81 FR 68435 - Workshop on Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 192 (October 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 192 (October 4, 2016)
| Page Range | 68435-68437 | |
| FR Document | 2016-23894 |
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)] [Notices] [Pages 68435-68437] From the Federal Register Online [www.thefederalregister.org] [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: 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: [email protected]. 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 [[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 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 ([email protected]) 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
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Electronic Submissions information you claim to be confidential including in particular (but not limited
Submit electronic comments in the with a heading or cover note that states to) section III. Comments on these
following way: ‘‘THIS DOCUMENT CONTAINS issues, the revised draft guidance, and
• Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The the relevant portions of the 2011 draft
www.regulations.gov. Follow the Agency will review this copy, including guidance, will contribute to our final
instructions for submitting comments. the claimed confidential information, in guidance on new dietary ingredient
Comments submitted electronically, its consideration of comments. The notifications and related issues. The
including attachments, to http:// second copy, which will have the comment period was scheduled to end
www.regulations.gov will be posted to claimed confidential information on October 11, 2016.
the docket unchanged. Because your redacted/blacked out, will be available We received requests for 30- and 90-
comment will be made public, you are for public viewing and posted on http:// day extensions of the comment period.
solely responsible for ensuring that your www.regulations.gov. Submit both In general, the requests conveyed
comment does not include any copies to the Division of Dockets concern that the current 60-day
confidential information that you or a Management. If you do not wish your comment period does not allow
third party may not wish to be posted, name and contact information to be sufficient time for interested parties to
such as medical information, your or made publicly available, you can develop a meaningful or thoughtful
anyone else’s Social Security number, or provide this information on the cover response to the draft guidance. Some
confidential business information, such sheet and not in the body of your requests mentioned that the requests for
as a manufacturing process. Please note comments and you must identify this comment may necessitate indepth
that if you include your name, contact information as ‘‘confidential.’’ Any research and/or require supporting data
information, or other information that information marked as ‘‘confidential’’ to provide meaningful responses.
identifies you in the body of your will not be disclosed except in We considered the requests and are
comments, that information will be accordance with 21 CFR 10.20 and other extending the comment period for the
posted on http://www.regulations.gov. applicable disclosure law. For more draft guidance for 60 days until
• If you want to submit a comment information about FDA’s posting of December 12, 2016. We believe that this
with confidential information that you comments to public dockets, see 80 FR extension allows adequate time for
do not wish to be made available to the 56469, September 18, 2015, or access interested persons to submit comments
public, submit the comment as a the information at: http://www.fda.gov/ without significantly delaying finalizing
written/paper submission and in the regulatoryinformation/dockets/ the guidance.
manner detailed (see ‘‘Written/Paper default.htm. Dated: September 28, 2016.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Leslie Kux,
read background documents or the
Written/Paper Submissions Associate Commissioner for Policy.
electronic and written/paper comments
received, go to http:// [FR Doc. 2016–23931 Filed 10–3–16; 8:45 am]
Submit written/paper submissions as
www.regulations.gov and insert the BILLING CODE 4164–01–P
follows:
• Mail/Hand delivery/Courier (for docket number, found in brackets in the
written/paper submissions): Division of heading of this document, into the
‘‘Search’’ box and follow the prompts DEPARTMENT OF HEALTH AND
Dockets Management (HFA–305), Food HUMAN SERVICES
and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. Food and Drug Administration
• For written/paper comments 1061, Rockville, MD 20852.
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Cara [Docket No. FDA–2016–N–2873]
Management, FDA will post your Welch, Office of Dietary Supplement
Programs, Center for Food Safety and Workshop on Promoting Semantic
comment, as well as any attachments,
Applied Nutrition (HFS–810), Food and Interoperability of Laboratory Data;
except for information submitted,
Drug Administration, 5001 Campus Dr., Public Workshop; Request for
marked and identified, as confidential,
College Park, MD 20740, 240–402–2333. Comments
if submitted as detailed in
‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: In the AGENCY: Food and Drug Administration,
Instructions: All submissions received Federal Register of August 12, 2016, we HHS.
must include the Docket No. FDA– published a notice announcing the ACTION: Notice of public workshop;
2011–D–0376 for ‘‘Dietary Supplements: availability of a revised draft guidance request for comments.
