Document ID: FDA-2023-N-1006-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals
Posted Date: 2023-04-11T04:00Z

[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21677-21679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07524]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1006]

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, Agency, or we) 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 information collection 
associated with reports of removals and corrections for medical and 
radiation emitting products regulated by FDA's Center for Devices and 
Radiological Health.

DATES: Either electronic or written comments on the collection of 
information must be submitted by June 12, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 12, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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

[[Page 21678]]

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-2023-N-1006 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, 240-402-7500.
     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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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 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--Revision

    This information collection supports implementation of provisions 
of section 519(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360i(g)) requiring device manufacturers and importers to report 
promptly to FDA certain actions concerning device corrections and 
removals and to maintain associated records. Applicable regulations are 
found in 21 CFR part 806 and set forth definitions, prescribe format 
and required content elements for reporting, and identify actions that 
are exempt from the reporting requirements. The information collected 
is used by FDA to identify marketed devices that have serious problems 
and to ensure that defective devices are removed from the market. The 
information also helps ensure that FDA has current and complete 
information regarding these corrections and removals to determine 
whether recall action is adequate.
    Reports of corrections and removals may be submitted to FDA via 
mail, email, or using FDA's Electronic Submission Gateway (ESG). To 
assist respondents with submitting reports of corrections or removals, 
we developed a fillable PDF electronic submission template entitled, 
``Device Correction/Removal Report for Industry,'' that transmits 
required data to FDA's Recall Enterprise System. Instructions for the 
fillable template are provided in pop-up text boxes that appear over 
each data field. We expect that use of the fillable template will 
expedite processing of the reports of corrections or removals submitted 
to FDA.
    We estimate the burden of the information collection as follows:

[[Page 21679]]

                                                       Table 1--Estimated Annual Reporting Burden
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                                                                                                                                               Total
                                                             Number of       Number of     Total annual       Average                      operating and
            21 CFR part; collection activity                respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
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Electronic process setup................................             517               1             517            3.08           1,592         $25,850
806; Submission of corrections and removals.............           1,033               1           1,033              10          10,330  ..............
4.102(c)(1)(iii)); Submitting correction or removal                   20               1              20              10             200  ..............
 reports................................................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............          25,850
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    For respondents who submit corrections and removals using the ESG, 
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 reduced if the respondent has already purchased a 
verification certificate for other electronic submissions to FDA. This 
burden may also be reduced if respondents utilize the new PDF template 
and submit it to the Agency using email, mitigating the need for a 
digital verification certificate.

                             Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                   Number of                     Average  burden
    21 CFR part; collection        Number of      records per    Total annual          per          Total hours
           activity              recordkeepers   recordkeeper       records       recordkeeping
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806; Records of corrections                 93               1              93  10..............             930
 and removals.
4.105(b); recordkeeping by                 279               1             279  0.5 (30 minutes)             140
 device-led combination
 products.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,070
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Figures have been rounded.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. We estimate that 50 percent of submitters will use the ESG to 
submit the required information. 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 
the purposes of estimating the burden, we assume that all respondents 
who submit corrections and removals using the electronic process will 
establish a new WebTrader account and purchase a digital verification 
certificate.

    Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07524 Filed 4-10-23; 8:45 am]
BILLING CODE 4164-01-P