[Federal Register Volume 85, Number 215 (Thursday, November 5, 2020)]
[Notices]
[Pages 70634-70637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5569]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Device Tracking

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 information collection requirements for the 
tracking of medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by January 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 January 4, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 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

[[Page 70635]]

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-2017-N-5569 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Devices; Device 
Tracking.'' 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: 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: 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 Devices; Device Tracking--21 CFR Part 821

OMB Control Number 0910-0442--Extension

    Section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360i(e)(1)), as amended by Food and Drug Administration 
Modernization Act (Pub. L. 105-115), provides that FDA may require by 
order that a manufacturer adopt a method for tracking a class II or III 
medical device, if the device meets one of the three following 
criteria: (1) The failure of the device would be reasonably likely to 
have serious adverse health consequences, (2) the device is intended to 
be implanted in the human body for more than 1 year (referred to as a 
``tracked implant''), or (3) the device is life-sustaining or life-
supporting (referred to as a ``tracked l/s-l/s device'') and is used 
outside a device user facility.
    Tracked device information is collected to facilitate identifying 
the current location of medical devices and patients possessing those 
devices, to the extent that patients permit the collection of 
identifying information. Manufacturers and FDA (where necessary) use 
the data to: (1) Expedite the recall of distributed medical devices 
that are dangerous or defective and (2) facilitate the timely 
notification of patients or licensed practitioners of the risks 
associated with the medical device.
    In addition, the regulations include provisions for: (1) Exemptions 
and variances; (2) system and content requirements for tracking; (3) 
obligations of persons other than device manufacturers, e.g., 
distributors; (4) records and inspection requirements; (5) 
confidentiality; and (6) record retention requirements.
    Respondents for this collection of information are medical device

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manufacturers, importers, and distributors of tracked implants or 
tracked l/s-l/s devices used outside a device user facility. 
Distributors include multiple and final distributors, including 
hospitals.
    The annual hourly burden for respondents involved with medical 
device tracking is estimated to be 615,380 hours per year. The burden 
estimates cited in tables 1 through 3 are based on the approximate 
number of device tracking orders, 12 annually. FDA estimates that 
approximately 22,000 respondents may be subject to tracking reporting 
requirements.
    Under Sec.  821.25(a) (21 CFR 821.25(a)), device manufacturers 
subject to FDA tracking orders must adopt a tracking method that can 
provide certain device, patient, and distributor information to FDA 
within 3 to 10 working days. Assuming one occurrence per year, FDA 
estimates it would take a firm 20 hours to provide FDA with location 
data for all tracked devices and 56 hours to identify all patients and/
or multiple distributors possessing tracked devices.
    Under Sec.  821.25(d) manufacturers must notify FDA of distributor 
noncompliance with reporting requirements. Based on the number of 
audits manufacturers conduct annually, FDA estimates it would receive 
no more than one notice in any year, and that it would take 1 hour per 
incident.
    Under Sec.  821.30(c)(2) (21 CFR 821.30(c)(2)), multiple 
distributors must provide data on current users of tracked devices, 
current device locations, and other information, upon request from a 
manufacturer or FDA. FDA has not made such a request and is not aware 
of any manufacturer making a request. Assuming one multiple distributor 
receives one request in a year from either a manufacturer or FDA, and 
that lists may be generated electronically, the Agency estimates a 
burden of 1 hour to comply.
    Under Sec.  821.30(d) distributors must verify data or make 
required records available for auditing, if a manufacturer provides a 
written request. FDA's estimate of the burden for distributor audit 
responses assumes that manufacturers audit database entries for 5 
percent of tracked devices distributed. Each audited database entry 
prompts one distributor audit response. Because lists may be generated 
electronically, FDA estimates a burden of 1 hour to comply.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
    Activity; 21 CFR part        Number of       responses per    Total  annual  Average  burden    Total hours
                                respondents       respondent        responses     per  response
----------------------------------------------------------------------------------------------------------------
Discontinuation of business--               1                 1               1                1               1
 821.1(d)...................
Exemption or variance--821.2                1                 1               1                1               1
 and 821.30(e)..............
Notification of failure to                  1                 1               1                1               1
 comply--821.25(d)..........
Multiple distributor data--                 1                 1               1                1               1
 821.30(c)(2)...............
                             -----------------------------------------------------------------------------------
    Total...................  ...............  ................  ..............  ...............               4
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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
    Activity; 21 CFR part        Number of        records per     Total  annual        per          Total hours
                               recordkeepers     recordkeeper        records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Tracking information--                     12                 1              12               76             912
 821.25(a)..................
Record of tracking data--                  12            46,260         555,120                1         555,120
 821.25(b)..................
Standard operating                         12                 1              12               63             756
 procedures--821.25(c) \2\..
Manufacturer data audit--                  12             1,124          13,488                1          13,488
 821.25(c)(3)...............
Multiple distributor data              22,000                 1          22,000                1          22,000
 and distributor tracking
 records--821.30(c)(2) and
 (d)........................
                             -----------------------------------------------------------------------------------
    Total...................  ...............  ................  ..............  ...............         592,276
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ One-time burden.


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                   Number of
    Activity; 21 CFR part        Number of     disclosures  per   Total  annual  Average  burden    Total hours
                                respondents       respondent       disclosures   per  disclosure
----------------------------------------------------------------------------------------------------------------
Acquisition of tracked                 22,000                 1          22,000                1          22,000
 devices and final
 distributor data--821.30(a)
 and (b)....................
Multiple distributor data               1,100                 1           1,100                1           1,100
 and distributor tracking
 records--821.30(c)(2) and
 (d)........................
                             -----------------------------------------------------------------------------------
    Total...................  ...............  ................  ..............  ...............          23,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


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    The burden estimate for this information collection has not changed 
since the last OMB approval.

    Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24541 Filed 11-4-20; 8:45 am]
BILLING CODE 4164-01-P