[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]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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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: http://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