Meeting of the Advisory Committee on Blood Safety and Availability, 22950 [E8-9230]
Download as PDF
<![CDATA[
22950
Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Non-Participants (or Proxies) ........
Telephone Interview .....................
Mary Oliver-Anderson,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E8–9176 Filed 4–25–08; 8:45 am]
BILLING CODE 4150–05–P
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:
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 Thursday, May 29
and Friday, May 30, 2008.
DATES: The meeting will take place
Thursday, May 29 and Friday, May 30,
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: Updates
will be provided to the Committee on
previous recommendations as follows:
At the January 2003 meeting of the
ACBSA, the Committee recognized that
the leading causes of transfusion related
fatalities were: bacterial contamination
of platelets; hemolysis, primarily due to
errors in release and administration of
incorrect blood; and transfusion related
acute lung injury (TRALI). Progress has
been made on all three of these causes
of transfusion related fatalities. Updates
will be provided on the rate of bacterial
contamination and reports of sepsis
associated with 5 day and 7 day dating
of apheresis platelets and on the use of
improved methods to reduce errors in
the identification of patients and
pwalker on PROD1PC71 with NOTICES
SUMMARY:
VerDate Aug<31>2005
18:22 Apr 25, 2008
Jkt 214001
Number of responses per
respondent
600
transfusion products. In addition, the
Committee will review progress made to
reduce the risk of TRALI. In 2007, the
AABB recommended to its institutional
members to devise strategies to reduce
the risk of TRALI in transfused patients.
Total voluntary implementation was to
be complete by November 2008. To this
end, many blood centers and hospitals
have implemented strategies to decrease
the adverse risk of TRALI by using male
only apheresis platelets and plasma
donors. Various strategies will be
presented and discussed as well as
messaging to potential donors.
The Committee will also hear an
update from the Food and Drug
Administration’s sponsored public
workshop entitled: ‘‘Hemoglobin Based
Oxygen Carriers: Current Status and
Future Directions,’’ which will be held
on April 29 and 30, 2008. The
Committee will also hear an update
from Health Resources and Services
Administration (HRSA) regarding its
April 4, 2008 meeting on potential
rulemaking with respect to vascularized
composite allografts and whether
vascularized composite allografts
should be included within the
definition of organs covered by the
regulations governing the operation of
the Organ Procurement and
Transplantation Network and covered
by section 301 of the National Organ
Transplant Act of 1984.
The Committee will then be asked to
discuss and make recommendations on
reports of adverse outcomes associated
with transfusion of older red cells.
There have been additional studies and
peer reviewed publications reporting
adverse outcomes associated with the
administration of red cells older than 14
days of storage. Currently human red
cells for transfusion are good for up to
42 days of storage depending on the
anticoagulant and additive solutions
used in storage. Presentations and
discussions will review current blood
distribution and transfusion practices as
well as available outcome data related to
clinical studies with older red cells.
Public comment will be solicited on
both May 29 and 30, 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Average burden
per response
(in hours)
1
Total burden
hours
27/60
270
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 May
27, 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 May 27, 2008.
Dated: April 22, 2008.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on
Blood Safety and Availability.
[FR Doc. E8–9230 Filed 4–25–08; 8:45 am]
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the President’s Council on
Physical Fitness and Sports
Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
ACTION: Notice.
AGENCY:
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (DHHS) is hereby giving notice
that the President’s Council on Physical
Fitness and Sports will hold a meeting.
This meeting is open to the public. A
description of the Council’s functions is
included also with this notice.
DATES: May 14, 2008, from 9 a.m. to 4
p.m.
ADDRESSES: Department of Health and
Human Services, Hubert H. Humphrey
Building, Room 800, 200 Independence
Avenue, SW., Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Melissa Johnson, Executive Director,
President’s Council on Physical Fitness
and Sports, Hubert H. Humphrey
Building, Room 738H, 200
Independence Avenue, SW.,
Washington, DC 20201, (202) 690–5187.
SUPPLEMENTARY INFORMATION: The
President’s Council on Physical Fitness
and Sports (PCPFS) was established
originally by Executive Order 10673,
dated July 16, 1956. PCPFS was
established by President Eisenhower
after published reports indicated that
American boys and girls were unfit
compared to the children of Western
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Notices]
[Page 22950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9230]
-----------------------------------------------------------------------
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
Thursday, May 29 and Friday, May 30, 2008.
DATES: The meeting will take place Thursday, May 29 and Friday, May 30,
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: Updates will be provided to the Committee on
previous recommendations as follows:
At the January 2003 meeting of the ACBSA, the Committee recognized
that the leading causes of transfusion related fatalities were:
bacterial contamination of platelets; hemolysis, primarily due to
errors in release and administration of incorrect blood; and
transfusion related acute lung injury (TRALI). Progress has been made
on all three of these causes of transfusion related fatalities. Updates
will be provided on the rate of bacterial contamination and reports of
sepsis associated with 5 day and 7 day dating of apheresis platelets
and on the use of improved methods to reduce errors in the
identification of patients and transfusion products. In addition, the
Committee will review progress made to reduce the risk of TRALI. In
2007, the AABB recommended to its institutional members to devise
strategies to reduce the risk of TRALI in transfused patients. Total
voluntary implementation was to be complete by November 2008. To this
end, many blood centers and hospitals have implemented strategies to
decrease the adverse risk of TRALI by using male only apheresis
platelets and plasma donors. Various strategies will be presented and
discussed as well as messaging to potential donors.
The Committee will also hear an update from the Food and Drug
Administration's sponsored public workshop entitled: ``Hemoglobin Based
Oxygen Carriers: Current Status and Future Directions,'' which will be
held on April 29 and 30, 2008. The Committee will also hear an update
from Health Resources and Services Administration (HRSA) regarding its
April 4, 2008 meeting on potential rulemaking with respect to
vascularized composite allografts and whether vascularized composite
allografts should be included within the definition of organs covered
by the regulations governing the operation of the Organ Procurement and
Transplantation Network and covered by section 301 of the National
Organ Transplant Act of 1984.
The Committee will then be asked to discuss and make
recommendations on reports of adverse outcomes associated with
transfusion of older red cells. There have been additional studies and
peer reviewed publications reporting adverse outcomes associated with
the administration of red cells older than 14 days of storage.
Currently human red cells for transfusion are good for up to 42 days of
storage depending on the anticoagulant and additive solutions used in
storage. Presentations and discussions will review current blood
distribution and transfusion practices as well as available outcome
data related to clinical studies with older red cells.
Public comment will be solicited on both May 29 and 30, 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 May 27, 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
May 27, 2008.
Dated: April 22, 2008.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on Blood Safety and
Availability.
[FR Doc. E8-9230 Filed 4-25-08; 8:45 am]
BILLING CODE 4150-41-P
