Medical Device Epidemiology Network 2011: Second Annual Public Workshop, 17657-17658 [2011-7434]
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Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Notices
registrations and listings for additional
information is estimated to be 12,375
hours, and the annual respondent
recordkeeping burden is estimated to be
45,000 hours. Therefore, the total
burden hours for this collection are
estimated to be 57,375. The estimates
cited in tables 1 and 2 of this document
are based primarily on fiscal year 2010
data from current systems and on
conversations with industry and trade
association representatives.
In the Federal Register of December 7,
2010 (75 FR 76008), FDA published a
17657
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
No. of
respondents
No. of
responses per
respondent
Total annual
respondents
Average
burden per
response
(in hours)
Total hours
807.31(d)(2) .........................................................................
807.31(e) ..............................................................................
2,250
22,500
1
1
2,250
22,500
0.5
0.5
1,125
11,250
........................
........................
........................
........................
12,375
Total ..............................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
No. of recordkeepers
No. of records
per recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total hours
807.31(a) to (c) ....................................................................
22,500
4
90,000
0.5
45,000
........................
........................
........................
........................
45,000
Total ..............................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–7389 Filed 3–29–11; 8:45 am]
encouraged to arrive early to ensure
time for parking and security screening
before the meeting. Registration will
begin at 7 a.m.
BILLING CODE 4160–01–P
LOCATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The public workshop will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503 (the Great Room), Silver
Spring, MD 20993.
Food and Drug Administration
CONTACTS:
[Docket No. FDA–2011–N–0002]
Medical Device Epidemiology Network
2011: Second Annual Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Medical Device Epidemiology
Network (MDEpiNet) 2011: Second
Annual Public Workshop.’’ The purpose
of the public workshop is to provide a
public update on the development of
MDEpiNet and to facilitate discussion
among FDA and all stakeholders with
expertise in epidemiology and health
services research on issues related to the
methodology for studying medical
device performance.
DATE AND TIME: The public workshop
will be held on April 25, 2011 from 8
a.m. to 5 p.m. Participants are
VerDate Mar<15>2010
14:59 Mar 29, 2011
Jkt 223001
Mary Beth Ritchey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Avenue, Silver Spring,
MD 20993, 301–796–6638, e-mail:
MaryElizabeth.Ritchey@fda.hhs.gov; or
Ellen Pinnow, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–6066, e-mail:
Ellen.Pinnow@fda.hhs.gov.
Registration: Registration is available
through April 15, 2011, at the following
Web site: https://fda-ws.s-3.net/
EpiNetWSApr11/. There is no fee to
attend the workshop, but attendees must
register in advance. Registration will be
on a first-come, first-served basis and
we ask that one person per institution
be selected to represent the entity at the
workshop. Non-U.S. citizens are subject
to additional security screening, and
they should register as soon as possible.
If you need special accommodations
because of a disability, please contact
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Mary Beth Ritchey (see CONTACTS) at
least 7 days before the public workshop.
SUPPLEMENTARY INFORMATION:
I. Why are we holding this public
workshop?
The purpose of the public workshop
is to facilitate continuing discussion
among FDA, the academic epidemiology
and health services research
community, and all stakeholders on
issues related to the methodology of
studies for medical device performance.
We aim to describe and solicit feedback
on the establishment of a network that
works with FDA experts to determine
the evidence gaps and questions,
datasets and approaches for conducting
robust analytic studies and improve our
understanding of the performance of
medical devices (including comparative
effectiveness studies). We also aim to
reach out to stakeholders to initiate
development of scientific, methodology,
and device-area priorities for MDEpiNet.
II. Who is the target audience for this
public workshop? Who should attend
this public workshop?
This workshop is open to all
interested parties. The target audience is
comprised of academic researchers with
experience in epidemiology or health
services research with an interest in
medical device outcome and
epidemiologic study methodology.
E:\FR\FM\30MRN1.SGM
30MRN1
17658
Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Notices
III. What are the topics we intend to
address at the public workshop?
We intend to discuss a large number
of issues at the workshop, including, but
not limited to the following:
• Establishment of the MDEpiNet
infrastructure,
• Gaps and challenges in medical
device outcomes and epidemiologic
studies,
• Opportunities for medical device
epidemiologic research and
partnerships between the Center for
Devices and Radiological Health and
academia.
IV. Where can I find out more about
this public workshop?
Background information on the public
workshop, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at https://fda-ws.s-3.net/
EpiNetWSApr11/.
Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–7434 Filed 3–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Forum for State and Territorial
Chief Executives (National Forum)
Program Cooperative Agreement
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of Non-competitive OneYear Extension With Funds for the
National Forum for State and Territorial
Chief Executives (National Forum)
Program Cooperative Agreement.
Original Period of Support: April 1,
2008, to March 31, 2011.
Amount of Supplement Award:
$160,000.
Authority: Sections 241 and 301 of the
Public Health Service Act, as amended
(42 U.S.C. 238J and 241 respectively).
CFDA Number: 93.224.
