[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37315-37317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16269]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Unique Device Identification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 associated with the 
Unique Device Identification System.

DATES: Submit either electronic or written comments on the collection 
of information by September 30, 2019.

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 September 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 30, 2019. 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 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-2016-N-4319 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Unique Device Identification 
System.'' 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.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your

[[Page 37316]]

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.gpo.gov/fdsys/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.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.

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 agency to furnish FDA an application 
containing certain information, materials, and supporting 
documentation.
    Under Sec.  830.120, an FDA-accredited issuing agency 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.
    Section 830.360 requires each labeler to retain records showing all 
UDIs used

[[Page 37317]]

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).
    FDA estimates the burden of this collection of information as 
follows:

                                                            Table 1--Estimated Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                           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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: July 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16269 Filed 7-30-19; 8:45 am]
 BILLING CODE 4164-01-P