
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68435-68437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2873]


Workshop on 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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SUMMARY: The Centers for Disease Control and Prevention (CDC), the Food 
and Drug Administration (FDA), the National Library of Medicine (NLM) 
of the National Institutes of Health (NIH), the Office of the National 
Coordinator for Health Information Technology (ONC), and the Centers 
for Medicare and Medicaid Services (CMS) are announcing the following 
public workshop entitled ``CDC/FDA/NLM/ONC/CMS Workshop on Promoting 
Semantic Interoperability of Laboratory Data.'' The purpose of this 
public workshop is to receive and discuss input from stakeholders 
regarding

[[Page 68436]]

proposed approaches to facilitate the adoption and implementation of 
interoperability standards in a manner that enables consistent, 
accurate, and harmonized descriptions of in vitro diagnostic tests and 
results.

DATES: The public workshop will be held on November 8, 2016, from 8 
a.m. to 5 p.m. (EDT). Submit either electronic or written comments on 
the public workshop by December 9, 2016.

ADDRESSES: The public workshop will be held at the NLM NIH Bethesda 
Campus, 8600 Rockville Pike, NIH Building 38A, Bethesda, MD 20894. For 
general information, including parking and security information, please 
refer to: https://www.nlm.nih.gov/about/lhcaud_gen.html.
    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.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2873 for the ``CDC/FDA/NLM/ONC/CMS Workshop on Promoting 
Semantic Interoperability of Laboratory Data.'' 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. EDT, 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: Michael Waters, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4535, Silver Spring, MD 20993-0002, 301-796-4653, 
FAX: 301-847-2512, email: michael.waters@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    This public workshop is a followup to the FDA/CDC/NLM Workshop on 
``Promoting Semantic Interoperability of Laboratory Data'' held on 
September 28, 2015. For more information on the content of the previous 
public workshop, the Webcast, the transcript, and any presentations 
from the 2015 workshop can be found at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm453897.htm.
    The primary purpose of the current workshop is to discuss with 
stakeholders the means to facilitate adoption and implementation of 
interoperability standards in a manner that enables consistent, 
accurate, and harmonized electronic health data reporting. Specifically 
this workshop will discuss aspects of semantic interoperability of 
laboratory data including the use of Logical Observation Identifiers 
Names and Codes (LOINC; http://loinc.org/) for identifying laboratory 
tests and the use of Uniform Systematized Nomenclature of Medicine-
Clinical Terms (SNOMED-CT; http://www.ihtsdo.org/snomed-ct) coding sets 
for describing results of qualitative test results.
    In order to build on the foundations of what was discussed during 
the 2015 workshop, discussions will begin by summarizing the previous 
workshop and addressing questions and concerns that were raised at the 
previous meeting. These conversations will be followed by a discussion 
on potential mechanisms for implementation of structured communication 
models containing device information, LOINC (http://loinc.org/), 
transmission codes, and other information that can be used to 
consolidate a semantically interoperable and transmittable message.

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of brief presentations to provide 
a framework and a context for a series of interactive panel 
discussions. Presentations will focus on mechanisms for attaining 
harmonized semantically interoperable information and advancing the 
probable functional models for information transmission, including 
possible challenges and solutions for implementation. Presentations and 
discussions will address proposals for harmonization

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and communication that can facilitate practical adoption of 
semantically interoperable data. Following the presentations on each 
topic, 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, CDC, FDA, NLM, ONC, and CMS will place 
an agenda on file in the public docket (the 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. 
See DATES for the deadline for submitting comments to the agenda for 
the public workshop.
    The agencies will use the input from this workshop and public 
comments to determine the appropriate next steps to advance semantic 
interoperability of laboratory data.
    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. (EDT) October 28, 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 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 Rebecca Goodwin at 301-496-4441 (Rebecca.Goodwin@nih.gov) and/
or the Federal Relay at 1-800-877-8339. Requests should be made no 
later than November 3, 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 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 Michael Waters 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 videocast. Videocast access will be available at https://videocast.nih.gov/. The videocast link will also be available on the 
registration Web page. FDA has verified the Web site addresses, 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. 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. 
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 public comment session. Following the close of 
registration, 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 November 1, 2016. All 
requests to make oral presentations must be received by the close of 
registration on 4 p.m. (EDT) October 28, 2016. If selected for 
presentation, any presentation materials must be emailed to Michael 
Waters (see FOR FURTHER INFORMATION CONTACT) no later than October 28, 
2016. No commercial or promotional material will be permitted to be 
presented or distributed at the public workshop.
    CDC, FDA, NLM, ONC, and CMS are holding this public workshop to 
obtain input from stakeholders regarding proposed approaches to 
facilitate the adoption and implementation of interoperability 
standards in a manner that enables consistent, accurate, and harmonized 
electronic laboratory reporting. 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. See DATES for the deadline for submitting comments to the 
agenda for the public workshop.
    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 transcript 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 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23894 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P


