Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation; Public Workshop, 56719-56720 [2013-22311]
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Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices
heading of this document. 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances or
https://www.regulations.gov.
Dated: September 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Submit
written requests for single copies of the
draft guidance to the Office of Food
Safety, Center for Food Safety and
Applied Nutrition (HFS–317), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4160–01–P
Lauren Posnick Robin, Center for Food
Safety and Applied Nutrition (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 240–402–1639.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–22309 Filed 9–12–13; 8:45 am]
[Docket No. FDA–2012–D–0322]
Draft Guidance for Industry on Arsenic
in Apple Juice: Action Level;
Supporting Document for Action Level
for Arsenic in Apple Juice; A
Quantitative Assessment of Inorganic
Arsenic in Apple Juice; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
draft guidance for industry entitled
‘‘Arsenic in Apple Juice: Action Level’’
that appeared in the Federal Register of
July 15, 2013 (78 FR 42086). The draft
guidance identifies for the industry an
action level for inorganic arsenic in
apple juice that FDA considers
protective of human health and
achievable with the use of good
manufacturing practices. It also
describes FDA’s intended sampling and
enforcement approach. In the notice, we
requested comments on the draft
guidance. We are taking this action in
response to a request for an extension to
allow interested persons additional time
to submit comments.
DATES: FDA is extending the comment
period on the draft guidance. Submit
either electronic or written comments
by November 12, 2013.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments on the draft guidance
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SUMMARY:
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II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. 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.
Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
In the Federal Register of July 15,
2013 (78 FR 42086), we published a
notice announcing the availability of
three documents, a draft guidance for
industry entitled ‘‘Arsenic in Apple
Juice: Action Level,’’ a draft supporting
document entitled ‘‘Supporting
Document for Action Level for Arsenic
in Apple Juice,’’ and a risk assessment
document entitled ‘‘A Quantitative
Assessment of Inorganic Arsenic in
Apple Juice.’’ The draft guidance
identifies an action level for inorganic
arsenic in apple juice of 10 micrograms/
kilogram (mg/kg) or 10 parts per billion
(ppb), and identifies FDA’s intended
sampling and enforcement approach.
The draft supporting document reviews
data on arsenic levels, health effects,
and achievability, and explains FDA’s
rationale for identifying an action level
for inorganic arsenic in apple juice of 10
mg/kg. The risk assessment document
provides estimates of arsenic exposure
and risk to humans at different
hypothetical limits for inorganic arsenic
in apple juice. The notice invited
comments on the draft guidance by
September 13, 2013.
As of August 28, 2013, we have
received two requests for an extension
of the comment period. The requests,
from the Arsenic Science Task Force
and the Juice Products Association,
explained that they needed more time to
complete their analyses of the
supporting documents.
We have considered the request and
are extending the comment period for
the notice for 60 days, until November
12, 2013. We believe that a 60-day
extension allows adequate time for
interested persons to submit comments
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without significantly delaying further
FDA action on this guidance.
[FR Doc. 2013–22313 Filed 9–12–13; 8:45 am]
I. Background
Food and Drug Administration
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Challenging Regulatory and
Reimbursement Paradigms for Medical
Devices in the Treatment of Metabolic
Diseases: How to Estimate and Reward
True Patient-Centric Value in
Innovation; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Changing Regulatory and
Reimbursement Paradigms for Medical
Devices in the Treatment of Metabolic
Diseases: How to Estimate and Reward
True Patient-Centric Value in
Innovation.’’ FDA is cosponsoring the
workshop with the American
Gastroenterological Association (AGA).
The purpose of the workshop is to
facilitate discussion between FDA,
AGA, and other interested parties of the
development of medical devices for the
treatment of morbid obesity and other
metabolic diseases and evolving
approaches for the regulation and
reimbursement of minimally invasive
procedures.
Dates and Times: The public
workshop will be held on October 17,
2013, from 8:30 a.m. to 5 p.m. and
October 18, 2013, from 8:30 a.m. to
12:15 p.m.
