[Federal Register Volume 82, Number 88 (Tuesday, May 9, 2017)]
[Notices]
[Pages 21538-21541]
[FR Doc No: 2017-09341]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RD17-5-000 and IC17-6-000]

Commission Information Collection Activities (FERC-725E); Comment
Request; Revision and Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of revised information collection and request for
comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on revisions to the information
collection, FERC-725E (Mandatory Reliability Standards for the Western
Electric Coordinating Council) and will be submitting FERC-725E to the
Office of Management and Budget (OMB) for review of the information
collection requirements.

DATES: Comments on the collection of information are due July 10, 2017.

ADDRESSES: You may submit comments identified by Docket Nos. RD17-5-000
and IC17-6-000 by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.

Instructions: All submissions must be formatted and filed in accordance
with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support by email at
<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER> (toll-free),
or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725E, Mandatory Reliability Standards for the Western
Electric Coordinating Council.
    OMB Control No.: 1902-0246.
    Type of Request: Three-year approval of the FERC-725E information
collection requirements, as modified by Docket No. RD17-5-000.
    Abstract: The information collected by the FERC-725E is required to
implement the statutory provisions of section 215 of the Federal Power
Act (FPA) (16 U.S.C. 824o). Section 215 of the FPA buttresses the
Commission's efforts to strengthen the reliability of the interstate
grid through the grant of new authority by providing for a system of
mandatory Reliability Standards developed by the Electric Reliability
Organization (ERO). Reliability Standards that the ERO proposes to the
Commission may include Reliability Standards that are proposed to the
ERO by a Regional Entity.\1\ A Regional Entity is an entity that has
been approved by the Commission to enforce Reliability Standards under
delegated authority from the ERO.\2\ On June 8, 2008, the Commission
approved eight regional Reliability Standards submitted by the ERO that
were proposed by the Western Electricity Coordinating Council
(WECC).\3\
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    \1\ 16 U.S.C. 824o(e)(4).
    \2\ 16 U.S.C. 824o(a)(7) and (e)(4).
    \3\ North American Electric Reliability Corp., 119 FERC 61,260
(2007).
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    WECC promotes bulk electric system reliability in the Western
Interconnection. WECC is the Regional Entity responsible for compliance
monitoring and enforcement. In addition, WECC provides an environment
for the development of Reliability Standards and the coordination of
the operating and planning activities of its members as set forth in
the WECC Bylaws.
    There are several regional Reliability Standards in the WECC
region. These regional Reliability Standards generally require entities
to document compliance with substantive requirements, retain
documentation, and submit reports to WECC.
    BAL-002-WECC-2a (Contingency Reserve) \4\ requires balancing
authorities and reserve sharing groups to document compliance with the
contingency reserve requirements described in the standard.
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    \4\ BAL-002-WECC-2 is included in the OMB-approved inventory for
FERC-725E. On November 9, 2016, NERC and WECC submitted a joint
petition for approval of an interpretation of BAL-002-WECC-2, to be
designated BAL-002-WECC-2a. BAL-002-WECC-2a was approved by order in
Docket No. RD17-3-000 on January 24, 2017. The Order determined: The
proposed interpretation provides clarification regarding the types
of resources that may be used to satisfy Contingency Reserve
requirements in regional Reliability Standard BAL-002-WECC-2. BAL-
002-WECC-2a did not trigger the Paperwork Reduction Act and did not
affect the burden estimate. BAL-002-WECC-2a is being included in
this Notice and the Commission's submittal to OMB as part of the
FERC-725E.
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     BAL-004-WECC-02 (Automatic Time Error Correction) requires
balancing authorities to document that time error corrections and
primary inadvertent interchange payback were conducted according the
requirements in the standard.
     FAC-501-WECC-1 (Transmission Maintenance) requires
transmission owners with certain transmission paths to have a
transmission maintenance and inspection plan and to document
maintenance and inspection activities according to the plan.
     IRO-006-WECC-2 (Qualified Transfer Path Unscheduled Flow
(USF) Relief) \5\ requires balancing authorities and reliability
coordinators document actions taken to mitigate unscheduled flow.
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    \5\ On December 20, 2013, NERC and WECC submitted a joint
petition for approval of IRO-006-WECC-2 and retirement of IRO-006-
WECC-1. IRO-006-WECC-2 was approved by order in Docket No. RD14-9-
000 on May 13, 2014. Because the reporting burden for IRO-006-WECC-2
did not increase for entities that operate within the Western
Interconnection, FERC submitted the order to OMB for information
only. The burden related to IRO-006-WECC-2 does not differ from the
burden of IRO-006-WECC-1, which is included in the OMB-approved
inventory. IRO-006-WECC-2 is being included in this Notice and the
Commission's submittal to OMB as part of FERC-725E.
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     PRC-004-WECC-2 (Protection System and Remedial Action
Scheme Misoperation) \6\ requires transmission owners, generator owners
and transmission operators to document their analysis and/or mitigation
due to certain misoperations on major transfer

