Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices, 41417-41418 [2012-17082]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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: https://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 https://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:  https://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 https://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 https://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at https://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 
https://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 https://www.regulations.gov. This information will also be 
available at  https://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