82 FR 29567 - Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 124 (June 29, 2017)

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices.'' The purpose of this workshop is to discuss potential scientific and regulatory challenges associated with developing traditional antimicrobial susceptibility testing (AST) devices and devices that detect antimicrobial resistance markers by molecular or novel diagnostic technologies, and to provide an overview of relevant provisions of the 21st Century Cures Act that may impact the development of such devices. Public input and feedback gained through this workshop will aid in the development of science-based approaches to regulatory decisionmaking regarding traditional and novel AST devices. Further, this workshop will explore opportunities for the efficient development and evaluation of AST devices, which may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship.

[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29567-29569]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13611]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3854]


Antimicrobial Susceptibility and Resistance: Addressing 
Challenges of Diagnostic Devices; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Antimicrobial 
Susceptibility and Resistance: Addressing Challenges of Diagnostic 
Devices.'' The purpose of this workshop is to discuss potential 
scientific and regulatory challenges associated with developing 
traditional antimicrobial susceptibility testing (AST) devices and 
devices that detect antimicrobial resistance markers by molecular or 
novel diagnostic technologies, and to provide an overview of relevant 
provisions of the 21st Century Cures Act that may impact the 
development of such devices. Public input and feedback gained through 
this workshop will aid in the development of science-based approaches 
to regulatory decisionmaking regarding traditional and novel AST 
devices. Further, this workshop will explore opportunities for the 
efficient development and evaluation of AST devices, which may lead to 
better patient care and reduce antimicrobial resistance through 
improved antibiotic stewardship.

DATES: The public workshop will be held on September 13, 2017, from 
8:30 a.m. to 5 p.m.
    Submit either electronic or written comments on this public 
workshop by October 20, 2017. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), 
Silver Spring, MD 20993. Entrance for the public meeting participants 
(non-FDA employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before October 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 20, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be public, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and

[[Page 29568]]

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-3854 for ``Antimicrobial Susceptibility and Resistance: 
Addressing Challenges of Diagnostic Devices.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Natasha Townsend, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5525, Silver Spring, MD 20993-0002, 301-
796-5927, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The accurate detection of antimicrobial resistance is important due 
to the emergence and spread of highly resistant pathogenic bacteria. 
Traditional AST systems continue to provide the bulk of antimicrobial 
susceptibility testing. However, the spread of antimicrobial resistance 
has spurred the development of a range of novel diagnostic technologies 
(e.g., detection of molecular resistance markers) that can provide more 
rapid bacterial identification and susceptibility testing results than 
is possible with current phenotypic methods. In light of the need for 
accurate susceptibility information and the development of these 
innovative diagnostic technologies, there is a need to explore and 
discuss new approaches for the efficient development and evaluation of 
AST devices--that are important to patient care and antibiotic 
stewardship--to allow for the timely availability of these devices.
    The purpose of the public workshop is to discuss potential 
scientific and regulatory challenges associated with developing 
traditional AST devices and devices that detect antimicrobial 
resistance markers by molecular or novel diagnostic technologies, and 
to provide an overview of relevant provisions of the 21st Century Cures 
Act that may impact the development of such devices. Specifically, 
section 3044 of the 21st Century Cures Act, entitled ``Susceptibility 
Test Interpretive Criteria for Microorganisms; Antimicrobial 
Susceptibility Testing Devices,'' adds section 511A to the Federal 
Food, Drug, and Cosmetic Act, which creates a new regulatory framework 
for updating AST devices with current susceptibility test interpretive 
criteria for approved antimicrobial drugs. Further, this workshop will 
explore opportunities for the efficient development and evaluation of 
AST devices, including new science-based approaches to regulatory 
decisionmaking regarding traditional and novel AST devices. In 
addition, FDA is considering the development of a draft guidance, and 
will look to the meeting to help inform the Agency's thinking on 
relevant topics. Therefore, FDA seeks input and feedback from industry, 
other government agencies, standard-setting organizations, clinical 
laboratories, and patient care professionals with an interest in the 
future development of AST devices.

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of brief presentations providing 
information to frame interactive discussions via two panel sessions. 
The presentations and panel discussions will focus on:
    1. Industry and FDA perspectives on AST device evaluation 
requirements, including opportunities to streamline the premarket 
review processes that may allow for more rapid availability of AST 
devices for new antimicrobial drugs;
    2. Performance review of traditional AST devices;
    3. An overview of relevant provisions of the 21st Century Cures Act 
that may impact the development of AST devices;
    4. The clinical laboratory perspective on AST result interpretation 
and reporting;
    5. Novel technologies for detection of resistance markers;
    6. Standards-setting organization perspective on reference methods 
and organism resources;
    7. The role of new technologies for promoting antibiotic 
stewardship, improving patient care, aiding the selection of 
appropriate antimicrobial therapy, and reducing the impact of 
antimicrobial resistance; and
    8. Direct-from-specimen testing and the challenges of the clinical 
use and phenotypic interpretation of genotypic results.

III. Participating in the Public Workshop

    Registration: 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 this public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone 
number.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by September 1, 2017, 4 p.m. Eastern Time. Early 
registration is recommended because seating is

[[Page 29569]]

limited; therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted. If time and space permit, onsite registration on the day of 
the public meeting/public workshop will be provided beginning at 8 a.m. 
We will let registrants know if registration closes before the day of 
the public workshop.
    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] no later than August 30, 2017.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during the public comment session, and 
which topic you wish to present. We will do our best to accommodate 
requests to make public comments. 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, we will determine the amount of time allotted to 
each presenter and the approximate time each oral presentation is to 
begin, and will select and begin notifying participants by September 5, 
2017. All requests to make oral presentations must be received by the 
close of registration on September 1, 2017. If selected for 
presentation, any presentation materials must be emailed to Natasha 
Townsend (see FOR FURTHER INFORMATION CONTACT) no later than September 
8, 2017, 5 p.m. No commercial or promotional material will be permitted 
to be presented or distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by September 8, 2017, 4 p.m. The Webcast link will be 
available on the registration Web page after September 8, 2017. 
Organizations are requested to register all participants, but to view 
using one connection per location.
    If you have never attended a Connect Pro event 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, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

    Dated: June 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13611 Filed 6-28-17; 8:45 am]
 BILLING CODE 4164-01-P