Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network), 49526-49528 [2019-20355]
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49526
Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices
that help ensure food and feed
produced, processed, and distributed
within their jurisdictions are safe and in
compliance with State laws and
regulations. States primarily perform
inspections under their own regulatory
authority. Some States conduct
inspections of feed facilities under
contract with FDA. Because
jurisdictions may overlap, FDA and
States collaborate and share resources to
protect animal feed.
The FDA Food Safety Modernization
Act passed on January 4, 2011, calls for
enhanced partnerships and provides a
legal mandate for developing an
Integrated Food Safety System (IFSS).
FDA is committed to implementing an
IFSS thereby optimizing coordination of
food and feed safety efforts with
Federal, State, local, tribal, and
territorial regulatory and public health
agencies. Model standards provide a
consistent, underlying foundation that
is critical for uniformity across State
and Federal Agencies to ensure
credibility of food and feed programs
within the IFSS.
II. Significance of Feed Program
Standards
The AFRPS provide a uniform and
consistent approach to feed regulation
in the United States. Implementation of
the draft feed program standards is
voluntary. States implementing the
standards will identify and maintain
program improvements that will
strengthen the safety and integrity of the
U.S. animal feed supply.
The feed standards are the framework
that each State should use to design,
manage, and improve its feed program.
The standards include the following: (1)
Regulatory foundation; (2) training; (3)
inspection program; (4) auditing; (5)
feed-related illness or death and
emergency response; (6) enforcement
program; (7) outreach activities; (8)
budget and planning; (9) assessment and
improvement; (10) laboratory services;
and (11) sampling program.
Each standard has a purpose
statement, requirement summary,
description of program elements,
projected outcomes, and a list of
required documentation. When a State
program voluntarily agrees to
implement the feed standards, it must
fully implement and maintain the
individual program elements and
documentation requirements in each
standard in order to fully implement the
standard.
The feed standards package includes
forms, worksheets, and templates to
help the State program assess and meet
the program elements in the standard.
State programs are not obligated to use
the forms, worksheets, and templates
provided with the feed standards. Other
manual or automated forms, worksheets,
and templates may be used as long as
the pertinent data elements are present.
Records and other documents specified
in the feed standards must be
maintained in good order by the State
program and must be available to verify
the implementation of each standard.
The feed standards are not intended to
address the performance appraisal
processes that a State agency may use to
evaluate individual employee
performance.
As set forth in the feed standards, the
State program is expected to review and
update its improvement plan on an
annual basis. The State program
completes an evaluation of its
implementation status at least every 3
years following the baseline evaluation
by reviewing and updating the selfassessment worksheets and required
documentation for each standard. The
evaluation is needed to determine if
each standard’s requirements are, or
remain, fully met, partially met, or not
met. The State program revises the
improvement plan based upon this
evaluation.
Although FDA plans to provide
financial support to State programs that
implement the feed standards, funding
opportunities are contingent upon the
availability of funds. Funding
opportunities may be only available to
State feed regulatory programs that
currently have an FDA feed inspection
contract. State programs receiving
financial support to implement the feed
standards will be audited by FDA.
III. Electronic Access
Persons with access to the internet
may submit requests for a single copy of
the current feed standards from OPPRA@fda.hhs.gov.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
State animal feed regulatory Program in the United
States .........................................................................
34
1
34
569
19,346
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to the information
collection are State agencies seeking to
avail themselves of the options
described in the document. States
agencies that conduct feed inspections
under contract are interested in
implementing the standards. The total
estimated annual recordkeeping burden
for implementation is 569 hours per
respondent. The burden was determined
by capturing the average amount of time
for each respondent to assess the current
state of the program and work toward
implementation of each of the eleven
standards contained in the AFRPS. The
hours per state feed regulatory program
will average the same to account for
VerDate Sep<11>2014
17:13 Sep 19, 2019
Jkt 247001
continual improvement and selfsufficiency in the program. Our burden
estimate reflects a decrease of 100,654
hours as a result of fewer respondents
to the collection and a reevaluation of
the time we ascribe for recordkeeping
activities.
