[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Proposed Rules]
[Pages 30639-30647]
[FR Doc No: 2019-13582]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 40

[Docket No. RM19-10-000]

Transmission Planning Reliability Standard TPL-001-5

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION:  Notice of proposed rulemaking.

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SUMMARY: The Federal Energy Regulatory Commission (Commission) proposes
to approve Reliability Standard TPL-001-5 (Transmission System Planning
Performance Requirements). The North American Electric Reliability
Corporation (NERC), the Commission-certified Electric Reliability
Organization, submitted the proposed Reliability Standard for
Commission approval to address: Reliability issues concerning the study
of single points of failure of protection systems; and Commission
directives regarding planned maintenance outages and stability analysis
for spare equipment strategy. In addition, the Commission proposes to
direct NERC to modify the Reliability Standards to require corrective
action plans for protection system single points of failure in
combination with a three-phase fault if planning studies indicate
potential cascading.

DATES: Comments are due August 26, 2019.

ADDRESSES: Comments, identified by docket number, may be filed in the
following ways:
     Electronic Filing through http://www.ferc.gov. Documents
created electronically using word processing software should be filed
in native applications or print-to-PDF format and not in a scanned
format.
     Mail/Hand Delivery: Those unable to file electronically
may mail or hand-deliver comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process,

see the Comment Procedures Section of this document.

FOR FURTHER INFORMATION CONTACT: Eugene Blick (Technical Information),
Office of Electric Reliability, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Bob Stroh (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    1. Pursuant to section 215(d)(2) of the Federal Power Act (FPA),
the Commission proposes to approve Reliability Standard TPL-001-5
(Transmission System Planning Performance Requirements).\1\ The North
American Electric Reliability Corporation (NERC), the Commission-
certified Electric Reliability Organization (ERO), submitted proposed
Reliability Standard TPL-001-5 for Commission approval to address:
reliability issues concerning the study of single points of failure of
protection systems discussed in Order No. 754; and directives from
Order No. 786 regarding planned maintenance outages and stability
analysis for spare equipment strategy.\2\
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    \1\ 16 U.S.C. 824o(d)(2) (2012).
    \2\ Interpretation of Transmission Planning Reliability Standard
Order No. 754, 136 FERC ] 61,186 at P 19 (2011); Transmission
Planning Reliability Standards, Order No. 786, 145 FERC ] 61,051, at
PP 40, 89 (2013).
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    2. Proposed Reliability Standard TPL-001-5 is one of two
transmission planning Reliability Standards containing requirements for
planning authorities and transmission planners to develop studies of
their portions of the bulk electric system. Proposed Reliability
Standard TPL-001-5 establishes transmission system planning performance
requirements within the planning horizon to promote a bulk electric
system that will operate reliably over a broad spectrum of system
conditions and following a wide range of probable contingencies. NERC
states that the revisions in the proposed Reliability Standard are
intended to enhance requirements for the study of protection system
single points of failure.\3\
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    \3\ A protection system ``single point of failure'' refers to a
non-redundant component of a protection system that, if it failed,
would affect normal clearing of faults. NERC Petition at 4.
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    3. Proposed Reliability Standard TPL-001-5 requires each planning
authority and transmission planner to perform an annual planning
assessment of its portion of the bulk electric system considering a
number of system conditions and contingencies. The proposed Reliability
Standard employs a risk-based approach to the study of contingencies
and the types of corrective action that are required if the entity's
system cannot meet the specified performance requirements.\4\ For
scenarios considered to be more commonplace (i.e., planning events),
the planning entity must develop a corrective action plan if it
determines through studies that its system would experience performance
issues. For the scenarios considered to be less commonplace, but which
could result in potentially severe impacts such as cascading (i.e.,
extreme events), the planning entity must conduct a comprehensive
analysis to understand both the potential impacts on its system and the
types of actions that could reduce or mitigate those impacts.\5\
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    \4\ NERC defines ``Corrective Action Plan'' as, ``A list of
actions and an associated timetable for implementation to remedy a
specific problem.'' Glossary of Terms Used in NERC Reliability
Standards (May 13, 2019) (NERC Glossary).
    \5\ NERC defines ``Cascading'' as, ``The uncontrolled successive
loss of System Elements triggered by an incident at any location.
Cascading results in widespread electric service interruption that
cannot be restrained from sequentially spreading beyond an area
predetermined by studies.'' NERC Glossary.
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    4. Proposed Reliability Standard TPL-001-5 contains revisions to
both the planning event (Category P5) and extreme events (Stability
2.a-h)--identified in Table 1 (Steady State and Stability Performance
Planning Events and Steady State and Stability Performance Extreme
Events) and the associated footnote 13--to provide for more
comprehensive study of the potential impacts of protection system
single points of failure.\6\ Planning entities would be required to
take action, consistent with currently-effective Reliability Standard
TPL-001-4 requirements, to address system performance issues identified
as a result of these studies. Additionally, the proposed Reliability
Standard addresses the two Commission directives in Order No. 786.
Accordingly, pursuant to section 215(d)(2) of the FPA, the Commission
proposes to approve proposed Reliability Standard TPL-001-5 because it
is responsive to the Commission's directives and improves upon the
currently-effective Reliability Standard by enhancing requirements for
the study of protection system single points of failure.
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    \6\ Proposed Reliability Standard TPL-001-5 includes an expanded
list of protection system components for single points of failure
studies. The selected list of components account for: (1) Those
failed non-redundant components of a protection system that may
impact one or more protection systems; (2) the duration that faults
remain energized until delayed fault clearing; and (3) the
additional system equipment removed from service following fault
clearing depending on the specific failed non-redundant component of
a protection system. NERC Petition at 16.
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    5. Non-redundant protection systems can also misoperate when faced
with a three-phase fault. Because three-phase faults are more serious
than single-phase-to-ground faults, the consequences can be more
severe, including cascading. However, rather than require a corrective
action plan to address such events, proposed Reliability Standard TPL-
001-5 only requires an evaluation of possible actions designed to
reduce the likelihood or mitigate their consequences and adverse
impacts.\7\ NERC has not adequately justified categorizing protection
system single points of failure in combination with a three-phase fault
as an ``extreme event'' that only requires study, but not a corrective
action plan, when there is the potential for cascading. We are not
persuaded that such events do not necessitate corrective action plans
because of their alleged rarity, particularly because their potential
impacts may result in cascading. Thus, pursuant to section 215(d)(5) of
the FPA, we also propose to direct that NERC develop modifications to
the Reliability Standards to require corrective action plans for
protection system single points of failure in combination with three-
phase faults if planning studies indicate potential cascading.\8\
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    \7\ NERC, Informational Filing, Docket No. RM10-06-000, at 10
(filed March 15, 2012) (2012 Informational Filing). A three-phase
fault can originate as a single-line-to-ground (SLG) fault as ``it
is not uncommon for a SLG fault to evolve to a multi-phase fault.''
Id.
    \8\ 16 U.S.C. 824o(d)(5).
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I. Background

