[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]


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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.

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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\
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                                                                                             Number of
                  Activity/CFR section                     FDA Form No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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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
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\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\
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                                                     Number of                    Average burden
     Activity/21 CFR section         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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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
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    Total.......................  ..............  ..............  ..............  ..............           5,952
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\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\
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                                                                                         Number of
                      Activity/21 CFR section                           Number of     disclosures per    Total annual    Average burden  Total hours \3\
                                                                       respondents       respondent      disclosures     per disclosure
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Importer Reporting, Death and Serious Injury--803.40 and 803.42 \2\             578               25           14,450             0.35            5,058
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\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