Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development; Notice of Public Workshop; Request for Comments, 29560-29561 [2010-12588]
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Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices
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materials, parking, and speaker
expenses.
If you need special accommodations
due to a disability, please contact Linda
Hartley (see Contact) at least 10 days in
advance.
Dated: May 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–12615 Filed 5–25–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0237]
Identifying Unmet Public Health Needs
and Facilitating Innovation in Medical
Device Development; Notice of Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
ACTION: Notice of public workshop;
request for comments.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Identifying Unmet Public
Health Needs and Facilitating
Innovation in Medical Device
Development.’’ The purpose of the
workshop is to obtain public input on
what are the most important unmet
public health needs and what are the
barriers to the development of medical
devices that can cure, significantly
improve, or prevent these illnesses and
injuries.
Dates and Times: This workshop will
be held on June 24, 2010, from 8 a.m.
to 5 p.m. Persons interested in attending
the meeting must register by 5 p.m. on
June 10, 2010. Submit electronic or
written comments by July 23, 2010.
Location: The public workshop will
be held at Hilton Washington DC/North
VerDate Mar<15>2010
15:16 May 25, 2010
Jkt 220001
Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
Contact Person: Melanie Fleming,
Office of the Center Director, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5407,
Silver Spring, MD 20993, 301–796–
5424, FAX: 301–847–8510,
melanie.fleming@fda.hhs.gov.
Registration and Requests for Oral
Presentations: Interested persons may
register at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm
(select the appropriate meeting from the
list). Registrants must provide the
following information: (1) name, (2)
title, (3) company or organization (if
applicable), (4) mailing address, (5)
telephone number, and (6) e-mail
address. There is no registration fee for
the public workshop. Early registration
is recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
If you wish to make an oral
presentation during any of the open
comment sessions at the meeting (see
section II of this document), you must
indicate this at the time of registration.
FDA requests that presentations focus
on the areas defined in section III of this
document. You should also identify
which discussion topic you wish to
address in your presentation and you
must submit a brief statement that
describes your experience and/or
expertise relevant to your proposed
presentation. In order to keep each open
session focused on the discussion topic
at hand, each oral presentation should
address only one discussion topic. FDA
will do its best to accommodate requests
to speak.
If you need special accommodations
due to a disability, please contact
Melanie Fleming (see Contact Person) at
least 7 days in advance.
Comments: FDA is holding this public
workshop to obtain information on a
number of specific questions regarding
unmet public health needs and steps the
Federal Government can take to reduce
barriers to the development of medical
devices that can cure, significantly
improve, or prevent these illnesses and
injuries. The deadline for submitting
comments regarding this public
workshop is July 23, 2010.
Regardless of attendance at the public
workshop, interested persons may
submit electronic comments to https://
www.regulations.gov, or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
1061, Rockville, MD 20852. 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. In addition,
when responding to specific questions
as outlined in section III of this
document, please identify the question
you are addressing. Received comments
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
FDA’s Center for Devices and
Radiological Health (CDRH) has
undertaken an initiative to proactively
facilitate medical device innovation to
address unmet public health needs
defined as illnesses and injuries that
meet the following criteria: (1) Are
serious or have moderate adverse
impact on health, but affect many
individuals; (2) could be cured,
significantly improved, or prevented by
the development or redesign of a device;
and (3) the device(s) is not being
developed or redesigned due to barriers
that the Federal Government can
directly or indirectly remove or
minimize, where those barriers are out
of proportion to what is warranted
based on the public health needs.
Medical device development and/or
redesign is responsible for significant
public health benefits, including the
prevention, treatment, diagnosis, and
monitoring of serious or life-threatening
diseases and improved quality of life.
However, unnecessary barriers to
market may exist either due to market
failures or regulatory inefficiencies. For
example, payment practices can affect
financial incentives for manufacturers to
develop a new or improved technology.
A predictable and consistent regulatory
pathway can encourage would-be
innovators to invest in the development
of an innovative device.
As part of this initiative, CDRH
established a Council on Medical Device
Innovation composed of participants
from federal agencies. Agencies
represented include the National
Institutes of Health, the Centers for
Disease Control and Prevention, the
Centers for Medicare and Medicaid
Services, the Agency for Healthcare
Research and Quality, the Department of
Defense, the Defense Advanced
Research Projects Agency, and the
Department of Veterans Affairs. The
purpose of the Council is to identify the
most important unmet public health
needs, the barriers to innovative
medical device development or redesign
that could address those needs, and
actions the Federal Government can
E:\FR\FM\26MYN1.SGM
26MYN1
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices
take to reduce those barriers while
assuring the safety, effectiveness, and
quality of medical devices marketed in
the United States.
The Council seeks input from a wide
range of constituencies to include but
not be limited to industry, academia,
patient/consumer advocacy groups,
professional organizations, and other
State and Federal bodies under aligned
public health missions, to address the
issues outlined in this document.
During the public workshop, there
will be an open dialogue between
Federal Government Council members
and experts from the private and public
sectors regarding the topics described in
this document. Workshop participants
will not be expected to develop
consensus recommendations, but rather
to provide their perspectives on priority
areas in which medical device
innovations can have the highest
positive impact on public health.
Participants will also be encouraged to
comment on devices not being
developed or redesigned due to barriers
that the Federal Government can and
should directly or indirectly remove or
minimize.
Additional information on the public
workshop, including an agenda, will be
made available in advance of June 24,
2010, at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm
(select the appropriate meeting from the
list).
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
II. Public Participation
If you wish to make an oral
presentation during the public
workshop, you must indicate this at the
time of registration. There are two types
of opportunities for participation
planned for the public workshop. In
one, formal presentations will address
one of the two topics (see section III of
this document) that will be limited to 15
minutes and require submission of the
presentation in advance of the meeting.
The other will be time-limited, based on
the number of requests, as part of the
public comment period. When
registering, you will be required to
identify the title of the topic you wish
to address in your presentation and
answer all the related questions on the
web registration form. FDA will do its
best to accommodate requests to present
and will focus discussions to the topics
described in this document (see section
III of this document). Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and to request time for
joint presentations. FDA will determine
the amount of time allotted to each
VerDate Mar<15>2010
15:16 May 25, 2010
Jkt 220001
presenter and the approximate time that
each oral presentation is to begin.
III. Issues for Discussion
IV. Transcripts
Please be advised that as soon as a
transcript is available, it can be obtained
in either hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
(HFI–35), Office of Management
Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857. A transcript
of the public workshop will be available
on the Internet at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm
(select the appropriate meeting from the
list).
Frm 00055
Fmt 4703
Sfmt 4703
Dated: May 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–12588 Filed 5–25–10; 8:45 am]
The workshop will focus on three
topics: (1) Identification of the most
important unmet public health needs;
(2) delineation of the barriers to the
development, redesign, and patient and
healthcare professional access to
medical devices that can cure,
significantly improve, or prevent these
illnesses or injuries; and (3)
identification of the actions the Federal
Government can take to remove or
minimize these barriers. The discussion
of these general topics should not be
limited by current statutes or
regulations and will include, but not be
limited to, discussion of the following
questions:
1. Identifying areas of public health
need:
a. Which unmet public health needs
could be most effectively addressed by
the development of new, or the redesign
of existing, medical devices?
b. How should the Council set
priorities amongst the identified public
health needs? Are there specific factors
that should be considered? If so, which
and why?
2. Addressing barriers to development
and/or redesign of medical devices:
a. What are the significant barriers
facing innovators, academics, and/or
industry that limit the availability and
clinical use of medical devices that have
the potential to improve public health?
b. How should any perceived or
actual barriers be evaluated to
determine whether federal intervention
is appropriate?
c. How should federal agencies—
including those present and others not
represented—address those barriers that
are out of proportion to what is
warranted based on the public health
needs?
