Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 8885-8886 [2018-04167]
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Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
determine whether changes or updates
to the currently recognized
susceptibility test interpretive criteria
are appropriate. FDA will then update
the Interpretive Criteria web page to
reflect these changes, as needed.
Dated: February 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04175 Filed 2–28–18; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0627]
Clinical Chemistry and Clinical
Toxicology Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Clinical Chemistry and
Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public.
DATES: The meeting will be held on
March 29 and 30, 2018, from 8 a.m. to
6 p.m.
ADDRESSES: Hilton Washington DC
North/Gaithersburg; Salons A, B, C, and
D; 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G610, Silver Spring,
MD 20993, patricio.garcia@fda.hhs.gov;
301–796–6875, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
amozie on DSK30RV082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:26 Feb 28, 2018
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Jkt 244001
Agenda: On March 29, 2018, the
committee will discuss, make
recommendations, and vote on
information regarding a premarket
approval application to market a novel
continuous glucose monitoring (CGM)
device system, the Senseonics, Inc.
Eversense CGM System. This device
requires minor surgery to implant and
remove, and if approved, would provide
90 days of sensor glucose values from
each implanted sensor.
The Eversense CGM System measures
patients’ glucose concentrations from
subcutaneous interstitial fluid similar to
approved CGM systems. All CGM
devices currently or previously
marketed used electrochemistry to
measure glucose in interstitial fluids,
last for 3 to 11 days and are inserted via
a small-gauge needle by the end user.
The proposed CGM system uses a
fluorescence-based measurement
technique, requires minor surgery for
subcutaneous implantation, and will
have a 90-day sensor wear period. The
proposed CGM sensor also includes a
drug component (dexamethasone
acetate) intended to mitigate negative
effects on sensor accuracy and sensor
life from the foreign body response at
the sensor insertion site. The proposed
intended use, as stated by the sponsor,
is as follows:
The Eversense CGM System
continually measures glucose levels in
adults (age 18 and older) with diabetes
for the operating life of the sensor.
The system is intended to:
• Aid in the management of diabetes.
• Provide real-time glucose readings.
• Provide glucose trend information.
• Provide alerts for the detection and
prediction of episodes of low blood
glucose (hypoglycemia) and high blood
glucose (hyperglycemia).
The system is a prescription device.
Historical data from the system can be
interpreted to aid in providing therapy
adjustments. These adjustments should
be based on patterns seen over time.
On March 30, 2018, the committee
will discuss and make
recommendations regarding measuring
blood glucose using capillary blood
with blood glucose meters in all
hospital patients, including those
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
8885
receiving intensive medical
intervention/therapy and patients with
decreased peripheral blood flow, such
as with severe hypotension, shock,
hyperosmolar-hyperglycemia and severe
dehydration (e.g., patients in intensive
care settings). Currently, FDA has
cleared one glucose meter for use all
over the hospital using venous and
arterial blood. FDA understands that
being able to make capillary blood
measurements in all hospitalized
patients using FDA cleared and Clinical
Laboratory Improvement Amendments
(CLIA) waived (i.e., designated as
waived per the standards in the CLIA)
glucose meters would be more
convenient and timely for hospital staff.
FDA would like to present new data
from capillary blood measurements on
glucose meters in patients receiving
intensive medical intervention/therapy
to the Clinical Chemistry and Clinical
Toxicology Devices Panel. FDA would
like to receive feedback from the
advisory panel on the benefits and risks
of measuring capillary blood using
blood glucose meters in this intended
use population, and the considerations
for CLIA waiver for this use.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 22, 2018.
Oral presentations from the public will
be scheduled on March 29 and 30, 2018,
between approximately 1 p.m. and 2
p.m. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before March 14, 2018. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
E:\FR\FM\01MRN1.SGM
01MRN1
8886
Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 15, 2018.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact AnnMarie
Williams, at annmarie.williams@
fda.hhs.gov, 301–796–5966 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Nakia C. Brown, Ph.D.,
Scientific Review Officer, National Institute
of Arthritis and Musculoskeletal and Skin
Diseases, National Institutes of Health, 6701
Democracy Boulevard, Suite 816, Bethesda,
MD 20817, 301–827–4905, nikia.brown@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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.
[FR Doc. 2018–04167 Filed 2–28–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
amozie on DSK30RV082PROD with NOTICES
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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: Arthritis and
Musculoskeletal and Skin Diseases Initial
Review Group; Arthritis and Musculoskeletal
and Skin Diseases Special Grants Review
Committee.
Date: March 15–16, 2018.