paths. This standard requires that documentation be kept for six years.
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    \6\ Order No. 818, issued on November 19, 2015 in Docket Nos.
RM15-7, RM15-12, and RM15-13, stated in part: ``NERC requested
approval of the following Reliability Standards to incorporate the
proposed definition of Remedial Action Scheme and eliminate use of
the term Special Protection System: . . . PRC-004-WECC-2, . . . NERC
did not propose any changes to the Violation Risk Factors or
Violation Severity Levels for the modified standards.'' Revisions to
Emergency Operations Reliability Standards; Revisions to
Undervoltage Load Shedding Reliability Standards; Revisions to the
Definition of ``Remedial Action Scheme'' and Related Reliability
Standards, Order No. 818, 153 FERC ] 61,228, at P 23 n.31 (2015). In
addition, Order No. 818 stated: ``The Commission approved the
definition of Special Protection System (Remedial Action Scheme) in
Order No. 693. We approve a revision to the previously approved
definition. The revisions to the Remedial Action Scheme definition
and related Reliability Standards are not expected to result in
changes to the scope of systems covered by the Reliability Standards
and other Reliability Standards that include the term Remedial
Action Scheme. Therefore, the Commission does not expect the
revisions to affect applicable entities' current reporting burden.''
Id. P 67. The change to the definition did not affect the burden of
PRC-004-WECC-1 (which is included in the current OMB-approved
inventory). PRC-004-WECC-2 (the current version of the standard) is
being included in this Notice and the Commission's submittal to OMB
as part of the FERC-725E.
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     VAR-002-WECC-2 (Automatic Voltage Regulators (AVR)) \7\
requires generator operators and transmission operators to provide
quarterly reports to the compliance monitor and have evidence related
to their synchronous generators, synchronous condensers, and automatic
voltage regulators.
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    \7\ VAR-002-WECC-2 was approved by order in Docket No. RD15-1 on
March 3, 2015. Regional Reliability Standard VAR-002-WECC-2 made a
non-material or non-substantive change to the reporting and
recordkeeping requirements associated with VAR-002-WECC-1 (currently
included in the OMB-approved inventory). VAR-002-WECC-2 (the current
version of the standard) is being included in this Notice and the
Commission's submittal to OMB as part of FERC-725E.
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    The associated reporting and recordkeeping requirements included in
the standards above are not being revised, and the Commission will be
submitting a request to OMB to extend these requirements for three
years. The Commission's request to OMB will also reflect the following:
     Eliminating the burden associated with regional
Reliability Standard TOP-007-WECC-1a, which is being retired (addressed
in Docket No. RD16-10); \8\ and
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    \8\ The Commission approved the retirement of regional
Reliability Standard TOP-007-WECC-1a (System Operating Limits (SOL))
by order in Docket No. RD16-10-000 on March 10, 2017. On March 31,
2017, the Commission issued a 60-day Notice requesting public
comment on the effect on burden. The Notice is available at 82 FR
16823 (April 6, 2017). Comments are due in Docket No. RD16-10-000 by
June 5, 2017. See Docket No. RD16-10-000 for additional information
(including the estimated annual burden reduction of 1,188 hours).
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     Implementing the regional Reliability Standard VAR-501-
WECC-3 and the retirement of regional Reliability Standard VAR-501-
WECC-2 (addressed in Docket No. RD17-5 and discussed below).
    On March 10, 2017, NERC and WECC filed a joint petition in Docket
No. RD17-5-000 \9\ requesting Commission approval of: (a) Regional
Reliability Standard VAR-501-WECC-3 (Power System Stabilizers), and (b)
the retirement of then-existing regional Reliability Standard VAR-501-
WECC-2. The petition states: ``Regional Reliability Standard VAR-501-
WECC-3 establishes the performance criteria for power system
stabilizers to help ensure the Western Interconnection is operated in a
coordinated manner under normal and abnormal conditions.'' VAR-501-
WECC-3 was approved by order in Docket No. RD17-5-000 on April 28,
2017. In this document, we provide estimates of the burden and cost
related to those revisions to FERC-725E.
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    \9\ The joint petition and exhibits are posted in the
Commission's eLibrary system in Docket No. RD17-5-000.
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    Type of Respondents: Balancing authorities, reserve sharing groups,
transmission owners, reliability coordinators, transmission operators,
generator operators, and generator owners.
    Estimate of Annual Burden \10\: Details follow on the changes in
Docket No. RD17-5-000, and on the continuing burdens, which will be
submitted to OMB for approval in a consolidated package under FERC-
725E.
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    \10\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, refer to 5 Code of Federal Regulations 1320.3.
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    Estimate of Changes to Burden Due to Docket No. RD17-5: The joint
petition requested Commission approval of regional Reliability Standard
VAR-501-WECC-3 and retirement of then-existing regional Reliability
Standard VAR-501-WECC-2. The estimated effects on burden and cost \11\
are as follow:
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    \11\ For VAR-501-WECC-3, the hourly cost (for salary plus
benefits) uses the figures from the Bureau of Labor Statistics for
three positions involved in the reporting and recordkeeping
requirements. These figures include salary (http://bls.gov/oes/current/naics2_22.htm) and benefits (http://www.bls.gov/news.release/ecec.nr0.htm) and are:
     Manager: $89.07/hour
     Engineer: $64.91/hour
     File Clerk: $31.19/hour
    The hourly cost for the reporting requirements ($76.99) is an
average of the cost of a manager and engineer. The hourly cost for
recordkeeping requirements uses the cost of a file clerk.

                                   FERC-725E, Mandatory Reliability Standards for the Western Electric Coordinating Council, Changes in Docket No. RD17-5-000
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                                                        Annual  number
                                           Number of     of  responses   Annual  number   Average burden hrs. &  cost per      Total annual  burden hours &
                Entity                    respondents         per        of  responses             response  ($)                  total annual cost  ($)            Cost per respondent  ($)
                                             \12\         respondent
                                                   (1)             (2)  (1) * (2) = (3)  (4)..............................  (3) * (4) = (5)..................  (5) / (1) = (6)
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                                                             Retirement Of Former Standard VAR-501-WECC-2 and Associated Reductions
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Reporting Requirements (Annually)
Generator Operators...................             249               4              996  1 hr.; $76.22....................  996 hrs.; $75,915.12 (reduction).  $304.88 (reduction)
Recordkeeping Requirements (Annually)
Generator Operators...................             249               4              996  0.5 hrs.; $31.19.................  498 hrs.; $15,532.62 (reduction).  $62.38 (reduction)
Reductions (Annually).................  ..............  ..............  ...............  .................................  1,494 hrs.; $91,447.74             .................................
                                                                                (reduction).
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                                                                                New Standard VAR-501-WECC-3
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Reporting Requirements................
Generator Owners and/or Operators, in              291               3              873  1 hr.; $76.99....................  873 hrs.; $67,212.27.............  $230.97
 Year 1.
Generator Owners and/or Operators, in              291               2              582  1 hr.; $76.99....................  582 hrs.; $44,808.18.............  $153.98
 Year 2 and Ongoing.
Recordkeeping Requirements
Generator Owners and/or Operators, in              291               3              873  1 hr.; $31.19....................  873 hrs.; $27,228.87.............  $93.57
 Year 1.
Generator Owners and/or Operators, in              291               2              582  0.5 hrs.; $15.595................  291 hrs.; $9,076.29..............  $31.19
 Year 2 and Ongoing.
New Burden, in Year 1.................  ..............  ..............  ...............  .................................  1,746 hrs.; $94,441.14...........  .................................
New Burden, in Year 2 & Ongoing.......  ..............  ..............  ...............  .................................  873 hrs.; $53,884.47.............  .................................
Net Burden Change in Year 1...........  ..............  ..............  ...............  .................................  +252 hrs (increase)..............  .................................

Net Burden Change in Year 2 and         ..............  ..............  ...............  .................................  -621 hrs. (decrease).............  .................................
 Ongoing.
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    Estimate of Continuing Annual Burden for Renewal and New
Reliability Standard VAR-501-WECC-3: \13\ The Commission estimates the
annual public reporting burden and cost \14\ as follows for FERC-725E.
(This information will be submitted to OMB for approval.) These
estimates reflect:
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    \12\ The number of respondents is derived from the NERC
Compliance Registry as of March 10, 2017.
    \13\ The Commission is also removing 36 one-time burden hours
associated with the requirements in Docket No. RM13-13. The one-time
burden has been completed and will now be administratively removed
on submittal to OMB. Those hours are not included in the table.
    \14\ The hourly cost (for salary plus benefits) uses the figures
from the Bureau of Labor Statistics for three positions involved in
the reporting and recordkeeping requirements. These figures include
salary (http://bls.gov/oes/current/naics2_22.htm) and other
associated benefits (http://www.bls.gov/news.release/ecec.nr0.htm)
and are:
     Manager: $89.07/hour
     Engineer: $64.91/hour
     File Clerk: $31.19/hour
    The hourly cost for the reporting requirements ($76.99) is an
average of the cost of a manager and engineer. The hourly cost for
recordkeeping requirements uses the cost of a file clerk.
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     Reliability Standards in FERC-725E which continue and
remain unchanged (BAL-002-WECC-2a, BAL-004-WECC-02, FAC-501-WECC-1,
IRO-006-WECC-2, PRC-004-WECC-2, and VAR-002-WECC-2);
     Removal of burden due to the retirement of TOP-007-WECC-1a
(discussed in Docket No. RD16-10-000)
     Additional burden due to VAR-501-WECC-3, and removal of
burden due to the retirement of VAR-501-WECC-2 (detailed above and in
Docket No. RD17-5-000).
    (The burdens and costs related to TOP-007-WECC-1a and VAR-501-WECC-
2 [the standards being retired] are omitted from the table below, which
describes the new and continuing information collection requirements.)

