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, 29561 [2010-12627]
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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
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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
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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]
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Between the Food and Drug
Administration and Drugs.Com
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\26MYN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 101 (Wednesday, May 26, 2010)]
[Notices]
[Page 29561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12627]
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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
