81 FR 34356 - 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 81, Issue 104 (May 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 104 (May 31, 2016)
| Page Range | 34356-34357 | |
| FR Document | 2016-12641 |
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)] [Notices] [Pages 34356-34357] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12641] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] 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 July 21 and July 22, 2016, 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: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1116, 10903 New Hampshire Ave., 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 Web site at http://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 July 21, 2016, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application (PMA) panel-track supplement for a proposed change in intended use of Dexcom, Inc.'s, Dexcom G5[supreg] Mobile Continuous Glucose Monitoring System (CGM) device so that, in addition to tracking and trending interstitial fluid glucose concentrations, patients can use the device as a replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM. On July 22, 2016, the committee will discuss and make recommendations on information regarding a premarket notification (510(k)) submission for the Alere AfinionTM HbA1c Dx point- of-care test system, sponsored by Alere Technologies AS. The proposed intended use, as stated by the sponsor: Alere Afinion HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human whole blood. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. For use in clinical laboratories and point of care laboratory settings. Current clinical guidelines contraindicate the use of point-of-care hemoglobin A1c (HbA1c) tests to diagnose diabetes. FDA is seeking feedback from the clinical community to determine significant, scientific and practical, reservations or support for using this point- of-care HbA1c test as an aid in the diagnosis of diabetes and pre- diabetes. 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 Web site 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 Web site after the meeting. Background material is available at http://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 July 15, 2016. Oral presentations from the public will be scheduled on July 21 and 22, 2016, 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 July 7, 2016. Time allotted for each presentation may be limited. If the [[Page 34357]] number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled 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 July 8, 2016. 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], or 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 Web site at http://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: May 24, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-12641 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
![34356 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
pharmacogenomics and toxicogenomics; ACTION: Notice. decisions based on the interstitial fluid
however, next-generation sequencing glucose concentration reported by the
technologies promise to provide some SUMMARY: The Food and Drug CGM.
unique advantages in DNA and RNA Administration (FDA) announces a On July 22, 2016, the committee will
analyses and are expected to be adopted forthcoming public advisory committee discuss and make recommendations on
by the pharmaceutical and medical meeting of the Clinical Chemistry and information regarding a premarket
industries for advancing personalized Clinical Toxicology Devices Panel of the notification (510(k)) submission for the
nutrition and medicine. Medical Devices Advisory Committee. Alere AfinionTM HbA1c Dx point-of-care
Starting in 2005, FDA initiated an The general function of the committee is test system, sponsored by Alere
open project, MicroArray Quality to provide advice and recommendations Technologies AS. The proposed
Control (MAQC), which has gone to the Agency on FDA’s regulatory intended use, as stated by the sponsor:
through three phases. MAQC–I focused issues. The meeting will be open to the
public. Alere Afinion HbA1c Dx is an in vitro
on the technical aspects of microarray- diagnostic test for quantitative determination
based gene expression measurements, DATES: The meeting will be held on July of glycated hemoglobin (% hemoglobin A1c,
the MAQC–II focused on validation of 21 and July 22, 2016, from 8 a.m. to 6 HbA1c) in human whole blood. This test is
microarray-based predictive models, p.m. to be used as an aid in the diagnosis of
and MAQC–III, which is also called the ADDRESSES: Hilton Washington DC diabetes and as an aid in identifying patients
Sequencing Quality Control (SEQC), North/Gaithersburg, Salons A, B, C, and who may be at risk for developing diabetes.
focused on assessing the performance of D, 620 Perry Pkwy., Gaithersburg, MD The measurement of % HbA1c is
20877. The hotel’s telephone number is recommended as a marker of long-term
whole transcriptome sequencing (RNA-
metabolic control in persons with diabetes
seq). 301–977–8900. Answers to commonly mellitus. For use in clinical laboratories and
The Sequencing Quality Control asked questions including information point of care laboratory settings.
Phase 2 (SEQC–II) is a natural extension regarding special accommodations due
of the SEQC project with emphasis on to a disability, visitor parking, and Current clinical guidelines
DNA-Seq for various applications. The transportation may be accessed at: contraindicate the use of point-of-care
SEQC–II project, with broad http://www.fda.gov/ hemoglobin A1c (HbA1c) tests to
participation from scientists and AdvisoryCommittees/ diagnose diabetes. FDA is seeking
reviewers within FDA and collaborators AboutAdvisoryCommittees/ feedback from the clinical community to
across the public, academic, and private ucm408555.htm. determine significant, scientific and
sectors, is expected to help prepare FDA practical, reservations or support for
FOR FURTHER INFORMATION CONTACT:
for the next wave of submission of using this point-of-care HbA1c test as an
Patricio Garcia, Center for Devices and aid in the diagnosis of diabetes and pre-
genomic data generated from the next- Radiological Health, Food and Drug
generation sequencing technologies. diabetes.