                                                    FERC-725E, Mandatory Reliability Standards for the Western Electric Coordinating Council
                                                                    [New and Continuing Information Collection Requirements]
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                                           Number of     Annual number
                Entity                    respondents    of responses    Annual number     Average burden hrs. & cost per      Total annual  burden hours &         Cost per respondent  ($)
                                             \15\       per respondent    of responses             response  ($)                  total annual cost  ($)
                                                   (1)             (2)    (1)*(2) = (3)  (4)..............................  (3)*(4) = (5)....................  (5)/(1) = (6)
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                                                                                Reporting Requirements
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Balancing Authorities.................              34               1               34  21 hrs., $1,616.79...............  714 hrs., $54,970.86.............  $1,616.79
Generator Operators...................             228               1              228  10 hrs., $769.90.................  2,280 hrs., $175,537.20..........  $769.90
Transmission Operators applicable to                86               4              344  10 hrs., $769.90.................  3,440 hrs., $264,845.60..........  $769.90
 standard VAR-002.
Transmission Owners that operate                     5               3               15  40 hrs., $3,079.60...............  600 hrs., $46,194.00.............  $3,079.60
 qualified transfer paths.
Reliability Coordinators..............               1               1                1  1 hr., $76.99....................  1 hr., $76.99....................  $76.99
Reserve Sharing Group.................               3               1                3  1 hr., $76.99....................  3 hrs., $230.97..................  $76.99
Generator Owners and/or Operators , in             291               3              873  1 hr.; $76.99....................  873 hrs.; $67,212.27.............  $230.97
 Year 1, per RD17-5 for VAR-501-WECC-3.
Generator Owners and/or Operators, in              291               2              582  1 hr.; $76.99....................  582 hrs.; $44,808.18.............  $153.98
 Year 2 and Ongoing, per RD17-5 for
 VAR-501-WECC-3.
    Sub-Total for Reporting             ..............  ..............  ...............  .................................  7,911 hrs.; $609,067.89..........  .................................
     Requirement in Year 1.
    Sub-Total for Reporting             ..............  ..............  ...............  .................................  7,620 hrs.; $586,663.80..........  .................................
     Requirement Burden in Year 2 &
     ongoing.
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                                                                                Recordkeeping Requirements
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Balancing Authorities.................              34               1               34  2.1 hrs., $65.50.................  71.4 hrs., $2,226.97.............  $65.50
Balancing Authorities (IRO-006).......              34               1               34  1 hr., $31.19....................  34 hrs., $1,060.46...............  $31.19
Generator Operators...................             228               1              228  1 hr., $31.19....................  228 hrs., $7,111.32..............  $31.19
Transmission Operator (VAR-002).......              86               1               86  4 hrs., $124.76..................  344 hrs., $10,729.36.............  $124.76
Transmission Owner that operate                      5               1                5  12 hrs., $374.28.................  60 hrs., $1,871.40...............  $374.28
 qualified transfer paths.
Reliability Coordinator...............               1               1                1  1 hr.; $31.19....................  1 hr.; $31.19....................  $31.19
Generator Owners and/or Operators, in              291               3              873  1 hr.; $31.19....................  873 hrs.; $27,228.87.............  $93.57
 Year 1, per RD17-5 for VAR-501-WECC-3.

Generator Owners and/or Operators, in              291               2              582  0.5 hrs.; $15.595................  291 hrs.; $9,076.29..............  $31.19
 Year 2 and Ongoing, per RD17-5 for
 VAR-501-WECC-3.
                                       ---------------------------------------------------------------------------------------------------------------------------------------------------------
    Sub-Total for Recordkeeping         ..............  ..............  ...............  .................................  1,611.4 hrs.; $50,259.57.........  .................................
     Requirements in Yr. 1.
    Sub-Total for Recordkeeping         ..............  ..............  ...............  .................................  1,029.4 hrs.; $32,106.99.........  .................................
     Requirements in Yr. 2 & ongoing.
        TOTAL FOR FERC-725E, IN YR. 1.  ..............  ..............  ...............  .................................  9,522.4 hrs.; $659,327.46........  .................................
        TOTAL FOR FERC-725E, IN YR. 2   ..............  ..............  ...............  .................................  8,649.4 hrs.; $618,770.79........  .................................
         & ONGOING.
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: May 3, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-09341 Filed 5-8-17; 8:45 am]
 BILLING CODE 6717-01-P


distinct identification code as required by Sec.  1271.290(c) of this
chapter, the UDI must include a production identifier segment that
conveys such information.
    (c) If the AIDC technology is not evident upon visual examination
of the label or device package, the label or device package must
disclose the presence of AIDC technology.
    (d) A class I device that bears a Universal Product Code (UPC) on
its label and device packages is deemed to meet all requirements of
subpart B of this part. The UPC will serve as the unique device
identifier required by Sec.  801.20.

Sec.  801.45  Devices that must be directly marked with a unique device
identifier.

    (a) In general. A device that must bear a unique device identifier
(UDI) on its label must also bear a permanent marking providing the UDI
on the device itself if the device is intended to be used more than
once and intended to be reprocessed before each use.
    (b) UDI for direct marking. The UDI provided through a direct
marking on a device may be:
    (1) Identical to the UDI that appears on the label of the device,
or
    (2) A different UDI used to distinguish the unpackaged device from
any device package containing the device.
    (c) Form of a UDI when provided as a direct marking. When a device
must bear a UDI as a direct marking, the UDI may be provided through
either or both of the following:
    (1) Easily readable plain-text;
    (2) Automatic identification and data capture (AIDC) technology, or
any alternative technology, that will provide the UDI of the device on
demand.
    (d) Exceptions. The requirement of paragraph (a) of this section
shall not apply to any device that meets any of the following criteria:
    (1) Any type of direct marking would interfere with the safety or
effectiveness of the device;
    (2) The device cannot be directly marked because it is not
technologically feasible;
    (3) The device is a single-use device and is subjected to
additional processing and manufacturing for the purpose of an
additional single use.
    (4) The device has been previously marked under paragraph (a) of
this section.

    (e) Exception to be noted in design history file. A labeler that
decides to make use of an exception under paragraph (d of this section)
must document the basis of that decision in the design history file
required by Sec.  820.30(j) of this chapter.

Sec.  801.50  Labeling requirements for stand-alone software.

    (a) Stand-alone software that is not distributed in packaged form
(e.g., when downloaded from a Web site) is deemed to meet the UDI
labeling requirements of this subpart if it complies with the
requirements of paragraph (b) of this section and conveys the version
number in its production identifier.
    (b) Regardless of whether it is or is not distributed in packaged
form, stand-alone software regulated as a medical device must provide
its unique device identifier through either or both of the following:
    (1) An easily readable plain-text statement displayed whenever the
software is started;
    (2) An easily readable plain-text statement displayed through a
menu command (e.g., an ``About * * *'' command).
    (c) Stand-alone software that is distributed in both packaged form
and in a form that is not packaged (e.g., when downloaded from a Web
site) may be identified with the same device identifier.

