Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments, 46010-46012 [2015-18910]
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Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
email address indicated in the
registration file, or via regular mail if
email is not an option. The invoice will
contain information regarding the
obligation incurred, the amount owed,
and payment procedures. A facility will
not be deemed registered as an
outsourcing facility until it has paid the
annual establishment fee under section
744K of the FD&C Act. Accordingly, it
is important that facilities seeking to
operate as registered outsourcing
facilities pay all fees immediately upon
receiving an invoice. If an entity does
not pay the full invoiced amount within
15 calendar days after FDA issues the
invoice, FDA will consider the
submission of registration information
to have been withdrawn and adjust the
invoice to reflect that no fee is due.
Outsourcing facilities that registered
in FY 2015 and wish to maintain their
status as an outsourcing facility in FY
2016 must register during the annual
registration period that lasts from
October 1, 2015, to December 31, 2015.
Failure to register and complete
payment by December 31, 2015, will
result in a loss of status as an
outsourcing facility on January 1, 2016.
Entities should submit their registration
information no later than December 10,
2015, to allow enough time for review
of the registration information,
invoicing, and payment of fees before
the end of the registration period.
mstockstill on DSK4VPTVN1PROD with NOTICES
B. Reinspection Fee
FDA will issue invoices for each
reinspection after the conclusion of the
reinspection, via email to the email
address indicated in the registration file
or via regular mail if email is not an
option. Invoices must be paid within 30
days.
C. Fee Payment Procedures
1. The preferred payment method is
online using electronic check
(Automated Clearing House (ACH) also
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
Express). Secure electronic payments
can be submitted using the User Fees
Payment Portal at https://
userfees.fda.gov/pay. Once you search
for your invoice, click ‘‘Pay Now’’ to be
redirected to Pay.gov. Note that
electronic payment options are based on
the balance due. Payment by credit card
is available for balances less than
$50,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be drawn on
U.S. bank accounts as well as U.S. credit
cards.
2. If paying with a paper check:
Checks must be in U.S. currency from
a U.S. bank and made payable to the
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18:35 Jul 31, 2015
Jkt 235001
Food and Drug Administration.
Payments can be mailed to: Food and
Drug Administration, P.O. Box 956733,
St. Louis, MO 63195–6733. If a check is
sent by a courier that requests a street
address, the courier can deliver the
check to: U.S. Bank, Attn: Government
Lockbox 956733, 1005 Convention
Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery
only; do not send mail to this address.)
3. If paying with a wire transfer: Use
the following account information when
sending a wire transfer: New York
Federal Reserve Bank, U.S. Dept of
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.
75060099, Routing No. 021030004,
SWIFT: FRNYUS33, Beneficiary: FDA,
8455 Colesville Rd., Silver Spring, MD
20993. The originating financial
institution may charge a wire transfer
fee. An outsourcing facility should ask
its financial institution about the fee
and add it to the payment to ensure that
the order is fully paid. The tax
identification number of FDA is 53–
0196965.
Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18916 Filed 7–31–15; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public workshop;
request for comments.
ACTION:
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.
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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 https://
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: steven.gitterman@
fda.hhs.gov.
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:
susan.monahan@fda.hhs.gov 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 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 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
E:\FR\FM\03AUN1.SGM
03AUN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
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 https://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 michael.waters@
fda.hhs.gov 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
VerDate Sep<11>2014
18:35 Jul 31, 2015
Jkt 235001
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 https://
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 https://
www.regulations.gov.
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 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 https://
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
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46011
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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03AUN1
46012
Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
on file in the public docket (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.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0007]
Animal Generic Drug User Fee Rates
and Payment Procedures for Fiscal
Year 2016
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
fiscal year (FY) 2016 generic new
animal drug user fees. The Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Animal
Generic Drug User Fee Amendments of
2013 (AGDUFA II), authorizes FDA to
collect user fees for certain abbreviated
applications for generic new animal
drugs, for certain generic new animal
drug products, and for certain sponsors
of such abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs. This notice
establishes the fee rates for FY 2016.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/default.htm,
or contact Lisa Kable, Center for
Veterinary Medicine (HFV–10), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–402–
6888. For general questions, you may
also email the Center for Veterinary
Medicine (CVM) at cvmagdufa@
fda.hhs.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:35 Jul 31, 2015
Jkt 235001
SUPPLEMENTARY INFORMATION:
II. Revenue Amount for FY 2016
I. Background
A. Statutory Fee Revenue Amounts
Section 741 of the FD&C Act (21
U.S.C. 379j–21) establishes three
different types of user fees: (1) Fees for
certain types of abbreviated applications
for generic new animal drugs; (2) annual
fees for certain generic new animal drug
products; and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). When certain conditions are met,
FDA will waive or reduce fees for
generic new animal drugs intended
solely to provide for a minor use or
minor species indication (21 U.S.C.
