Workshop on Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments, 68435-68437 [2016-23894]
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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
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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 https://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’’).
mstockstill on DSK3G9T082PROD with NOTICES
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–
2011–D–0376 for ‘‘Dietary Supplements:
New Dietary Ingredient Notifications
and Related Issues; Revised Draft
Guidance for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://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
VerDate Sep<11>2014
19:01 Oct 03, 2016
Jkt 241001
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 https://
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: https://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 https://
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: Cara
Welch, Office of Dietary Supplement
Programs, Center for Food Safety and
Applied Nutrition (HFS–810), Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2333.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 12, 2016, we
published a notice announcing the
availability of a revised draft guidance
for industry entitled ‘‘Dietary
Supplements: New Dietary Ingredient
Notifications and Related Issues.’’ The
revised draft guidance, when finalized,
will help industry in evaluating whether
to submit a premarket safety notification
for a new dietary ingredient (NDI), or for
a dietary supplement containing an NDI,
and in preparing such premarket safety
notifications (also referred to as NDI
notifications). section III of the notice
(81 FR 53486 at 53489), ‘‘Other Issues
for Consideration,’’ listed specific issues
to be addressed.
The notice provided a 60-day period
for the submission of comments
pertaining to the revised draft guidance,
PO 00000
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68435
including in particular (but not limited
to) section III. Comments on these
issues, the revised draft guidance, and
the relevant portions of the 2011 draft
guidance, will contribute to our final
guidance on new dietary ingredient
notifications and related issues. The
comment period was scheduled to end
on October 11, 2016.
We received requests for 30- and 90day extensions of the comment period.
In general, the requests conveyed
concern that the current 60-day
comment period does not allow
sufficient time for interested parties to
develop a meaningful or thoughtful
response to the draft guidance. Some
requests mentioned that the requests for
comment may necessitate indepth
research and/or require supporting data
to provide meaningful responses.
We considered the requests and are
extending the comment period for the
draft guidance for 60 days until
December 12, 2016. We believe that this
extension allows adequate time for
interested persons to submit comments
without significantly delaying finalizing
the guidance.
Dated: September 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–23931 Filed 10–3–16; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public workshop;
request for comments.
ACTION:
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
SUMMARY:
E:\FR\FM\04OCN1.SGM
04OCN1
68436
Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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’’).
mstockstill on DSK3G9T082PROD with NOTICES
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,
VerDate Sep<11>2014
19:01 Oct 03, 2016
Jkt 241001
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
https://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 https://
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: https://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 https://
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,
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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: https://
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;
https://loinc.org/) for identifying
laboratory tests and the use of Uniform
Systematized Nomenclature of
Medicine-Clinical Terms (SNOMED–CT;
https://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 (https://
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
E:\FR\FM\04OCN1.SGM
04OCN1
mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
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 https://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 https://
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
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19:01 Oct 03, 2016
Jkt 241001
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 https://
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
https://www.fda.gov. A link to the
transcript will also be available
approximately 45 days after the public
workshop on the Internet at https://
PO 00000
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Fmt 4703
Sfmt 9990
68437
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Mentored Patient-Oriented Research Review
Committee October 27–28, 2016.
Date: October 27–28, 2016.
Time: 8:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Cambria Suites—Rockville 1 Helen
Heneghan Way, Rockville, MD 20850.
Contact Person: Stephanie Johnson Webb,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7196, Bethesda, MD 20892, 301–
435–0291, stephanie.webb@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 28, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–23881 Filed 10–3–16; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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: https://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; https://loinc.org/) for identifying laboratory
tests and the use of Uniform Systematized Nomenclature of Medicine-
Clinical Terms (SNOMED-CT; https://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 (https://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
[[Page 68437]]
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 https://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 https://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 https://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
https://www.fda.gov. A link to the transcript will also be available
approximately 45 days after the public workshop on the Internet at
https://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