0
5c. Effective December 23, 2013, add Sec.  801.57 to subpart B to read
as follows:

Sec.  801.57  Discontinuation of legacy FDA identification numbers
assigned to devices.

    (a) On the date your device must bear a unique device identifier
(UDI) on its label, any National Health-Related Item Code (NHRIC) or
National Drug Code (NDC) number assigned to that device is rescinded,
and you may no longer provide an NHRIC or NDC number on the label of
your device or on any device package.
    (b) If your device is not required to bear a UDI on its label, any
NHRIC or NDC number assigned to that device is rescinded as of
September 24, 2018, and beginning on that date, you may no longer
provide an NHRIC or NDC number of the label of your device or on any
device package.
    (c) A labeler who has been assigned an FDA labeler code to
facilitate use of NHRIC or NDC numbers may continue to use that labeler
code under a system for the issuance of UDIs, provided that--
    (1) Such use is consistent with the framework of the issuing agency
that operates that system; and
    (2) No later than September 24, 2014, the labeler submits, and
obtains FDA approval of, a request for continued use of the assigned
labeler code. A request for continued use of an assigned labeler code
must be submitted by email to<EMAIL_ADDRESS>or by correspondence
to: UDI Regulatory Policy Support, Center for Devices and Radiological
Health, Food and Drug Administration, Bldg. 66, Rm. 3303, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002.
    (d) Each request for continued use of an assigned labeler code must
provide--
    (1) The name, mailing address, email address, and phone number of
the labeler who is currently using the labeler code;
    (2) The owner/operator account identification used by the labeler
to submit registration and listing information using FDA's Unified
Registration and Listing System (FURLS).
    (3) The FDA labeler code that the labeler wants to continue using.

0
6. Revise Sec.  801.119 to read as follows:

Sec.  801.119  In vitro diagnostic products.

    A product intended for use in the diagnosis of disease and which is
an in vitro diagnostic product as defined in Sec.  809.3(a) of this
chapter shall be deemed to be in compliance with the requirements of
this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic
Act if it meets the requirements of subpart B of this part and the
requirements of Sec.  809.10 of this chapter.

0
7. Amend Sec.  801.128 by redesignating paragraphs (f)(2) through
(f)(7) as paragraphs (f)(3) through (f)(8), respectively, and by adding
new paragraph (f)(2) to read as follows:

Sec.  801.128  Exceptions or alternatives to labeling requirements for
medical devices held by the Strategic National Stockpile.

* * * * *
    (f) * * *
    (2) Subpart B of this part and part 830 of this chapter in its
entirety;
* * * * *

PART 803--MEDICAL DEVICE REPORTING

0
8. The authority citation for 21 CFR part 803 continues to read as
follows:

    Authority:  21 U.S.C. 352, 360, 360i, 360j, 371, 374.

0
9. Amend Sec.  803.3 by alphabetically adding the following definitions
to read as follows:

Sec.  803.3  How does FDA define the terms used in this part?

* * * * *
    Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of
this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
* * * * *
    Unique device identifier (UDI) means an identifier that adequately
identifies a device through its distribution and use by meeting the
requirements of Sec.  830.20 of this chapter. A unique device
identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.
* * * * *

0
10. Amend Sec.  803.32 by redesignating paragraphs (c)(6) through
(c)(10) as paragraphs (c)(7) through (c)(11), respectively, and by
adding new paragraph (c)(6) to read as follows:

Sec.  803.32  If I am a user facility, what information must I submit
in my individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device
label or on the device package;
* * * * *

0
11. Amend Sec.  803.33 by redesignating paragraphs (a)(7)(iv) through
(a)(7)(vi) as paragraphs (a)(7)(v) through (a)(7)(vii), respectively,
and by adding new paragraph (a)(7)(iv) to read as follows:

Sec.  803.33  If I am a user facility, what must I include when I
submit an annual report?

    (a) * * *
    (7) * * *
    (iv) The unique device identifier (UDI) that appears on the device
label or on the device package;
* * * * *

0
12. Amend Sec.  803.42 by redesignating paragraphs (c)(6) through
(c)(10) as paragraphs (c)(7) through (c)(11), respectively, and by
adding new paragraph (c)(6) to read as follows:

Sec.  803.42  If I am an importer, what information must I submit in my
individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device
label or on the device package;
* * * * *

0
13. Amend Sec.  803.52 by redesignating paragraphs (c)(6) through
(c)(10) as paragraphs (c)(7) through (c)(11), respectively, and by
adding new paragraph (c)(6) to read as follows:

Sec.  803.52  If I am a manufacturer, what information must I submit in
my individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device
label or on the device package;
* * * * *

PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

0
14. The authority citation for 21 CFR part 806 continues to read as
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

0
15. Amend Sec.  806.2 by redesignating paragraphs (f) through (l) as
paragraphs (g) through (m), respectively, and by adding paragraphs (f)
and (n) to read as follows:

Sec.  806.2  Definitions.

* * * * *
    (f) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of
this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
* * * * *
    (n) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A UDI is
composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.

0
16. Amend Sec.  806.10 by revising paragraph (c)(5) to read as follows:

Sec.  806.10  Reports of corrections and removals.

* * * * *
    (c) * * *
    (5) The unique device identifier (UDI) that appears on the device
label or on the device package, or the device identifier, universal
product code (UPC), model, catalog, or code number of the device and
the manufacturing lot or serial number of the device or other
identification number.
* * * * *
0
17. Amend Sec.  806.20 by revising paragraph (b)(2) to read as follows:

Sec.  806.20  Records of corrections and removals not required to be
reported.

* * * * *
    (b) * * *
    (2) The unique device identifier (UDI) of the device, or the device
identifier, universal product code (UPC), model, catalog, or code
number of the device and the manufacturing lot or serial number of the
device or other identification number.
* * * * *

PART 810--MEDICAL DEVICE RECALL AUTHORITY

0
18. The authority citation for 21 CFR part 810 is revised to read as
follows:

    Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355,
360h, 360i, 371, 374, 375.

0
19. Amend Sec.  810.2 by redesignating paragraphs (h) through (k) as
paragraphs (i) through (l), respectively, and by adding paragraphs (h)
and (m) to read as follows:

Sec.  810.2  Definitions.

* * * * *
    (h) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of
this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
* * * * *
    (m) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A unique
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.

0
20. Amend Sec.  810.10 by removing the word ``and'' at the end of
paragraph (b)(2)(iii) and by adding paragraph (b)(2)(v) to read as
follows:

Sec.  810.10  Cease distribution and notification order.

* * * * *
    (b) * * *
    (2) * * *
    (v) The unique device identifier (UDI) that appears on the device
label or on the device package; and
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
21. The authority citation for 21 CFR part 814 continues to read as
follows:

    Authority:  21 U.S.C. 351, 352, 353, 360c-360j, 371, 372, 373,
374, 375, 379, 379e, 381.

0
22. Amend Sec.  814.3 by adding new paragraphs (p), (q), and (r) to
read as follows:

Sec.  814.3  Definitions.

* * * * *
    (p) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of
this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
    (q) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A unique
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:

    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.
    (r) Universal product code (UPC) means the product identifier used
to identify an item sold at retail in the United States.

