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Daily Rules, Proposed Rules, and Notices of the Federal Government

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.
SUMMARY: 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 tohttp://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.govor 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 athttp://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 (seeContact). 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 willalso 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 athttps://collaboration.fda.gov/common/help/en/support/meeting_test.htm.To get a quick overview of the Connect Pro program, visithttp://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 theFederal 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 (seeContact) 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 tohttp://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 athttp://www.regulations.gov.

Transcripts:Please be advised that as soon as a transcript is available, it will be accessible athttp://www.regulations.gov.It may be viewed at the Division of Dockets Management (seeComments). 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 athttp://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 carein 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.