81 FR 94386 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 247 (December 23, 2016)

Page Range		94386-94388
FR Document		2016-30966

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.

Federal Register, Volume 81 Issue 247 (Friday, December 23, 2016)

[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Notices]
[Pages 94386-94388]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30966]


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

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.

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

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: Fax written comments on the collection of information by January 
23, 2017.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [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.

Unique Device Identification System OMB Control Number 0910-0720--
Extension

    In accordance with the collection of information entitled ``Unique 
Device Identification System (UDI),'' 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 
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 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

[[Page 94387]]

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).
     Part 822--Postmarket Surveillance (OMB control number 
0910-0449).
    In the Federal Register of September 16, 2016 (81 FR 63768), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one letter in response to the 
notice, containing multiple comments.
    (Comment 1) The commenter questioned the practical utility of 
certain data elements (``Kit'' and ``Unit of Use DI number'') in the 
GUDID and stated that they do not consider them necessary for the 
proper performance of FDA's functions.
    (Response 1) Kit is an optional data element in the GUDID. The 
respondent may choose not to provide this information. Certain kits may 
include individual devices that may not be required to have a UDI. It 
is therefore useful to be able to identify whether a device reported in 
GUDID is an individual device or a kit. The Unit of Use data element is 
used when the base package contains multiple units of the same device. 
Although not included on the device label, the Unit of Use DI number 
can specifically identify device use on the patient by either pulling 
it from AccessGUDID or hospital systems and linking/populating the 
information to the patient electronic health record. The UDI 
stakeholder community, which includes clinicians, healthcare providers 
and labelers, have expressed to us that this is a valuable data element 
to be in included in GUDID.
    (Comment 2) The commenter expressed concern that capital or 
operating and maintenance costs were excluded from the PRA burden 
analysis.
    (Response 2) While we did include an estimate of costs in the 
economic analysis of the final rule, this information was not in the 
PRA section of the final rule or subsequently, the 60-day notice for 
comment on the extension of this information collection. We appreciate 
the comment and have included estimated costs of $85.7 million, based 
on the economic analysis of the final rule, in our analysis of the 
information collection burden. The estimate includes planning and 
administration and the costs to integrate the UDI into existing 
information systems; to install, test, and validate barcode printing 
software; and to train employees. Other significant components of one-
time costs include costs to redesign labels of devices to incorporate 
the barcode and date format, and to purchase and install equipment 
needed to print and verify the UDI on labels. In addition, labelers 
will incur one-time costs for recordkeeping and reporting requirements, 
and the direct marking of certain devices. The largest annual cost 
components include labor, operating, and maintenance associated with 
equipment for printing operations, and labor related to software 
maintenance and training needed to maintain the UDI information system. 
The total cost, which includes both capital costs and operating and 
maintenance costs, has been annualized over 10 years. We have included 
the total under capital costs for purposes of this information 
collection request.
    (Comment 3) The commenter suggested the following opportunities for 
FDA to enhance data quality, utility, and clarity of the information, 
including for FDA to:
     Provide data structure information for relevant conforming 
amendments;
     clarify how to address challenges of device systems;
     make more timely updates to related FDA databases and 
enhance interaction between systems; and
     increase GUDID performance to be more consistent and 
predictable.
    Additionally, the commenter suggested additional ways that FDA 
could minimize the burden of collection of information if FDA were to 
identify PMA supplement numbers through the PMA database, rather than 
having the data provided again through GUDID by the labeler.
     More timely updates of Global Medical Device Nomenclature 
codes.
     Added transparency regarding logic and validation rule 
changes.
     Auto-populating data elements which already reside in 
another FDA system.
    (Response 3) These comments continue to be evaluated, but FDA is 
making no change to the information collection at this time.
    FDA estimates the burden of this collection of information as 
follows:

                                                            Table 1--Estimated Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                        Number of       Number of     Total annual    Average burden per    Total hours    operating and
                                                       respondents    responses per   responses \3\  response (in hours)        \5\         maintenance
                                                           \1\       respondent \2\                          \4\                               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 No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer respondents.
\2\ Maximum No. 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 shown in this table.



[[Page 94388]]

    Dated: December 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30966 Filed 12-22-16; 8:45 am]
BILLING CODE 4164-01-P

94386 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of
Activity responses per annual burden per Total hours
respondents respondent responses response

Application ............................................................................ 600 1 600 1.33 798
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: December 19, 2016. Unique Device Identification System label of that device and utilize the
Leslie Kux, OMB Control Number 0910–0720— GUDID.
Associate Commissioner for Policy. Extension Under § 801.45, any device that has to
[FR Doc. 2016–30967 Filed 12–22–16; 8:45 am] be labeled with a UDI also has to bear
In accordance with the collection of
a permanent marking providing the UDI
BILLING CODE 4164–01–P information entitled ‘‘Unique Device
on the device itself if the device is
Identification System (UDI),’’ medical
intended for more than one use and
device labelers, unless excepted, are
DEPARTMENT OF HEALTH AND intended to be reprocessed before each
required to design and use medical
HUMAN SERVICES use.
device labels and device packages that
Section 801.50 requires stand-alone
bear a UDI, present dates on labels in a
Food and Drug Administration software to comply with specific
particular format, and submit data
labeling requirements that identify the
concerning each version or model of a
[Docket No. FDA–2016–N–4319] software.
device to the Global Unique Device Section 801.55 authorizes additional,
Identification Database (GUDID) no later case-by-case, labeling exceptions and
Agency Information Collection
than the date the label of the device alternatives to standard UDI labeling
Activities; Submission for Office of
must bear a UDI. Once a device becomes requirements.
Management and Budget Review;
subject to UDI requirements, If a labeler relabels or modifies a label
Comment Request; Unique Device
respondents will be required to update of a device that is required to bear a
Identification System
the information reported whenever the UDI, under § 830.60 it has to keep a
AGENCY: Food and Drug Administration, information changes. record showing the relationship of the
HHS. The recordkeeping, reporting, and original device identifier to the new
ACTION: Notice. third-party disclosure requirements device identifier.
referenced in this document are Section 830.110 requires an applicant
SUMMARY: The Food and Drug imposed on any person who causes a seeking initial FDA accreditation as a
Administration (FDA) is announcing label to be applied to a device, or who UDI-issuing agency to furnish FDA an
that a proposed collection of causes the label to be modified, with the application containing certain
information has been submitted to the intent that the device will be information, materials, and supporting
Office of Management and Budget commercially distributed without any documentation.
(OMB) for review and clearance under subsequent replacement or modification Under § 830.120, an FDA-accredited
the Paperwork Reduction Act of 1995. of the label. In most instances, the issuing agency is required to disclose
DATES: Fax written comments on the labeler would be the device information concerning its system for
collection of information by January 23, manufacturer, but other types of labelers the assignment of UDIs; maintain a list
2017. include a specification developer, a of labelers that use its system for the
single-use device reprocessor, a assignment of UDIs, and provide FDA a
ADDRESSES: To ensure that comments on
convenience kit assembler, a repackager, copy of such list; and upon request,
the information collection are received, or a relabeler. Respondents may also
OMB recommends that written provide FDA with information
include any private organization that concerning a labeler that is employing
comments be faxed to the Office of applies for accreditation by FDA as an
Information and Regulatory Affairs, the issuing agency’s system for
issuing agency. assignment of UDIs.
OMB, Attn: FDA Desk Officer, FAX:
FDA has identified the following Sections 830.310 and 830.320 require
202–395–7285, or emailed to oira_
requirements as having burdens that the labeler to provide certain
submission@omb.eop.gov. All
must be accounted for under the PRA; information to the GUDID concerning
comments should be identified with the
the burdens associated with these the labeler and each version or model of
OMB control number 0910–0720. Also
requirements are summarized in the a device required to be labeled with a
include the FDA docket number found
table that follows: UDI, unless the labeler obtains a waiver.
in brackets in the heading of this
Section 801.18 requires that whenever Section 830.360 requires each labeler
document.
a labeler of a medical device includes an to retain records showing all UDIs used
FOR FURTHER INFORMATION CONTACT: FDA expiration date, a date of manufacture, to identify devices that must be labeled
PRA Staff, Office of Operations, Food or any other date intended to be brought with a UDI and the particular version or
and Drug Administration, Three White to the attention of the user of the device, model associated with each device
Flint North 10A–12M, 11601 the labeler must present the date on the identifier, until 3 years after it ceases to
mstockstill on DSK3G9T082PROD with NOTICES

Landsdown St., North Bethesda, MD label in a format that meets the market a version or model of a device.
20852, PRAStaff@fda.hhs.gov. requirements of this section. Respondents who are required to
SUPPLEMENTARY INFORMATION: In Section 801.20 requires every medical submit data to the Agency under certain
compliance with 44 U.S.C. 3507, FDA device label and package to bear a UDI. other approved information collections
has submitted the following proposed Under § 801.35, any labeler of a (listed below) are required to include
collection of information to OMB for device that is not required to bear a UDI UDI data elements for the device that is
review and clearance. on its label may include a UDI on the the subject of such information