PO 00000
29561
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Surveillance,
Natural History, Quality of Care and
Outcomes of Diabetes Mellitus with
Onset in Childhood and Adolescence,
RFA DP 10–001, Initial Review
Correction: This notice was published
in the Federal Register on March 22,
2010, volume 75, Number 54, Page
13560. The Place and time should read
as follows:
Time and Date: 8:30 a.m.–6 p.m., June
15, 2010 (Closed).
Place: W Hotel, 3377 Peachtree Road,
NE., Atlanta, GA 30326, Telephone:
678–500–3100.
Contact Person for More Information:
Donald Blackman, Ph.D., Scientific
Review Officer, National Center for
Chronic Disease Prevention and Health
Promotion, Office of the Director,
Extramural Research Program Office,
4770 Buford Highway, NE., Mailstop K–
92, Atlanta, GA 30341, Telephone: (770)
488–3023, E-mail: DBY7@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: May 20, 2010.
Andre Tyler,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2010–12627 Filed 5–25–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0004]
[FDA 225–09–0012]
Memorandum of Understanding
Between the Food and Drug
Administration and Drugs.Com
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\26MYN1.SGM
26MYN1
]]>Agencies
[Federal Register Volume 75, Number 101 (Wednesday, May 26, 2010)]
[Notices]
[Pages 29560-29561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12588]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0237]
Identifying Unmet Public Health Needs and Facilitating Innovation
in Medical Device Development; Notice of Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Identifying Unmet Public Health Needs and
Facilitating Innovation in Medical Device Development.'' The purpose of
the workshop is to obtain public input on what are the most important
unmet public health needs and what are the barriers to the development
of medical devices that can cure, significantly improve, or prevent
these illnesses and injuries.
Dates and Times: This workshop will be held on June 24, 2010, from
8 a.m. to 5 p.m. Persons interested in attending the meeting must
register by 5 p.m. on June 10, 2010. Submit electronic or written
comments by July 23, 2010.
Location: The public workshop will be held at Hilton Washington DC/
North Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
Contact Person: Melanie Fleming, Office of the Center Director,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5407, Silver
Spring, MD 20993, 301-796-5424, FAX: 301-847-8510,
melanie.fleming@fda.hhs.gov.
Registration and Requests for Oral Presentations: Interested
persons may register at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from
the list). Registrants must provide the following information: (1)
name, (2) title, (3) company or organization (if applicable), (4)
mailing address, (5) telephone number, and (6) e-mail address. There is
no registration fee for the public workshop. Early registration is
recommended because seating is limited. Registration on the day of the
public workshop will be provided on a space available basis beginning
at 7:30 a.m.
If you wish to make an oral presentation during any of the open
comment sessions at the meeting (see section II of this document), you
must indicate this at the time of registration. FDA requests that
presentations focus on the areas defined in section III of this
document. You should also identify which discussion topic you wish to
address in your presentation and you must submit a brief statement that
describes your experience and/or expertise relevant to your proposed
presentation. In order to keep each open session focused on the
discussion topic at hand, each oral presentation should address only
one discussion topic. FDA will do its best to accommodate requests to
speak.
If you need special accommodations due to a disability, please
contact Melanie Fleming (see Contact Person) at least 7 days in
advance.
Comments: FDA is holding this public workshop to obtain information
on a number of specific questions regarding unmet public health needs
and steps the Federal Government can take to reduce barriers to the
development of medical devices that can cure, significantly improve, or
prevent these illnesses and injuries. The deadline for submitting
comments regarding this public workshop is July 23, 2010.
Regardless of attendance at the public workshop, interested persons
may submit electronic comments to https://www.regulations.gov, or
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. 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. In addition, when responding to specific questions as
outlined in section III of this document, please identify the question
you are addressing. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's Center for Devices and Radiological Health (CDRH) has
undertaken an initiative to proactively facilitate medical device
innovation to address unmet public health needs defined as illnesses
and injuries that meet the following criteria: (1) Are serious or have
moderate adverse impact on health, but affect many individuals; (2)
could be cured, significantly improved, or prevented by the development
or redesign of a device; and (3) the device(s) is not being developed
or redesigned due to barriers that the Federal Government can directly
or indirectly remove or minimize, where those barriers are out of
proportion to what is warranted based on the public health needs.