VerDate Sep<11>2014
17:26 Feb 28, 2018
Jkt 244001
Dated: February 23, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–04119 Filed 2–28–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Epidemiology of Chronic and Infectious
Disease.
Date: March 5, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kate Fothergill, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive Room 3142,
Bethesda, MD 20892, 301–435–2309,
fothergillke@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR17–029:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Dynamic Interactions between Systemic or
Non-Neuronal Systems and the Brain in
Aging and in Alzheimer’s Disease.
Date: March 8, 2018.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Inese Z. Beitins, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6152,
MSC 7892, Bethesda, MD 20892, 301–435–
1034, beitinsi@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Collaborative Minority Health and Health
Disparities Research with Tribal
Epidemiology Centers.
Date: March 8, 2018.
Time: 1:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowships
Overflow: Risk, Prevention and Health
Behavior.
Date: March 9, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Dupont Hotel, 1500 New
Hampshire Avenue NW, Washington, DC
20036.
Contact Person: Lee S. Mann, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3224,
MSC 7808, Bethesda, MD 20892, 301–435–
0677, mannl@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Molecular Sciences and
Technology.
Date: March 9, 2018.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Raj K. Krishnaraju, Ph.D.,
Scientific Review Officer, Center for
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8885-8886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04167]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0627]
Clinical Chemistry and Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Clinical Chemistry and
Clinical Toxicology Devices Panel of the Medical Devices Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on March 29 and 30, 2018, from 8 a.m.
to 6 p.m.
ADDRESSES: Hilton Washington DC North/Gaithersburg; Salons A, B, C, and
D; 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is 301-977-8900. Answers to commonly asked questions including
information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993,
[email protected]; 301-796-6875, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On March 29, 2018, the committee will discuss, make
recommendations, and vote on information regarding a premarket approval
application to market a novel continuous glucose monitoring (CGM)
device system, the Senseonics, Inc. Eversense CGM System. This device
requires minor surgery to implant and remove, and if approved, would
provide 90 days of sensor glucose values from each implanted sensor.
The Eversense CGM System measures patients' glucose concentrations
from subcutaneous interstitial fluid similar to approved CGM systems.
All CGM devices currently or previously marketed used electrochemistry
to measure glucose in interstitial fluids, last for 3 to 11 days and
are inserted via a small-gauge needle by the end user. The proposed CGM
system uses a fluorescence-based measurement technique, requires minor
surgery for subcutaneous implantation, and will have a 90-day sensor
wear period. The proposed CGM sensor also includes a drug component
(dexamethasone acetate) intended to mitigate negative effects on sensor
accuracy and sensor life from the foreign body response at the sensor
insertion site. The proposed intended use, as stated by the sponsor, is
as follows:
The Eversense CGM System continually measures glucose levels in
adults (age 18 and older) with diabetes for the operating life of the
sensor.
The system is intended to:
Aid in the management of diabetes.
Provide real-time glucose readings.
Provide glucose trend information.
Provide alerts for the detection and prediction of
episodes of low blood glucose (hypoglycemia) and high blood glucose
(hyperglycemia).
The system is a prescription device. Historical data from the
system can be interpreted to aid in providing therapy adjustments.
These adjustments should be based on patterns seen over time.
On March 30, 2018, the committee will discuss and make
recommendations regarding measuring blood glucose using capillary blood
with blood glucose meters in all hospital patients, including those
receiving intensive medical intervention/therapy and patients with
decreased peripheral blood flow, such as with severe hypotension,
shock, hyperosmolar-hyperglycemia and severe dehydration (e.g.,
patients in intensive care settings). Currently, FDA has cleared one
glucose meter for use all over the hospital using venous and arterial
blood. FDA understands that being able to make capillary blood
measurements in all hospitalized patients using FDA cleared and
Clinical Laboratory Improvement Amendments (CLIA) waived (i.e.,
designated as waived per the standards in the CLIA) glucose meters
would be more convenient and timely for hospital staff. FDA would like
to present new data from capillary blood measurements on glucose meters
in patients receiving intensive medical intervention/therapy to the
Clinical Chemistry and Clinical Toxicology Devices Panel. FDA would
like to receive feedback from the advisory panel on the benefits and
risks of measuring capillary blood using blood glucose meters in this
intended use population, and the considerations for CLIA waiver for
this use.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 22, 2018. Oral presentations from the public will be scheduled on
March 29 and 30, 2018, between approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
March 14, 2018. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled
[[Page 8886]]
open public hearing session, FDA may conduct a lottery to determine the
speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by March 15, 2018.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams, at [email protected], 301-796-
5966 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04167 Filed 2-28-18; 8:45 am]
BILLING CODE 4164-01-P
