Notice2023-26653
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 5, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 232 (Tuesday, December 5, 2023)</title>
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[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Pages 84337-84339]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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, <a href="/cdn-cgi/l/email-protection#f3a3a1b2a087929595b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="0f5f5d4e5c7b6e69694f696b6e2167677c21686079">[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 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)...................
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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 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)...........
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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
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)...........
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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.
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]
BILLING CODE 4161-01-P
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