[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Notices]
[Pages 41973-41974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16635]



[[Page 41973]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0405]


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, the 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 3, 2021.

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 0910-0432. Also include the FDA docket 
number found in brackets in the heading of this document.

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, 
<a href="/cdn-cgi/l/email-protection#28787a697b5c494e4e684e4c490640405b064f475e"><span class="__cf_email__" data-cfemail="035351425077626565436567622d6b6b702d646c75">[email protected]</span></a>.

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--21 CFR Part 810

OMB Control Number 0910-0432--Extension

    This collection of information implements section 518(e) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and 
part 810 (21 CFR part 810), 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.
    FDA will then provide the person named in the cease distribution 
and notification order with the opportunity for an informal hearing on 
whether the order should be amended to require a mandatory recall of 
the device. If, after providing the opportunity for an informal 
hearing, FDA determines that such an order is necessary, the Agency may 
amend the order to require a mandatory recall.
    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 will be used by FDA to implement mandatory 
recalls.
    In the Federal Register of April 5, 2021 (86 FR 17610), 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
    Activity; 21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Collections Specified in the                   2               1               2               8              16
 Order--810.10(d)...............
Request for Regulatory Hearing--               1               1               1               8               8
 810.11(a)......................
Written Request for Review--                   1               1               1               8               8
 810.12(a) and (b)..............
Mandatory Recall Strategy--                    2               1               2              16              32
 810.14.........................
Periodic Status Reports--                      2              12              24              40             960
 810.16(a) and (b)..............
Termination Request--810.17(a)..               2               1               2               8              16
                                 -------------------------------------------------------------------------------
    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                       Average burden
                      Activity; 21 CFR section                          Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation of Notifications to Recipients--810.15(b)............               2                1                2                8               16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
    Activity; 21 CFR section         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients--                   2               1               2              12              24
 810.15(a) through (c)..........
Notification to Recipients;                    2               1               2               4               8
 Follow-up--810.15(d)...........
Notification of Consignees by                 10               1              10               1              10
 Recipients--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.


[[Page 41974]]

    The burden estimates are based on FDA's experience with voluntary 
recalls under 21 CFR part 7. FDA expects no more than two mandatory 
recalls per year, as most recalls are done voluntarily.
    Section 810.10(d)--Collections Specified in the Order--
(Reporting)--FDA may require the person named in the cease distribution 
and notification order to submit certain information to the Agency, 
e.g., distribution information, progress reports.
    Section 810.11(a)--Request for Regulatory Hearing--(Reporting)--A 
request for regulatory hearing regarding the cease distribution and 
notification order must be submitted in writing to FDA.
    Section 810.12(a) and (b)--Written Request for Review--
(Reporting)--In lieu of requesting a regulatory hearing under Sec.  
810.11, the person named in the cease distribution and notification 
order may submit a written request to FDA asking that the order be 
modified or vacated. A written request for review of a cease 
distribution and notification order shall identify each ground upon 
which the requestor relies in asking that the order be modified or 
vacated, address an appropriate cease distribution and notification 
strategy, and address whether the order should be amended to require a 
recall of the device that was the subject of the order and the actions 
required by such a recall order.
    Section 810.14--Mandatory Recall Strategy--(Reporting)--The person 
named in the cease distribution and notification order or a mandatory 
recall order must develop and submit a strategy to FDA for complying 
with the order that is appropriate for the individual circumstances.
    Section 810.15(a) through (c)--Notifications to Recipients--(Third-
Party Disclosure)--The person named in a cease distribution and 
notification order or a mandatory recall order must promptly notify 
each health professional, user facility, consignee, or individual of 
the order.
    Section 810.15(b)--Documentation of Notifications to Recipients--
(Recordkeeping)--Telephone calls or other personal contacts may be made 
in addition to, but not as a substitute for, the verified written 
communication, and shall be documented in an appropriate manner.
    Section 810.15(d)--Notification to Recipients; Followup--(Third-
Party Disclosure)--The person named in the cease distribution and 
notification order or mandatory recall order shall ensure that followup 
communications are sent to all who fail to respond to the initial 
communication.
    Section 810.15(e)--Notification of Consignees by Recipients--
(Third-Party Disclosure)--Health professionals, device user facilities, 
and consignees should immediately notify their consignees of the order.
    Section 810.16(a) and (b)--Periodic Status Reports--(Reporting)--
The person named in a cease distribution and notification order or a 
mandatory recall order must submit periodic status reports to FDA to 
enable the Agency to assess the person's progress in complying with the 
order. The frequency of such reports and the Agency official to whom 
such reports must be submitted will be specified in the order.
    Section 810.17(a)--Termination Request--(Reporting)--The person 
named in a cease distribution and notification order or a mandatory 
recall order may request termination of the order by submitting a 
written request to FDA. The person submitting a request must certify 
that he or she has complied in full with all the requirements of the 
order and shall include a copy of the most current status report 
submitted to the Agency.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no changes to the burden 
estimate.

    Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16635 Filed 8-3-21; 8:45 am]
BILLING CODE 4164-01-P


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