[Federal Register Volume 89, Number 109 (Wednesday, June 5, 2024)]
[Notices]
[Pages 48174-48176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12346]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2381]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device Recall Authority

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 information collection provisions 
related to Medical Device Recall Authority.

DATES: Either electronic or written comments on the collection of 
information must be submitted by August 5, 2024.

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

[[Page 48175]]

August 5, 2024. 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 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-2024-N-2381 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Device Recall 
Authority.'' 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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[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 Device Recall Authority--21 CFR Part 810

OMB Control Number 0910-0432--Extension

    This collection of information helps to implement section 518(e) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) 
and regulations in part 810 (21 CFR part 810) which set forth mandatory 
medical device recall authority provisions. Section 518(e) of the FD&C 
Act provides FDA with the authority to issue an order requiring an 
appropriate person, including manufacturers, importers, distributors, 
and retailers of a device, if FDA finds that there is reasonable 
probability that the device intended for human use would cause serious, 
adverse health consequences or death, to: (1) Immediately cease 
distribution of such device and (2) immediately notify health 
professionals and device-user facilities of the order and to instruct 
such professionals and facilities to cease use of such device.
    The person named in the order will have an opportunity for a 
regulatory hearing or to provide a written request to FDA asking that 
the order be modified, vacated, or amended. FDA may later amend the 
order to require a mandatory recall of the device. FDA currently allows 
for these requests, along with other reports and records concerning 
mandatory recalls, to be submitted to the agency using electronic

[[Page 48176]]

methods including email and FDA's eSubmitter program (https://www.fda.gov/industry/fda-esubmitter).
    FDA issued part 810 to implement the provisions of section 518 of 
the FD&C Act. The information collected under the mandatory recall 
authority provisions is used by FDA to implement mandatory recalls.
    Description of Respondents: Respondents for this collection of 
information are firms, including medical device manufacturers, 
importers, distributors, and retailers, that have been issued a cease 
distribution and notification order or mandatory recall order in 
accordance with the provisions under part 810, during the timeframe(s) 
specified in the order.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                Number of       Total       Average
      Collection activity--21 CFR section        Number of    responses per     annual     burden per    Total
                                                respondents    respondent     responses     response     hours
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Submission of information to FDA about device             2               1            2            8         16
 distribution and remedial actions to be
 taken, as specified in the order--810.10(d)..
Submission of a written request for regulatory            1               1            1            8          8
 hearing--810.11(a)...........................
Submission of a written request to FDA asking             1               1            1            8          8
 that the order be modified or vacated--
 810.12(a-b)..................................
Submission of a strategy for compliance with              2               1            2           16         32
 cease distribution and notification or
 mandatory recall order--810.14...............
Submission of periodic status reports to FDA              2              12           24           40        960
 to enable the agency to assess progress in
 compliance with the order--810.16(a-b).......
Submission of a written request to FDA to                 2               1            2            8         16
 certify compliance with and terminate the
 order--810.17(a).............................
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    Total Hours...............................  ...........  ..............  ...........  ...........      1,040
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                         Number of                    Average burden
 Collection activity--21 CFR section     Number of      records per    Total annual        per           Total
                                       recordkeepers    recordkeeper      records     recordkeeping      hours
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Documentation of communications to                2                1             2                8          16
 appropriate person(s)--810.15(b)....
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                             Number of                      Average
    Collection activity--21 CFR section       Number of     disclosures    Total annual    burden per    Total
                                             respondents  per respondent    disclosures    disclosure    hours
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Communications to appropriate person(s)                2               1               2           12         24
 concerning a cease distribution and
 notification or mandatory recall order--
 810.15(a)-(c).............................
Follow up communications to appropriate                2               1               2            4          8
 person(s) who fail to respond to the
 initial communication--810.15(d)..........
Notifications provided by recipients of               10               1              10            1         10
 communications to appropriate consignees--
 810.15(e).................................
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    Total..................................  ...........  ..............  ..............  ...........         42
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden per response, burden per recordkeeping, and burden per 
disclosure estimates are based on FDA's recent experience with 
voluntary recalls under 21 CFR part 7. Based on an analysis of cease 
distribution and notification and mandatory recall order activity over 
the last 3 years, FDA expects no more than two of such actions per year 
as a conservative estimate.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12346 Filed 6-4-24; 8:45 am]
BILLING CODE 4164-01-P