[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41417-41418]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17082]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0622]
Regulatory Science Considerations for Medical Countermeasure
Radiation Biodosimetry Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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The Food and Drug Administration (FDA) is announcing the following
public meeting entitled ``Regulatory Science Considerations for Medical
Countermeasure (MCM) Radiation Biodosimetry Devices.'' The purpose of
the public meeting is to obtain input from academia, Government,
industry, and other stakeholders on the clinical application and
scientific and technological challenges for performance validation of
radiation biodosimetry devices.
Date and Time: The public meeting will be held on September 27 and
28, 2012, from 8 a.m. to 5 p.m.
Location: The public meeting will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Bldg. 1 where
routine security check procedures will be performed. For parking and
security information, please visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The public meeting will also
be webcast.
Contact: Jennifer S. Dickey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 4254, Silver Spring, MD 20993-0002, 301-796-5028, Fax: 301-847-
8512, email: Jennifer.Dickey@fda.hhs.gov.
Registration: Registration is free and will be on a first-come,
first-served basis. Persons interested in attending this public meeting
must register online by 4 p.m., September 13, 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 permits, onsite registration on the day of the public meeting
will be provided beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321,
Silver Spring, MD 20993-0002, 301-796-5661, email:
Susan.Monahan@fda.hhs.gov at least 7 days in advance of the meeting.
To register for the public meeting, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public meeting from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, email, and telephone number. Those without Internet
access should contact Susan Monahan to register (see previous
paragraph). 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 Meeting: This public meeting will
also be webcast. Persons interested in viewing the webcast must
register online by 4 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 20, 2012. If you have never attended
a Connect Pro meeting 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 Oral Presentations: This public meeting includes
public comment sessions. During online registration you may indicate if
you wish to present during a public comment session or participate in a
specific session, and which topics you wish to address. FDA has
included general topics in this document. FDA will do its best to
accommodate requests to make public comment. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation. Following the close of registration, FDA will determine
the amount of time allotted to each presenter and the approximate time
that each oral presentation is to begin, and will select and notify
participants by September 18, 2012. All requests to make oral
presentations must be received by the close of registration on
September 13, 2012 by 4 p.m. If selected for presentation, any
presentation materials must be emailed to Jennifer Dickey (see Contact)
no later than September 24, 2012. No commercial or promotional material
will be permitted to be presented or distributed at the meeting.
Comments: FDA is holding this public meeting to obtain information
on the clinical application and scientific and technological challenges
for performance validation of radiation biodosimetry devices. In order
to permit
[[Page 41418]]
the widest possible opportunity to obtain public comment, FDA is
soliciting either electronic or written comments on all aspects of the
public meeting topics. The deadline for submitting comments related to
this public meeting is October 12, 2012 (2 weeks after the public
meeting).
Regardless of attendance at the public meeting, 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 III 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 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 transcript will also be available
approximately 45 days after the public meeting on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this meeting from the posted events list.)
SUPPLEMENTARY INFORMATION:
I. Background
In the event of an accident or terrorist attack that exposes a
large population to radiation, an accurate assessment of the absorbed
ionizing radiation dose received by victims will be essential for
triage and medical management. Because there is currently no cleared or
approved radiation biodosimeter for use in a mass exposure scenario,
the development of proper radiation biodosimetry tools is a critical
unmet public health need. However, because it is impossible to obtain
samples that accurately reflect the intended use population of the
device, validating the performance of radiation biodosimeters poses
significant scientific and regulatory challenges. As such, FDA is
holding this public meeting to obtain input from academia, Government,
industry, and other stakeholders on the clinical application and
scientific and technological challenges for performance validation of
radiation biodosimetry devices. Individual perspectives from meeting
participants may help to identify solutions for the scientific
challenges associated with radiation biodosimetry development, and may
clarify the regulatory path forward to ensure device safety and
effectiveness and thereby provide significant clinical and public
health benefits.
II. Meeting Overview
The public meeting will consist of the following: (1) Presentations
providing background on anticipated uses of radiation biodosimetry
medical countermeasure devices, (2) the device design and performance
evaluation challenges identified by FDA, (3) specific technology
considerations in radiation biodosimetry, (4) an open public comment
session, and (5) an open discussion on topics identified by FDA and
those raised by the presentations (see section III of this document).
The purpose of this meeting is for participants to share individual
perspectives during the discussions. FDA is not seeking group opinions,
recommendations, or advice on any matter. Additional information,
including a meeting agenda, will be available on the Internet
immediately after publication of this document in the Federal Register.
This information will be placed on file in the public docket (docket
number found in brackets in the heading of this document), which is
available at http://www.regulations.gov. This information will also be
available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select the appropriate meeting from
the list.)
III. Topics for Discussion at the Public Meeting
The following questions represent the kinds of topics that will be
discussed at the meeting.
1. Performance Evaluation for Radiation Biodosimetry:
A. What data would support the use of ex vivo radiation human
samples in device performance validation?
B. What types of in vivo radiation human samples may be available
to validate the performance of radiation biodosimeters?
C. What pre-clinical or clinical animal model testing might be
necessary to demonstrate radiation biodosimeter performance?
D. Would a non-human primate pivotal clinical study be appropriate
to support clearance/approval of biodosimetry MCM devices?
E. What data would support device applicability to both partial
body and total body irradiation scenarios?
F. How should the impact of delays in sampling, delays in testing,
combined injury, and other potential confounders on the performance of
a radiation biodosimeter be assessed?
G. What challenges does the use of novel technologies bring to
radiation biodosimetry development and performance validation?
2. Public Health Considerations for Radiation Biodosimetry:
A. What device design elements would address the need for rapid
patient triage in a crisis scenario?
B. What device design elements should be included to account for
the potential for high demand, device use by untrained medical
personnel, and therapeutic decisionmaking based on limited resources?
C. What information should the Agency clarify in regards to the
regulatory path forward for radiation biodosimetry MCM devices?
Dated: July 5, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17082 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P