[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18611-18612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0257]
Summit on Color in Medical Imaging; Cosponsored Public Workshop;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of cosponsored public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) and cosponsor
International Color Consortium (ICC) are announcing the following
public workshop entitled ``Summit on Color in Medical Imaging: An
International Workshop on the Technical Framework for Consistency and
Interoperability Approaches for Dealing with Color in Medical Images.''
The purpose of the workshop is to bring together key stakeholders to
clearly identify areas of need, investigate solutions, and propose
best-practice approaches. The recommendations of the summit might
include the creation of a technical special interest group either as
part of the ICC or in some other forum and the establishment of best-
practice guidelines for industry.
DATES: Date and Time: The workshop will be held on May 8 and 9, 2013,
from 8:30 a.m. to 5 p.m.
Location: 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
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.
Contact: Aldo Badano, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm.
3116, Silver Spring, MD 20993-0002, 301-796-2534,
[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 April 26, 2013. 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 7:30 a.m.
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, mailing address, email address, and telephone
number. Those without Internet access should contact Susan Monahan at
301-796-5661 to register. Registrants will receive confirmation after
they have been accepted. You will be notified if you are on a waiting
list.
If you need special accommodations due to a disability, please
contact Susan Monahan ([email protected] or 301-796-5661) no
later than April 26, 2013.
Streaming Webcast of the Public Workshop: This workshop will also
be available via Webcast. Persons interested in viewing the Webcast
must register online by 5 p.m. on April 26, 2013. 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 May 2, 2013. 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.)
Requests for Oral Presentations: This workshop includes a public
comment session. If you wish to present during a public comment
session, you must indicate this at the time of registration. You shall
also submit a title and short abstract of your comments to Veronika
Lovell at [email protected].
Comments: FDA is holding this public workshop to obtain information
on the topics identified in Section II. No commercial or promotional
material will be permitted to be presented or distributed at the
workshop. 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 May 31, 2013.
Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments. Submit electronic
comments to http://www.regulations.gov. Submit 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. Please identify comments with the docket
number found in brackets in the heading of this document. In addition,
when responding to specific topics as outlined in section II, please
identify the topic 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
[[Page 18612]]
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 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).
SUPPLEMENTARY INFORMATION:
I. Background
There is increased utilization of color in several areas of medical
imaging and a wider range of availability of a variety of hardware and
software platforms that rely on medical and non-medical devices to
implement medical imaging product solutions for color imagery. This new
reality has brought up issues related to the interoperability of
devices and to the framework of accurately dealing with color data in
medical imaging products. This workshop brings together key
stakeholders to clearly identify areas of need, investigate solutions
and propose best-practice approaches. The recommendations of the summit
might include the creation of a technical special interest group either
as part of the ICC or in some other forum and the establishment of
best-practice guidelines for industry. The summit will address emerging
utilization of color in medical imaging in areas including clinical
photography, ophthalmic photography, digital microscopy, digital
histopathology, endoscopy, laparoscopy, telemedicine, handheld mobile
displays, display devices, color measurement, and standards and
professional group recommendations from organizations such as the
Digital Imaging and Communications in Medicine, ICC, International
Commission on Illumination, International Electrotechnical Commission,
and American Association of Physicists in Medicine.
I. Topics
There is increasing use of color in medical imaging but so far
there is no clear definition of a technical framework for color
management across the imaging chain from acquisition, pre- and post-
processing, to storage, transfer and display. Due to the increasing use
of color images and the need for integrated electronic health records,
this issue is of current relevance for device manufacturers, users, and
regulators. In addition, topics might include color methods for
handheld display devices, system approaches for color consistency, and
inter-vendor interoperability.
Scheduled session topics include: (1) General landscape of color
use in medical imaging, (2) whole-slide imagers and digital microscopy/
histopathology, (3) endoscopy and laparoscopy, (4) other medical
imaging modalities, (5) standards and professional organization
recommendations, (6) color in telemedicine, and (7) color in mobile
displays.
Dated: March 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07031 Filed 3-26-13; 8:45 am]
BILLING CODE 4160-01-P