Medical device development and/or redesign is responsible for
significant public health benefits, including the prevention,
treatment, diagnosis, and monitoring of serious or life-threatening
diseases and improved quality of life. However, unnecessary barriers to
market may exist either due to market failures or regulatory
inefficiencies. For example, payment practices can affect financial
incentives for manufacturers to develop a new or improved technology. A
predictable and consistent regulatory pathway can encourage would-be
innovators to invest in the development of an innovative device.
As part of this initiative, CDRH established a Council on Medical
Device Innovation composed of participants from federal agencies.
Agencies represented include the National Institutes of Health, the
Centers for Disease Control and Prevention, the Centers for Medicare
and Medicaid Services, the Agency for Healthcare Research and Quality,
the Department of Defense, the Defense Advanced Research Projects
Agency, and the Department of Veterans Affairs. The purpose of the
Council is to identify the most important unmet public health needs,
the barriers to innovative medical device development or redesign that
could address those needs, and actions the Federal Government can
[[Page 29561]]
take to reduce those barriers while assuring the safety, effectiveness,
and quality of medical devices marketed in the United States.
The Council seeks input from a wide range of constituencies to
include but not be limited to industry, academia, patient/consumer
advocacy groups, professional organizations, and other State and
Federal bodies under aligned public health missions, to address the
issues outlined in this document.
During the public workshop, there will be an open dialogue between
Federal Government Council members and experts from the private and
public sectors regarding the topics described in this document.
Workshop participants will not be expected to develop consensus
recommendations, but rather to provide their perspectives on priority
areas in which medical device innovations can have the highest positive
impact on public health. Participants will also be encouraged to
comment on devices not being developed or redesigned due to barriers
that the Federal Government can and should directly or indirectly
remove or minimize.
Additional information on the public workshop, including an agenda,
will be made available in advance of June 24, 2010, at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
(select the appropriate meeting from the list).
II. Public Participation
If you wish to make an oral presentation during the public
workshop, you must indicate this at the time of registration. There are
two types of opportunities for participation planned for the public
workshop. In one, formal presentations will address one of the two
topics (see section III of this document) that will be limited to 15
minutes and require submission of the presentation in advance of the
meeting. The other will be time-limited, based on the number of
requests, as part of the public comment period. When registering, you
will be required to identify the title of the topic you wish to address
in your presentation and answer all the related questions on the web
registration form. FDA will do its best to accommodate requests to
present and will focus discussions to the topics described in this
document (see section III of this document). Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and to request time for joint
presentations. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is to
begin.
III. Issues for Discussion
The workshop will focus on three topics: (1) Identification of the
most important unmet public health needs; (2) delineation of the
barriers to the development, redesign, and patient and healthcare
professional access to medical devices that can cure, significantly
improve, or prevent these illnesses or injuries; and (3) identification
of the actions the Federal Government can take to remove or minimize
these barriers. The discussion of these general topics should not be
limited by current statutes or regulations and will include, but not be
limited to, discussion of the following questions:
1. Identifying areas of public health need:
a. Which unmet public health needs could be most effectively
addressed by the development of new, or the redesign of existing,
medical devices?
b. How should the Council set priorities amongst the identified
public health needs? Are there specific factors that should be
considered? If so, which and why?
2. Addressing barriers to development and/or redesign of medical
devices:
a. What are the significant barriers facing innovators, academics,
and/or industry that limit the availability and clinical use of medical
devices that have the potential to improve public health?
b. How should any perceived or actual barriers be evaluated to
determine whether federal intervention is appropriate?
c. How should federal agencies--including those present and others
not represented--address those barriers that are out of proportion to
what is warranted based on the public health needs?
IV. Transcripts
Please be advised that as soon as a transcript is available, it can
be obtained in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857. A transcript of the public workshop will be
available on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate
meeting from the list).
Dated: May 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12588 Filed 5-25-10; 8:45 am]
BILLING CODE 4160-01-S
