[Federal Register Volume 89, Number 186 (Wednesday, September 25, 2024)]
[Notices]
[Pages 78313-78315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21904]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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, 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 October 25, 2024.

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

[[Page 78314]]

by using the search function. The OMB control number for this 
information collection is 0910-0432. Also include the FDA docket number 
found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device Recall Authority

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 
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.
    In the Federal Register of June 5, 2024 (89 FR 48174), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                  Number of       Total      Average
       Collection activity--21 CFR section         Number of    responses per    annual     burden per    Total
                                                  respondents    respondent     responses    response     hours
----------------------------------------------------------------------------------------------------------------
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 to             2              12          24           40       960
 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)...............................
                                                 ---------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                             Number of       Total     Average burden
  Collection activity--21 CFR section       Number of       records per      annual         per          Total
                                          recordkeepers     recordkeeper    records    recordkeeping     hours
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
                                                                   Number of
                                                      Number of   disclosures     Total      Average      Total
        Collection activity--21 CFR section          respondents      per        annual     burden per    hours
                                                                   respondent   responses   disclosure
----------------------------------------------------------------------------------------------------------------
Communications to appropriate person(s) concerning             2            1           2           12        24
 a cease distribution and notification or mandatory
 recall order--810.15(a)-(c).......................
Follow up communications to appropriate person(s)              2            1           2            4         8
 who fail to respond to the initial communication--
 810.15(d).........................................

[[Page 78315]]

 
Notifications provided by recipients of                       10            1          10            1        10
 communications to appropriate consignees--
 810.15(e).........................................
                                                    ------------------------------------------------------------
    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: September 19, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21904 Filed 9-24-24; 8:45 am]
BILLING CODE 4164-01-P