Location: The public workshop will
be held at the Grand Hyatt Washington,
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56720
Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices
1000 H St. NW., Washington, DC 20001,
202–582–1234.
Contact Person: Herbert Lerner,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. G114, Silver Spring, MD 20993–
0002, 301–796–6511, email:
herbert.lerner@fda.hhs.gov.
Registration: Registration is limited
and is available on a first-come, firstserved basis. Persons interested in
attending this public workshop must
register online by 4 p.m. (EDT), October
10, 2013. Onsite registration will be
available after this date. To register for
the public workshop, please visit AGA’s
Web site at https://www.gastro.org/
education-meetings/live-meetings/agafda-regulation-and-reimbursementworkshop. For more information on the
workshop, please visit FDA’s Medical
Devices News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
The AGA will collect a registration fee
to cover its share of the expenses
associated with the public workshop,
which is included in the registration
information on the AGA Web site.
If you need special accommodations
due to a disability, please contact
Herbert Lerner (see ‘‘Contact Person’’) at
least 7 days before the public workshop.
SUPPLEMENTARY INFORMATION:
tkelley on DSK3SPTVN1PROD with NOTICES
I. Background
The purpose of the public workshop
is to facilitate discussion between FDA,
the AGA and other interested parties on
the issues of device development,
public and private payer
reimbursement, venture capital, and
regulatory pathways for device
innovation and marketing. The
workshop will provide a forum for
discussing new approaches for the
treatment of morbid obesity and other
metabolic diseases as well as evolving
approaches for the regulation and
reimbursement of minimally invasive
procedures.
II. Topics for Discussion at the Public
Workshop
Topics to be discussed at the public
workshop include, but are not limited
to:
• Challenges to MedTech Innovation
in the United States;
• Evolving Approaches for the
Regulation of Minimally Invasive
Procedures: The FDA Benefit/Risk
Paradigm;
• Evolving Approaches for the
Reimbursement of Minimally Invasive
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Procedures: How to Put a Price on
Value;
• Obesity as a Disease: Redefining the
Regulatory and Reimbursement Context;
and
• The ‘‘Process’’—Investigational
Device Exemption Review.
Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22311 Filed 9–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR Part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Aortic Access From Vena Cava for
Large Caliber Transcatheter
Cardiovascular Interventions
Description of Technology: The
invention pertains to a device and
method for transcatheter correction of
cardiovascular abnormalities, such as
the delivery of prosthetic valves to the
heart. Featured is a device implant for
closing a caval-aortic iatrogenic fistula
created by the introduction of a
transcatheter device from the inferior
vena cava into the abdominal aorta. The
occlusion device includes an
expandable transvascular implant with
an elastomeric surface capable of
extending between a vein and artery
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which conforms to the boundaries of an
arteriovenous fistula tract between the
artery and vein. A guidewire channel is
disposed within the occlusion device
where the channel also has elastomeric
wall surfaces that conform or can be
expanded to the area so that it occludes
the channel when the guidewire is not
present. The implant is resiliently
deformable into a radially compressed
configuration for delivery through the
catheter. When not deformed into the
radially compressed configuration, the
distal end of the device is radially
enlarged, relative to the intermediate
neck, whereby the distal end forms an
enlarged distal skirt, such as a disk or
button shaped member. A polymer
coating on the radially enlarged distal
end conforms to the endoluminal aortic
wall for deployment against an internal
wall of the artery.
Potential Commercial Applications:
• cardiovascular surgery.
• heart valve implantation.
• valve-repair.
Competitive Advantages:
• closure of the caval-aortic iatrogenic
fistula.
• vascular access.
Development Stage:
• Prototype.
• In vivo data available (animal).
• In vivo data available (human).
Inventors: Robert Lederman and
Ozgur Kocaturk (NHLBI).
Publications:
1. Kodali SK, et al. Two-year outcomes
after transcatheter or surgical aorticvalve replacement. N Engl J Med.
