Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network), 20887-20888 [2014-08212]
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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
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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:
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Federal Register / Vol. 79, No. 71 / Monday, April 14, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
MedSun facilities participating in the electronic
reporting of adverse events program (Form
FDA 3670) ........................................................
1 There
[FR Doc. 2014–08212 Filed 4–11–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
250
15
Total annual
responses
3,750
Average burden
per response
0.75 (45 minutes)
Total hours
2,813
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Circulatory
System Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 6 and 7, 2014, from 8 a.m.
to 6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: Jamie Waterhouse,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–3063,
email: Jamie.Waterhouse@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last-minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
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site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On May 6, 2014, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application for the RESQCPR
System sponsored by Advanced
Circulatory Systems, Inc. The RESQCPR
System is comprised of two devices: the
RESQPOD 16.0 Impedance Threshold
Device, and the RESQPUMP Active
Compression Decompression CPR
Device. These devices are used together
during manual cardiopulmonary
resuscitation (CPR) in an attempt to
enhance venous return to the heart and
blood flow to vital organs during CPR to
ultimately increase survival and
neurologic outcome in patients suffering
from out of hospital cardiac arrest.
Advanced Circulatory Systems, Inc.
has proposed the following indications
for use: the RESQCPR System is
intended for use in the performance of
CPR to increase survival with favorable
neurologic function in adult patients
with non-traumatic cardiac arrest.
On May 7, 2014, during session I, the
committee will discuss and make
recommendations regarding the
classification of membrane lung for
long-term pulmonary support systems,
one of the remaining preamendment
Class III devices regulated under the
510(k) pathway. A membrane lung for
long-term pulmonary support refers to
the oxygenator component of an
extracorporeal circuit used during longterm procedures, commonly referred to
as extracorporeal membrane
oxygenation (ECMO). An ECMO
procedure provides assisted
extracorporeal circulation and
physiologic gas exchange of a patient’s
blood when an acute (reversible)
condition prevents the patient’s own
body from providing the physiologic gas
exchange needed to sustain life. The
circuit is comprised of multiple device
types, including, but not limited to, an
oxygenator, blood pump, cannulae, heat
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exchanger, tubing, filters, monitors/
detectors, and other accessories; the
circuit components and configuration
(e.g., arteriovenous, veno-venous) may
differ based on the needs of the
individual patient or the condition
being treated. ECMO is currently used
for patients with acute reversible
respiratory or cardiac failure,
unresponsive to optimal ventilation
and/or pharmacologic management.
On January 8, 2013 the FDA issued a
proposed order which, if made final,
would make the class III ECMO devices
class II subject to premarket notification
(510(k)) and special controls. FDA
discussed the regulatory history of
ECMO devices as part of the proposed
order. On September 12, 2013, the
classification of ECMO was discussed at
a meeting of the Circulatory System
Devices Panel. The Panel agreed with
FDA’s proposal to reclassify ECMO to
class II (special controls) as outlined in
the January 8, 2013, proposed order, but
recommended that a panel be
reconvened to discuss use of ECMO in
an adult patient population as the
September 12, 2013, panel meeting was
focused on the use of ECMO in a
pediatric patient population.
The discussion at this panel meeting
will involve making recommendations
regarding regulatory classification to
either reconfirm to class III (subject to
premarket approval application (PMA))
or reclassify to class II and comment on
whether special controls are adequate to
assure the safety and effectiveness of
this device in an adult patient
population.
On May 7, 2014, during session II, the
committee will discuss and make
recommendations regarding the
classification of More-than-Minimally
Manipulated Allograft Heart Valves
(MMM Allograft HVs). An MMM
Allograft HV is a human valve or
valved-conduit that has been aseptically
recovered from qualified donors,
dissected free from the human heart,
and then subjected to a manufacturing
process(es) which alters the original
relevant characteristics of the tissue (cf.
21 CFR 1271.3(f), 21 CFR 1271.10(a)(1),
and 21 CFR 1271.20). The valve is then
stored until needed by a recipient. An
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]]>Agencies
[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Pages 20887-20888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08212]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1439]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event Program
for Medical Devices (Medical Product Safety Network)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
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 device-related 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 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:
[[Page 20888]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
MedSun facilities participating in the electronic reporting of 250 15 3,750 0.75 (45 minutes) 2,813
adverse events program (Form FDA 3670)........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08212 Filed 4-11-14; 8:45 am]
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