0
23. Amend Sec.  814.84 by adding new paragraph (b)(4) to read as
follows:

Sec.  814.84  Reports.

* * * * *
    (b) * * *
    (4) Identify each device identifier currently in use for the
device, and each device identifier for the device that has been
discontinued since the previous periodic report. It is not necessary to
identify any device identifier discontinued prior to December 23, 2013.

PART 820--QUALITY SYSTEM REGULATION

0
24. The authority citation for 21 CFR part 820 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

0
25. Amend Sec.  820.3 by adding new paragraphs (bb), (cc), and (dd) to
read as follows:

Sec.  820.3  Definitions.

* * * * *
    (bb) Human cell, tissue, or cellular or tissue-based product (HCT/
P) regulated as a device means an HCT/P as defined in Sec.  1271.3(d)
of this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
    (cc) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A unique
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.
    (dd) Universal product code (UPC) means the product identifier used
to identify an item sold at retail in the United States.

0
26. Amend Sec.  820.120 by revising the first sentence of paragraph (b)
to read as follows:

Sec.  820.120  Device labeling.

* * * * *
    (b) Labeling inspection. Labeling shall not be released for storage
or use until a designated individual(s) has examined the labeling for
accuracy including, where applicable, the correct unique device
identifier (UDI) or universal product code (UPC), expiration date,
control number, storage instructions, handling instructions, and any
additional processing instructions. * * *
* * * * *

0
27. Amend Sec.  820.184 by revising paragraph (f) to read as follows:

Sec.  820.184  Device history record.

* * * * *
    (f) Any unique device identifier (UDI) or universal product code
(UPC), and any other device identification(s) and control number(s)
used.

0
28. Amend Sec.  820.198 by revising paragraph (e)(3) to read as
follows:

Sec.  820.198  Complaint files.

* * * * *
    (e) * * *
    (3) Any unique device identifier (UDI) or universal product code
(UPC), and any other device identification(s) and control number(s)
used;
* * * * *

0
29. Amend Sec.  820.200 by revising paragraph (d)(2) to read as
follows:

Sec.  820.200  Servicing.

* * * * *
    (d) * * *
    (2) Any unique device identifier (UDI) or universal product code
(UPC), and any other device identification(s) and control number(s)
used;
* * * * *

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

0
30. The authority citation for 21 CFR part 821 continues to read as
follows:

    Authority:  21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371,
374.

0
31. Amend Sec.  821.3 by adding new paragraphs (n) and (o) to read as
follows:

Sec.  821.3  Definitions.

* * * * *
    (n) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of
this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
    (o) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A unique
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.

0
32. Amend Sec.  821.25 by revising paragraphs (a)(2)(i) and (a)(3)(i)
to read as follows:

Sec.  821.25  Device tracking system and content requirements:
manufacturer requirements.

    (a) * * *
    (2) * * *
    (i) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier
necessary to provide for effective tracking of the devices;
* * * * *
    (3) * * *
    (i) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier
necessary to provide for effective tracking of the devices;
* * * * *

0
33. Amend Sec.  821.30 by revising paragraphs (a)(2), (b)(2), and
(c)(1)(i) to read as follows:

Sec.  821.30  Tracking obligations of persons other than device
manufacturers: distributor requirements.

    (a) * * *
    (2) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier used
by the manufacturer to track the device;
* * * * *
    (b) * * *
    (2) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier used
by the manufacturer to track the device;
* * * * *
    (c) * * *
    (1) * * *
    (i) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier used
by the manufacturer to track the device;
* * * * *

PART 822--POSTMARKET SURVEILLANCE

0
34. The authority citation for 21 CFR part 822 continues to read as
follows:

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

0
35. Amend Sec.  822.3 by redesignating paragraphs (e) through (m) as
paragraphs (f) through (n), respectively, and by adding new paragraphs
(e) and (o) to read as follows:

Sec.  822.3  How do you define the terms used in this part?

* * * * *
    (e) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of
this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
* * * * *
    (o) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A UDI is
composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.

0
36. Amend Sec.  822.9 by revising paragraph (a)(4) to read as follows:

Sec.  822.9  What must I include in my submission?

* * * * *
    (a) * * *
    (4) Premarket application/submission number and device identifiers
for your device;
* * * * *

0
37a. Effective October 24, 2013, add new part 830 to read as follows:

PART 830--UNIQUE DEVICE IDENTIFICATION

Subpart A--[Reserved]
Subpart B--Requirements for a Unique Device Identifier
Sec.
830.10 Incorporation by reference.
Subpart C--FDA Accreditation of an Issuing Agency
830.100 FDA accreditation of an issuing agency.
830.110 Application for accreditation as an issuing agency.
830.120 Responsibilities of an FDA-accredited issuing agency.
830.130 Suspension or revocation of the accreditation of an issuing
agency.
Subpart D--[Reserved]
Subpart E--[Reserved]

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j,
371.

Subpart A--[Reserved]

Subpart B--Requirements for a Unique Device Identifier

Sec.  830.10  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other
than that specified in this section, the Food and Drug Administration
must publish notice of change in the Federal Register and the material
must be available to the public. All approved material is available for
inspection at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
301-827-6860, and is available from the source listed in paragraph (b)
of this section. Copies are also available for purchase from the
American National Standards Institute (ANSI), mailing address: ANSI,
Attn: Customer Service Department, 25 West 43rd St., 4th floor, New
York, NY 10036, phone:<PHONE_NUMBER>, and may be ordered online at
http://webstore.ansi.org/. The material is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) International Organization for Standardization (ISO), mailing
address: ISO, Attn: ISO Central Secretariat, 1, ch. de la Voie-Creuse,
Case postale 56, CH-1211 Geneva 20, Switzerland, phone (dialing from
the United States): 011-41-22-749-0111, and may be ordered online at
http://www.standardsinfo.net.
    (1) ISO/IEC 646:1991(E), Information technology--ISO 7-bit coded
character set for information interchange (third edition; December 15,
1991), into Sec. Sec.  830.20(c) and 830.100(b);
    (2) ISO/IEC 15459-2:2006(E), Information technology--Unique
identifiers--Part 2: Registration procedures (second edition; March 1,
2006), into Sec. Sec.  830.20(b) and 830.100(b);
    (3) ISO/IEC 15459-4:2008(E), Information technology--Unique
identifiers--Part 4: Individual items (second edition; July 15, 2008),
into Sec. Sec.  830.20(b) and 830.100(b);
    (4) ISO/IEC 15459-6:2007(E), Information technology--Unique
identifiers--Part 6: Unique identifier for product groupings (first
edition; June 15, 2007), into Sec. Sec.  830.20(b) and 830.100(b).

Subpart C--FDA Accreditation of an Issuing Agency

Sec.  830.100  FDA accreditation of an issuing agency.

    (a) Eligibility. A private organization may apply for accreditation
as an issuing agency.
    (b) Accreditation criteria. FDA may accredit an organization as an
issuing agency, if the system it will operate:
    (1) Will employ unique device identifiers (UDIs) that meet the
requirements of this part to adequately identify a device through its
distribution and use;
    (2) Conforms to each of the following international standards:
    (i) ISO/IEC 15459-2, which is incorporated by reference at Sec.
830.10;
    (ii) ISO/IEC 15459-4, which is incorporated by reference at Sec.
830.10;
    (iii) ISO/IEC 15459-6, which is incorporated by reference at Sec.
830.10.

    (3) Uses only characters and numbers from the invariant character
set of ISO/IEC 646, which is incorporated by reference at Sec.  830.10.
    (4) Will be available to all users according to a single set of
consistent, fair, and reasonable terms and conditions.
    (5) Will protect against conflicts of interest between the issuing
agency (and its officers, employees, and other agents) and labelers
(and their officers, employees, and other agents) seeking to use UDIs
that may impede the applicant's ability to independently operate a fair
and neutral identifier system.

Sec.  830.110  Application for accreditation as an issuing agency.

    (a) Application for initial accreditation. (1) An applicant seeking
initial FDA accreditation as an issuing agency shall notify FDA of its
desire to be accredited by sending a notification by email to
<EMAIL_ADDRESS>or by correspondence to: UDI Regulatory Policy
Support, Center for Devices and Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002.
    (2) FDA will provide the applicant with additional information to
aid in submission of an application for approval as an issuing agency,
together with an email address for submission of an application.
    (3) The applicant shall furnish to FDA, via email to the email
address provided in paragraph (a)(1) of this section, an application
containing the following information, materials, and supporting
documentation:
    (i) Name, address, and phone number of the applicant;
    (ii) Detailed descriptions of any standards or criteria the
applicant will apply to participating labelers;
    (iii) A detailed description of the guidelines that govern
assignment of a unique device identifier (UDI) to a device;
    (iv) A detailed description of the review and decisionmaking
process the applicant will apply when determining whether a particular
labeler may use the applicant's UDI system, including:
    (A) Copies of the application forms, guidelines, instructions, and
other materials the applicant will send to medical device labelers who
wish to use the applicant's unique device identification system;
    (B) Policies and procedures for notifying a labeler of deficiencies
in its use of UDIs;
    (C) Procedures for monitoring a labeler's correction of
deficiencies in its use of UDIs;
    (D) Policies and procedures for suspending or revoking a labeler's
use of the applicant's UDI system, including any appeals process.
    (v) Description of the applicant's electronic data management
system with respect to its review and decision processes and the
applicant's ability to provide electronic data in a format compatible
with FDA data systems;
    (vi) Fee schedules, if any, together with an explanation of any fee
waivers or reductions that are available;
    (vii) Detailed information regarding any financial or other
relationship between the applicant and any labeler(s) or governmental
entity(ies); and
    (viii) Other information required by FDA to clarify the application
for accreditation.
    (b) Application for renewal of accreditation. An accredited issuing
agency that intends to continue to serve as an issuing agency beyond
its current term shall apply to FDA for renewal or notify FDA of its
plans not to apply for renewal in accordance with the following
procedures and schedule:
    (1) At least 9 months before the date of expiration of its
accreditation, an issuing agency shall inform FDA, at the address given
in paragraph (a)(1) of this section, of its intent to seek renewal.
    (2) FDA will notify the issuing agency of the relevant information,
materials, and supporting documentation that we will require the
issuing agency to submit as part of the renewal procedure. We will
tailor these requirements to reflect our experience with the issuing
agency during the current and any prior period of accreditation. We
will limit our request to the types of the information required by
paragraph (a)(3) of this section, and we will require less information
if experience shows that we need only a subset of that information.
    (3) At least 6 months before the date of expiration of its
accreditation, an issuing agency shall furnish to FDA, at the email
address we provide, a copy of a renewal application containing the
information, materials, and supporting documentation requested by FDA
in accordance with paragraph (b)(2) of this section.
    (4) Any issuing agency that does not plan to renew its
accreditation shall so notify FDA at the address given in paragraph
(a)(1) of this section at least 9 months before the expiration of the
issuing agency's term of accreditation and shall include a description
of its plans for allowing continued use of UDIs issued prior to the
expiration of the current term of accreditation.
    (c) FDA action on an application for initial or renewal
accreditation. (1) FDA will conduct a review and evaluation to
determine whether the applicant meets the requirements of this subpart
and whether the UDI system proposed by the applicant will meet the
requirements of this subpart.
    (2) Within 60 days of receipt of an application for accreditation,
FDA will notify the applicant of any deficiencies in its application
and will request correction of those deficiencies within 60 days. The
applicant may request an extension if it needs additional time to
correct deficiencies in its application. If the deficiencies are not
resolved to FDA's satisfaction within the specified time period, the
application for accreditation as an issuing agency may be denied.
    (3) FDA shall notify the applicant whether the application for
accreditation has been granted or denied. That notification shall list
any conditions of approval or state the reasons for denial.
    (4) If FDA denies an application, we will advise the applicant of
the circumstances under which a denied application may be resubmitted.
    (5) If FDA does not reach a final decision on a renewal application
before the expiration of an issuing agency's current accreditation, the
approval will be deemed extended until FDA reaches a final decision on
the application.
    (d) Relinquishment of accreditation. If an issuing agency decides
to relinquish its accreditation before expiration of the current term
of accreditation, it shall submit a letter of such intent to FDA, at
the address provided in paragraph (a)(1) of this section, at least 9
months before relinquishing its accreditation.
    (e) Notice of termination of accreditation. An issuing agency that
does not apply for renewal of its accreditation, is denied renewal of
accreditation by FDA, or relinquishes its accreditation and duties
before expiration of the current term of accreditation, shall notify
all labelers that are using the issuing agency's UDI system, in a
manner and time period approved by FDA, of the date that the issuing
agency will cease to serve as an FDA-accredited issuing agency.
    (f) Term of accreditation. The initial term of accreditation for an
issuing agency shall be for a period of 3 years. An issuing agency's
term of accreditation may be periodically renewed for a period of 7
years.

Sec.  830.120  Responsibilities of an FDA-accredited issuing agency.

    To maintain its accreditation, an issuing agency must:
    (a) Operate a system for assignment of unique device identifiers
(UDIs) that meets the requirements of Sec.  830.20;

    (b) Make available information concerning its system for the
assignment of UDIs;
    (c) Maintain a list of labelers that use its system for the
assignment of UDIs and provide FDA a copy of such list in electronic
form by December 31 of each year;
    (d) Upon request, provide FDA with information concerning a labeler
that is employing the issuing agency's system for assignment of UDIs;
and
    (e) Remain in compliance with the eligibility and accreditation
criteria set forth in Sec.  830.100.

Sec.  830.130  Suspension or revocation of the accreditation of an
issuing agency.

    FDA may suspend or revoke the accreditation of an issuing agency if
FDA finds, after providing the issuing agency with notice and
opportunity for an informal hearing in accordance with part 16 of this
chapter, that the issuing agency or any officer, employee, or other
agent of the issuing agency:
    (a) Has been guilty of misrepresentation or failure to disclose
required information in obtaining accreditation;
    (b) Has failed to fulfill the responsibilities outlined in Sec.
830.120;
    (c) Has failed to protect against conflicts of interest that may
impede the issuing agency's ability to independently operate a fair and
neutral identifier system;
    (d) In the operation of the issuing agency, has engaged in any
anticompetitive activity to restrain trade; or
    (e) Has violated or aided and abetted in the violation of any
regulation issued under section 510(e) or section 519(f) of the Federal
Food, Drug, and Cosmetic Act.

