[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9514-9516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 March 18, 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 0910-0442. 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

[[Page 9515]]

Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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 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 
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.
    In the Federal Register of November 5, 2020 (85 FR 70634), 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\
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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
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Discontinuation of business--                  1               1               1               1               1
 821.1(d).......................
Exemption or variance--821.2 and               1               1               1               1               1
 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)...................
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    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
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Tracking information--821.25(a).              12               1              12              76             912
Record of tracking data--                     12          46,260         555,120               1         555,120
 821.25(b)......................
Standard operating procedures--               12               1              12              63             756
 821.25(c) \2\..................
Manufacturer data audit--                     12           1,124          13,488               1          13,488
 821.25(c)(3)...................

[[Page 9516]]

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

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

    Dated: February 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03017 Filed 2-12-21; 8:45 am]
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