83 FR 8885 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 41 (March 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 41 (March 1, 2018)
| Page Range | 8885-8886 | |
| FR Document | 2018-04167 |
[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)] [Notices] [Pages 8885-8886] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices 8885
determine whether changes or updates enough to provide timely notice. receiving intensive medical
to the currently recognized Therefore, you should always check the intervention/therapy and patients with
susceptibility test interpretive criteria Agency’s website at https:// decreased peripheral blood flow, such
are appropriate. FDA will then update www.fda.gov/AdvisoryCommittees/ as with severe hypotension, shock,
the Interpretive Criteria web page to default.htm and scroll down to the hyperosmolar-hyperglycemia and severe
reflect these changes, as needed. appropriate advisory committee meeting dehydration (e.g., patients in intensive
Dated: February 22, 2018. link, or call the advisory committee care settings). Currently, FDA has
Leslie Kux, information line to learn about possible cleared one glucose meter for use all
modifications before coming to the over the hospital using venous and
Associate Commissioner for Policy.
meeting. arterial blood. FDA understands that
[FR Doc. 2018–04175 Filed 2–28–18; 8:45 am]
being able to make capillary blood
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION:
measurements in all hospitalized
Agenda: On March 29, 2018, the
patients using FDA cleared and Clinical
committee will discuss, make
Laboratory Improvement Amendments
DEPARTMENT OF HEALTH AND recommendations, and vote on
(CLIA) waived (i.e., designated as
HUMAN SERVICES information regarding a premarket
waived per the standards in the CLIA)
approval application to market a novel
Food and Drug Administration glucose meters would be more
continuous glucose monitoring (CGM)
convenient and timely for hospital staff.
[Docket No. FDA–2018–N–0627] device system, the Senseonics, Inc.
FDA would like to present new data
Eversense CGM System. This device from capillary blood measurements on
Clinical Chemistry and Clinical requires minor surgery to implant and glucose meters in patients receiving
Toxicology Devices Panel of the remove, and if approved, would provide intensive medical intervention/therapy
Medical Devices Advisory Committee; 90 days of sensor glucose values from to the Clinical Chemistry and Clinical
Notice of Meeting each implanted sensor. Toxicology Devices Panel. FDA would
The Eversense CGM System measures like to receive feedback from the
AGENCY: Food and Drug Administration, patients’ glucose concentrations from
HHS. advisory panel on the benefits and risks
subcutaneous interstitial fluid similar to of measuring capillary blood using
ACTION: Notice. approved CGM systems. All CGM blood glucose meters in this intended
SUMMARY: The Food and Drug devices currently or previously use population, and the considerations
Administration (FDA) announces a marketed used electrochemistry to for CLIA waiver for this use.
forthcoming public advisory committee measure glucose in interstitial fluids, FDA intends to make background
meeting of the Clinical Chemistry and last for 3 to 11 days and are inserted via material available to the public no later
Clinical Toxicology Devices Panel of the a small-gauge needle by the end user. than 2 business days before the meeting.
Medical Devices Advisory Committee. The proposed CGM system uses a If FDA is unable to post the background
The general function of the committee is fluorescence-based measurement material on its website prior to the
to provide advice and recommendations technique, requires minor surgery for meeting, the background material will
to the Agency on FDA’s regulatory subcutaneous implantation, and will be made publicly available at the
issues. The meeting will be open to the have a 90-day sensor wear period. The location of the advisory committee
public. proposed CGM sensor also includes a meeting, and the background material
DATES: The meeting will be held on
drug component (dexamethasone will be posted on FDA’s website after
March 29 and 30, 2018, from 8 a.m. to acetate) intended to mitigate negative the meeting. Background material is
6 p.m. effects on sensor accuracy and sensor available at https://www.fda.gov/
life from the foreign body response at AdvisoryCommittees/Calendar/
ADDRESSES: Hilton Washington DC
the sensor insertion site. The proposed default.htm. Scroll down to the
North/Gaithersburg; Salons A, B, C, and
intended use, as stated by the sponsor, appropriate advisory committee meeting
D; 620 Perry Pkwy., Gaithersburg, MD
is as follows: link.