379j–21(d)).
For FY 2014 through FY 2018, the
FD&C Act establishes aggregate yearly
base revenue amounts for each of these
fee categories. Base revenue amounts
established for fiscal years after FY 2014
may be adjusted for workload. The
target revenue amounts for each fee
category for FY 2016, after the
adjustment for workload, are as follows:
For application fees the target revenue
amount is $2,426,000; for product fees
the target revenue amount is $3,639,000;
and for sponsor fees the target revenue
amount is $3,639,000.
For FY 2016, the generic new animal
drug user fee rates are: $233,300 for
each abbreviated application for a
generic new animal drug other than
those subject to the criteria in section
512(d)(4) of the FD&C Act (21 U.S.C.
360b(d)(4)); $116,650 for each
abbreviated application for a generic
new animal drug subject to the criteria
in section 512(d)(4); $8,705 for each
generic new animal drug product;
$83,800 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $62,850 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $41,900
for each generic new animal drug
sponsor paying 50 percent of the
sponsor fee. FDA will issue invoices for
FY 2016 product and sponsor fees by
December 31, 2015. These fees will be
due by January 31, 2016. The
application fee rates are effective for all
abbreviated applications for a generic
new animal drug submitted on or after
October 1, 2015, and will remain in
effect through September 30, 2016.
Applications will not be accepted for
review until FDA has received full
payment of related application fees and
any other fees owed under the Animal
Generic Drug User Fee program.
AGDUFA II, Title II of Public Law
113–14, specifies that the aggregate
revenue amount for FY 2016 for
abbreviated application fees is
$1,857,000 and each of the other two
generic new animal drug user fee
categories, annual product fees and
annual sponsor fees, is $2,786,000 each
(see 21 U.S.C. 379j–21(b)).
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B. Inflation Adjustment to Fee Revenue
Amount
The amounts established in AGDUFA
II for each year for FY 2014 through FY
2018 include an inflation adjustment;
therefore, no further inflation
adjustment is required.
C. Workload Adjustment Fee Revenue
Amount
For each FY beginning after FY 2014,
AGDUFA provides that statutory fee
revenue amounts shall be further
adjusted to reflect changes in review
workload. (See 21 U.S.C. 379j–21(c)(2).)
FDA calculated the average number of
each of the four types of applications
and submissions specified in the
workload adjustment provision
(abbreviated applications for generic
new animal drugs, manufacturing
supplemental abbreviated applications
for generic new animal drugs,
investigational generic new animal drug
study submissions, and investigational
generic new animal drug protocol
submissions) received over the 5-year
period that ended on September 30,
2013 (the base years), and the average
number of each of these types of
applications and submissions over the
most recent 5-year period that ended on
June 30, 2015.
The results of these calculations are
presented in the first two columns in
table 1. Column 3 reflects the percent
change in workload over the two 5-year
periods. Column 4 shows the weighting
factor for each type of application,
reflecting how much of the total FDA
generic new animal drug review
workload was accounted for by each
type of application or submission in the
table during the most recent 5 years.
Column 5 is the weighted percent
change in each category of workload
and was derived by multiplying the
weighting factor in each line in column
4 by the percent change from the base
years in column 3. At the bottom right
of table 1, the sum of the values in
column 5 is calculated, reflecting a total
change in workload of 30.6305 percent
for FY 2016. This is the workload
adjuster for FY 2016.
E:\FR\FM\03AUN1.SGM
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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: steven.gitterman@fda.hhs.gov.
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:
susan.monahan@fda.hhs.gov 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 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 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
[[Page 46011]]
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 https://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
michael.waters@fda.hhs.gov 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 https://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 https://www.regulations.gov.
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 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
https://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
[[Page 46012]]
on file in the public docket (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. 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