Document ID: FDA-2023-N-1006-0002
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: 2023-08-11T04:00Z

[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54621-54622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17264]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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, Agency, or we) 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 11, 2023.

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 20852, 301-796-5733, 
[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.

[[Page 54622]]

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.
    In the Federal Register of April 11, 2023 (88 FR 21677), we 
published a 60-day notice soliciting 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Number of                                                     Total operating
           21 CFR part; collection activity               Number of     responses per   Total annual   Average burden    Total hours    and maintenance
                                                         respondents     respondent       responses     per response                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (including any sharing of information with
 other constituent part applicants as required under
 4.103)..............................................
    Total............................................  ..............  ..............  ..............  ..............          12,122             25,850
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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
      21 CFR part; collection activity           Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
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806; Records of corrections and removals....              93               1              93  10........................................             930
4.105(b); recordkeeping by device-led                    279               1             279  0.5 (30 minutes)..........................             140
 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, however we have revised the collection to include the new 
electronic reporting instrument ``Device Correction/Removal Report for 
Industry.'' 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: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17264 Filed 8-10-23; 8:45 am]
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