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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of public meeting; request for comments.

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,                           ( print page 48170)                        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:                     *raquel.peat@fda.hhs.gov.*

*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:                     *susan.monahan@fda.hhs.gov*                     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                           ( print page 48171)                        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