[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Page 43601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18110]



Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Risks and Benefits of Hydroxyethyl Starch Solutions; Public 

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: [email protected].
    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 
    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 
    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]