[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46010-46012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18910]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2372]


Promoting Semantic Interoperability of Laboratory Data; Public 
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA), the Centers for Disease 
Control and Prevention (CDC), and the National Library of Medicine 
(NLM) of the National Institutes of Health are announcing the following 
public workshop entitled ``FDA/CDC/NLM Workshop on Promoting Semantic 
Interoperability of Laboratory Data.'' The purpose of this workshop is 
to receive and discuss input from stakeholders regarding proposed 
approaches to promoting the semantic interoperability of laboratory 
data between in vitro diagnostic devices and database systems, 
including laboratory information systems and electronic health records.
    Date and Time: The public workshop will be held on September 28, 
2015, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Building 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.
    Contact Person: Steven Gitterman, Food and Drug Administration, 
Center for Devices and Radiological Health, Bldg. 66, Rm. 5518, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6694, FAX: 
301-847-2512, 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 4 p.m. September 18, 2015. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the public workshop will be provided beginning at 7 a.m. (EDT).
    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. 32, Rm. 5231, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
[email protected] no later than 4 p.m. on September 14, 2015.
    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 and affiliation, address, 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

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online by September 18, 2015, 4 p.m. 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 September 23, 2015. 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 public workshop includes a 
public comment session. During online registration you may indicate if 
you wish to present during a public comment session, and which topics 
you wish to address. FDA has included general topics in this document 
which will be addressed in greater detail in a subsequent discussion 
paper (see SUPPLEMENTARY INFORMATION). FDA will do its 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, or submit requests for designated representatives to 
participate in the focused sessions. All requests to make oral 
presentations must be received by September 2, 2015. 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 September 7, 2015. If selected for presentation, any 
presentation materials must be emailed to Michael Waters at 
[email protected] no later than September 18, 2015, 5 p.m. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public workshop.
    Comments: FDA, CDC, and NLM are holding this public workshop to 
receive input from stakeholders and discuss proposed approaches to 
promoting the semantic interoperability of laboratory data between in 
vitro diagnostic devices and database systems, including electronic 
health records. 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 4 p.m. on 
October 26, 2015.
    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. 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 
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 broad acknowledgement that interoperability between 
information providers and information consumers is essential for 
progress in health care. Semantic interoperability is the building 
block for permitting meaningful use of medical information across 
disparate systems; it is essential for supporting patient care, medical 
research, epidemiology, and numerous other patient health public health 
goals.
    Laboratory tests are a critical aspect of patient care that may 
influence between 70 to 80 percent of clinical decisions and represent 
an important target for achieving interoperability. Much of laboratory 
information is directly generated by medical devices and as such should 
be readily amenable to standardization that would enable semantic 
interoperability; however, significant challenges exist both in the 
adoption of standards by device manufacturers and implementation by 
clinical and public health laboratories. FDA, CDC, and NLM are in 
unique positions to encourage and promote the adoption of standards for 
laboratory data that can enable semantic interoperability through the 
public health mandate of the Department of Human and Health Services 
(HHS), the role of FDA in device regulation, the leadership role of CDC 
in laboratory science and support, and the pivotal role of NLM in the 
development, enhancement, and adoption of clinical vocabulary 
standards.
    The primary purpose of this workshop is to discuss and receive 
input from stakeholders regarding standards for the reporting of 
laboratory data and means to facilitate adoption by industry and 
laboratories. Specific models for semantic interoperability of 
laboratory data will be discussed, including the use of Logical 
Observation Identifiers Names and Codes (LOINC) for identifying 
laboratory tests, uniform Systematized Nomenclature of Medicine-
Clinical Terms (SNOMED-CT) coding sets for describing results of 
qualitative test results and Unified Code for Units of Measure (UCUM) 
reporting of quantitative results. The use of other standards within 
interoperable laboratory result messages such as Unique Device 
Identifier (UDI) codes will also be addressed, as well as mechanisms 
for distributing device coding information such as Structured Product 
Labeling (SPL) or Electronically Exchanging Directory of Services 
(eDOS). Specifically, NLM, CDC, and FDA seek input from laboratorians, 
industry, government, academia, health care practitioners, and other 
stakeholders on these topics. This discussion is viewed as essential in 
expediting the adoption of standards to facilitate semantic 
interoperability of laboratory results.

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of brief presentations providing 
information to frame the goals of the workshop, and an interactive 
discussion via several panel sessions. The presentations will focus on 
proposed interoperability standards and mechanisms to promote adoption 
and implementation. Following the presentations there will be a 
moderated discussion where the participants and additional panelists 
will be asked to provide their individual perspectives.
    In advance of the meeting, FDA, CDC, and NLM will place a summary 
of the issues they believe need to be addressed for promoting semantic 
interoperability

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on file in the public docket (docket number found in brackets in the 
heading of this document) and will post it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The 
deadline for submitting comments to this document for presentation at 
the public workshop is September 18, 2015, although comments related to 
this document can be made until September 28, 2015.
    The Agencies will use the input from this workshop and public 
comments to determine appropriate next steps to advance sematic 
interoperability of laboratory data.

    Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18910 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P