Administration, Bldg. 66, Rm. 1116, FDA intends to make background
Registration: Mail, fax, or email your
10903 New Hampshire Ave., Silver material available to the public no later
registration information (including
Spring, MD 20993; patricio.garcia@ than 2 business days before the meeting.
name, title, firm name, address,
fda.hhs.gov; 301–796–6875, or FDA If FDA is unable to post the background
telephone, and fax numbers) to the
Advisory Committee Information Line, material on its Web site prior to the
contact person by August 31, 2016. FDA
1–800–741–8138 (301–443–0572 in the meeting, the background material will
will email a confirmation to those who
have registered. There is no registration Washington, DC area). A notice in the be made publicly available at the
fee for the public workshop. Early Federal Register about last minute location of the advisory committee
registration is recommended because modifications that impact a previously meeting, and the background material
seating is limited. No registration on the announced advisory committee meeting will be posted on FDA’s Web site after
day of the public workshop will be cannot always be published quickly the meeting. Background material is
provided. enough to provide timely notice. available at http://www.fda.gov/
If you need special accommodations Therefore, you should always check the AdvisoryCommittees/Calendar/
due to a disability, please contact Weida Agency’s Web site at http:// default.htm. Scroll down to the
Tong (see FOR FURTHER INFORMATION www.fda.gov/AdvisoryCommittees/ appropriate advisory committee meeting
CONTACT) at least 7 days in advance. default.htm and scroll down to the link.
appropriate advisory committee meeting Procedure: Interested persons may
Dated: May 24, 2016.
link, or call the advisory committee present data, information, or views,
Leslie Kux, information line to learn about possible orally or in writing, on issues pending
Associate Commissioner for Policy. modifications before coming to the before the committee. Written
[FR Doc. 2016–12656 Filed 5–27–16; 8:45 am] meeting. submissions may be made to the contact
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION: person on or before July 15, 2016. Oral
Agenda: On July 21, 2016, the presentations from the public will be
committee will discuss, make scheduled on July 21 and 22, 2016,
DEPARTMENT OF HEALTH AND
recommendations, and vote on between approximately 1 p.m. and 2
HUMAN SERVICES
information regarding a premarket p.m. Those individuals interested in
Food and Drug Administration approval application (PMA) panel-track making formal oral presentations should
supplement for a proposed change in notify the contact person and submit a
[Docket No. FDA–2016–N–0001] intended use of Dexcom, Inc.’s, Dexcom brief statement of the general nature of
sradovich on DSK3TPTVN1PROD with NOTICES
G5® Mobile Continuous Glucose the evidence or arguments they wish to
Clinical Chemistry and Clinical
Monitoring System (CGM) device so present, the names and addresses of
Toxicology Devices Panel of the
that, in addition to tracking and proposed participants, and an
Medical Devices Advisory Committee;
trending interstitial fluid glucose indication of the approximate time
Notice of Meeting
concentrations, patients can use the requested to make their presentation on
AGENCY: Food and Drug Administration, device as a replacement for their blood or before July 7, 2016. Time allotted for
HHS. glucose meters and make treatment each presentation may be limited. If the
VerDate Sep<11>2014 20:07 May 27, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1](https://thefederalregister.org/doc/81_FR_34460/page/1.svg)
![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34357
number of registrants requesting to from 2005–2006, and Research Assistant phosphorylated c-Jun-N-terminal kinase
speak is greater than can be reasonably Professor, Department of Surgery, UC, (JNK) expression in mN/SF exposed to
accommodated during the scheduled from 2007–2011, engaged in research cadmium, when the experiment was not
open public hearing session, FDA may misconduct in research supported by performed.
conduct a lottery to determine the National Heart, Lung, and Blood D The research record contained
speakers for the scheduled open public Institute (NHLBI), National Institutes of ninety (90) Western blot images and
hearing session. The contact person will Health (NIH), grants K08 HL081472 and ninety (90) densitometry measurement
notify interested persons regarding their R01 HL107949. files for 45 experiments that examined
request to speak by July 8, 2016. ORI found that falsified and/or phosphorylated JNK or Mitogen-
Persons attending FDA’s advisory fabricated data were included in the activated protein kinase 4 (MMK4)
committee meetings are advised that the following three (3) NIH grant expression in mN/SF exposed to UV
Agency is not responsible for providing applications, one (1) NIH grant progress light, H2O2, cadmium, or anisomycin,
access to electrical outlets. report, one (1) publication, seven (7) when the experiments were not
FDA welcomes the attendance of the presentations, and one (1) image file: performed.
public at its advisory committee • R03 AG029508–01 D The research record contained
meetings and will make every effort to • R21 AG030361–01 densitometric analyses for an additional
accommodate persons with disabilities. • R01 HL102405–01 twenty-eight (28) experiments that
If you require accommodations due to a • K08 HL081472–05 Progress Report examined phosphorylated JNK or
disability, please contact AnnMarie • J Biol Chem. 285(18):13748–60, 2010 MMK4 expression in mN/SF exposed to
Williams, at Annmarie.Williams@ Apr 30 (hereafter referred to as ‘‘JBC UV light, H2O2, cadmium, or
fda.hhs.gov, or 301–796–5966 at least 7 2010’’) anisomycin, when the quantifications
days in advance of the meeting. • Presentation: Autophagy were based on experiments that were
FDA is committed to the orderly Pathway.ppt, MKK4 expression after not performed.
conduct of its advisory committee UV.ppt, Oct PPt.ppt, RicDec.ppt, • While at UM, Respondent falsified
meetings. Please visit our Web site at Ricky Presentation 06.ppt, Ricky and/or fabricated Western blots for
http://www.fda.gov/ STC.ppt, and RM.ppt phosphorylated and total Rac1/cdc42
AdvisoryCommittees/ • Image file: Final LC 3.jpg expression in mN/SF, total JNK
AboutAdvisoryCommittees/ ORI found that Respondent reused expression in mN/SF treated with
ucm111462.htm for procedures on and falsely relabeled Western blot gel anisomycin, phosphorylated JNK
public conduct during advisory images, falsified the related expression in Snell dwarf mice
committee meetings. densitometry measurements based on fibroblasts treated with cadmium, b-
Notice of this meeting is given under the falsified Western blots, and falsified actin expression in mN/SF, b-actin
the Federal Advisory Committee Act (5 and/or fabricated data for experiments expression in Snell dwarf mice
U.S.C. app. 2). that were not performed. Respondent fibroblasts treated with or without
Dated: May 24, 2016. continued this falsification at UC, after MMS, b-actin expression in normal
Jill Hartzler Warner, the UM research misconduct mice fibroblasts treated with cadmium,
Associate Commissioner for Special Medical investigation was completed. and b-actin expression in mN/SF treated
Programs. Specifically: with H2O2 in the presentations
[FR Doc. 2016–12641 Filed 5–27–16; 8:45 am] • While at UM, Respondent falsified Autophagy Pathway.ppt, Oct PPt.ppt,
BILLING CODE 4164–01–P and/or fabricated images in R03 RicDec.ppt, Ricky Presentation 06.ppt,
AG029508–01 and three (3) Ricky STC.ppt, and RM.ppt, and the
presentations, where: image file Final LC 3.jpg, when the
DEPARTMENT OF HEALTH AND D R03 AG029508–01, Figure 2, images were duplicated and falsely
HUMAN SERVICES represented Western blots for relabeled Western blots of unrelated
phosphorylated p53 (Ser15) and b-actin experiments.
Office of the Secretary expression in normal and Snell dwarf • While at UM, Respondent falsified
mice fibroblasts (mN/SF) treated with twenty-four (24) Western blots for
Findings of Research Misconduct the DNA alkylating agent methyl phosphorylated JNK or MMK4
AGENCY: Office of the Secretary, HHS. methanesulfonate (MMS), when the expression in mN/SF exposed to UV
same images were duplicated to light, H2O2, cadmium, or anisomycin in
ACTION: Notice. the seven (7) presentations and twenty-
represent different proteins and
SUMMARY: Notice is hereby given that treatments in the presentations six (26) data files in the research record,
the Office of Research Integrity (ORI) Autophagy Pathway.ppt and RM.ppt. when the images were duplicated and
has taken final action in the following D R03 AG029508–01, Figure 3, falsely relabeled Western blots of
case: represented Western blots for p16Ink4a unrelated experiments.
Ricky Malhotra, Ph.D., University of and b-actin expression in mN/SF, when • While at UC, Respondent falsified
Michigan and University of Chicago: the same images were duplicated to and/or fabricated Western blots by using
Based on the Respondent’s admission to represent different proteins and images from unrelated experiments and
committing research misconduct at the treatments in the presentations the related densitometric analyses that
University of Michigan (UM) and Autophagy Pathways.ppt, RicDec.ppt, were based on falsified Western blots in
subsequently at the University of and RM.ppt. the following:
sradovich on DSK3TPTVN1PROD with NOTICES
Chicago (UC), the reports of separate • While at UM, Respondent D R01 HL102405–01 for:
investigations conducted by UM and fabricated data in R21 AG030361–01 —Figure 1A for phosphorylated
UC, and additional analysis conducted and supporting data for the grant Rhodopsin (Rho) expression in
by ORI in its oversight review, ORI application in the research record, neonatal rat ventricular cardiac
found that Dr. Ricky Malhotra, former where: myocytes (NRVCM) subjected to
Research Assistant Professor, D R21 AG030361–01, Figure 2, stimulation with Angiotension II (Ang
Department of Internal Medicine, UM, represented a Western blot for II)
VerDate Sep<11>2014 20:07 May 27, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1](https://thefederalregister.org/doc/81_FR_34460/page/2.svg)
Document Created: 2016-05-28 03:57:50
Document Modified: 2016-05-28 03:57:50
| 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 July 21 and July 22, 2016, from 8 a.m. to 6 p.m. | |
| Contact | Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1116, 10903 New Hampshire Ave., 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 Web site at http://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 | 81 FR 34356 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR