Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 20887 [2014-08307]
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Federal Register / Vol. 79, No. 71 / Monday, April 14, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse Event
Program for Medical Devices (Medical
Product Safety Network)
[Docket No. FDA–2013–N–1439]
mstockstill on DSK4VPTVN1PROD with NOTICES
The meeting announced below
concerns Improving Access to Eye Care
among Persons at High Risk of
Glaucoma, FOA DP14–002, initial
review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 9:00 a.m.—6:00 p.m.,
EST, May 6, 2014 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Improving Access to Eye Care among
Persons at High Risk of Glaucoma, FOA
DP14–002, initial review.’’
Contact Person for More Information:
M. Chris Langub, Ph.D., Scientific
Review Officer, CDC, 4770 Buford
Highway NE., Mailstop F–80, Atlanta,
Georgia 30341, Telephone: (770) 488–
3585, EEO6@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 the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Gary J. Johnson,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2014–08307 Filed 4–11–14; 8:45 am]
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 14,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0471. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Adverse Event Program for Medical
Devices (Medical Product Safety
Network)—(OMB Control Number
0910–0471)—Extension
Among other things, section 519 of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360i)
authorizes FDA to require (1)
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions, and (2) user facilities to
report device-related deaths directly to
manufacturers and FDA and serious
injuries to the manufacturer. Section
213 of the Food and Drug
PO 00000
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20887
Administration Modernization Act of
1997 (Pub. L. 105–115) amended section
519(b) of the FD&C Act relating to
mandatory reporting by user facilities of
deaths, serious injuries, and serious
illnesses associated with the use of
medical devices. This amendment
legislated the replacement of universal
user facility reporting by a system that
is limited to a ‘‘. . . subset of user
facilities that constitutes a
representative profile of user reports’’
for device-related deaths and serious
injuries. This amendment is reflected in
section 519(b)(5)(A) of the FD&C Act.
This legislation provides FDA with the
opportunity to design and implement a
national surveillance network,
composed of well-trained clinical
facilities, to provide high-quality data
on medical devices in clinical use. This
system is called the Medical Product
Safety Network (MedSun).
FDA is seeking OMB clearance to
continue to use electronic data
collection to obtain the information on
Form FDA 3500A (approved under
OMB control number 0910–0291)
related to medical devices and tissue
products from the user facilities
participating in MedSun, to obtain a
demographic profile of the facilities,
and for additional questions which will
permit FDA to better understand the
cause of reported adverse events.
Participation in the program is
voluntary and currently includes 250
facilities.
In addition to collecting data on the
electronic adverse event report form,
MedSun collects additional information
from participating sites about reported
problems emerging from the MedSun
hospitals. This data collection is also
voluntary and is collected on the same
Web site as the report information.
The burden estimate is based on the
number of facilities currently
participating in MedSun (250). FDA
estimates an average of 15 reports per
site annually. This estimate is based on
MedSun working to promote reporting
in general from the sites, as well as
promoting reporting from specific parts
of the hospitals, such as the pediatric
intensive care units, the
electrophysiology laboratories, and the
hospital laboratories.
In the Federal Register of November
29, 2013 (78 FR 71620), FDA published
a 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:
E:\FR\FM\14APN1.SGM
14APN1
]]>Agencies
[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Page 20887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08307]
[[Page 20887]]
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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): Initial Review
The meeting announced below concerns Improving Access to Eye Care
among Persons at High Risk of Glaucoma, FOA DP14-002, initial review.
In accordance with Section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the aforementioned meeting:
Time and Date: 9:00 a.m.--6:00 p.m., EST, May 6, 2014 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director, Management Analysis and Services
Office, CDC, pursuant to Public Law 92-463.
Matters for Discussion: The meeting will include the initial
review, discussion, and evaluation of applications received in response
to ``Improving Access to Eye Care among Persons at High Risk of
Glaucoma, FOA DP14-002, initial review.''
Contact Person for More Information: M. Chris Langub, Ph.D.,
Scientific Review Officer, CDC, 4770 Buford Highway NE., Mailstop F-80,
Atlanta, Georgia 30341, Telephone: (770) 488-3585, EEO6@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 the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Gary J. Johnson,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. 2014-08307 Filed 4-11-14; 8:45 am]
BILLING CODE 4163-18-P
