[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Pages 52746-52748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-21400]



Food and Drug Administration

[Docket No. FDA-2012-N-0913]

Medical Countermeasures for a Burn Mass Casualty Incident

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for abstracts for poster 


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Medical Countermeasures (MCM) for 
a Burn Mass Casualty Incident.'' The purpose of this public workshop is 
to describe medical countermeasure requirements for burn injuries of 
radiological, nuclear, or chemical origin in a scarce resources 
environment; identify gaps in the product landscape so as to articulate 
a consensus-based needs assessment; discuss testing approaches and 
regulatory pathways; and to educate workshop attendees on the concept 
of medical utilization and response integration. The overall goal is to 
engage stakeholders across the public and private sector in strategic 
dialogue related to development, evaluation, deployment, and monitoring 
of medical countermeasures to mitigate the adverse health consequences 
arising from public health emergencies, specifically those involving 
radiological, nuclear, or chemical threats.
    Date and Time: The public workshop will be held on September 27, 
2012, from 8:30 a.m. to 5 p.m. and September 28, 2012, from 8:30 a.m. 
to 12 p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (rm. 1503A), Silver Spring, MD 20993. Entrance for the 
public meeting participants (non-FDA-employees) is through Building 1 
where routine security check procedures will be performed. For parking 
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact: Suzanne Schwartz, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. G439, 301-796-6970, Fax: 301-847-8507, email: 
[email protected].
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 5 p.m. on September 21, 2012. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permit, onsite registration on the day 
of the public workshop will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Cindy Garris, email: [email protected] or phone: 301 
796-5861 no later than September 21, 2012.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone number. Those without 
Internet access should contact Suzanne Schwartz to register (see 
Contact). Registrants will receive confirmation after they have been 
accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will

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also be webcast. Persons interested in viewing the webcast must 
register online by 5 p.m. September 13, 2012. Early registration is 
recommended because webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after September 21, 2012. If you have never attended 
a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get 
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site 
addresses in this document, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Requests for Poster Presentations: This public workshop will 
include a poster session. During online registration you may indicate 
if you wish to present an abstract during the poster session. FDA has 
identified general topics in this document. FDA will do its best to 
accommodate requests for poster presentation and will select and notify 
participants by September 7, 2012. All abstract submissions for poster 
presentations must be emailed to Suzanne Schwartz (see Contact) no 
later than 5 p.m. on August 31, 2012. No commercial promotional 
material will be permitted to be presented or distributed at the public 
    Comments: FDA is holding this public workshop to obtain information 
on medical countermeasures for a burn mass casualty incident. In order 
to permit the widest possible opportunity to obtain public comment, FDA 
is soliciting either electronic or written comments on all aspects of 
the public workshop topics. The deadline for submitting comments 
related to this public workshop is October 31, 2012. However, only 
comments received prior to August 31, 2012 will be incorporated into 
the workshop while comments received after that date will be reviewed 
by FDA after the conclusion of the workshop.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic or written comments. Submit electronic 
comments to http://www.regulations.gov. Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary 
to send one set of comments. Please identify comments with the docket 
number found in brackets in the heading of this document. In addition, 
when responding to specific topics as outlined in section II of this 
document, please identify the topic you are addressing. Received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday and will be posted to the docket 
at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)


I. Background

    The Public Health Emergency Medical Countermeasures Enterprise 
(PHEMCE) was established by the Department of Health and Human Services 
(HHS) in 2006 as a Federal inter-Agency coordinating body responsible 
for providing recommendations to the Secretary of HHS on medical 
countermeasure priorities, development and acquisition activities, and 
strategies for distributing and using medical countermeasures held in 
the Strategic National Stockpile (SNS) to prevent or mitigate potential 
health effects from exposure to chemical, biological, radiological, and 
nuclear agents and other terrorist threats. The PHEMCE mission is 
therefore to advance national preparedness for natural, accidental, and 
intentional threats by coordinating medical countermeasure-related 
efforts within HHS and in cooperation with PHEMCE inter-Agency 
    The 2012 PHEMCE Strategy has established the following 4 goals over 
the next 5 years: (1) Identify, create, develop, manufacture, and 
procure critical medical countermeasures; (2) establish and communicate 
clear regulatory pathways to facilitate medical countermeasures 
development and use; (3) develop logistics and operational plans for 
optimized use of medical countermeasures at all levels of response; and 
(4) address medical countermeasure gaps for all sectors of the American 
population. This is a complex mission space and many Federal Agencies, 
including FDA, have responsibilities that are critical to its success.
    FDA is hosting this public workshop to address topics specific to 
national preparedness for a burn mass casualty incident of 
radiological, nuclear, or chemical origin. The blast and subsequent 
fires from such weapons could inflict serious thermal burns. With 
respect to a nuclear detonation, these injuries could affect hundreds 
to thousands of people. In such an attack, stabilizing individuals with 
burns and concomitant injuries becomes an immediate priority. Medical 
care for burns in a mass casualty incident would require the ready 
availability of large quantities of medical countermeasures for 
resuscitation, wound management, pain relief, and nutritional- and 
airway/breathing support in the initial post-injury period. The overall 
response is further complicated by the complex, expensive, and 
resource-intensive needs that extend over the longer-term treatment 
period for serious burns compounded by burn care expertise being in 
short supply.
    There are approximately 1,850 burn beds in 126 burn units across 
the United States. The American Burn Association estimates that 700-800 
of these beds may be occupied at any given time. To respond to a mass 
casualty incident such as a nuclear detonation--whereupon an estimated 
10,000 or more individuals could require specialized burn care--
patients may need to be transferred to specialized burn centers 
throughout the country because there may be relatively few dedicated 
burn beds available in the region. Also, patients may need to be 
treated in other care sites, such as local or regional trauma centers, 
if specialized burn centers are filled to capacity. The short supply of 
specialized burn experts and facilities may need to be considered one 
driver in regard to burn care product(s) design and development, 
enabling versatile use in the hands of nonspecialists as well.

II. Topics for Discussion at the Public Workshop

    The workshop sessions will focus on the following general topics: 
Product (drug, device, biologic, and combination products) development 
challenges; clinical study design considerations for new products; 
regulatory pathways to market; challenges related to the organization 
and delivery of burn care

[[Page 52748]]

in disaster management (including medical utilization and response 
integration); FDA's role in coordination with the Centers for Disease 
Control and Prevention for deployment of assets in SNS; protecting the 
public from counterfeit as well as nonregulated ineffective products; 
FDA's responsibility for developing and implementing strategies to 
assess, evaluate and monitor medical countermeasure safety, 
performance, and patient compliance during and after a burn mass 
casualty incident; and a discussion of specific medical countermeasure 
needs for at-risk individuals.

    Dated: August 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-21400 Filed 8-29-12; 8:45 am]