New Dietary Ingredient Notifications for industry entitled ‘‘Dietary
and Related Issues; Revised Draft Supplements: New Dietary Ingredient SUMMARY: The Centers for Disease
Guidance for Industry.’’ Received Notifications and Related Issues.’’ The Control and Prevention (CDC), the Food
comments will be placed in the docket revised draft guidance, when finalized, and Drug Administration (FDA), the
and, except for those submitted as will help industry in evaluating whether National Library of Medicine (NLM) of
‘‘Confidential Submissions,’’ publicly to submit a premarket safety notification the National Institutes of Health (NIH),
viewable at http://www.regulations.gov for a new dietary ingredient (NDI), or for the Office of the National Coordinator
or at the Division of Dockets a dietary supplement containing an NDI, for Health Information Technology
Management between 9 a.m. and 4 p.m., and in preparing such premarket safety (ONC), and the Centers for Medicare
Monday through Friday. notifications (also referred to as NDI and Medicaid Services (CMS) are
mstockstill on DSK3G9T082PROD with NOTICES
• Confidential Submissions—To notifications). section III of the notice announcing the following public
submit a comment with confidential (81 FR 53486 at 53489), ‘‘Other Issues workshop entitled ‘‘CDC/FDA/NLM/
information that you do not wish to be for Consideration,’’ listed specific issues ONC/CMS Workshop on Promoting
made publicly available, submit your to be addressed. Semantic Interoperability of Laboratory
comments only as a written/paper The notice provided a 60-day period Data.’’ The purpose of this public
submission. You should submit two for the submission of comments workshop is to receive and discuss
copies total. One copy will include the pertaining to the revised draft guidance, input from stakeholders regarding
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![Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices 68437
and communication that can facilitate addresses, as of the date this document www.fda.gov/MedicalDevices/
practical adoption of semantically publishes in the Federal Register, but NewsEvents/WorkshopsConferences/
interoperable data. Following the Web sites are subject to change over default.htm. (Select this public
presentations on each topic, there will time. workshop from the posted events list).
be a moderated discussion where the Requests for Oral Presentations: This
public workshop includes a public Dated: September 28, 2016.
participants and additional panelists
will be asked to provide their individual comment session. During online Leslie Kux,
perspectives. registration you may indicate if you Associate Commissioner for Policy.
In advance of the meeting, CDC, FDA, wish to present during a public [FR Doc. 2016–23894 Filed 10–3–16; 8:45 am]
NLM, ONC, and CMS will place an comment session, and which topics you BILLING CODE 4164–01–P
agenda on file in the public docket (the wish to address. FDA has included
docket number found in brackets in the general topics in this document. FDA
heading of this document) and will post will do its best to accommodate requests DEPARTMENT OF HEALTH AND
it at http://www.fda.gov/ to make public comments. Individuals HUMAN SERVICES
MedicalDevices/NewsEvents/ and organizations with common
WorkshopsConferences/default.htm. See interests are urged to consolidate or National Institutes of Health
DATES for the deadline for submitting coordinate their presentations, and
comments to the agenda for the public request time for a joint presentation, or National Heart, Lung, and Blood
workshop. submit requests for designated Institute; Notice of Closed Meeting
The agencies will use the input from representatives to participate in the
this workshop and public comments to public comment session. Following the Pursuant to section 10(d) of the
determine the appropriate next steps to close of registration, FDA will Federal Advisory Committee Act, as
advance semantic interoperability of determine the amount of time allotted to amended (5 U.S.C. App.), notice is
laboratory data. each presenter and the approximate hereby given of the following meeting.
