Clinical Study Design and Performance of Hospital Glucose Sensors, 30016-30017 [2012-12180]
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Federal Register / Vol. 77, No. 98 / Monday, May 21, 2012 / Notices
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 8:00 a.m.–12:00 p.m., June
11, 2012 (Closed).
Place: Crowne Plaza Hotel Atlanta
Perimeter at Ravinia, 4355 Ashford
Dunwoody Road, Atlanta, Georgia 30346.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Field Triage of Traumatic Brain
Injury (TBI) in Older Adults Taking
Anticoagulants or Platelet Inhibitors, FOA
CE12–005.’’
Contact Person for More Information:
J. Felix Rogers, Ph.D., M.P.H., Scientific
Review Officer, CDC, 4770 Buford Highway
NE., Mailstop F63, Atlanta, Georgia 30341,
Telephone (770) 488–4334.
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Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: May 15, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–12276 Filed 5–18–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0377]
Clinical Study Design and Performance
of Hospital Glucose Sensors
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ebenthall on DSK5SPTVN1PROD with NOTICES
ACTION:
The Food and Drug Administration
(FDA) is announcing the following
public meeting entitled ‘‘Clinical Study
Design and Performance of Hospital
Glucose Sensors.’’ The purpose of this
public meeting is to discuss clinical
study design considerations and
performance metrics for innovative
glucose sensors intended to be used in
hospital point of care settings.
DATES: Date and Time: The public
meeting will be held on June 25, 2012,
from 8 a.m. to 5 p.m.
VerDate Mar<15>2010
18:18 May 18, 2012
Jkt 226001
Location: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31, 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/WhiteOak
CampusInformation/ucm241740.htm.
The public meeting will also be
available to be viewed online via
webcast.
Contact: Vicki Moyer, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5626,
Silver Spring, MD 20993, 301–796–
6148, FAX: 301–847–8513, email:
vicki.moyer@fda.hhs.gov.
Registration: Registration is free and
on a first-come, first-served basis.
Persons interested in attending this
meeting must register online by 4 p.m.,
June 15, 2012. 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
meeting will be provided beginning at 7
a.m.
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. 66, Rm. 4321, Silver Spring,
MD 20993, 301–796–5661, email:
susan.monahan@fda.hhs.gov, no later
than June 15, 2012.
To register for the public meeting,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://www.fda.
gov/MedicalDevices/NewsEvents/Work
shopsConferences/default.htm. (Select
this public meeting from the posted
events list.) Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone number.
Those without Internet access should
contact Susan Monahan to register (see
Registration section of this document).
Registrants will receive confirmation
after they have been accepted. You will
be notified if you are on a waiting list.
Streaming Web cast of the Public
Meeting: This public meeting will also
be Web cast. Persons interested in
viewing the Web cast must register
online by 4 p.m., June 15, 2012. Early
registration is recommended because
Web cast connections are limited.
Organizations are requested to register
PO 00000
Frm 00054
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all participants, but to view using one
connection per location. Web cast
participants will be sent technical
system requirements after registration
and will be sent connection access
information after June 20, 2012. 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 meeting includes a public
comment session. During online
registration you may indicate if you
wish to speak and the proposed title for
the 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
comment. Following the close of
registration, FDA will determine the
amount of time allotted to each speaker
and will select and notify participants
by June 19, 2012. No commercial or
promotional material will be permitted
to be presented or distributed at the
meeting.
Comments: FDA is holding this public
meeting to obtain information on
innovative kinds of hospital glucose
sensors. In order to permit the widest
possible opportunity to obtain public
comment, FDA is soliciting electronic or
written comments on all aspects of the
meeting topics. The deadline for
submitting comments related to this
public meeting is July 23, 2012.
Regardless of attendance at the public
meeting, interested persons may submit
either electronic or written comments.
Submit electronic comments to https://
www.regulations.gov. Submit 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.
Please identify comments with the
docket number found in brackets in the
heading of this document. In addition,
when responding to specific questions
as outlined in section II of this
document, please identify the question
you are addressing. 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.
E:\FR\FM\21MYN1.SGM
21MYN1
Federal Register / Vol. 77, No. 98 / Monday, May 21, 2012 / Notices
ebenthall on DSK5SPTVN1PROD with NOTICES
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 meeting
on the Internet at https://www.fda.gov/
MedicalDevices/NewsEvents/Workshops
Conferences/default.htm. (Select this
meeting from the posted events list.).
SUPPLEMENTARY INFORMATION:
I. Background
FDA is seeking input from the clinical
community, academia, Government,
industry, clinical laboratories, and other
stakeholders regarding clinical
validation studies and performance
criteria for hospital glucose sensors.
These types of devices are intended to
be used at the patient bedside, and are
different from currently available
glucose sensors in that they are
generally indwelling or inserted.
