Approaches to Reduce Risk of Transfusion-Transmitted Babesiosis in the United States; Public Workshop, 39972 [E8-15799]
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Federal Register / Vol. 73, No. 134 / Friday, July 11, 2008 / Notices
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Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: July 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15766 Filed 7–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Approaches to Reduce Risk of
Transfusion-Transmitted Babesiosis in
the United States; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Approaches to Reduce the
Risk of Transfusion-Transmitted
Babesiosis in the United States.’’ The
purpose of the public workshop is to
discuss the risk and possible approaches
to minimize the incidence of
transfusion-transmitted babesiosis in the
United States. We are convening this
workshop at the present time because
FDA has observed a recent increase in
the number of reports of transfusiontransmitted babesiosis, thus warranting
additional discussion to address this
blood safety issue. The public workshop
will feature presentations and
roundtable discussions led by experts
from academic institutions, government,
and industry.
Date and Time: The public workshop
will be held on September 12, 2008,
from 7:30 a.m. to 5:30 p.m.
VerDate Aug<31>2005
17:19 Jul 10, 2008
Jkt 214001
Location: The public workshop will
be held at the Lister Hill Center
Auditorium, Bldg. 38A, National
Institutes of Health, 8800 Rockville
Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax or e-mail your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
contact person by August 25, 2008.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is limited
to 175 attendees. Registration on the day
of the public workshop will be provided
on a space available basis beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: Babesiosis
is a malaria-like illness caused by
infection of erythrocytes with protozoan
parasites belonging to the genus
Babesia. Transfusion-transmitted
babesiosis is caused by transfusion of
blood or blood components collected
from donors infected with Babesia
parasites. During the last 40 years, more
than 60 cases of transfusion-transmitted
babesiosis have been recognized in the
United States. In fiscal years 2006 and
2007, FDA received a total of five
reports of fatal transfusion-transmitted
babesiosis (primary or contributory
cause of death) in the United States.
The public workshop will facilitate a
scientific discussion on approaches to
reduce the risk of transfusiontransmitted babesiosis in the United
States. Topics to be discussed include:
(1) Biology, pathogenesis, transmission
and epidemiology of babesiosis; (2) risk
of Babesia infections through
transfusion of blood and blood
components; (3) laboratory testing to
detect Babesia infections; and, (4)
possible approaches, including donor
testing and donor deferral, to reduce the
risk of transfusion-transmitted
babesiosis while maintaining blood
availability and safety.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
accepted by FDA only through FDMS at
https://www.regulations.gov.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/cber/
minutes/workshop-min.htm.
Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15799 Filed 7–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting
Members on Public Advisory
Committee, Food Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Food Advisory Committee
(FAC), Center for Food Safety and
Applied Nutrition (CFSAN).
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: Nominations received on or
before August 11, 2008 will be given
first consideration for membership on
the Food Advisory Committee.
Nominations received after August 11,
2008 will be considered for nomination
to the committee should nominees still
be needed.
ADDRESSES: All Nominations for
membership should be sent
electronically to CV@FDA.HHS.GOV or
by mail to: Advisory Committee
Oversight and Management Staff, 5600
Fisher Lane (HF–4), rm. 15A–12,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is
Carolyn Jeletic, Center for Food Safety
and Applied Nutrition, 301–436–1913,
FAX: 301–436–2633, e-mail:
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 73, Number 134 (Friday, July 11, 2008)]
[Notices]
[Page 39972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15799]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Approaches to Reduce Risk of Transfusion-Transmitted Babesiosis
in the United States; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Approaches to Reduce the Risk of Transfusion-
Transmitted Babesiosis in the United States.'' The purpose of the
public workshop is to discuss the risk and possible approaches to
minimize the incidence of transfusion-transmitted babesiosis in the
United States. We are convening this workshop at the present time
because FDA has observed a recent increase in the number of reports of
transfusion-transmitted babesiosis, thus warranting additional
discussion to address this blood safety issue. The public workshop will
feature presentations and roundtable discussions led by experts from
academic institutions, government, and industry.
Date and Time: The public workshop will be held on September 12,
2008, from 7:30 a.m. to 5:30 p.m.
Location: The public workshop will be held at the Lister Hill
Center Auditorium, Bldg. 38A, National Institutes of Health, 8800
Rockville Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax or e-mail your registration information
(including name, title, firm name, address, telephone and fax numbers)
to the contact person by August 25, 2008. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited to 175 attendees. Registration on the day of the
public workshop will be provided on a space available basis beginning
at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: Babesiosis is a malaria-like illness caused
by infection of erythrocytes with protozoan parasites belonging to the
genus Babesia. Transfusion-transmitted babesiosis is caused by
transfusion of blood or blood components collected from donors infected
with Babesia parasites. During the last 40 years, more than 60 cases of
transfusion-transmitted babesiosis have been recognized in the United
States. In fiscal years 2006 and 2007, FDA received a total of five
reports of fatal transfusion-transmitted babesiosis (primary or
contributory cause of death) in the United States.
The public workshop will facilitate a scientific discussion on
approaches to reduce the risk of transfusion-transmitted babesiosis in
the United States. Topics to be discussed include: (1) Biology,
pathogenesis, transmission and epidemiology of babesiosis; (2) risk of
Babesia infections through transfusion of blood and blood components;
(3) laboratory testing to detect Babesia infections; and, (4) possible
approaches, including donor testing and donor deferral, to reduce the
risk of transfusion-transmitted babesiosis while maintaining blood
availability and safety.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at https://www.fda.gov/cber/minutes/workshop-min.htm.
Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15799 Filed 7-10-08; 8:45 am]
BILLING CODE 4160-01-S