Subpart D--[Reserved]

Subpart E--[Reserved]

0
37b. Effective December 23, 2013, add subpart A to part 830 to read as
follows:

Subpart A--General Provisions

Sec.  830.3  Definitions.

    As used in this part:
    Automatic identification and data capture (AIDC) means any
technology that conveys the unique device identifier or the device
identifier of a device in a form that can be entered into an electronic
patient record or other computer system via an automated process.
    Center Director means the Director of the Center for Devices and
Radiological Health or the Director of the Center for Biologics
Evaluation and Research, depending on which Center has been assigned
lead responsibility for the device.
    Device package means a package that contains a fixed quantity of a
particular version or model of a device.
    Expiration date means the date by which the label of a device
states the device must or should be used.
    FDA, we, or us means the Food and Drug Administration.
    Federal Food, Drug, and Cosmetic Act means 21 U.S.C. 321 et seq.,
as amended.
    Finished device means any device or accessory to any device that is
suitable for use or capable of functioning.
    Global Unique Device Identification Database (GUDID) means the
database that serves as a repository of information to facilitate the
identification of medical devices through their distribution and use.
    Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of
this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
    Issuing agency means an organization accredited by FDA to operate a
system for the issuance of unique device identifiers.
    Label has the meaning set forth in section 201(k) of the Federal
Food, Drug, and Cosmetic Act.
    Labeler means:
    (1) Any person who causes a label to be applied to a device with
the intent that the device will be commercially distributed without any
subsequent replacement or modification of the label; and
    (2) Any person who causes the label of a device to be replaced or
modified with the intent that the device will be commercially
distributed without any subsequent replacement or modification of the
label, except that the addition of the name of, and contact information
for, a person who distributes the device, without making any other
changes to the label, is not a modification for the purposes of
determining whether a person is a labeler.
    Lot or batch means one finished device or more that consist of a
single type, model, class, size, composition, or software version that
are manufactured under essentially the same conditions and that are
intended to have uniform characteristics and quality within specified
limits.
    Shipping container means a container used during the shipment or
transportation of devices, and whose contents may vary from one
shipment to another.
    Small business means a medical device manufacturer with 500 or
fewer employees, or a medical device relabeler or repackager with 100
or fewer employees.
    Specification means any requirement with which a device must
conform.
    Unique device identifier (UDI) means an identifier that adequately
identifies a device through its distribution and use by meeting the
requirements of Sec.  830.20. A UDI is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.
    Universal product code (UPC) means the product identifier used to
identify an item sold at retail in the United States.
    Version or model means all devices that have specifications,
performance, size, and composition, within limits set by the labeler.

0
37c. Effective December 23, 2013, add Sec. Sec.  830.20, 830.40,
830.50, and 830.60 to subpart B to read as follows:

Sec.
830.20 Requirements for a unique device identifier.
830.40 Use and discontinuation of a device identifier.
830.50 Changes that require use of a new device identifier.
830.60 Relabeling of a device that is required to bear a unique
device identifier.

Sec.  830.20  Requirements for a unique device identifier.

    A unique device identifier (UDI) must:
    (a) Be issued under a system operated by FDA or an FDA-accredited
issuing agency;
    (b) Conform to each of the following international standards:
    (1) ISO/IEC 15459-2, which is incorporated by reference at Sec.
830.10;
    (2) ISO/IEC 15459-4, which is incorporated by reference at Sec.
830.10; and

    (3) ISO/IEC 15459-6, which is incorporated by reference at Sec.
830.10.
    (c) Use only characters and numbers from the invariant character
set of ISO/IEC 646, which is incorporated by reference at Sec.  830.10.

Sec.  830.40  Use and discontinuation of a device identifier.

    (a) Only one device identifier from any particular system for the
issuance of unique device identifiers (UDIs) may be used to identify a
particular version or model of a device. A particular version or model
may be identified by UDIs from two or more systems for the issuance of
UDIs.
    (b) A device identifier shall be used to identify only one version
or model.
    (c) In the event that a version or model of a device is
discontinued, its device identifier may not be reassigned to another
device. If a discontinued version or model is re-introduced and no
changes have been made that would require the use of a new device
identifier, the device identifier that was previously in use may be
used to identify the device.
    (d) In the event that an issuing agency relinquishes or does not
renew its accreditation, you may continue to use a previously issued
UDI until such time as Sec.  830.50 requires you to assign a new device
identifier.

Sec.  830.50  Changes that require use of a new device identifier.

    (a) Whenever you make a change to a device that is required to bear
a unique device identifier (UDI) on its label, and the change results
in a new version or model, you must assign a new device identifier to
the new version or model.
    (b) Whenever you create a new device package, you must assign a new
device identifier to the new device package.

Sec.  830.60  Relabeling of a device that is required to bear a unique
device identifier.

    If you relabel a device that is required to bear a unique device
identifier (UDI), you must:
    (a) Assign a new device identifier to the device, and
    (b) Keep a record showing the relationship of the prior device
identifier to your new device identifier.

0
37d. Effective December 23, 2013, add subparts D and E to part 830 to
read as follows:
Subpart D--FDA as an Issuing Agency
830.200 When FDA will act as an issuing agency.
830.210 Eligibility for use of FDA as an issuing agency.
830.220 Termination of FDA service as an issuing agency.
Subpart E--Global Unique Device Identification Database
830.300 Devices subject to device identification data submission
requirements.
830.310 Information required for unique device identification.
830.320 Submission of unique device identification information.
830.330 Times for submission of unique device identification
information.
830.340 Voluntary submission of ancillary device identification
information.
830.350 Correction of information submitted to the Global Unique
Device Identification Database.
830.360 Records to be maintained by the labeler.

Subpart D--FDA as an Issuing Agency

Sec.  830.200  When FDA will act as an issuing agency.

    (a) During any period where there is no accredited issuing agency,
FDA will act as an issuing agency.
    (b) If FDA determines that a significant number of small businesses
would be substantially and adversely affected by the fees required by
all accredited issuing agencies, FDA will act as an issuing agency.
    (c) FDA may, in its discretion, act as an issuing agency if we
determine it is necessary for us to do so to ensure the continuity or
the effectiveness of the system for the identification of medical
devices.
    (d) FDA may, in its discretion, act as an issuing agency if we
determine it is appropriate for us to do so in order to facilitate or
implement an alternative granted under Sec.  801.55 of this chapter.

Sec.  830.210  Eligibility for use of FDA as an issuing agency.

    When FDA acts as an issuing agency, any labeler will be permitted
to use FDA's unique device identification system, regardless of whether
the labeler is considered a small business.

Sec.  830.220  Termination of FDA service as an issuing agency.

    (a) FDA may end our services as an issuing agency if we determine
that the conditions that prompted us to act no longer exist and that
ending our services would not be likely to lead to a return of the
conditions that prompted us to act.
    (b) If FDA has ended our services as an issuing agency, a labeler
may continue to use a device identifier assigned under FDA's unique
device identification system until such time as Sec.  830.50 requires
the use of a new device identifier.

Subpart E--Global Unique Device Identification Database

Sec.  830.300  Devices subject to device identification data submission
requirements.