20877. The hotel’s telephone number is The Eversense CGM System Procedure: Interested persons may
301–977–8900. Answers to commonly continually measures glucose levels in present data, information, or views,
asked questions including information adults (age 18 and older) with diabetes orally or in writing, on issues pending
regarding special accommodations due for the operating life of the sensor. before the committee. Written
to a disability, visitor parking, and The system is intended to: submissions may be made to the contact
transportation may be accessed at: • Aid in the management of diabetes. person on or before March 22, 2018.
https://www.fda.gov/Advisory • Provide real-time glucose readings. Oral presentations from the public will
Committees/AboutAdvisoryCommittees/ • Provide glucose trend information. be scheduled on March 29 and 30, 2018,
ucm408555.htm. • Provide alerts for the detection and between approximately 1 p.m. and 2
FOR FURTHER INFORMATION CONTACT: prediction of episodes of low blood p.m. Those individuals interested in
Patricio Garcia, Center for Devices and glucose (hypoglycemia) and high blood making formal oral presentations should
Radiological Health, Food and Drug glucose (hyperglycemia). notify the contact person and submit a
Administration, 10903 New Hampshire The system is a prescription device. brief statement of the general nature of
Ave., Bldg. 66, Rm. G610, Silver Spring, Historical data from the system can be the evidence or arguments they wish to
MD 20993, patricio.garcia@fda.hhs.gov; interpreted to aid in providing therapy present, the names and addresses of
301–796–6875, or FDA Advisory adjustments. These adjustments should proposed participants, and an
amozie on DSK30RV082PROD with NOTICES
Committee Information Line, 1–800– be based on patterns seen over time. indication of the approximate time
741–8138 (301–443–0572 in the On March 30, 2018, the committee requested to make their presentation on
Washington, DC area). A notice in the will discuss and make or before March 14, 2018. Time allotted
Federal Register about last minute recommendations regarding measuring for each presentation may be limited. If
modifications that impact a previously blood glucose using capillary blood the number of registrants requesting to
announced advisory committee meeting with blood glucose meters in all speak is greater than can be reasonably
cannot always be published quickly hospital patients, including those accommodated during the scheduled
VerDate Sep<11>2014 17:26 Feb 28, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\01MRN1.SGM 01MRN1](https://thefederalregister.org/doc/83_FR_8926/page/1.svg)
![8886 Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
open public hearing session, FDA may Time: 8:00 a.m. to 5:00 p.m. Dynamic Interactions between Systemic or
conduct a lottery to determine the Agenda: To review and evaluate grant Non-Neuronal Systems and the Brain in
speakers for the scheduled open public applications. Aging and in Alzheimer’s Disease.
Place: Bethesda Marriott Suites, 6711 Date: March 8, 2018.
hearing session. The contact person will Time: 11:00 a.m. to 6:00 p.m.
Democracy Boulevard, Bethesda, MD 20817.
notify interested persons regarding their Contact Person: Nakia C. Brown, Ph.D., Agenda: To review and evaluate grant
request to speak by March 15, 2018. Scientific Review Officer, National Institute applications.
Persons attending FDA’s advisory of Arthritis and Musculoskeletal and Skin Place: National Institutes of Health, 6701
committee meetings are advised that the Diseases, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892
Agency is not responsible for providing Democracy Boulevard, Suite 816, Bethesda, (Telephone Conference Call).
access to electrical outlets. MD 20817, 301–827–4905, nikia.brown@ Contact Person: Inese Z. Beitins, MD,
FDA welcomes the attendance of the nih.gov. Scientific Review Officer, Center for
(Catalogue of Federal Domestic Assistance Scientific Review, National Institutes of
public at its advisory committee
Program Nos. 93.846, Arthritis, Health, 6701 Rockledge Drive, Room 6152,
meetings and will make every effort to MSC 7892, Bethesda, MD 20892, 301–435–
accommodate persons with disabilities. Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS) 1034, beitinsi@csr.nih.gov.
If you require accommodations due to a This notice is being published less than 15
disability, please contact AnnMarie Dated: February 23, 2018. days prior to the meeting due to the timing
Williams, at annmarie.williams@ Sylvia L. Neal, limitations imposed by the review and
fda.hhs.gov, 301–796–5966 at least 7 Program Analyst, Office of Federal Advisory funding cycle.
days in advance of the meeting. Committee Policy. Name of Committee: Center for Scientific
FDA is committed to the orderly [FR Doc. 2018–04119 Filed 2–28–18; 8:45 am] Review Special Emphasis Panel;
conduct of its advisory committee BILLING CODE 4140–01–P
Collaborative Minority Health and Health
meetings. Please visit our website at Disparities Research with Tribal
Epidemiology Centers.
https://www.fda.gov/Advisory
Date: March 8, 2018.
Committees/AboutAdvisoryCommittees/ DEPARTMENT OF HEALTH AND Time: 1:00 p.m. to 3:30 p.m.
ucm111462.htm for procedures on HUMAN SERVICES Agenda: To review and evaluate grant
public conduct during advisory applications.
committee meetings. National Institutes of Health Place: National Institutes of Health, 6701
Notice of this meeting is given under Rockledge Drive, Bethesda, MD 20892
the Federal Advisory Committee Act (5 Center for Scientific Review; Notice of (Telephone Conference Call).
