Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Malfunction Summary Reporting Program for Manufacturers, 26694-26696 [2018-12336]
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26694
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES1
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Annual MLR
and Rebate Calculation Report and MLR
Rebate Notices; Use: Under Section
2718 of the Affordable Care Act and
implementing regulation at 45 CFR part
158, a health insurance issuer (issuer)
offering group or individual health
insurance coverage must submit a report
to the Secretary concerning the amount
the issuer spends each year on claims,
quality improvement expenses, nonclaims costs, Federal and State taxes
and licensing and regulatory fees, the
amount of earned premium, and
beginning with the 2014 reporting year,
the amounts related to the transitional
reinsurance, risk corridors, and risk
adjustment programs established under
sections 1341, 1342, and 1343,
respectively, of the Affordable Care Act.
An issuer must provide an annual rebate
if the amount it spends on certain costs
compared to its premium revenue
(excluding Federal and States taxes and
licensing and regulatory fees) does not
meet a certain ratio, referred to as the
medical loss ratio (MLR). Each issuer is
required to submit annually MLR data,
including information about any rebates
it must provide, on a form prescribed by
CMS, for each State in which the issuer
conducts business. Each issuer is also
required to provide a rebate notice to
each policyholder that is owed a rebate
and each subscriber of policyholders
that are owed a rebate for any given
MLR reporting year. Additionally, each
issuer is required to maintain for a
period of seven years all documents,
records and other evidence that support
the data included in each issuer’s
annual report to the Secretary. Based
upon CMS’ experience in the MLR data
collection and evaluation process, CMS
is updating its annual burden hour
estimates to reflect the actual numbers
of submissions, rebates and rebate
notices.
The 2017 MLR Reporting Form and
Instructions reflect changes for the 2017
reporting year and beyond. The 2017
MLR Reporting Form and instructions
are also modified to eliminate the
reporting elements that were required
under the risk corridors data submission
requirements in 45 CFR 153.530 for the
2014 through 2016 benefit years. For
2017, it is expected that issuers will
submit fewer reports and on average,
send fewer notices and rebate checks in
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the mail to policyholders and
subscribers, which will reduce burden
on issuers. In addition, issuers of
qualified health plans will no longer
have to submit on the annual report the
data for the risk corridors program
established under section 1342 of the
Patient Protection and Affordable Care
Act. Form Number: CMS–10418 (OMB
control number: 0938–1164); Frequency:
Annually; Affected Public: Private
Sector, Business or other for-profit and
not-for-profit institutions; Number of
Respondents: 522; Number of
Responses: 2,138; Total Annual Hours:
170,589. (For policy questions regarding
this collection contact Christina
Whitefield at 301–492–4172.)
Dated: June 5, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–12394 Filed 6–7–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6730]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary
Malfunction Summary Reporting
Program for Manufacturers
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 July 9,
2018.
SUMMARY:
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 0910–0437. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
PO 00000
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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.
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.
Medical Device Reporting: Electronic
Submission Requirements
OMB Control Number 0910–0437—
Extension
The information collection associated
with 21 CFR part 803 is approved under
OMB control number 0910–0437. We
request revision of the information
collection approval as described in this
document.
In the Federal Register of December
26, 2017 (82 FR 60922), FDA published
a notification and request for comments
entitled ‘‘Center for Devices and
Radiological Health; Medical Devices
and Combination Products; Voluntary
Malfunction Summary Reporting
Program for Manufacturers’’ (the
notification) which, among other things,
proposed a program for manufacturer
reporting of certain device malfunction
medical device reports (MDRs) in
summary form—the Voluntary
Malfunction Summary Reporting
Program. The proposed program would
permit manufacturers of devices in
certain product codes to report
malfunctions for those devices on a
quarterly basis and in a summary format
(instead of reporting them as individual,
30-day reports), subject to certain
conditions. Therefore, we have added a
line item to the reporting burden table
in OMB control number 0910–0437,
‘‘Medical Device Reporting: Electronic
Submission Requirements,’’ for the
proposed Voluntary Malfunction
Summary Reporting Program.
FDA believes that submission of
voluntary summary reports in the
format described in this document
would provide the most compact and
efficient reporting mechanism for
streamlining malfunction reporting that
still provides sufficient detail for FDA to
monitor devices effectively. The
proposed Voluntary Malfunction
Summary Reporting Program is meant to
streamline the process of reporting
malfunctions. It does not change
regulatory requirements for MDR-related
investigations or recordkeeping by
manufacturers. The proposed program
would neither apply to importers or
device user facilities, nor affect
E:\FR\FM\08JNN1.SGM
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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
requirements under part 803 for
importers or device user facilities. The
proposed program would not apply to
reportable death or serious injury
events, as described in section III.A of
the notification (82 FR 60922 at 60924).
In addition, the reporting requirements
at § 803.53, which require a 5-day report
to be filed at the written request of FDA
or if a manufacturer becomes aware of
an MDR reportable event that
necessitates remedial action to prevent
an unreasonable risk of substantial harm
to the public health, would continue to
apply to manufacturers participating in
the proposed program. The conditions
of the proposed Voluntary Summary
Malfunction Reporting Program would
also require manufacturers to submit
individual malfunction reports in
certain circumstances (see section III.A
of the notification). These factors were
considered in determining the revised
burden estimates described in table 1.
In the Federal Register of December
26, 2017 (82 FR 60922), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment related to the information
collection, that stated that the average
burden on manufacturers per response
of 6 minutes appears to be a very low
estimate.
FDA disagrees with this comment.
The estimation of time is the amount of
time needed to submit a summary
malfunction report. It is essentially the
same amount of time needed to submit
an individual report because the event
narrative should be the same, with the
exception of one additional line that is
entered that indicates the number of
adverse events represented by the
report. It does not include the time
needed to investigate the issue.
Manufacturers have 120 calendar days
from the date they become aware of a
reportable malfunction to submit a
summary malfunction report that is
allowed as part of this voluntary
reporting program.
For the convenience of the reader, we
have noted below the information
collection line-items (ICs) that we
anticipate would be affected by the
Voluntary Malfunction Summary
Reporting Program. While the other ICs
from OMB control number 0910–0437
are not affected by the Voluntary
Malfunction Summary Reporting
Program, for consistency and accuracy,
we have adjusted the respondent
estimates for the ICs using more recent
data.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Activity/CFR section
FDA
Form No.
Total annual
responses
Exemptions—803.19 2 ..............................
User Facility Reporting—803.30 and
803.32 2 ................................................
User Facility Annual Reporting—803.33 2
Importer Reporting, Death and Serious
Injury—803.40 and 803.42 2 .................
Manufacturer Reporting—803.50 through
803.53 3 ................................................
Voluntary Malfunction Summary Reporting Program 3 ........................................
Supplemental Reports—803.56 3 .............
........................
85
4
340
1
340
........................
3419
520
159
10.06
1
5,232
159
0.35
1
1,831
159
........................
578
1
578
1
578
........................
1,240
272.50
337,900
0.10
33,790
........................
........................
1,240
1,050
54.47
128.71
67,546
135,148
0.10
0.10
6,755
13,515
Total ..................................................
........................
........................
........................
........................
........................
56,968
Total hours
1 There
is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information.
IC has been adjusted based on calendar year (CY) 2016 data; however, there is no program change to this IC.
3 This IC revises OMB control number 0910–0437 to reflect the Voluntary Malfunction Summary Reporting Program.
2 This
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
MDR Procedures—803.17 2 .................................................
MDR Files—803.18 2 ...........................................................
1,240
1,240
1
1
1,240
1,240
3.3
1.5
4,092
1,860
Total ..............................................................................
........................
........................
........................
........................
5,952
1 There
2 This
is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information.
IC has been adjusted based on CY 2016 data; however, there is no program change to this IC.
amozie on DSK3GDR082PROD with NOTICES1
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours 3
Importer Reporting, Death and Serious Injury—803.40 and
803.42 2 ............................................................................
578
25
14,450
0.35
5,058
1 There
2 This
is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information.
IC has been adjusted based on CY 2016 data; however, there is no program change to this IC.
has been rounded.
3 Number
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26696
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
For consistency and accuracy, we
have adjusted the respondent estimates
for all the ICs from OMB control number
0910–0437, including those that are not
affected by the Voluntary Malfunction
Summary Reporting Program, to reflect
more recent data from calendar year
(CY) 2016 (the currently approved
estimates are based on CY 2006–2009
data). This adjustment, along with the
revisions for the Voluntary Malfunction
Summary Reporting Program increases
the estimated total burden of OMB
control number 0910–0437 by 21,532
hours (currently approved for 46,446
hours; requesting 67,978 hours).
