Risks and Benefits of Hydroxyethyl Starch Solutions; Public Workshop, 43601 [2012-18110]
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Federal Register / Vol. 77, No. 143 / Wednesday, July 25, 2012 / Notices
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Risks and Benefits of Hydroxyethyl
Starch Solutions; Public Workshop
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Risks and Benefits of
Hydroxyethyl Starch Solutions.’’ The
purpose of this public workshop is to
discuss new information on the risks
and benefits of FDA-approved
hydroxyethyl starch (HES) solutions.
The public workshop has been
planned in partnership with the
Department of Defense and the National
Heart, Lung and Blood Institute,
National Institutes of Health, and will
include presentations and panel
VerDate Mar<15>2010
17:49 Jul 24, 2012
Jkt 226001
HES
solutions are synthetic colloids
administered intravenously to patients
to maintain or expand plasma volume
when clinically indicated. Currently,
three such products are approved by
FDA. HES solutions are indicated for
the treatment of hypovolemia (low
blood volume) that may result from
trauma, sepsis, burns, or anaphylaxis.
These products are used in the
prehospital and hospital environment in
both military and civilian settings. This
public workshop will serve as a forum
for discussing new information on the
potential effects of HES solutions on
hemostasis and on the renal system.
The first day of the public workshop
will include presentations and panel
discussions on the following topics: (1)
The risks and benefits associated with
HES solutions in different clinical
settings and (2) the findings of two
recent major clinical studies conducted
on HES solutions.
The second day of the public
workshop will include a summary
discussion and presentations
concerning the overall safety profile of
HES solutions and a discussion of future
SUPPLEMENTARY INFORMATION:
[FR Doc. 2012–18095 Filed 7–24–12; 8:45 am]
AGENCY:
discussions with experts from academia,
regulated industry, government, and
other stakeholders.
Date and Time: The public workshop
will be held on September 6, 2012, from
8:00 a.m. to 5:30 p.m., and September 7,
2012, from 8:30 a.m. to 1:00 p.m.
Location: The public workshop will
be held at the Masur Auditorium,
National Institutes of Health, 10 Center
Dr., Bldg. 10, Clinical Center, Bethesda,
MD 20892.
Contact Person: Jennifer Scharpf,
Center for Biologics Evaluation and
Research (HFM–300), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
Phone: 301–827–6128, FAX: 301–827–
2843, email:
CBEROBRRWorkshops@fda.hhs.gov.
Registration: Mail, fax, or email your
registration information (including
name, title, firm or organization name,
address, telephone and fax numbers,
and email address) to Jennifer Scharpf
(see Contact Person) by August 15,
2012. There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:00
a.m. If you need special
accommodations due to a disability,
please contact Jennifer Scharpf (see
Contact Person) at least 7 days in
advance.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
43601
clinical research for the evaluation of
HES solutions.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857.
Dated: July 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18110 Filed 7–24–12; 8:45 am]
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[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Notices]
[Page 43601]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18110]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Risks and Benefits of Hydroxyethyl Starch Solutions; 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: ``Risks and Benefits of Hydroxyethyl Starch
Solutions.'' The purpose of this public workshop is to discuss new
information on the risks and benefits of FDA-approved hydroxyethyl
starch (HES) solutions.
The public workshop has been planned in partnership with the
Department of Defense and the National Heart, Lung and Blood Institute,
National Institutes of Health, and will include presentations and panel
discussions with experts from academia, regulated industry, government,
and other stakeholders.
Date and Time: The public workshop will be held on September 6,
2012, from 8:00 a.m. to 5:30 p.m., and September 7, 2012, from 8:30
a.m. to 1:00 p.m.
Location: The public workshop will be held at the Masur Auditorium,
National Institutes of Health, 10 Center Dr., Bldg. 10, Clinical
Center, Bethesda, MD 20892.
Contact Person: Jennifer Scharpf, Center for Biologics Evaluation
and Research (HFM-300), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448, Phone: 301-827-6128, FAX:
301-827-2843, email: CBEROBRRWorkshops@fda.hhs.gov.
Registration: Mail, fax, or email your registration information
(including name, title, firm or organization name, address, telephone
and fax numbers, and email address) to Jennifer Scharpf (see Contact
Person) by August 15, 2012. There is no registration fee for the public
workshop. Early registration is recommended because seating is limited.
Registration on the day of the public workshop will be provided on a
space available basis beginning at 7:00 a.m. If you need special
accommodations due to a disability, please contact Jennifer Scharpf
(see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: HES solutions are synthetic colloids
administered intravenously to patients to maintain or expand plasma
volume when clinically indicated. Currently, three such products are
approved by FDA. HES solutions are indicated for the treatment of
hypovolemia (low blood volume) that may result from trauma, sepsis,
burns, or anaphylaxis. These products are used in the prehospital and
hospital environment in both military and civilian settings. This
public workshop will serve as a forum for discussing new information on
the potential effects of HES solutions on hemostasis and on the renal
system.
The first day of the public workshop will include presentations and
panel discussions on the following topics: (1) The risks and benefits
associated with HES solutions in different clinical settings and (2)
the findings of two recent major clinical studies conducted on HES
solutions.
The second day of the public workshop will include a summary
discussion and presentations concerning the overall safety profile of
HES solutions and a discussion of future clinical research for the
evaluation of HES solutions.
Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857.
Dated: July 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18110 Filed 7-24-12; 8:45 am]
BILLING CODE 4160-01-P
