[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Pages 84337-84339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26653]


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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 January 4, 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 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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10 
a.m.-12 p.m., 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 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)) 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.

[[Page 84338]]

    In addition, applicable regulations in 21 CFR part 821 (21 CFR 
821.1 through 821.60) 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 to the 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. We currently estimate 22,000 potential respondents.
    In the Federal Register of August 8, 2023 (88 FR 53494), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. No comments were received.
    We estimate 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 section         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)...................
                                 -------------------------------------------------------------------------------
    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 section         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)...................
Multiple distributor data and             22,000               1          22,000               1          22,000
 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
                                     Number of      disclosures    Total annual   Average burden
    Activity; 21 CFR section        respondents         per         disclosures   per disclosure    Total hours
                                                    respondent
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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)...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          23,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Upon evaluation of the information collection, we have made no 
adjustment to our currently approved burden estimate of 615,380 hours 
annually, based on 12 tracking orders. We attribute the attendant 
burden to the following activities:
    Under Sec.  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, we estimate 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, we estimate no more than one 
notice will be received in any year, and that it would take 1 hour per 
incident.
    Under Sec.  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. Assuming 
one multiple distributor receives one request in a year from either a 
manufacturer or FDA, and that lists may be generated electronically, we 
estimate 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. We assume 5 percent of tracked devices distributed for 
estimating burden. Each audited

[[Page 84339]]

database entry prompts one distributor audit response. Because lists 
may be generated electronically, we estimate a burden of 1 hour to 
comply.

    Dated: November 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26653 Filed 12-4-23; 8:45 am]
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