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Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices 94387

collection. Addition of the UDI data same device. Although not included on with equipment for printing operations,
elements is included in this burden the device label, the Unit of Use DI and labor related to software
estimate for the conforming number can specifically identify device maintenance and training needed to
amendments in the following 21 CFR use on the patient by either pulling it maintain the UDI information system.
parts: from AccessGUDID or hospital systems The total cost, which includes both
• Part 803—Medical Device Reporting and linking/populating the information capital costs and operating and
(OMB control number 0910–0437). to the patient electronic health record. maintenance costs, has been annualized
• Part 806—Medical Devices; Reports The UDI stakeholder community, which over 10 years. We have included the
of Corrections and Removals (OMB includes clinicians, healthcare total under capital costs for purposes of
control number 0910–0359). providers and labelers, have expressed this information collection request.
• Part 814—Premarket Approval of to us that this is a valuable data element (Comment 3) The commenter
Medical Devices (OMB control number to be in included in GUDID. suggested the following opportunities
0910–0231). (Comment 2) The commenter for FDA to enhance data quality, utility,
• Part 820—Quality System and clarity of the information, including
expressed concern that capital or
Regulation (OMB control number 0910– for FDA to:
operating and maintenance costs were
0073). • Provide data structure information
excluded from the PRA burden analysis.
• Part 821—Medical Device Tracking for relevant conforming amendments;
Requirements (OMB control number (Response 2) While we did include an
estimate of costs in the economic • clarify how to address challenges of
0910–0442).
device systems;
• Part 822—Postmarket Surveillance analysis of the final rule, this
(OMB control number 0910–0449). information was not in the PRA section • make more timely updates to
In the Federal Register of September of the final rule or subsequently, the 60- related FDA databases and enhance
16, 2016 (81 FR 63768), FDA published day notice for comment on the interaction between systems; and
a 60-day notice requesting public extension of this information collection. • increase GUDID performance to be
comment on the proposed collection of We appreciate the comment and have more consistent and predictable.
information. FDA received one letter in included estimated costs of $85.7 Additionally, the commenter
response to the notice, containing million, based on the economic analysis suggested additional ways that FDA
multiple comments. of the final rule, in our analysis of the could minimize the burden of collection
(Comment 1) The commenter information collection burden. The of information if FDA were to identify
questioned the practical utility of estimate includes planning and PMA supplement numbers through the
certain data elements (‘‘Kit’’ and ‘‘Unit administration and the costs to integrate PMA database, rather than having the
of Use DI number’’) in the GUDID and the UDI into existing information data provided again through GUDID by
stated that they do not consider them systems; to install, test, and validate the labeler.
necessary for the proper performance of barcode printing software; and to train • More timely updates of Global
FDA’s functions. employees. Other significant Medical Device Nomenclature codes.
(Response 1) Kit is an optional data components of one-time costs include • Added transparency regarding logic
element in the GUDID. The respondent costs to redesign labels of devices to and validation rule changes.
may choose not to provide this incorporate the barcode and date format, • Auto-populating data elements
information. Certain kits may include and to purchase and install equipment which already reside in another FDA
individual devices that may not be needed to print and verify the UDI on system.
required to have a UDI. It is therefore labels. In addition, labelers will incur (Response 3) These comments
useful to be able to identify whether a one-time costs for recordkeeping and continue to be evaluated, but FDA is
device reported in GUDID is an reporting requirements, and the direct making no change to the information
individual device or a kit. The Unit of marking of certain devices. The largest collection at this time.
Use data element is used when the base annual cost components include labor, FDA estimates the burden of this
package contains multiple units of the operating, and maintenance associated collection of information as follows:

TABLE 1—ESTIMATED ANNUAL BURDEN
Number of Average burden per Total operating
Number of Total annual Total hours 5
responses per response and mainte-
respondents 1 responses 3
respondent 2 (in hours) 4 nance 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 No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category
may involve fewer respondents.
2 Maximum No. 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 cat-
egory 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.
mstockstill on DSK3G9T082PROD with NOTICES

5 Total Hours is based on a more precise Burden per Response than the rounded value shown in this table.

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Document Created: 2016-12-23 12:29:07
Document Modified: 2016-12-23 12:29:07

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by January 23, 2017.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		81 FR 94386

81 FR 94386 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 247 (December 23, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration