Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 9733-9734 [2015-03687]
Download as PDF
<![CDATA[
Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Anesthetic and Analgesic Drug
Products Advisory Committee; Notice of
Meeting’’ that appeared in the Federal
Register of February 6, 2015 (80 FR
6731). The document announced a
forthcoming meeting of a public
advisory committee of the Food and
Drug Administration (FDA). The
document was published with the
incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Planning,
Legislation, and Analysis, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3330,
Silver Spring, MD 20993, 301–796–
9115.
SUMMARY:
In the
Federal Register of February 6, 2015, in
FR Doc. 2015–02408, on page 6731, the
following correction is made:
On page 6731, in the first column, in
the Docket No. heading, ‘‘[Docket No.
FDA–2011–N–0824]’’ is corrected to
read ‘‘[Docket No. FDA–2015–N–0001]’’.
SUPPLEMENTARY INFORMATION:
Dated: February 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03688 Filed 2–23–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
VerDate Sep<11>2014
17:31 Feb 23, 2015
Jkt 235001
Name of Committee: Neurological
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 17, 2015, from 8 a.m. to
4 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. 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.
Contact Person: Jamie Waterhouse,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993, Jamie.Waterhouse@
fda.hhs.gov, 301–796–3063, 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 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.
Agenda: On April 17, 2015, the
committee will discuss the current
knowledge regarding the conduct of
clinical studies and evaluation of
clinical study data for flow diverter
technology. FDA is convening this
committee to seek expert opinion on
scientific and clinical considerations
relating to the study design and existing
clinical studies, for flow diverter
technology indicated for the
neurovasculature.
Flow diverters are an endoluminal
treatment option for intracranial
aneurysms. They are similar to
traditional stents in their tubular metal
structure but with a significantly higher
mesh density. The working principle is
that the high-mesh density reduces flow
rate into the aneurysm which promotes
blood stasis and occlusion of the
aneurysm. Flow diverters are
advantageous for the treatment of large/
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
9733
giant wide-neck aneurysms and offer an
alternative to other interventional
techniques or surgery.
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 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 April 3, 2015. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. and 11:30 a.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
24, 2015. 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
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 27, 2015.
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 physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov, 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
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
E:\FR\FM\24FEN1.SGM
24FEN1
9734
Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices
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 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
I. Funding Opportunity Description
RFA–FD–15–005
93.103
[FR Doc. 2015–03687 Filed 2–23–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0012]
Partnership To Develop the Branded
Food Products Database for Public
Health (R01)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of the Agricultural Technology
Innovation Partnership’s (ATIP)
Branded Food Products Database for
Public Health. ATIP, in conjunction
with the U.S. Department of Agriculture
(USDA) Agricultural Research Service
(ARS) and the International Life Science
Institute North America (ILSI North
America), has established a publicprivate partnership to enhance the
public’s health. The Office of Foods and
Veterinary Medicine (OFVM) has grant
funds available to help support ATIP
consolidate food composition data from
manufacturers. OFVM’s goal is to
monitor the sodium content of branded
foods and to make nutrient composition
data available to the public.
DATES: Important dates are as follows:
1. The application due date is April
2, 2015.
2. The anticipated start date is May
2015.
3. The opening date is February 13,
2015.
4. The expiration date is April 3,
2015.
SUMMARY:
For more information, see
section III of the SUPPLEMENTARY
INFORMATION section of this notice.
FOR FURTHER INFORMATION CONTACT:
Claudine Kavanaugh, Office of Foods
and Veterinary Medicine, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–4647; or Vieda
Hubbard, Division of Acquisition
Support and Grants, Food and Drug
Administration, 5630 Fishers Lane
tkelley on DSK3SPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
17:31 Feb 23, 2015
Jkt 235001
(HFA–500), Rockville, MD 20857, 240–
402–7588.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA.
SUPPLEMENTARY INFORMATION:
A. Background
OFVM is interested in monitoring the
sodium content of branded foods in the
U.S. marketplace. Knowing the nutrient
profile of branded foods is critical to
FDA’s work and to the public’s health.
Public health experts have linked
excessive sodium consumption to
hypertension, cardiovascular disease,
and other chronic diseases. A database
that reflects the sodium content of foods
will help OFVM research strategies
regarding sodium reduction and help
the public maintain healthy diets.
