[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52746-52748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21400]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
presentation.
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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:
Suzanne.Schwartz@fda.hhs.gov.
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: Cynthia.garris@fda.hhs.gov 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
workshop.
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.)
SUPPLEMENTARY INFORMATION:
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
partners.
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
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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]
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