Vol. 72, No. 89, pages 26395–26396).
The ICCVAM draft BRD and draft
recommendations, the Panel’s report,
and all public comments were made
available to the Scientific Advisory
Committee on Alternative Toxicological
Methods (SACATM) for review and
comment at their meeting on June 12,
2007 (Vol. 72, No. 83, pages 23831–
23832).
ICCVAM considered the Panel’s
report, all public comments, and the
comments of SACATM in finalizing its
recommendations on the use of these
five in vitro test methods proposed for
assessing potential pyrogenicity of
pharmaceuticals and other products.
The ICCVAM TMER includes the
ICCVAM recommendations on uses and
limitations for each test method,
standardized protocols, future studies,
and the development of performance
standards, as well as the Panel’s report
and Federal Register notices. The final
BRD, which provides the supporting
documentation for this report, is
available as a separate document.
ICCVAM forwarded the ICCVAM TMER
and the supporting final BRD to U.S.
Federal agencies for consideration, in
accordance with the ICCVAM
Authorization Act of 2000 (42 U.S.C.
285l–3). Agency responses to the
ICCVAM test method recommendations
will be made available on the
NICEATM–ICCVAM Web site as they
are received.
Background Information on ICCVAM,
NICEATM, and SACATM
ICCVAM is an interagency committee
composed of representatives from 15
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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
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 established 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 U.S.
Federal agencies. Additional
information about ICCVAM and
NICEATM can be found at https://
www.iccvam.niehs.nih.gov.
SACATM was established January 9,
2002 (Vol. 67, No. 49, page 11358), and
is composed of scientists from the
public and private sectors. SACATM
provides advice to the Director of the
NIEHS, to ICCVAM, and to NICEATM
regarding the statutorily mandated
duties of ICCVAM and activities of
NICEATM. Additional information
about SACATM, including the charter,
roster, and records of past meetings, can
be found at https://ntp.niehs.nih.gov/go/
167.
Dated: November 7, 2008.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E8–27790 Filed 11–21–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Membership on the Secretary’s
Advisory Committee on Human
Research Protections
Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
ACTION: Notice.
AGENCY:
Authority: 42 U.S.C. 217a, Section 222 of
the Public Health Service Act, as amended.
The Committee is governed by the provisions
of Public Law 92–463, as amended (5 U.S.C.
Appendix 2), which sets forth standards for
the formation and use of advisory
committees.
SUMMARY: The Office for Human
Research Protections (OHRP), a program
E:\FR\FM\24NON1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Notices]
[Pages 71003-71004]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27790]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Availability
of the Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) Test Method Evaluation Report: Validation
Status of Five In Vitro Test Methods Proposed for Assessing Potential
Pyrogenicity of Pharmaceuticals and Other Products and Final Background
Review Document: Validation Status of Five In Vitro Test Methods
Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and
Other Products; Notice of Transmittal of ICCVAM Test Method
Recommendations to Federal Agencies
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH)
ACTION: Availability of the ICCVAM Test Method Evaluation Report and
Final Background Review Document.
-----------------------------------------------------------------------
SUMMARY: NICEATM announces availability of the ICCVAM Test Method
Evaluation Report: Validation Status of Five In Vitro Test Methods
Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and
Other Products (NIH Publication 08-6392). The test method evaluation
report (TMER) describes five in vitro pyrogen test methods that can be
used for detecting Gram-negative endotoxin in human parenteral
pharmaceuticals. The report includes ICCVAM's (a) Recommendations on
uses and limitations for each test method, (b) recommendations for
standardized protocols, (c) recommendations for future studies, and (d)
recommendations for the development of performance standards.
ICCVAM concludes that none of these test methods can be considered
as a complete replacement for the rabbit pyrogen test (RPT) for all
testing situations for the detection of Gram-negative endotoxin.
However, ICCVAM recommends that they can be considered for use on a
case-by-case basis to detect Gram-negative endotoxin in human
parenteral drugs, subject to product-specific validation to demonstrate
equivalence to the RPT, in accordance with applicable U.S. Food and
Drug Administration regulations. When used in this manner, these
methods can reduce the number of animals needed for pyrogenicity
testing. The report also recommends that these
[[Page 71004]]
and other in vitro alternative test methods be considered prior to in
vivo pyrogenicity testing, where determined appropriate for a specific
testing situation.
