Document ID: FDA-2014-D-0191-0001
Agency: fda
Document Type: Notice
Title: Advancing Regulatory Science for High Throughput Sequencing Devices
for Microbial Identification and Detection of Antimicrobial Resistance
Markers AGENCY: Food and Drug Administration
Posted Date: 2014-03-07T05:00Z

[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Notices]
[Pages 13062-13063]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04940]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0191]

Advancing Regulatory Science for High Throughput Sequencing 
Devices for Microbial Identification and Detection of Antimicrobial 
Resistance Markers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Advancing Regulatory Science for High 
Throughput Sequencing Devices for Microbial Identification and 
Detection of Antimicrobial Resistance Markers.'' The purpose of the 
public workshop is to discuss the clinical and public health 
applications and performance validation of these devices, the quality 
criteria for establishing the accuracy of reference databases for 
regulatory use and ways to streamline clinical trials for microbial 
identification. This discussion is essential to establish the safety 
and effectiveness of high throughput sequencing devices when used to 
test human specimens or clinical isolates for the diagnosis of 
infectious diseases and detection of antimicrobial resistance markers.

DATES: Date and Time: The public workshop will be held on April 1, 
2014, from 9 a.m. to 4:30 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. 1503), 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.
    Contact Person: Heike Sichtig, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5269, Silver Spring, MD 20993-0002, email: 
Heike.Sichtig@fda.hhs.gov.
    Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this public workshop must 
register online by 5 p.m. on March 25, 2014. Early registration is 
recommended because seating is limited. FDA may limit the number of 
participants from each organization based on space limitations.

[[Page 13063]]

Registrants will receive confirmation once their registration has been 
accepted. Onsite registration on the day of the public workshop will be 
provided on a space-available basis 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 workshop.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events-Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm 
(select the appropriate meeting from the list). Please provide complete 
contact information for each attendee, including name, title, 
affiliation, email, and telephone number. If you are unable to register 
online, please contact Susan Monahan (301-796-5661, email: 
susan.monahan@fda.hhs.gov). Registration requests should be received by 
5 p.m., March 25, 2014.
    In advance of the meeting, registered attendees will receive a 
draft of FDA's proposed concept for the performance evaluation of High 
Throughput Sequencing Devices for Microbial Identification and 
Detection of Antimicrobial Resistance Markers. Additional information, 
including a workshop agenda, will be available at a later date.

SUPPLEMENTARY INFORMATION:

I. Background

    High throughput sequencing devices for the diagnosis of infectious 
diseases, including detection of antimicrobial resistance markers, are 
a new generation of diagnostic products that have the capability to 
simultaneously identify and differentiate a large number of microbial 
pathogens using a single clinical specimen or clinical isolate. These 
devices have already emerged as a critical tool in many research areas 
and soon they will become both a fixture in clinical microbiology 
reference laboratories and a routine part of diagnostic laboratory 
workflows. Use of this technology requires a process of sample/library 
preparation, sequencing, and output de-convolution/results 
interpretation. The identification of the organism or resistance marker 
is often based on genomic sequence information in comparison to 
reference databases that were created by the device manufacturer or are 
otherwise publicly available.
    High throughput sequencing devices have the potential to 
dramatically change clinical microbiology. These diagnostic devices 
present several advantages, such as identifying potential disease 
etiology in situations where many different pathogens share a common 
clinical manifestation without the need for any a priori target 
specific information to select the appropriate test. However, the 
processes of selecting the methods used to establish and validate the 
performance of these devices to make informed clinical and public 
health decisions pose significant scientific and regulatory challenges.
    The purpose of the public workshop is to discuss the implementation 
of high throughput sequencing devices for the diagnosis of infectious 
disease. Specifically, the FDA seeks input from clinical laboratories, 
infectious disease physicians, industry, government, academia, and 
other stakeholders on the following topics: Clinical applications and 
public health needs; device performance validation; reference 
databases; and ways to streamline clinical evaluations/trials for 
microbial identification. This information is viewed as essential in 
establishing the safety and effectiveness of high throughput sequencing 
devices when used for the clinical diagnosis of infectious diseases and 
markers of antimicrobial resistance from human specimens or clinical 
isolates.

II. Workshop Overview

    This public workshop will consist of brief presentations providing 
information to frame the goals of the workshop, and an interactive 
discussion. The presentations will focus on current and anticipated 
uses for high throughput sequencing devices, a proposal for the 
performance evaluation approach preferred by FDA, and information on 
the criteria for acceptable reference databases. Following the 
presentations there will be a moderated discussion where the 
participants will be asked to provide their individual perspectives. 
The outcome of the meeting will be captured and released as a draft 
guidance document.
    The draft guidance document 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 workshop 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 applications and public health needs: Identify specific 
applications where high throughput sequencing could be used for 
diagnosis of infectious diseases and markers of antimicrobial 
resistance from human specimens or clinical isolates.
    2. Device validation: Develop and adapt standards for the microbial 
genome sequencing process (from sample collection to result reporting), 
discuss best practices for sample/library preparation, variant 
identification, genome annotation, output de-convolution/results 
interpretation, and reporting.
    3. Reference databases: Develop quality criteria to establish 
accurate reference databases, methods for curating, maintaining, and 
updating these databases.
    4. Streamline clinical evaluations/trials for microbial 
identification: Establish a new comparator paradigm for high throughput 
sequencing as the reference method to augment or replace existing 
reference testing methods.

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., Rockville, 
MD 20857.

    Dated: February 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04940 Filed 3-6-14; 8:45 am]
BILLING CODE 4160-01-P