Furthermore, they are often designed to
collect continuous or near-continuous
glucose concentrations for each patient.
These devices have the potential to
benefit patient care but to date they are
not widely available. This is due, in
part, to the challenges in designing and
studying these complex devices. One
challenge is the study design itself;
determining the types of patients to
include and what data are needed to
adequately validate performance is often
difficult given the varied hospital
environment and patient populations.
Once the study is complete, determining
whether or not the results are
sufficiently accurate and reliable for the
proposed intended use(s) is equally
challenging.
The purpose of this public meeting is
to share information about the
challenges in validating these kinds of
hospital glucose sensors and solicit
public input and discussion. The
feedback may increase communication
and collaboration within the
stakeholder community, and,
ultimately, help overcome some of the
current challenges associated with
designing clinical studies and
generating clinical performance data for
these devices.
The public meeting will include two
sessions of the following topics: (1) The
clinical studies and data needed to
VerDate Mar<15>2010
18:18 May 18, 2012
Jkt 226001
30017
adequately validate the performance of
these devices in the intended use
population and (2) discussion of metrics
that may be used to evaluate results to
demonstrate a safe and effective device.
Each session will include presentations
from physicians, Government, and other
experts in the field. Presentations will
be followed by panel discussions of
session topics and questions from the
audience.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Topics for Discussion at the Public
Meeting
ACTION:
The following questions represent the
kinds of topics that will be discussed at
the meeting. The final questions to be
discussed at each session will be
available the day of the meeting.
1. Who is the likely intended use
population for these devices and how
will they be used in patient
management? For example, will they be
used for general hospital, surgical,
critically ill, pediatric patients, etc.?
What are the study considerations for
evaluating the devices in these different
populations?
2. How does the intended use of the
device affect the design of the clinical
studies and the evaluation and
adequacy of device performance? For
example, are the accuracy needs for a
device used to monitor trends over time
different from the accuracy needs of one
where the individual glucose results are
used to replace discrete glucose
measurements? Is greater accuracy
needed when the device is used in
certain populations? What metrics can
be used to evaluate whether or not
results from these devices are
sufficiently accurate and reliable for the
proposed intended use(s)?
3. What conditions, medications, or
therapies have the potential to cause
interference and require evaluation?
What kinds of studies/models are
appropriate to evaluate interference?
4. Differences in glucose
concentrations may be observed when
testing arterial and venous blood
samples from the same patient. How can
the potential differences in blood
glucose concentrations be addressed
when conducting the clinical studies?
The Food and Drug Administration
(FDA or Agency) is announcing a public
meeting entitled ‘‘International Capacity
Building with Respect to Food Safety.’’
This public meeting will provide
interested persons an opportunity to
discuss FDA’s comprehensive plan to
expand the technical, scientific, and
regulatory capacity of foreign
governments and their respective food
industries in countries that export foods
to the United States (the ‘‘capacitybuilding plan’’). FDA is developing this
plan under the Food Safety
Modernization Act (FSMA). More
specifically, the public will have an
opportunity to provide information and
share views that will inform FDA’s
development of the capacity-building
plan. FDA is also establishing a docket
to collect comments, data, and
information relevant to the capacitybuilding plan.
Date and Time: See section III. ‘‘How
to Participate in the Public Meeting’’ in
the SUPPLEMENTARY INFORMATION section
of this document for dates and times of
the public meeting, closing dates for
advance registration, and information
on deadlines for submitting either
electronic or written comments to FDA’s
Division of Dockets Management.
Contact Persons: For questions about
registering for the meeting, to register
orally, or to submit a notice of
participation by mail, Fax, or email:
Courtney Treece, Planning
Professionals, Ltd., 1210 West
McDermott, Suite 111, Allen, TX 75013,
704–258–4983, Fax: 469–854–6992,
email: ctreece@planning
professionals.com.
For questions about the content of the
public meeting or if special
accommodations are needed due to a
disability, contact Juanita Yates, Center
for Food Safety and Applied Nutrition
(HFS–009), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1731, email: Juanita.Yates@
fda.hhs.gov.
Dated: May 15, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2012–12180 Filed 5–18–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Food and Drug Administration
[Docket No. FDA–2012–N–0437]
International Capacity Building With
Respect to Food Safety; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
SUPPLEMENTARY INFORMATION:
Frm 00055
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E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Notices]
[Pages 30016-30017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0377]
Clinical Study Design and Performance of Hospital Glucose Sensors
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
public meeting entitled ``Clinical Study Design and Performance of
Hospital Glucose Sensors.'' The purpose of this public meeting is to
discuss clinical study design considerations and performance metrics
for innovative glucose sensors intended to be used in hospital point of
care settings.