NICEATM also announces availability of the final ICCVAM Background
Review Document: Validation Status of Five In Vitro Test Methods
Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and
Other Products (NIH Publication 08-6391). The final background review
document (BRD) provides the data and analyses used to assess the
current validation status of these five in vitro test methods.
The ICCVAM TMER and supporting BRDs have been forwarded to U.S.
Federal agencies for regulatory and other acceptance consideration,
where applicable. Responses received will be posted on the NICEATM-
ICCVAM Web site.
ADDRESSES: Electronic copies of the ICCVAM TMER and final BRD are
available from the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov or by contacting NICEATM (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director,
NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC
27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail)
niceatm@niehs.nih.gov Courier address: NICEATM, NIEHS, 79 T.W.
Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC
27709.
SUPPLEMENTARY INFORMATION:
Background
In 2005, the European Centre for the Validation of Alternative
Methods (ECVAM), a unit of the Institute for Health and Consumer
Protection at the European Commission's Joint Research Centre,
submitted BRDs for five in vitro pyrogen test methods proposed as
replacements for the RPT to ICCVAM for formal evaluation of their
scientific validity for regulatory testing purposes. ICCVAM unanimously
agreed that the five submitted in vitro pyrogen test methods should
have high priority for evaluation. On December 16, 2005, NICEATM
published a Federal Register notice (Vol. 70, No. 241, pages 74833-
74834), requesting public comments on the appropriateness and relative
priority of convening an independent peer review panel (Panel) to
evaluate the validation status of the five in vitro pyrogen test
methods, the nomination of scientists to serve on the Panel, and the
submission of data from in vivo and in vitro pyrogenicity testing.
Based on the ECVAM BRDs as well as data and information submitted in
response to the aforementioned Federal Register notice, NICEATM
subsequently compiled a comprehensive draft BRD on the five in vitro
pyrogen test methods and released it for public comment on December 12,
2006 (Vol. 71, No. 238, pages 74533-74534).
On February 6, 2007, NICEATM and ICCVAM convened a Panel to review
the ICCVAM draft BRD for errors and omissions and to evaluate the
validation status of the five in vitro pyrogen test methods. The Panel
also reviewed the extent that the information contained in the ICCVAM
draft BRD supported the ICCVAM draft test method recommendations for
proposed test method uses, standardized protocols, test method
performance standards, and additional studies. The Panel considered
public comments made at the Panel meeting, as well as public comments
submitted in advance of the meeting, before concluding their
deliberations. NICEATM made the Panel's report available in May 2007
(Vol. 72, No. 89, pages 26395-26396). The ICCVAM draft BRD and draft
recommendations, the Panel's report, and all public comments were made
available to the Scientific Advisory Committee on Alternative
Toxicological Methods (SACATM) for review and comment at their meeting
on June 12, 2007 (Vol. 72, No. 83, pages 23831-23832).
ICCVAM considered the Panel's report, all public comments, and the
comments of SACATM in finalizing its recommendations on the use of
these five in vitro test methods proposed for assessing potential
pyrogenicity of pharmaceuticals and other products. The ICCVAM TMER
includes the ICCVAM recommendations on uses and limitations for each
test method, standardized protocols, future studies, and the
development of performance standards, as well as the Panel's report and
Federal Register notices. The final BRD, which provides the supporting
documentation for this report, is available as a separate document.
ICCVAM forwarded the ICCVAM TMER and the supporting final BRD to U.S.
Federal agencies for consideration, in accordance with the ICCVAM
Authorization Act of 2000 (42 U.S.C. 285l-3). Agency responses to the
ICCVAM test method recommendations will be made available on the
NICEATM-ICCVAM Web site as they are received.
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 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
established 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 U.S. Federal agencies. Additional
information about ICCVAM and NICEATM can be found at https://www.iccvam.niehs.nih.gov.
SACATM was established January 9, 2002 (Vol. 67, No. 49, page
11358), and is composed of scientists from the public and private
sectors. SACATM provides advice to the Director of the NIEHS, to
ICCVAM, and to NICEATM regarding the statutorily mandated duties of
ICCVAM and activities of NICEATM. Additional information about SACATM,
including the charter, roster, and records of past meetings, can be
found at https://ntp.niehs.nih.gov/go/167.
Dated: November 7, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E8-27790 Filed 11-21-08; 8:45 am]
BILLING CODE 4140-01-P