U.S.C. app. 2). Closed Meetings Contact Person: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Dated: February 23, 2018. Pursuant to section 10(d) of the Scientific Review, National Institutes of
Leslie Kux, Federal Advisory Committee Act, as Health, 6701 Rockledge Drive, Room 3158,
Associate Commissioner for Policy. amended, notice is hereby given of the MSC 7770, Bethesda, MD 20892, 301–435–
[FR Doc. 2018–04167 Filed 2–28–18; 8:45 am]
following meetings. 0684, olufokunbisamd@csr.nih.gov.
The meetings will be closed to the This notice is being published less than 15
BILLING CODE 4164–01–P
public in accordance with the days prior to the meeting due to the timing
provisions set forth in sections limitations imposed by the review and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., funding cycle.
DEPARTMENT OF HEALTH AND Name of Committee: Center for Scientific
as amended. The grant applications and
HUMAN SERVICES Review Special Emphasis Panel; Fellowships
the discussions could disclose
Overflow: Risk, Prevention and Health
National Institutes of Health confidential trade secrets or commercial Behavior.
property such as patentable material, Date: March 9, 2018.
National Institute of Arthritis and and personal information concerning Time: 8:00 a.m. to 6:00 p.m.
Musculoskeletal and Skin Diseases; individuals associated with the grant Agenda: To review and evaluate grant
Notice of Closed Meeting applications, the disclosure of which applications.
would constitute a clearly unwarranted Place: The Dupont Hotel, 1500 New
Pursuant to section 10(d) of the invasion of personal privacy. Hampshire Avenue NW, Washington, DC
Federal Advisory Committee Act, as 20036.
amended, notice is hereby given of the Name of Committee: Center for Scientific Contact Person: Lee S. Mann, Ph.D.,
Review Special Emphasis Panel; Scientific Review Officer, Center for
following meeting.
Epidemiology of Chronic and Infectious Scientific Review, National Institutes of
The meeting will be closed to the Disease. Health, 6701 Rockledge Drive, Room 3224,
public in accordance with the Date: March 5, 2018. MSC 7808, Bethesda, MD 20892, 301–435–
provisions set forth in sections Time: 11:00 a.m. to 3:00 p.m. 0677, mannl@csr.nih.gov.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant This notice is being published less than 15
as amended. The grant applications and applications. days prior to the meeting due to the timing
the discussions could disclose Place: National Institutes of Health, 6701 limitations imposed by the review and
confidential trade secrets or commercial Rockledge Drive, Bethesda, MD 20892 funding cycle.
property such as patentable material, (Virtual Meeting).
Contact Person: Kate Fothergill, Ph.D., Name of Committee: Center for Scientific
and personal information concerning Scientific Review Officer, Center for
Review Special Emphasis Panel; Member
individuals associated with the grant Conflict: Molecular Sciences and
Scientific Review, National Institutes of
applications, the disclosure of which Technology.
Health, 6701 Rockledge Drive Room 3142,
would constitute a clearly unwarranted Date: March 9, 2018.
Bethesda, MD 20892, 301–435–2309,
amozie on DSK30RV082PROD with NOTICES
Time: 10:00 a.m. to 1:00 p.m.
invasion of personal privacy. fothergillke@mail.nih.gov.
Agenda: To review and evaluate grant
Name of Committee: Arthritis and This notice is being published less than 15 applications.
Musculoskeletal and Skin Diseases Initial days prior to the meeting due to the timing Place: National Institutes of Health, 6701
Review Group; Arthritis and Musculoskeletal limitations imposed by the review and Rockledge Drive, Bethesda, MD 20892
and Skin Diseases Special Grants Review funding cycle. (Telephone Conference Call).
Committee. Name of Committee: Center for Scientific Contact Person: Raj K. Krishnaraju, Ph.D.,
Date: March 15–16, 2018. Review Special Emphasis Panel; PAR17–029: Scientific Review Officer, Center for
VerDate Sep<11>2014 17:26 Feb 28, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\01MRN1.SGM 01MRN1](https://thefederalregister.org/doc/83_FR_8926/page/2.svg)
Document Created: 2018-02-28 23:57:43
Document Modified: 2018-02-28 23:57:43
| 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. | |
| Dates | The meeting will be held on March 29 and 30, 2018, from 8 a.m. to 6 p.m. | |
| 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. | |
| FR Citation | 83 FR 8885 |
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