[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17610-17612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 collections related to 
Medical Device Recall Authority.

DATES: Submit either electronic or written comments on the collection 
of information by June 4, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 4, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 4, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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-2018-N-0405 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: 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, 
PRAStaff@fda.hhs.gov.

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

[[Page 17611]]

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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                Collection activity--21 CFR section                     Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Collections Specified in the Order--810.10(d)......................                2                1                2                8               16
Request for Regulatory Hearing--810.11(a)..........................                1                1                1                8                8
Written Request for Review--810.12(a) and (b)......................                1                1                1                8                8
Mandatory Recall Strategy--810.14..................................                2                1                2               16               32
Periodic Status Reports--810.16(a) and (b).........................                2               12               24               40              960
Termination Request--810.17(a).....................................                2                1                2                8               16
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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 hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Documentation of Notifications to Recipients--810.15(b)............                2                1                2                8               16
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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
                Collection activity--21 CFR section                     Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Notification to Recipients--810.15(a) through (c)..................                2                1                2               12               24
Notification to Recipients; Followup--810.15(d)....................                2                1                2                4                8
Notification of Consignees by Recipients--810.15(e)................               10                1               10                1               10
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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 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.

[[Page 17612]]

    21 CFR 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.
    21 CFR 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.
    21 CFR 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.
    21 CFR 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.
    21 CFR 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.
    21 CFR 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.
    21 CFR 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.
    21 CFR 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.
    21 CFR 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.
    21 CFR 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: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06960 Filed 4-2-21; 8:45 am]
BILLING CODE 4164-01-P


