[Federal Register Volume 75, Number 201 (Tuesday, October 19, 2010)]
[Pages 64314-64315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26212]



Food and Drug Administration

[Docket No. FDA-2010-N-0487]

Product Development Program for Interventions in Patients With 
Severe Bleeding Due to Trauma or Other Causes; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


    The Food and Drug Administration (FDA) is announcing a 2-day public 
workshop entitled ``Product Development Program for Interventions in 
Patients with Severe Bleeding Due to Trauma or Other Causes.'' The 
purpose of this public workshop is to discuss possible paradigms for 
the evaluation of products indicated for use to stop severe bleeding. 
The workshop has been planned in partnership with the Department of 
Health and Human Services, Office of Public Health and Science; the 
National Heart, Lung and Blood Institute; and the Department of 
Defense. The public workshop will include presentations and panel 
discussions by experts from academic institutions, government agencies, 
and industry.
    Dates and Times: The public workshop will be held on December 9, 
2010, from 8 a.m. to 5:30 p.m. and December 10, 2010, from 8 a.m. to 1 
    Location: The public workshop will be held at the Masur Auditorium, 
10 Center Dr., Bldg. 10, Clinical Center, National Institutes of 
Health, Bethesda, MD 20892.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,

[[Page 64315]]

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 (see Contact Person) by November 19, 2010. 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 7:30 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: Severe bleeding may be encountered in both 
traumatic and non-traumatic clinical situations. New products for the 
treatment of severe bleeding are needed to reduce the need for blood 
transfusions, minimize complications resulting from blood loss, and 
improve patient outcomes. The development and approval of new products 
for use in treatment of severe bleeding, particularly severe bleeding 
resulting from trauma, has been complicated by the lack of a consensus 
definition of severe bleeding as well as the need to identify 
appropriate clinical endpoints for assessment of product safety and 
efficacy. Clinical endpoints may vary depending on the product 
indications, patient characteristics, nature of injury, whether the 
product acts locally or systemically, the nature of the product (e.g., 
device, drug, biologic, or combination), and conditions of use.
    Because it may not always be feasible to obtain standard informed 
consent, clinical trials of products used for the treatment of life-
threatening severe bleeding resulting from trauma may raise significant 
ethical and legal considerations. Researchers studying products for use 
in such circumstances may need guidance to carry out appropriate 
consultation with representatives of the communities in which the 
clinical investigation will be conducted and from which the study 
participants will be selected. Clinical trials on products intended for 
use in trauma are also complicated by the difficulty of identifying 
patients who may meet study inclusion criteria. Given these challenges, 
further discussion is needed about how products approved for use for 
treatment of severe bleeding occurring during surgery or due to non-
surgical conditions may best be evaluated for use in treatment of 
severe bleeding in trauma.
    The first day of the workshop will include presentations and panel 
discussions on the following topics: (1) Current clinical scientific 
knowledge concerning the pathophysiology of trauma and assessment of 
severe bleeding; (2) currently available locally acting and systemic 
products used to treat severe bleeding in trauma and non-trauma 
settings; (3) animal models for pre-clinical evaluation of products; 
(4) ethical considerations for clinical trials to evaluate products 
used in treatment of severe bleeding in trauma; and (5) clinical 
evaluation of products for bleeding interventions, including clinical 
trials and endpoints. The second day of the workshop will include a 
discussion of whether products with an indication for use in severe 
bleeding due to trauma can be evaluated in clinical settings other than 
a trauma clinical trial and a summary of the sessions presented at the 
    Transcripts: Please be advised that as soon as a transcript is 
available, it can be obtained in either hardcopy or on CD-ROM, after 
submission of a Freedom of Information request. Written requests are to 
be sent to Division of Freedom of Information (HFI-35), Office of 
Management Programs, Food and Drug Administration, 5600 Fishers Lane, 
rm. 6-30, Rockville, MD 20857. A transcript of the public workshop will 
be available on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.

    Dated: October 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26212 Filed 10-18-10; 8:45 am]