2012 May 3;366(18):1686–95.
[PMID 22443479]
2. Makkar RR, et al. Transcatheter
aortic-valve replacement for
inoperable severe aortic stenosis. N
Engl J Med. 2012 May
3;366(18):1696–704. [PMID
22443478]
3. Smith CR, et al. Transcatheter versus
surgical aortic-valve replacement in
high-risk patients. N Engl J Med.
2011 Jun 9;364(23):2187–98. [PMID
21639811]
Intellectual Property: HHS Reference
No. E–553–2013/0—U.S. Provisional
Patent Application 61/863,071 filed
August 7, 2013.
Related Technologies:
• HHS Reference No. E–115–2013/0—
U.S. Provisional Patent Application
No. 61/834,357 filed June 12, 2013.
• HHS Reference No. E–027–2013/0—
U.S. Provisional Patent Application
No. 61/785,652 filed March 14, 2013.
Licensing Contact: Michael
Shmilovich; 301–435–5019; shmilovm@
mail.nih.gov.
Collaborative Research Opportunity:
The National Heart Lung & Blood
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[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56719-56720]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22311]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Challenging Regulatory and Reimbursement Paradigms for Medical
Devices in the Treatment of Metabolic Diseases: How to Estimate and
Reward True Patient-Centric Value in Innovation; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Changing Regulatory and Reimbursement Paradigms for
Medical Devices in the Treatment of Metabolic Diseases: How to Estimate
and Reward True Patient-Centric Value in Innovation.'' FDA is
cosponsoring the workshop with the American Gastroenterological
Association (AGA). The purpose of the workshop is to facilitate
discussion between FDA, AGA, and other interested parties of the
development of medical devices for the treatment of morbid obesity and
other metabolic diseases and evolving approaches for the regulation and
reimbursement of minimally invasive procedures.
Dates and Times: The public workshop will be held on October 17,
2013, from 8:30 a.m. to 5 p.m. and October 18, 2013, from 8:30 a.m. to
12:15 p.m.
Location: The public workshop will be held at the Grand Hyatt
Washington,
[[Page 56720]]
1000 H St. NW., Washington, DC 20001, 202-582-1234.
Contact Person: Herbert Lerner, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. G114, Silver Spring, MD 20993-0002, 301-796-6511, email:
herbert.lerner@fda.hhs.gov.
Registration: Registration is limited and is available on a first-
come, first-served basis. Persons interested in attending this public
workshop must register online by 4 p.m. (EDT), October 10, 2013. Onsite
registration will be available after this date. To register for the
public workshop, please visit AGA's Web site at https://www.gastro.org/education-meetings/live-meetings/aga-fda-regulation-and-reimbursement-workshop. For more information on the workshop, please visit FDA's
Medical Devices News & Events--Workshops & Conferences calendar at
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
The AGA will collect a registration fee to cover its share of the
expenses associated with the public workshop, which is included in the
registration information on the AGA Web site.
If you need special accommodations due to a disability, please
contact Herbert Lerner (see ``Contact Person'') at least 7 days before
the public workshop.
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of the public workshop is to facilitate discussion
between FDA, the AGA and other interested parties on the issues of
device development, public and private payer reimbursement, venture
capital, and regulatory pathways for device innovation and marketing.
The workshop will provide a forum for discussing new approaches for the
treatment of morbid obesity and other metabolic diseases as well as
evolving approaches for the regulation and reimbursement of minimally
invasive procedures.
II. Topics for Discussion at the Public Workshop
Topics to be discussed at the public workshop include, but are not
limited to:
Challenges to MedTech Innovation in the United States;
Evolving Approaches for the Regulation of Minimally
Invasive Procedures: The FDA Benefit/Risk Paradigm;
Evolving Approaches for the Reimbursement of Minimally
Invasive Procedures: How to Put a Price on Value;
Obesity as a Disease: Redefining the Regulatory and
Reimbursement Context; and
The ``Process''--Investigational Device Exemption Review.
Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22311 Filed 9-12-13; 8:45 am]
BILLING CODE 4160-01-P