Registration: Registration is free and time each oral presentation is to begin,
available on a first-come, first-served and will select and notify participants The meeting will be closed to the
basis. Persons interested in attending by November 1, 2016. All requests to public in accordance with the
this public workshop must register make oral presentations must be provisions set forth in sections
online by 4 p.m. (EDT) October 28, received by the close of registration on 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
2016. Early registration is recommended 4 p.m. (EDT) October 28, 2016. If as amended. The grant applications and
because facilities are limited and, selected for presentation, any the discussions could disclose
therefore, FDA may limit the number of presentation materials must be emailed confidential trade secrets or commercial
participants from each organization. If to Michael Waters (see FOR FURTHER property such as patentable material,
time and space permits, onsite INFORMATION CONTACT) no later than and personal information concerning
registration on the day of the public October 28, 2016. No commercial or individuals associated with the grant
workshop will be provided beginning at promotional material will be permitted applications, the disclosure of which
7 a.m. (EDT). to be presented or distributed at the would constitute a clearly unwarranted
If you need special accommodations public workshop. invasion of personal privacy.
due to a disability, please contact CDC, FDA, NLM, ONC, and CMS are
Rebecca Goodwin at 301–496–4441 holding this public workshop to obtain Name of Committee: Heart, Lung, and
(Rebecca.Goodwin@nih.gov) and/or the input from stakeholders regarding Blood Initial Review Group; NHLBI
Federal Relay at 1–800–877–8339. proposed approaches to facilitate the Mentored Patient-Oriented Research Review
Requests should be made no later than Committee October 27–28, 2016.
adoption and implementation of
November 3, 2016. Date: October 27–28, 2016.
interoperability standards in a manner
To register for the public workshop, Time: 8:30 a.m. to 12:00 p.m.
that enables consistent, accurate, and
please visit FDA’s Medical Devices Agenda: To review and evaluate grant
harmonized electronic laboratory
News & Events—Workshops & applications.
reporting. In order to permit the widest
Conferences calendar at http:// Place: Cambria Suites—Rockville 1 Helen
possible opportunity to obtain public
www.fda.gov/MedicalDevices/ Heneghan Way, Rockville, MD 20850.
comment, FDA is soliciting either
NewsEvents/WorkshopsConferences/ Contact Person: Stephanie Johnson Webb,
electronic or written comments on all
Ph.D., Scientific Review Officer, Office of
default.htm. (Select this public aspects of the public workshop topics.
Scientific Review/DERA, National Heart,
workshop from the posted events list.) See DATES for the deadline for
Lung, and Blood Institute, 6701 Rockledge
Please provide complete contact submitting comments to the agenda for
Drive, Room 7196, Bethesda, MD 20892, 301–
information for each attendee, including the public workshop.
435–0291, stephanie.webb@nih.gov.
name, title, affiliation, email, and Transcripts: Please be advised that as
telephone number. Those without soon as a transcript is available, it will (Catalogue of Federal Domestic Assistance
Internet access should contact Michael be accessible at http:// Program Nos. 93.233, National Center for
Waters to register (see FOR FURTHER www.regulations.gov. It may be viewed Sleep Disorders Research; 93.837, Heart and
INFORMATION CONTACT). Registrants will at the Division of Dockets Management Vascular Diseases Research; 93.838, Lung
receive confirmation after they have (see ADDRESSES). A transcript will also Diseases Research; 93.839, Blood Diseases
be available in either hardcopy or on and Resources Research, National Institutes
been accepted. You will be notified if
CD–ROM, after submission of a of Health, HHS)
you are on a waiting list.
mstockstill on DSK3G9T082PROD with NOTICES
Streaming Webcast of the Public Freedom of Information request. The Dated: September 28, 2016.
Workshop: This public workshop will Freedom of Information office address is
also be videocast. Videocast access will available on the Agency’s Web site at Michelle Trout,
be available at https://videocast.nih.gov/ http://www.fda.gov. A link to the Program Analyst, Office of Federal Advisory
. The videocast link will also be transcript will also be available Committee Policy.
available on the registration Web page. approximately 45 days after the public [FR Doc. 2016–23881 Filed 10–3–16; 8:45 am]
FDA has verified the Web site workshop on the Internet at http:// BILLING CODE 4140–01–P
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Document Created: 2016-10-04 03:03:55
Document Modified: 2016-10-04 03:03:55
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; request for comments. | |
| 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. | |
| 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: [email protected] | |
| FR Citation | 81 FR 68435 |
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