[Federal Register Volume 79, Number 16 (Friday, January 24, 2014)]
[Pages 4166-4167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01412]



Food and Drug Administration

[Docket No. FDA-2014-N-0056]

Biofilms, Medical Devices, and Anti-Biofilm Technology--
Challenges and Opportunities; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Biofilms, Medical Devices, and Anti-Biofilm 
Technology--Challenges and Opportunities.'' FDA is cosponsoring this 
workshop with the Center for Biofilm Engineering of Montana State 
University. The purpose of the public workshop is to initiate dialogue 
between academia, industry, and U.S. Government scientists on the 
science of developing products to address biofilm formation. Topics of 
discussion include current scientific and medical research on biofilms, 
their impact on medical devices, and biofilm prevention strategies and 
their public health impact.

DATES: The public workshop will be held on February 20, 2014, from 8 
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public 
workshop 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.

FOR FURTHER INFORMATION CONTACT: Geetha Jayan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 3622, Silver Spring, MD 20903-0002, 301-796-6300, 
email: [email protected].

    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 5 p.m. February 7, 2014. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permit, onsite registration on the day 
of the public workshop will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, (email: [email protected] or phone: 301-
796-5661) no later than February 7, 2014.
    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, email, and telephone number. Those without Internet 
access should contact Susan Monahan to register. Registrants will 
receive confirmation after they have been accepted. You will be 
notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by 5 p.m. (EST) on February 6, 2014. Early registration 
is recommended because Webcast connections are limited. Organizations 
are requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after February 14, 2014. 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, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Comments: FDA is holding this public workshop to obtain information 
on biofilms and anti-biofilm technology on medical devices. In order to 
permit the widest possible opportunity to obtain public comment, FDA is 
soliciting either electronic or written comments on all aspects of the 
public workshop topics. The deadline for submitting comments related to 
this public workshop is March 20, 2014.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or 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. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II, please identify the question 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 and 
will be posted to the docket at http://www.regulations.gov.
    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 (see Comments). 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 the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available

[[Page 4167]]

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).

I. Background

    Biofilms play a key role in the development of device-related and 
other healthcare associated infections. Published literature indicates 
that biofilms are a major culprit in the development of resistant 
infections. However, the biochemical and physiochemical characteristics 
of biofilms are not widely understood.
    With the increasing use of implanted and indwelling devices, 
understanding biofilm development on these devices and factors that 
impact biofilm formation is critical. Research on the basic science of 
biofilms may provide insight on device-associated biofilms, ultimately 
advancing research on technologies that are intended to prevent biofilm 
    This public workshop seeks to share scientific information between 
academia, industries interested in developing products to address 
biofilm contamination, and U.S. Government scientists.

II. Topics for Discussion at the Public Workshop

    FDA seeks to address and receive comments on the following topics:
    1. Research on biofilms and their public health impact.
    2. Challenges faced by the scientific community, government, and 
industry on addressing biofilm contamination of medical devices.
    3. Critical areas of research that will address the scientific and 
clinical challenges faced by the stakeholders when developing 
technologies that are intended to prevent biofilm formation.
    This public workshop may also form the basis for future discussions 
related to novel biofilm prevention technologies that could benefit 
U.S. public health.

    Dated: January 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01412 Filed 1-23-14; 8:45 am]