[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Pages 10168-10169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03458]



[[Page 10168]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is 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 submission of reports of corrections 
and removals that are associated with medical and radiation emitting 
products regulated by FDA's Center for Devices and Radiological Health.

DATES: Submit either electronic or written comments on the collection 
of information by April 21, 2020.

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 April 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 21, 2020. 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-2016-N-4620 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Devices; Reports of 
Corrections and Removals.'' 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.govinfo.gov/content/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. 3501-3521), 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

[[Page 10169]]

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.

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 
regarding 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). A description of the information collection requirements is 
provided as follows:
    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.
    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).
    FDA estimates 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
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Electronic process setup \3\............................             517               1             517            3.08       \4\ 1,592         $25,850
Submission of corrections and removals (part 806).......           1,033               1           1,033              10          10,330  ..............
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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.
\4\ Total is rounded to the nearest hour.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                       Activity (21 CFR part)                           Number of       records per     Total  annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Records of corrections and removals (part 806).....................              93                1               93               10              930
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    New information technology applications have allowed us to more 
accurately calculate the number of registrants of medical device 
facilities that submit information electronically. We have therefore 
revised the number of respondents to the information collection. This 
adjustment has resulted in a 1,556-hour decrease of the estimated 
burden.

    Dated: February 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03458 Filed 2-20-20; 8:45 am]
 BILLING CODE 4164-01-P