We have added the new burden
estimate for the Voluntary Malfunction
Summary Reporting Program. This
increases the reporting burden estimate
by 6,755 hours.
We have revised the burden estimates
for ‘‘Manufacturer Reporting’’ and
‘‘Supplemental Reports’’ to update the
respondent estimates using more recent
data, as described above, and to reflect
the revisions resulting from the
availability of the Voluntary
Malfunction Summary Reporting
Program. We believe the availability of
the summary reporting option for
manufacturers of certain devices would
cause a decrease in the number of
individual manufacturer reports for
malfunctions submitted under
§§ 803.50 and 803.52. However, because
we also adjusted the respondent
estimates for the ICs using more recent
data from CY 2016, the estimated
burden for these ICs is an increase of
12,139 hours from the currently
approved burden estimates (the
previous estimate based on CY 2006–
2008 data was 35,166 hours for these ICs
only). We attribute the increase to the
increase in the number of submissions
we received in recent years, rather than
the revisions related to the Voluntary
Malfunction Summary Reporting
Program.
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12336 Filed 6–7–18; 8:45 am]
amozie on DSK3GDR082PROD with NOTICES1
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1881]
Development of Inhaled Antibacterial
Drugs for Cystic Fibrosis and NonCystic Fibrosis Bronchiectasis; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Development of
Inhaled Antibacterial Drugs for Cystic
Fibrosis and Non-Cystic Fibrosis
Bronchiectasis.’’ The purpose of the
public workshop is to discuss the
clinical trial design challenges and
future considerations for inhaled
antibacterial products to treat cystic
fibrosis (CF) and non-CF bronchiectasis.
DATES: The public workshop will be
held on June 27, 2018, from 8:30 a.m.
to 4:30 p.m. Submit either electronic or
written comments on this public
workshop by July 16, 2018. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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 July 16, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time on July 16, 2018.
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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• 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–
2018–N–1881 for ‘‘Development of
Inhaled Antibacterial Drugs for Cystic
Fibrosis and Non-Cystic Fibrosis
Bronchiectasis.’’ 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
E:\FR\FM\08JNN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26694-26696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12336]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6730]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary Malfunction
Summary Reporting Program for Manufacturers
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 July 9,
2018.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0437.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device Reporting: Electronic Submission Requirements
OMB Control Number 0910-0437--Extension
The information collection associated with 21 CFR part 803 is
approved under OMB control number 0910-0437. We request revision of the
information collection approval as described in this document.
In the Federal Register of December 26, 2017 (82 FR 60922), FDA
published a notification and request for comments entitled ``Center for
Devices and Radiological Health; Medical Devices and Combination
Products; Voluntary Malfunction Summary Reporting Program for
Manufacturers'' (the notification) which, among other things, proposed
a program for manufacturer reporting of certain device malfunction
medical device reports (MDRs) in summary form--the Voluntary
Malfunction Summary Reporting Program. The proposed program would
permit manufacturers of devices in certain product codes to report
malfunctions for those devices on a quarterly basis and in a summary
format (instead of reporting them as individual, 30-day reports),
subject to certain conditions. Therefore, we have added a line item to
the reporting burden table in OMB control number 0910-0437, ``Medical
Device Reporting: Electronic Submission Requirements,'' for the
proposed Voluntary Malfunction Summary Reporting Program.
FDA believes that submission of voluntary summary reports in the
format described in this document would provide the most compact and
efficient reporting mechanism for streamlining malfunction reporting
that still provides sufficient detail for FDA to monitor devices
effectively. The proposed Voluntary Malfunction Summary Reporting
Program is meant to streamline the process of reporting malfunctions.
It does not change regulatory requirements for MDR-related
investigations or recordkeeping by manufacturers. The proposed program
would neither apply to importers or device user facilities, nor affect
[[Page 26695]]
requirements under part 803 for importers or device user facilities.
The proposed program would not apply to reportable death or serious
injury events, as described in section III.A of the notification (82 FR
60922 at 60924). In addition, the reporting requirements at Sec.
803.53, which require a 5-day report to be filed at the written request
of FDA or if a manufacturer becomes aware of an MDR reportable event
that necessitates remedial action to prevent an unreasonable risk of
substantial harm to the public health, would continue to apply to
manufacturers participating in the proposed program. The conditions of
the proposed Voluntary Summary Malfunction Reporting Program would also
require manufacturers to submit individual malfunction reports in
certain circumstances (see section III.A of the notification). These
factors were considered in determining the revised burden estimates
described in table 1.