    (a) In general. The labeler of a device must provide the
information required by this subpart for each version or model required
to bear a unique device identifier (UDI).
    (b) Voluntary submission of information. If a labeler voluntarily
includes a UDI on the label of a device under Sec.  801.40, the labeler
may also voluntarily submit information concerning that device under
this part.
    (c) Exclusions. FDA may reject or remove any device identification
data where:
    (1) The device identifier submitted does not conform to Sec.
830.20;
    (2) The information concerns a device that is neither manufactured
in the United States nor in interstate commerce in the United States,
    (3) The information concerns a product that FDA determines is not a
device or a combination product that includes a device constituent
part,
    (4) The information concerns a device or a combination product that
requires, but does not have, FDA premarket approval, licensure, or
clearance;
    (5) A device that FDA has banned under section 516 of the Federal
Food, Drug, and Cosmetic Act; or
    (6) FDA has suspended the accreditation of the issuing agency that
operates the system used by the labeler.

Sec.  830.310  Information required for unique device identification.

    The contact for device identification designated under Sec.
830.320(a) shall provide FDA with the following information concerning
each version or model of a device required to bear a unique device
identifier (UDI) on its label:
    (a) Concerning the labeler:
    (1) The name of the labeler;
    (2) A telephone number or email address that will allow FDA to
communicate with the contact for device identification designated under
Sec.  830.320(a); and
    (3) The name of each issuing agency whose system is used by the
labeler to assign UDIs used by the labeler.
    (b) Concerning each version or model of a device with a UDI on its
label:
    (1) The device identifier portion of the UDI assigned to the
version or model;
    (2) When reporting a substitution of a new device identifier that
will be used in lieu of a previously reported identifier, the device
identifier that was previously assigned to the version or model;

    (3) If Sec.  801.45 of this chapter requires the device to bear a
UDI as a permanent marking on the device itself, either:
    (i) A statement that the device identifier that appears as a
permanent marking on the device is identical to that reported under
paragraph (b)(1) of this section, or
    (ii) The device identifier portion of the UDI that appears as a
permanent marking on the device;
    (4) The proprietary, trade, or brand name of the device as it
appears on the label of the device;
    (5) Any version or model number or similar reference that appears
on the label of the device;
    (6) If the device is labeled as sterile, a statement to that
effect;
    (7) If the device is labeled as containing natural rubber latex
that contacts humans, or is labeled as having packaging containing
natural rubber latex that contacts humans, as described by Sec. Sec.
801.437(b)(1), 801.437(b)(3), and 801.437(f) of this chapter, a
statement to that effect;
    (8) Whether a patient may be safely exposed to magnetic resonance
imaging, nuclear magnetic resonance imaging, or magnetic resonance
tomography while using the device, or while the device is implanted in
patient.
    (9) If the device is available in more than one size, the size of
the particular version or model, together with the unit of measure, as
it appears on the label of the device;
    (10) The type of production identifiers that appear on the label of
the device;
    (11) The FDA premarket submission number of a cleared or approved
device, or a statement that FDA has by regulation exempted the device
from premarket notification;
    (12) The FDA listing number assigned to the device;
    (13) The Global Medical Device Nomenclature (GMDN) term or code for
the device;
    (14) The total number of individual devices contained in the device
package.

Sec.  830.320  Submission of unique device identification information.

    (a) Designation of contact for device identification. Each labeler
must designate an individual to serve as the point of contact with FDA
on matters relating to the identification of medical devices marketed
by the labeler. The contact for device information is responsible for
ensuring FDA is provided with all information required by this part.
The contact for device information may authorize an issuing agency or
any other person to provide information to FDA on behalf of the
labeler.
    (b) Information shall be submitted via electronic means. All
information required by this subpart shall be submitted electronically
to FDA's Global Unique Device Identification Database (GUDID) in a
format that we can process, review, and archive, unless the labeler has
obtained a waiver from electronic submission of unique device
identifier (UDI) data.
    (c) Waiver from electronic submission. (1) A labeler may request a
waiver from electronic submission of UDI data by submitting a letter
addressed to the appropriate Center Director explaining why electronic
submission is not technologically feasible; send the request by email
to<EMAIL_ADDRESS>or by correspondence to: UDI Regulatory Policy
Support, Center for Devices and Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002.
    (2) If the establishment where the labeler is located has obtained
a waiver from electronic submission of registration and listing
information under section 510(p) of the Federal Food, Drug, and
Cosmetic Act, the labeler is deemed to have a waiver from electronic
submission of UDI data.
    (3) A labeler that has a waiver from electronic submission of UDI
data must send a letter containing all of the information required by
Sec.  830.310, as well as any ancillary information permitted to be
submitted under Sec.  830.340 that the labeler wishes to submit, within
the time permitted by Sec.  830.330, addressed to: UDI Regulatory
Policy Support, Center for Devices and Radiological Health, Food and
Drug Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002.

Sec.  830.330  Times for submission of unique device identification
information.

    (a) The labeler shall submit to FDA the information required by
Sec.  830.310 no later than the date the label of the device must bear
a unique device identifier under Sec.  801.20 of this chapter.
    (b) The labeler of a device shall submit to FDA an update to the
information required by Sec.  830.310 whenever the information changes.
The updated information must be submitted no later than the date a
device is first labeled with the changed information. If the
information does not appear on the label of a device, the updated
information must be submitted within 10 business days of the change.

Sec.  830.340  Voluntary submission of ancillary device identification
information.

    (a) You may not submit any information to the Global Unique Device
Identification Database (GUDID) other than that specified by Sec.
830.310, except where FDA acts to permit the submission of specified
additional types of information, termed ancillary information.
    (b) FDA will provide information through the FDA Web site at http://www.fda.gov/udi/ concerning the types of ancillary information that
may be submitted to the GUDID.
    (c) FDA may periodically change the types of ancillary information
that may be submitted to the GUDID. We will announce any change on the
FDA Web site at http://www.fda.gov/udi/ at least 60 days before making
the change.

Sec.  830.350  Correction of information submitted to the Global Unique
Device Identification Database.

    (a) If FDA becomes aware that any information submitted to the
Global Unique Device Identification Database (GUDID) appears to be
incorrect or potentially misleading, we may notify the labeler of the
specific information that appears to be incorrect, and request that the
labeler provide corrected information or explain why the information is
correct. The labeler must provide corrected information or provide a
satisfactory explanation of why the information is correct within 30
days of receipt of FDA's notification.
    (b) If the labeler does not respond to FDA's notification within 30
days of receipt, or if FDA determines, at any time, that any
information in the GUDID is incorrect or could be misleading, we may
delete or correct the information. Any action taken by FDA under this
paragraph does not relieve the labeler of its responsibility under
paragraph (a) of this section to provide corrected information or an
explanation of why the information previously submitted is correct.

Sec.  830.360  Records to be maintained by the labeler.

    (a) Each labeler shall retain, and submit to FDA upon specific
request, records showing all unique device identifiers (UDIs) used to
identify devices that must bear a UDI on their label, and the
particular version or model associated with each device identifier.
These records must be retained for 3 years from the date the labeler
ceases to market the version or model.

    (b) Compliance with this section does not relieve the labeler of
the need to comply with recordkeeping requirements of any other FDA
regulation.

    Dated: September 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23059 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P