Justification for the Exception to
Competition: The National Forum
cooperative agreement provides a
unique vehicle for HRSA to collaborate
with the Nation’s governors on their
shared priorities, and provides
opportunities through which governors
can build on lessons others states have
learned in addressing similar health
policy challenges. A 1-year extension
with funds will allow the National
Forum to facilitate ongoing
communication on emerging strategies
addressing common priorities, public
health policy, and governance issues
affecting States and Territories thereby
allowing HRSA to reevaluate the focus
and implementation of this Program
prior to the FY 2012 competition for the
next 3-year project period. Further
funding beyond March 31, 2012, will be
competitively awarded in FY 2012.
FOR FURTHER INFORMATION CONTACT:
Mark Pincus, Director, Office of Policy
Analysis, HRSA, via e-mail:
mpincus@hrsa.gov or via telephone:
301–443–5911.
Dated: March 23, 2011.
Mary K. Wakefield,
Administrator.
[FR Doc. 2011–7444 Filed 3–29–11; 8:45 am]
BILLING CODE 4165–15–P
AGENCY:
HRSA will be providing a
one-year extension with funds in the
amount authorized in fiscal year (FY)
2010 to support activities that focus on
cross-cutting publicly-funded health
program integration and health access
issues identified by the State and
Territory governors and their senior
health policy advisors, including
addressing the needs of uninsured,
underinsured and special needs
populations, oral health, border health
and health information technology as
well as HRSA’s overall strategic goals.
SUPPLEMENTARY INFORMATION:
Cooperative Agreement Recipient of
Record: National Governors Association
Center for Best Practices (NGA),
Washington, DC.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
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14:59 Mar 29, 2011
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
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Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK Central
Repositories Non-Renewable Sample Access
(X01)-Hepatitis C.
Date: April 26, 2011.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call)
Contact Person: Najma Begum, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 749, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: March 24, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–7500 Filed 3–29–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; ‘‘Mouse Resource’’.
Date: April 20, 2011.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call)
Contact Person: Gregory P. Jarosik, PhD,
Scientific Review Administrator, Scientific
E:\FR\FM\30MRN1.SGM
30MRN1
]]>Agencies
[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Notices]
[Pages 17657-17658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7434]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Medical Device Epidemiology Network 2011: Second Annual 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 ``Medical Device Epidemiology Network (MDEpiNet)
2011: Second Annual Public Workshop.'' The purpose of the public
workshop is to provide a public update on the development of MDEpiNet
and to facilitate discussion among FDA and all stakeholders with
expertise in epidemiology and health services research on issues
related to the methodology for studying medical device performance.
Date and Time: The public workshop will be held on April 25, 2011 from
8 a.m. to 5 p.m. Participants are encouraged to arrive early to ensure
time for parking and security screening before the meeting.
Registration will begin at 7 a.m.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room),
Silver Spring, MD 20993.
Contacts: Mary Beth Ritchey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Avenue,
Silver Spring, MD 20993, 301-796-6638, e-mail:
MaryElizabeth.Ritchey@fda.hhs.gov; or Ellen Pinnow, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-6066, e-mail:
Ellen.Pinnow@fda.hhs.gov.
Registration: Registration is available through April 15, 2011, at
the following Web site: https://fda-ws.s-3.net/EpiNetWSApr11/. There is
no fee to attend the workshop, but attendees must register in advance.
Registration will be on a first-come, first-served basis and we ask
that one person per institution be selected to represent the entity at
the workshop. Non-U.S. citizens are subject to additional security
screening, and they should register as soon as possible. If you need
special accommodations because of a disability, please contact Mary
Beth Ritchey (see CONTACTS) at least 7 days before the public workshop.
SUPPLEMENTARY INFORMATION:
I. Why are we holding this public workshop?
The purpose of the public workshop is to facilitate continuing
discussion among FDA, the academic epidemiology and health services
research community, and all stakeholders on issues related to the
methodology of studies for medical device performance. We aim to
describe and solicit feedback on the establishment of a network that
works with FDA experts to determine the evidence gaps and questions,
datasets and approaches for conducting robust analytic studies and
improve our understanding of the performance of medical devices
(including comparative effectiveness studies). We also aim to reach out
to stakeholders to initiate development of scientific, methodology, and
device-area priorities for MDEpiNet.
II. Who is the target audience for this public workshop? Who should
attend this public workshop?
This workshop is open to all interested parties. The target
audience is comprised of academic researchers with experience in
epidemiology or health services research with an interest in medical
device outcome and epidemiologic study methodology.
[[Page 17658]]
III. What are the topics we intend to address at the public workshop?
We intend to discuss a large number of issues at the workshop,
including, but not limited to the following:
Establishment of the MDEpiNet infrastructure,
Gaps and challenges in medical device outcomes and
epidemiologic studies,
Opportunities for medical device epidemiologic research
and partnerships between the Center for Devices and Radiological Health
and academia.
IV. Where can I find out more about this public workshop?
Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
https://fda-ws.s-3.net/EpiNetWSApr11/.
Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7434 Filed 3-29-11; 8:45 am]
BILLING CODE 4160-01-P
