Document ID: FDA-2016-N-4319-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System
Posted Date: 2019-12-31T05:00Z

[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72368-72369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28246]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4319]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Unique Device 
Identification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Fax written comments on the collection of information by January 
30, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0720. 
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 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

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.

Unique Device Identification System--21 CFR Parts 16, 801, 803, 806, 
810, 814, 820, 821, 822, and 830

OMB Control Number 0910-0720--Extension

    In accordance with the Unique Device Identification (UDI) system 
(see 21 CFR part 801, subpart B), medical device labelers, unless 
excepted, are required to design and use medical device labels and 
device packages that bear a UDI, present dates on labels in a 
particular format, and submit data concerning each version or model of 
a device to the Global Unique Device Identification Database (GUDID) no 
later than the date the label of the device must bear a UDI. Once a 
device becomes subject to UDI requirements, respondents will be 
required to update the information reported whenever the information 
changes.
    The recordkeeping, reporting, and third-party disclosure 
requirements referenced in this document are imposed on any person who 
causes a label to be applied to a device, or who causes the label to be 
modified, with the intent that the device will be commercially 
distributed without any subsequent replacement or modification of the 
label. In most instances, the labeler would be the device manufacturer, 
but other types of labelers include a specification developer, a 
single-use device reprocessor, a convenience kit assembler, a private 
label distributor, a repackager, or a relabeler. Respondents may also 
include any private organization that applies for accreditation by FDA 
as an issuing agency.
    FDA has identified the following requirements as having burdens 
that must be accounted for under the PRA; the burdens associated with 
these requirements are summarized in the table that follows:
    Section 801.18 requires that whenever a labeler of a medical device 
includes an expiration date, a date of manufacture, or any other date 
intended to be brought to the attention of the user of the device, the 
labeler must present the date on the label in a format that meets the 
requirements of this section.
    Section 801.20 requires every medical device label and package to 
bear a UDI.
    Under Sec.  801.35, any labeler of a device that is not required to 
bear a UDI on its label may include a UDI on the label of that device 
and utilize the GUDID.
    Under Sec.  801.45, any device that has to be labeled with a UDI 
also has to bear a permanent marking providing the UDI on the device 
itself if the device is intended for more than one use and intended to 
be reprocessed before each use.
    Section 801.50 requires stand-alone software to comply with 
specific labeling requirements that identify the software.
    Section 801.55 authorizes additional, case-by-case, labeling 
exceptions and alternatives to standard UDI labeling requirements.
    If a labeler relabels or modifies a label of a device that is 
required to bear a UDI, under Sec.  830.60 it has to keep a record 
showing the relationship of the original device identifier to the new 
device identifier.
    Section 830.110 requires an applicant seeking initial FDA 
accreditation as a UDI-issuing to furnish FDA an application containing 
certain information, materials, and supporting documentation.
    Under Sec.  830.120, an FDA-accredited issuing is required to 
disclose information concerning its system for the assignment of UDIs; 
maintain a list of labelers that use its system for the assignment of 
UDIs and provide FDA a copy of such list; and upon request, provide FDA 
with information concerning a labeler that is employing the issuing 
agency's system for assignment of UDIs.
    Sections 830.310 and 830.320 require the labeler to provide certain 
information to the GUDID concerning the labeler and each version or 
model of a device required to be labeled with a UDI, unless the labeler 
obtains a waiver.

[[Page 72369]]

    Section 830.360 requires each labeler to retain records showing all 
UDIs used to identify devices that must be labeled with a UDI and the 
particular version or model associated with each device identifier, 
until 3 years after it ceases to market a version or model of a device.
    Respondents who are required to submit data to the Agency under 
certain other approved information collections (listed below) are 
required to include UDI data elements for the device that is the 
subject of such information collection. Addition of the UDI data 
elements is included in this burden estimate for the conforming 
amendments in the following 21 CFR parts:
    Part 803--Medical Device Reporting (OMB control number 0910-0437),
    Part 806--Medical Devices; Reports of Corrections and Removals (OMB 
control number 0910-0359),
    Part 814--Premarket Approval of Medical Devices (OMB control number 
0910-0231),
    Part 820--Quality System Regulation (OMB control number 0910-0073),
    Part 821--Medical Device Tracking Requirements (OMB control number 
0910-0442), and
    Part 822--Postmarket Surveillance (OMB control number 0910-0449).
    In the Federal Register of July 31, 2019 (84 FR 37315), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics.
    FDA estimates the burden of this collection of information as 
follows:

                                                            Table 1--Estimated Annual Burden
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                                                                                                                                           Total capital
                                            Number of       Number of                                                                        costs and
                                           respondents    responses per   Total annual    Average burden  per response \4\   Total hours   operating and
                                               \1\       respondent \2\   responses \3\                                          \5\        maintenance
                                                                                                                                               costs
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Reporting..............................           6,199              51         316,149  0.023 (1 minute)..................        7,289        $425,000
Recordkeeping..........................           5,987              51         305,337  0.989 (59 minutes)................      302,121      14,733,333
Third-Party Disclosure.................           5,987              51         305,337  0.885 (53 minutes)................      270,143      13,033,333
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\1\ Maximum number of respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may
  involve fewer respondents.
\2\ Maximum number of responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer responses.
\3\ Maximum total annual responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
  involve fewer total annual responses.
\4\ Rounded to three decimals. Total hours reflects a more precise, non-rounded average burden per response. An approximate (non-rounded) conversion to
  minutes is shown in parentheses.
\5\ Total hours is based on a more precise burden per response than the rounded value show in this table.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28246 Filed 12-30-19; 8:45 am]
 BILLING CODE 4164-01-P