81 FR 63768 - Agency Information Collection Activities; Proposed Collection; Comment Request; Unique Device Identification System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 180 (September 16, 2016)

Page Range		63768-63770
FR Document		2016-22340

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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.

Federal Register, Volume 81 Issue 180 (Friday, September 16, 2016)

[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63768-63770]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22340]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1853]


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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 November 15, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-D-1853 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Unique Device Identification 
System.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
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 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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: 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

[[Page 63769]]

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 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 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)

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

                                      Table 1--Estimated Annual Burden \1\
----------------------------------------------------------------------------------------------------------------
                                   Number of       Number of                     Average  burden
                                  respondents    responses per   Total annual   per response (in    Total hours
                                      \2\       respondent \3\   responses \4\     hours) \5\           \6\
----------------------------------------------------------------------------------------------------------------
Reporting.....................           6,199              51         316,149  0.023 [1 minute]           7,271
Recordkeeping.................           5,987              51         305,337  0.989 [59                301,978
                                                                                 minutes].
Third-Party Disclosure........           5,987              51         305,337  0.885 [53                270,223
                                                                                 minutes].
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer respondents.
\3\ Maximum No. of Responses for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer responses.

[[Page 63770]]

 
\4\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer total annual responses.
\5\ 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 square brackets.
\6\ Total Hours is based on a more precise Burden per Response than the rounded value shown in this table.


    Dated: September 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22340 Filed 9-15-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices 63769

requirement, FDA is publishing notice labeler would be the device information, materials, and supporting
of the proposed collection of manufacturer, but other types of labelers documentation.
information set forth in this document. include a specification developer, a Under § 830.120, an FDA-accredited
With respect to the following single-use device reprocessor, a issuing agency is required to disclose
collection of information, FDA invites convenience kit assembler, a repackager, information concerning its system for
comments on these topics: (1) Whether or a relabeler. Respondents may also the assignment of UDIs; maintain a list
the proposed collection of information include any private organization that of labelers that use its system for the
is necessary for the proper performance applies for accreditation by FDA as an assignment of UDIs, and provide FDA a
of FDA’s functions, including whether issuing agency. copy of such list; and upon request,
the information will have practical FDA has identified the following provide FDA with information
utility; (2) the accuracy of FDA’s requirements as having burdens that concerning a labeler that is employing
estimate of the burden of the proposed must be accounted for under the PRA; the issuing agency’s system for
collection of information, including the the burdens associated with these assignment of UDIs.
validity of the methodology and requirements are summarized in the Sections 830.310 and 830.320 require
assumptions used; (3) ways to enhance table that follows: the labeler to provide certain
the quality, utility, and clarity of the Section 801.18 requires that whenever information to the GUDID concerning
information to be collected; and (4) a labeler of a medical device includes an the labeler and each version or model of
ways to minimize the burden of the expiration date, a date of manufacture, a device required to be labeled with a
collection of information on or any other date intended to be brought UDI, unless the labeler obtains a waiver.
respondents, including through the use to the attention of the user of the device, Section 830.360 requires each labeler
of automated collection techniques, the labeler must present the date on the to retain records showing all UDIs used
when appropriate, and other forms of label in a format that meets the to identify devices that must be labeled
information technology. requirements of this section. with a UDI and the particular version or
Section 801.20 requires every medical model associated with each device
Unique Device Identification System—
device label and package to bear a UDI. identifier, until 3 years after it ceases to
21 CFR Parts 16, 801, 803, 806, 810, Under § 801.35, any labeler of a
814, 820, 821, 822 and 830—OMB market a version or model of a device.
device that is not required to bear a UDI Respondents who are required to
Control Number 0910–0720—Extension on its label may include a UDI on the submit data to the Agency under certain
In accordance with the collection of label of that device and utilize the other approved information collections
information entitled ‘‘Unique Device GUDID. (listed below) are required to include
Identification System (UDI),’’ medical Under § 801.45, any device that has to UDI data elements for the device that is
device labelers, unless excepted, are be labeled with a UDI also has to bear the subject of such information
required to design and use medical a permanent marking providing the UDI collection. Addition of the UDI data
device labels and device packages that on the device itself if the device is elements is included in this burden
bear a UDI, present dates on labels in a intended for more than one use and estimate for the conforming
particular format, and submit data intended to be reprocessed before each amendments in the following 21 CFR
concerning each version or model of a use. parts:
device to the Global Unique Device Section 801.50 requires stand-alone
Identification Database (GUDID) no later software to comply with specific • Part 803—Medical Device Reporting
than the date the label of the device labeling requirements that identify the (OMB control number 0910–0437)
must bear a UDI. Once a device becomes software. • Part 806—Medical Devices; Reports of
subject to UDI requirements, Section 801.55 authorizes additional, Corrections and Removals (OMB
respondents will be required to update case-by-case, labeling exceptions and control number 0910–0359)
the information reported whenever the alternatives to standard UDI labeling • Part 814—Premarket Approval of
information changes. requirements. Medical Devices (OMB control
The recordkeeping, reporting, and If a labeler relabels or modifies a label number 0910–0231)
third-party disclosure requirements of a device that is required to bear a • Part 820—Quality System Regulation
referenced in this document are UDI, under § 830.60 it has to keep a (OMB control number 0910–0073)
imposed on any person who causes a record showing the relationship of the • Part 821—Medical Device Tracking
label to be applied to a device, or who original device identifier to the new Requirements (OMB control
causes the label to be modified, with the device identifier. number 0910–0442)
intent that the device will be Section 830.110 requires an applicant • Part 822—Postmarket Surveillance
commercially distributed without any seeking initial FDA accreditation as a (OMB control number 0910–0449)
subsequent replacement or modification UDI-issuing agency to furnish FDA an FDA estimates the burden of this
of the label. In most instances, the application containing certain collection of information as follows:

TABLE 1—ESTIMATED ANNUAL BURDEN 1

Number of Number of Average
Total annual
respondents 2 responses per
responses 4 burden per response Total hours 6
respondent 3 (in hours) 5
mstockstill on DSK3G9T082PROD with NOTICES

Reporting ........................................... 6,199 51 316,149 0.023 [1 minute] ............................... 7,271
Recordkeeping .................................. 5,987 51 305,337 0.989 [59 minutes] ........................... 301,978
Third-Party Disclosure ...................... 5,987 51 305,337 0.885 [53 minutes] ........................... 270,223
1 Thereare no capital costs or operating and maintenance costs associated with this collection of information.
2 Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category
may involve fewer respondents.
3 Maximum No. of Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
involve fewer responses.

VerDate Sep<11>2014 17:55 Sep 15, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\16SEN1.SGM 16SEN1

Document Created: 2016-09-16 00:24:34
Document Modified: 2016-09-16 00:24:34

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		Submit either electronic or written comments on the collection of information by November 15, 2016.
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 63768

81 FR 63768 - Agency Information Collection Activities; Proposed Collection; Comment Request; Unique Device Identification System

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 180 (September 16, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration