[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48169-48171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0557]


Advancing Regulatory Science for Highly Multiplexed Microbiology/
Medical Countermeasure Devices; Public Meeting

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: ``Advancing Regulatory Science for Highly Multiplexed 
Microbiology/Medical Countermeasure Devices.'' The purpose of the 
public meeting is to discuss performance evaluation of highly 
multiplexed microbiology/medical countermeasure (MCM) devices, their 
clinical application and public health/clinical needs, and quality 
criteria for establishing the accuracy of reference databases. These 
considerations are essential to establish the safety and effectiveness 
of highly multiplexed devices when used for the clinical diagnosis of 
infectious diseases from a human specimen.
    Date and Time: The public meeting will be held on October 13, 2011, 
from 8 a.m. to 6 p.m.
    Location: The public meeting will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31,

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rm. 1503 (the Great Room), Silver Spring, MD 20993-0002. 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 available to be viewed online via webcast.
    Contact Person: Raquel Peat, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 5561, Silver Spring, MD 20993-0002, 301-796-6218, e-mail: 
[email protected].
    Registration and Requests for Oral Presentations: If you wish to 
attend or view the webcast of the public meeting, you must register 
online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from 
the list).
    Provide complete contact information for each attendee, including 
name, title, affiliation, email, and telephone number. Registration 
requests should be received by September 13, 2011.
    If you wish to make an oral presentation during the open comment 
session at the meeting, you must indicate this at the time of 
registration. FDA has included general discussion topics for comment in 
section III of this document, Topics for Input. You should also 
identify which discussion topic you wish to address in your 
presentation. FDA will do its best to accommodate requests to speak. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations and to request time for a 
joint presentation. FDA will determine the amount of time allotted to 
each presenter and the approximate time that each oral presentation is 
scheduled to begin. If the number of registrants requesting to speak is 
greater than what can be reasonably accommodated during the scheduled 
open public hearing session, FDA may conduct a lottery to determine the 
speakers for the scheduled open comment session.
    Registration is free and will be on a first-come, first-served 
basis. Early registration is recommended because seating is limited. 
FDA may limit the number of participants from each organization based 
on space limitations. Registrants will receive confirmation once their 
registration has been accepted. Onsite registration on the day of the 
public meeting will be provided on a space-available basis beginning at 
7 a.m. Non-U.S. citizens are subject to additional security screening, 
and they should register as soon as possible.
    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, e-mail: 
[email protected] at least 7 days in advance of the meeting.
    Streaming Webcast of the Public Meeting: There will be a 
registration process for the webcast, and it will be on a first-come, 
first-served basis (maximum capacity: 900). 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.)
    Comments: In advance of the meeting, FDA will place its proposed 
evaluation approach to assess the performance of highly multiplexed 
microbiology/MCM devices on file in the public docket (docket number 
found in brackets in the heading of this document) and will post it at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments to be presented at 
this public meeting is September 13, 2011 (see section III of this 
document.)
    Regardless of attendance at the public meeting, interested persons 
may submit either electronic or written comments on any discussion 
topic(s) to the open docket. The deadline for submitting comments to 
the docket is September 13, 2011. 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. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, if 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.

SUPPLEMENTARY INFORMATION:

I. Background

    Highly multiplexed devices for the diagnosis of infectious 
diseases, including those caused by MCM-related pathogens, are a new 
generation of diagnostic products designed to simultaneously identify 
and differentiate a large number of pathogens from a single clinical 
specimen. This involves the testing of multiple targets through a 
common process of sample preparation, amplification and/or detection, 
and result interpretation. The identification of the organism is often 
based on sequence information compared to reference databases created 
either by the device manufacturer or otherwise publicly available.
    These diagnostic devices present several advantages, such as 
identifying potential disease etiology in situations where many 
different pathogens share a common clinical manifestation and the 
simultaneous detection of co-infections. However, establishing and 
validating the performance of these devices to make informed clinical 
and public health decisions poses significant scientific challenges. 
This public meeting is to discuss the performance evaluation of highly 
multiplexed microbiology/MCM device, their clinical application and 
public health/clinical needs and quality criteria for establishing the 
accuracy of reference databases. These considerations are essential to 
establish the safety and effectiveness of highly multiplexed devices 
when used for the clinical diagnosis of infectious diseases from a 
human specimen.
    FDA is holding this public meeting to obtain input from academia, 
government, industry, clinical laboratories, and other stakeholders on 
the performance evaluation approach to be proposed by FDA, which 
includes validation methods, reference panels, and bioinformatic 
concepts needed to address the clinical and analytical performance 
requirements for highly multiplexed microbiology/MCM devices. The 
ultimate goal is to advance regulatory science for highly multiplexed 
devices used in pathogen detection in order to ensure their safety and 
effectiveness and thereby provide potential clinical and public health 
benefits.

II. Meeting Overview

    The public meeting will consist of presentations providing 
background on current and anticipated uses for highly multiplexed 
microbiology devices that may contain MCM analytes, the performance 
evaluation approach

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proposed by FDA, and information on reference databases; an open public 
comment session; and an open discussion on selected topics raised by 
the presentations (see section III of this document.) During the 
discussions, the participants will not be asked to develop consensus 
opinions but rather to provide their individual perspectives.
    Additional information, including a meeting agenda, will be 
available on the Internet, immediately after publication of this 
document in the Federal Register. The evaluation approach proposed by 
FDA is expected to be available at a later date. 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 Input

    FDA will seek input on its proposed performance evaluation 
approach, which will include the following topics:
    1. Clinical Application of Highly Multiplexed Microbiology Devices: 
Their clinical application and public health/clinical needs; inclusion 
of MCM-related pathogens that are expected to be rarely present in the 
tested specimens; the composition of clinically relevant panels of 
pathogens; the interpretation of the test results taking into 
consideration the possible detection of microorganisms that are not 
clinically relevant, and what is known and unknown about co-infections.
    2. Device Evaluation: How to evaluate the analytical and clinical 
performance of highly multiplexed microbiology devices; approaches to 
device validation when positive specimens are not easily available, 
which is the case for many MCM pathogens; sufficiency, feasibility, and 
practicality of the proposed FDA evaluation approach to establish 
device performance.
    3. Reference Databases: Quality criteria for establishing the 
accuracy of reference databases; methods for curating, maintaining, and 
updating these databases; what is the current practice for creating and 
maintaining reference databases.

IV. 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 (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., rm. 1050, 
Rockville, MD 20857.

    Dated: August 2, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19996 Filed 8-5-11; 8:45 am]
BILLING CODE 4160-01-P