[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68422-68424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23924]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2655]
Center for Devices and Radiological Health Veteran Amputee
Devices; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Center for Devices and
Radiological Health Veteran Amputee Devices.'' The purpose of this
workshop is to engage all stakeholders involved in the research,
development, and marketing of prosthetic limb medical devices used by
veteran amputees. A specific goal is to engage veteran amputees who use
prosthetic limb medical devices and hear their views on these devices
so that these perspectives may be considered in the total product life
cycle of prosthetic limb devices.
DATES: The public workshop will be held on October 31, 2016, from 9
a.m. to 4 p.m. Submit either electronic or written comments on the
public workshop by November 30, 2016.
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. 1503), 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:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 posted, 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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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.''
[[Page 68423]]
Instructions: All submissions received must include the Docket No.
FDA-2016-N-2655 for ``Center for Devices and Radiological Health
Veteran Amputee Devices.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Fabienne Santel, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3502, Silver Spring, MD 20993, 301-796-
9644, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Center for Devices and Radiological Health (CDRH) is committed
to including views of patients on the total product life cycle of
medical devices. To better understand their needs, CDRH plans to engage
patients throughout our regulatory process. CDRH is interested in
patients contributing their views, data, and resources to improve the
total product life cycle for medical devices, reduce adverse events,
and improve communication about the risks and benefits that matter most
to them.
Together with other centers and offices across FDA, we are testing
and developing ways to engage patients and capture their views through
public workshops. The CDRH Veteran Amputee Devices is one such workshop
intended to engage veteran amputees, such as those patients from the
Walter Reed National Military Medical Center, Warrior Clinic, who use
prosthetic limb medical devices.
II. Topics for Discussion at the CDRH Veteran Amputee Devices Public
Workshop
Topics to be discussed at the public workshop include, but are not
limited to the following:
Introduce the CDRH Total Product life Cycle (TPLC) for
prosthetic limb devices.
A focus group to obtain information on priorities for
upper-limb prosthetics from the perspective of upper-limb amputees.
Presentations from prosthetic limb device manufacturer.
Question and answer session where patients, their
caregivers and other interested parties have an opportunity to present
their views and ask questions about the total product life cycle of
medical devices.
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending the CDRH Veteran
Amputee Devices public workshop must register online by October 24,
2016. 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 begin at 8 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health,
Office of Communication, Education (OCE), 301-796-5661 email:
[email protected] no later than October 17, 2016.
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 meeting/public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number. Those without Internet access should contact Fabienne Santel to
register (see FOR FURTHER INFORMATION CONTACT). 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. The Webcast link will be available on the registration
Web page after October 21, 2016. Organizations are requested 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.
Requests for Oral Presentations: This public workshop includes a
public comment session and topic-focused sessions. During online
registration, you may indicate if you wish to present during a public
comment session or participate in a specific session, and which topics
you wish to address. FDA has included general topics in this document.
FDA will do its best to accommodate requests to make public comments or
give presentations during the focused sessions. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. FDA will determine the amount of
time allotted to each presenter and the approximate time each oral
presentation is to begin, and will select and notify participants by
October 17, 2016. All requests to make oral presentations must be
received by October 10, 2016. If selected for presentation, any
presentation materials must be emailed to Fabienne Santel (see FOR
FURTHER INFORMATION CONTACT) no later than October 28, 2016. If you are
a manufacturer and wish to have a display table, please submit this
[[Page 68424]]
request by October 17, 2016. Space is limited; therefore, FDA will
select and notify manufacturers by October 24, 2016. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
FDA is holding this public workshop to obtain views from patients
on prosthetic limb devices so that these perspectives may be considered
in the total product life cycle of prosthetic limb 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 patient workshop is November 30, 2016.
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 ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov. A link to the transcripts 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: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23924 Filed 10-3-16; 8:45 am]
BILLING CODE 4164-01-P