Document ID: FDA-2016-N-4620-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Medical Devices;
Reports of Corrections and Removals
Posted Date: 2020-08-20T04:00Z

[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51451-51453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18269]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4620]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Reports of Corrections and Removals

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: Submit written comments (including recommendations) on the 
collection of information by September 21, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0359. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD

[[Page 51452]]

20852, 301-796-5733, 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 Devices; Reports of Corrections and Removals--21 CFR part 806

OMB Control Number 0910-0359--Extension

    FDA is requesting approval for the collection of information 
pertaining to reports of corrections and removals required under part 
806 (21 CFR part 806), which implements section 519(g) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(g)), as amended 
by the Food and Drug Administration Modernization Act of 1997 (Pub. L. 
105-115).
    Under Sec.  806.10 (21 CFR 806.10), within 10 working days of 
initiating any action to correct or remove a device to reduce a risk to 
health posed by the device or to remedy a violation of the FD&C Act 
caused by the device that may present a risk to health, device 
manufacturers or importers must submit a written report to FDA of the 
correction or removal.
    Under Sec.  806.20(a) (21 CFR 806.20(a)), device manufacturers or 
importers that initiate a correction or removal that is not required to 
be reported to FDA must keep a record of the correction or removal.
    In the Federal Register of December 20, 2016 (81 FR 92603), FDA 
published a final rule titled ``Postmarketing Safety Reporting for 
Combination Products.'' This final rule describes the postmarketing 
safety reporting requirements that apply when two or more different 
types of regulated medical products (drugs, devices, and/or biological 
products, which are referred to as ``constituent parts'' of a 
combination product) comprise a combination product and the combination 
product or its constituent parts have received FDA marketing 
authorization. PMSR is approved under OMB control number 0910-0834.
    Under Sec.  4.102(c)(1)(iii) (21 CFR 4.102(c)(1)(iii)), combination 
product applicants whose combination products received marketing 
authorization under a BLA, NDA, or ANDA and include a device 
constituent part must also submit correction or removal reports as 
described in Sec.  806.10 and comply with recordkeeping requirements as 
described in Sec.  806.20.
    Under Sec.  4.105(b) (21 CFR 4.105(b)), combination product 
applicants must maintain records relating to their postmarketing safety 
reports for whichever is the longest required recordkeeping period 
under the PMSR requirements applicable to the combination product 
applicant under Sec.  4.102.
    The information collected in the reports of corrections and 
removals will be used by FDA to identify marketed devices that have 
serious problems and to ensure that defective devices are removed from 
the market. This will assure that FDA has current and complete 
information regarding these corrections and removals to determine 
whether recall action is adequate. Failure to collect this information 
would prevent FDA from receiving timely information about devices that 
may have a serious effect on the health of users of the devices.
    Reports of corrections and removals may be submitted to FDA via 
mail or using FDA's Electronic Submission Gateway (ESG). We estimate 
that approximately 50 percent of submitters will use the ESG. Our 
estimate of the reporting and recordkeeping burden is based on Agency 
records and our experience with this program, as well as similar 
programs that utilize FDA's ESG.
    For respondents who submit corrections and removals using the 
electronic process, the operating and maintenance costs associated with 
this information collection are approximately $50 per year to purchase 
a digital verification certificate (certificate must be valid for 1 to 
3 years). This burden may be minimized if the respondent has already 
purchased a verification certificate for other electronic submissions 
to FDA. However, FDA is assuming that all respondents who submit 
corrections and removals using the electronic process will be 
establishing a new WebTrader account and purchasing a digital 
verification certificate. We therefore estimate the total operating and 
maintenance costs to be $25,850 annually (517 respondents x $50).
    In the Federal Register of February 21, 2020 (85 FR 10168), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received. We estimate the 
burden of this collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                                                               Total
                                                             Number of       Number of     Total annual       Average       Total hours    operating and
                 Activity  (21 CFR part)                    respondents    responses per     responses      burden per          \2\         maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic process setup \3\............................             517               1             517            3.08           1,592         $25,850
Submission of corrections and removals (part 806).......           1,033               1           1,033              10          10,330  ..............
4.102(c)(1)(iii) Submitting correction or removal                     20               1              20              10             200  ..............
 reports................................................
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\1\ There are no capital costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
\3\ We estimate that approximately 50 percent of respondents will submit corrections and removals using the electronic process. The actual burden hours
  for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Information and
  Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in a total one-time
  burden of 4,782 hours for the setup of the electronic process.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
     Activity  (21 CFR Part)         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping        \2\
----------------------------------------------------------------------------------------------------------------
Records of corrections and                    93               1              93              10             930
 removals (part 806)............

[[Page 51453]]

 
4.105(b) additional                          279            0.45             126             0.5              63
 recordkeeping by device-led
 combination products...........
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.

    New information technology applications have allowed us to more 
accurately calculate the number of registrants of medical device 
facilities that submit information electronically. Therefore, there is 
a 50 percent reduction in the number of respondents who will submit 
corrections and removals using the electronic process.
    In addition, under OMB control number 0910-0834 (``Postmarketing 
Safety Reporting for Combination Products''), an additional 200 hours 
have been added to the annual reporting burden and an additional 63 
hours have been added to the annual recordkeeping burden to comply with 
the PMSR requirements.
    We have therefore revised the number of respondents to the 
information collection. This adjustment has resulted in a 1,293-hour 
decrease of the estimated burden.

    Dated: August 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-18269 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P