OFVM has funds available for ATIP to
compile compositional data for branded
foods for the public’s benefit. ATIP,
through ILSI North America and USDA,
has experience engaging the private
sector and expertise compiling brand
data. With OFVM’s fiscal contribution,
ATIP will be able to build upon USDA’s
National Nutrient Database—widely
recognized as the gold standard for food
compositional data—in a timely fashion.
ATIP’s database will reflect the breadth
and depth of the nation’s food supply
and will facilitate nutrition analysis and
research that otherwise may not be
possible.
The research community, healthcare
professionals, the food industry, and
policymakers will use ATIP’s database.
For example, drafters of the National
Health and Nutrition Examination
Survey will be able to more accurately
characterize food selection and sodium
consumption for Americans. Medical
researchers will be able to better link
sodium intake to measures of chronic
diseases. Food manufacturers will be
able to compare information to improve
product formulations. Policy-making
bodies will be able to develop better
guidelines that will promote public
health. Ultimately, having more robust
sodium data available will allow FDA to
develop targeted sodium reduction
strategies and the public to better
monitor sodium intake.
B. Research Objectives
ATIP will compile compositional data
for branded foods for the public’s
benefit. The database will include food
group information on branded foods and
branded restaurant food products. ATIP
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
will manage a large volume of datestamped branded product information
to link food intake and nutrient
composition to dietary patterns
recommendations. ATIP will collect and
publish comprehensive food
compositional data, including sodium
content, in a timely fashion.
C. Eligibility Information
This grant is available solely for ATIP.
Through ILSI North America and USDA,
respectively, ATIP has existing
relationships with industry and years of
food compositional data upon which
ATIP can build. ATIP has already
demonstrated that its database can
effectively manage a large volume of
date-stamped branded product
information. Compiling additional
compositional data for branded foods
will allow FDA to link sodium intake
and composition data to dietary patterns
recommendations more efficiently.
II. Award Information/Funds Available
A. Award Amount
OFVM has $35,000 available for a
single award to a single grantee—ATIP.
B. Length of Support
This grant is available for 1 year from
the start date.
III. Electronic Application,
Registration, and Submission
Only electronic applications will be
accepted. To submit an electronic
application in response to this FOA,
applicant should first review the full
announcement. (FDA has verified the
Web site addresses throughout this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.) For all
electronically submitted applications,
the following steps are required.
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With System for
Award Management (SAM)
• Step 3: Obtain Username & Password
• Step 4: Authorized Organization
Representative (AOR) Authorization
• Step 5: Track AOR Status
• Step 6: Register With Electronic
Research Administration (eRA)
Commons
Steps 1 through 5, in detail, can be
found at https://www07.grants.gov/
applicants/organization_
registration.jsp. Step 6, in detail, can be
found at https://commons.era.nih.gov/
commons/registration/
registrationInstructions.jsp. After you
have followed these steps, submit
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9733-9734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03687]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Neurological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Neurological Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 17, 2015, from 8
a.m. to 4 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. 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.
Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, Jamie.Waterhouse@fda.hhs.gov, 301-796-
3063, 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 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.
Agenda: On April 17, 2015, the committee will discuss the current
knowledge regarding the conduct of clinical studies and evaluation of
clinical study data for flow diverter technology. FDA is convening this
committee to seek expert opinion on scientific and clinical
considerations relating to the study design and existing clinical
studies, for flow diverter technology indicated for the
neurovasculature.
Flow diverters are an endoluminal treatment option for intracranial
aneurysms. They are similar to traditional stents in their tubular
metal structure but with a significantly higher mesh density. The
working principle is that the high-mesh density reduces flow rate into
the aneurysm which promotes blood stasis and occlusion of the aneurysm.
Flow diverters are advantageous for the treatment of large/giant wide-
neck aneurysms and offer an alternative to other interventional
techniques or surgery.
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 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
April 3, 2015. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. and 11:30 a.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 24, 2015. 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 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 27, 2015.
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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams at
Annmarie.Williams@fda.hhs.gov, 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on
[[Page 9734]]
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 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03687 Filed 2-23-15; 8:45 am]
BILLING CODE 4164-01-P