DATES: Date and Time: The public meeting will be held on June 25, 2012,
from 8 a.m. to 5 p.m.
Location: The meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31, 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. The
public meeting will also be available to be viewed online via webcast.
Contact: Vicki Moyer, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5626, Silver Spring, MD 20993, 301-796-6148, FAX: 301-847-8513, email:
vicki.moyer@fda.hhs.gov.
Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this meeting must
register online by 4 p.m., June 15, 2012. 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 meeting will be
provided beginning at 7 a.m.
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. 66, Rm. 4321,
Silver Spring, MD 20993, 301-796-5661, email:
susan.monahan@fda.hhs.gov, no later than June 15, 2012.
To register for the public meeting, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public meeting from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Susan Monahan to register (see
Registration section of this document). Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
Streaming Web cast of the Public Meeting: This public meeting will
also be Web cast. Persons interested in viewing the Web cast must
register online by 4 p.m., June 15, 2012. Early registration is
recommended because Web cast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Web cast participants will be sent technical
system requirements after registration and will be sent connection
access information after June 20, 2012. 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 meeting includes a
public comment session. During online registration you may indicate if
you wish to speak and the proposed title for the 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 comment. Following the close of registration, FDA will
determine the amount of time allotted to each speaker and will select
and notify participants by June 19, 2012. No commercial or promotional
material will be permitted to be presented or distributed at the
meeting.
Comments: FDA is holding this public meeting to obtain information
on innovative kinds of hospital glucose sensors. In order to permit the
widest possible opportunity to obtain public comment, FDA is soliciting
electronic or written comments on all aspects of the meeting topics.
The deadline for submitting comments related to this public meeting is
July 23, 2012.
Regardless of attendance at the public meeting, interested persons
may submit either electronic or written comments. Submit electronic
comments to https://www.regulations.gov. Submit 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. Please identify comments with the docket
number found in brackets in the heading of this document. In addition,
when responding to specific questions as outlined in section II of this
document, please identify the question you are addressing. 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.
[[Page 30017]]
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 meeting on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting from the posted events list.).
SUPPLEMENTARY INFORMATION:
I. Background
FDA is seeking input from the clinical community, academia,
Government, industry, clinical laboratories, and other stakeholders
regarding clinical validation studies and performance criteria for
hospital glucose sensors. These types of devices are intended to be
used at the patient bedside, and are different from currently available
glucose sensors in that they are generally indwelling or inserted.
Furthermore, they are often designed to collect continuous or near-
continuous glucose concentrations for each patient.
These devices have the potential to benefit patient care but to
date they are not widely available. This is due, in part, to the
challenges in designing and studying these complex devices. One
challenge is the study design itself; determining the types of patients
to include and what data are needed to adequately validate performance
is often difficult given the varied hospital environment and patient
populations. Once the study is complete, determining whether or not the
results are sufficiently accurate and reliable for the proposed
intended use(s) is equally challenging.
The purpose of this public meeting is to share information about
the challenges in validating these kinds of hospital glucose sensors
and solicit public input and discussion. The feedback may increase
communication and collaboration within the stakeholder community, and,
ultimately, help overcome some of the current challenges associated
with designing clinical studies and generating clinical performance
data for these devices.
The public meeting will include two sessions of the following
topics: (1) The clinical studies and data needed to adequately validate
the performance of these devices in the intended use population and (2)
discussion of metrics that may be used to evaluate results to
demonstrate a safe and effective device. Each session will include
presentations from physicians, Government, and other experts in the
field. Presentations will be followed by panel discussions of session
topics and questions from the audience.
II. Topics for Discussion at the Public Meeting
The following questions represent the kinds of topics that will be
discussed at the meeting. The final questions to be discussed at each
session will be available the day of the meeting.
1. Who is the likely intended use population for these devices and
how will they be used in patient management? For example, will they be
used for general hospital, surgical, critically ill, pediatric
patients, etc.? What are the study considerations for evaluating the
devices in these different populations?
2. How does the intended use of the device affect the design of the
clinical studies and the evaluation and adequacy of device performance?
For example, are the accuracy needs for a device used to monitor trends
over time different from the accuracy needs of one where the individual
glucose results are used to replace discrete glucose measurements? Is
greater accuracy needed when the device is used in certain populations?
What metrics can be used to evaluate whether or not results from these
devices are sufficiently accurate and reliable for the proposed
intended use(s)?
3. What conditions, medications, or therapies have the potential to
cause interference and require evaluation? What kinds of studies/models
are appropriate to evaluate interference?
4. Differences in glucose concentrations may be observed when
testing arterial and venous blood samples from the same patient. How
can the potential differences in blood glucose concentrations be
addressed when conducting the clinical studies?
Dated: May 15, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-12180 Filed 5-18-12; 8:45 am]
BILLING CODE 4160-01-P