Dated: September 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–20352 Filed 9–19–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0084]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Program for Medical Devices (Medical
Product Safety Network)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 Adverse Event
Program for Medical Devices (Medical
Program Safety Network (MedSun)).
DATES: Submit either electronic or
written comments on the collection of
information by November 19, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 19,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 19, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
VerDate Sep<11>2014
17:13 Sep 19, 2019
Jkt 247001
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–0084 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Adverse
Event Program for Medical Devices
(Medical Product Safety Network
(MedSun)).’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
PO 00000
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49527
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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
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 (MedSun))
OMB Control Number 0910–0471—
Extension
Section 519 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360i) authorizes FDA to require (1)
manufacturers to report medical devicerelated deaths, serious injuries, and
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Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices
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 includes approximately
300 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
website as the report information.
The burden estimate is based on the
number of facilities participating in
MedSun (300). FDA estimates an
average of 18 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
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Adverse event reporting ......................................
300
18
5,400
0.50 (30 minutes) ...........
2,700
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 113 hours despite a
corresponding increase of 1,650
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years but a decrease in the amount
of time spent entering data due to IT
efficiencies that have been built into the
MedSun reporting system to reduce data
entry by user facilities.
Dated: September 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–20355 Filed 9–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket Nos. FDA–2019–D–1647, FDA–
2019–D–1649, FDA–2019–D–1651, and FDA–
2019–D–1652]
Safety and Performance Based
Pathway Device-Specific Guidance;
Draft Guidances for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:13 Sep 19, 2019
Jkt 247001
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of several
device-specific draft guidance
documents for the Safety and
Performance Based Pathway—
specifically, ‘‘Spinal Plating Systems—
Performance Criteria for Safety and
Performance Based Pathway; Draft
Guidance for Industry and Food and
Drug Administration Staff’’; ‘‘Cutaneous
Electrode for Recording Purposes—
Performance Criteria for Safety and
Performance Based Pathway; Draft
Guidance for Industry and Food and
Drug Administration Staff’’;
‘‘Conventional Foley Catheters—
Performance Criteria for Safety and
Performance Based Pathway; Draft
Guidance for Industry and Food and
Drug Administration Staff’’; and
‘‘Orthopedic Non-Spinal Metallic Bone
Screws and Washers—Performance
Criteria for Safety and Performance
Based Pathway; Draft Guidance for
Industry and Food and Drug
Administration Staff.’’ The devicespecific draft guidances identified in
this notice were developed in
accordance with the finalized guidance
entitled ‘‘Safety and Performance Based
Pathway.’’ These draft guidances are not
final nor are they in effect at this time.
SUMMARY:
PO 00000
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Submit either electronic or
written comments on the draft
guidances by December 19, 2019 to
ensure that the Agency considers your
comment on these draft guidance
documents before it begins work on the
final version of the guidance
documents.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
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]]>Agencies
[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49526-49528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20355]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0084]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) is
[[Page 49527]]
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 Adverse Event Program for
Medical Devices (Medical Program Safety Network (MedSun)).
DATES: Submit either electronic or written comments on the collection
of information by November 19, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 19, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-0084 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Adverse Event Program for Medical
Devices (Medical Product Safety Network (MedSun)).'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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 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 (MedSun))
OMB Control Number 0910-0471--Extension
Section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360i) authorizes FDA to require (1) manufacturers to report
medical device-related deaths, serious injuries, and
[[Page 49528]]
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 includes
approximately 300 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 website
as the report information.
The burden estimate is based on the number of facilities
participating in MedSun (300). FDA estimates an average of 18 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adverse event reporting................. 300 18 5,400 0.50 (30 minutes)......................... 2,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall decrease of 113 hours despite a corresponding increase of 1,650
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years but a decrease in the
amount of time spent entering data due to IT efficiencies that have
been built into the MedSun reporting system to reduce data entry by
user facilities.
Dated: September 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20355 Filed 9-19-19; 8:45 am]
BILLING CODE 4164-01-P