In the Federal Register of December 26, 2017 (82 FR 60922), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment related to the
information collection, that stated that the average burden on
manufacturers per response of 6 minutes appears to be a very low
estimate.
FDA disagrees with this comment. The estimation of time is the
amount of time needed to submit a summary malfunction report. It is
essentially the same amount of time needed to submit an individual
report because the event narrative should be the same, with the
exception of one additional line that is entered that indicates the
number of adverse events represented by the report. It does not include
the time needed to investigate the issue. Manufacturers have 120
calendar days from the date they become aware of a reportable
malfunction to submit a summary malfunction report that is allowed as
part of this voluntary reporting program.
For the convenience of the reader, we have noted below the
information collection line-items (ICs) that we anticipate would be
affected by the Voluntary Malfunction Summary Reporting Program. While
the other ICs from OMB control number 0910-0437 are not affected by the
Voluntary Malfunction Summary Reporting Program, for consistency and
accuracy, we have adjusted the respondent estimates for the ICs using
more recent data.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/CFR section FDA Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions--803.19 \2\.................................. .............. 85 4 340 1 340
User Facility Reporting--803.30 and 803.32 \2\.......... .............. 520 10.06 5,232 0.35 1,831
User Facility Annual Reporting--803.33 \2\.............. 3419 159 1 159 1 159
Importer Reporting, Death and Serious Injury--803.40 and .............. 578 1 578 1 578
803.42 \2\.............................................
Manufacturer Reporting--803.50 through 803.53 \3\....... .............. 1,240 272.50 337,900 0.10 33,790
Voluntary Malfunction Summary Reporting Program \3\..... .............. 1,240 54.47 67,546 0.10 6,755
Supplemental Reports--803.56 \3\........................ .............. 1,050 128.71 135,148 0.10 13,515
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 56,968
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information.
\2\ This IC has been adjusted based on calendar year (CY) 2016 data; however, there is no program change to this IC.
\3\ This IC revises OMB control number 0910-0437 to reflect the Voluntary Malfunction Summary Reporting Program.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17 \2\...... 1,240 1 1,240 3.3 4,092
MDR Files--803.18 \2\........... 1,240 1 1,240 1.5 1,860
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,952
----------------------------------------------------------------------------------------------------------------
\1\ There is no change to the capital costs or operating and maintenance costs associated with the revision of
the collection of information.
\2\ This IC has been adjusted based on CY 2016 data; however, there is no program change to this IC.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours \3\
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importer Reporting, Death and Serious Injury--803.40 and 803.42 \2\ 578 25 14,450 0.35 5,058
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information.
\2\ This IC has been adjusted based on CY 2016 data; however, there is no program change to this IC.
\3\ Number has been rounded.
[[Page 26696]]
For consistency and accuracy, we have adjusted the respondent
estimates for all the ICs from OMB control number 0910-0437, including
those that are not affected by the Voluntary Malfunction Summary
Reporting Program, to reflect more recent data from calendar year (CY)
2016 (the currently approved estimates are based on CY 2006-2009 data).
This adjustment, along with the revisions for the Voluntary Malfunction
Summary Reporting Program increases the estimated total burden of OMB
control number 0910-0437 by 21,532 hours (currently approved for 46,446
hours; requesting 67,978 hours).
We have added the new burden estimate for the Voluntary Malfunction
Summary Reporting Program. This increases the reporting burden estimate
by 6,755 hours.
We have revised the burden estimates for ``Manufacturer Reporting''
and ``Supplemental Reports'' to update the respondent estimates using
more recent data, as described above, and to reflect the revisions
resulting from the availability of the Voluntary Malfunction Summary
Reporting Program. We believe the availability of the summary reporting
option for manufacturers of certain devices would cause a decrease in
the number of individual manufacturer reports for malfunctions
submitted under Sec. Sec. [thinsp]803.50 and 803.52. However, because
we also adjusted the respondent estimates for the ICs using more recent
data from CY 2016, the estimated burden for these ICs is an increase of
12,139 hours from the currently approved burden estimates (the previous
estimate based on CY 2006-2008 data was 35,166 hours for these ICs
only). We attribute the increase to the increase in the number of
submissions we received in recent years, rather than the revisions
related to the Voluntary Malfunction Summary Reporting Program.
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12336 Filed 6-7-18; 8:45 am]
BILLING CODE 4164-01-P
