Meeting of the Advisory Committee on Blood Safety and Availability, 71003 [E8-27852]
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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
sroberts on PROD1PC70 with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Aug<31>2005
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
]]>Agencies
[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Notices]
[Page 71003]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27852]
[[Page 71003]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Blood Safety and
Availability
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
-----------------------------------------------------------------------
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.
FOR FURTHER INFORMATION CONTACT: 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 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]
BILLING CODE 4150-41-P
