Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Products, 71620-71621 [2013-28600]
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Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices
++ Assess AOA/HFAP’s ability to
report deficiencies to the surveyed
facilities and respond to the facility’s
plan of correction in a timely manner.
++ Establish AOA/HFAP’s ability to
provide us with electronic data and
reports necessary for effective validation
and assessment of the organization’s
survey process.
++ Determine the adequacy of staff
and other resources.
++ Confirm AOA/HFAP’s ability to
provide adequate funding for
performing required surveys.
++ Confirm AOA/HFAP’s policies
with respect to whether surveys are
announced or unannounced.
++ Obtain AOA/HFAP’s agreement to
provide us with a copy of the most
current accreditation survey together
with any other information related to
the survey as we may require, including
corrective action plans.
In accordance with section
1865(a)(3)(A) of the Act, the June 25,
2013 proposed notice also solicited
public comments regarding whether
AOA/HFAP’s requirements met or
exceeded the Medicare conditions of
participation for CAHs. We received no
comments in response to our proposed
notice.
IV. Provisions of the Final Notice
sroberts on DSK5SPTVN1PROD with NOTICES
A. Differences Between AOA/HFAP’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey requirements
We compared AOA/HFAP’s CAH
requirements and survey process with
the Medicare CoPs and survey process
as outlined in the State Operations
Manual (SOM). Our review and
evaluation of AOA/HFAP’s CAH
application, which were conducted as
described in section III of this final
notice, yielded the following:
• To meet the requirements at
§ 485.623(b)(5), AOA/HFAP revised its
standards to require all ventilation
systems, both new and existing,
supplying operating rooms to meet the
humidity control requirements..
• To meet the requirements at
§ 485.623(c)(1), AOA/HFAP revised its
standards to incorporate specific staff
training requirements for protection in
place or methods for the evacuation of
patients, when necessary.
• To meet the requirements at
§ 485.635(e), AOA/HFAP revised its
standards to include staff qualification
requirements for rehabilitation therapy
services.
• To meet the requirements at
§ 488.4(a)(6), AOA/HFAP revised its
‘‘Complaint/Incident Management
Policy,’’ to ensure all onsite complaint
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17:56 Nov 27, 2013
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surveys are documented on a survey
report.
• To meet the requirements of section
2728 of the SOM, AOA/HFAP will
continue to use its internal monitoring
plan to ensure timeframes for sending or
receiving a plan of correction (PoC) are
met.
• To meet the requirements of section
2728B of the SOM, AOA/HFAP will
continue to conduct monthly internal
audits to ensure accepted PoC’s contain
all of the required elements.
B. Term of Approval
Based on our review and observations
described in section III of this final
notice, we have determined that AOA/
HFAP’s CAH accreditation program
requirements meet or exceed our
requirements. Therefore, we approve
AOA/HFAP as a national AO for CAHs
that request participation in the
Medicare program, effective December
27, 2013 through December 27, 2019.
V. Collection of Information
Requirements
This document does not impose
information collection, recordkeeping or
third party disclosure requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
Authority: (Catalog of Federal Domestic
Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare—
Hospital Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: November 12, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2013–28521 Filed 11–27–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1439]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Program for Medical Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information regarding
the Adverse Event Program for medical
devices.
DATES: Submit either electronic or
written comments on the collection of
information by January 28, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
E:\FR\FM\29NON1.SGM
29NON1
Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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
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,
71621
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
No. of
respondents
No. of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total hours
MedSun facilities participating in the electronic reporting of
adverse events program (Form FDA 3670) .....................
250
15
3,750
0.75
2,813
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–28600 Filed 11–27–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1422]
sroberts on DSK5SPTVN1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Eye Tracking
Study of Direct-to-Consumer
Prescription Drug Advertisement
Viewing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
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17:56 Nov 27, 2013
Jkt 232001
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Eye Tracking Study
of Direct-to-Consumer Prescription Drug
Advertisement Viewing.’’ This study is
designed to use eye tracking technology
to explore how consumers view directto-consumer (DTC) prescription drug
advertisements (ads) that include text
regarding risk information and reporting
side effects and that vary in the amount
of distracting audio and visual content
during the presentation of the risk
information.
Submit either electronic or
written comments on the collection of
information by January 28, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
DATES:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71620-71621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28600]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1439]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Program for Medical Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
regarding the Adverse Event Program for medical devices.
DATES: Submit either electronic or written comments on the collection
of information by January 28, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and
[[Page 71621]]
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) ways to minimize the burden
of the collection of information on respondents, including through the
use of automated collection techniques, when appropriate, and other
forms of information technology.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
MedSun facilities participating in the electronic reporting of 250 15 3,750 0.75 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: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28600 Filed 11-27-13; 8:45 am]
BILLING CODE 4160-01-P
