[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18611-18612]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07031]


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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.

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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, 
Aldo.Badano@fda.hhs.gov.
    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 (Susan.Monahan@fda.hhs.gov 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 Veronika.lovell@sunchemical.com.
    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