[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Notices]
[Pages 13062-13063]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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:
[email protected] 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:
[email protected]). 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]
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