A. Section 215 and Mandatory Reliability Standards

    6. Section 215 of the FPA requires a Commission-certified ERO to
develop mandatory and enforceable Reliability Standards, subject to
Commission review and approval. Reliability Standards may be enforced
by the ERO, subject to Commission oversight, or by the Commission
independently.\9\ Pursuant to section 215 of the FPA, the Commission
established a process to

select and certify an ERO,\10\ and subsequently certified NERC.\11\
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    \9\ Id. 824o(e).
    \10\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, 114
FERC ] 61,104, order on reh'g, Order No. 672-A, 114 FERC ] 61,328
(2006).
    \11\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g and compliance, 117 FERC ] 61,126 (2006),
aff'd sub nom. Alcoa, Inc. v. FERC, 564 F.3d 1342 (D.C. Cir. 2009).
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B. Order No. 754

    7. In Order No. 754, which approved an interpretation of
Reliability Standard TPL-002-0, Requirement R1.3.10, the Commission
determined that ``there may be a system protection issue that merits
further exploration by technical experts'' and that there is ``an issue
concerning the study of the non[hyphen]operation of
non[hyphen]redundant primary protection systems; e.g., the study of a
single point of failure on protection systems.'' \12\ To address this
concern, the Commission directed ``Commission staff to meet with NERC
and its appropriate subject matter experts to explore the reliability
concern, including where it can best be addressed, and identify any
additional actions necessary to address the matter.'' \13\ The
Commission also directed NERC ``to make an informational filing . . .
explaining whether there is a further system protection issue that
needs to be addressed and, if so, what forum and process should be used
to address that issue and what priority it should be accorded relative
to other reliability initiatives planned by NERC.'' \14\
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    \12\ Order No. 754, 136 FERC ] 61,186 at P 19.
    \13\ Id. P 20.
    \14\ Id.
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    8. In October 2011, Commission staff hosted a technical conference
on single points of failure, which resulted in four consensus points
and the following problem statement: ``The group perceives a
reliability concern regarding the comprehensive assessment of potential
protection system failures by registered entities. The group agrees on
the need to study if a [reliability] gap exists regarding the study and
resolution of a single point of failure on protection systems.'' \15\
One outcome of the 2011 technical conference, as described in the 2012
Informational Filing, was that NERC would issue a data request to aid
in assessing whether single points of failure in protection systems
pose a reliability concern. To that end, the NERC Board of Trustees
subsequently approved a request for data under the NERC Rules of
Procedure.\16\ Over the next two years, NERC collected data from
transmission planners. Using the collected data, two subcommittees of
the NERC Planning Committee, the System Protection and Control
Subcommittee (SPCS) and the System Analysis and Modeling Subcommittee
(SAMS), conducted an assessment of protection system single points of
failure. The study examined in detail the protection systems related to
nearly 4,000 buses. The findings were presented in a September 2015
report that concluded that single points of failure on protection
systems posed a reliability risk that warranted further action.\17\ The
SPCS/SAMS Report recommended, after considering a variety of
alternatives, that NERC modify Reliability Standard TPL-001-4 to best
align with the Order No. 754 directives and maximize reliability of
protection system performance. In particular, the SPCS/SAMS Report
recommended that three-phase faults involving protection system
failures be assessed as an extreme event in Reliability Standard TPL-
001-4, as follows:
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    \15\ NERC, Order No. 754 Single Point of Failure Technical
Meeting Notes at 8 (October 24-25, 2011).
    \16\ 2012 NERC Informational Filing at 7 (stating that the data
request ``is based on an approach that utilizes . . . a three-phase
(3[Oslash]) fault and assesses simulated system performance against
performance measures'').
    \17\ NERC, Order No. 754 Assessment of Protection System Single
Points of Failure Based on the Section 1600 Data Request at 11
(September 2015) (SPCS/SAMS Report).

    Additional emphasis in planning studies should be placed on
assessment of three[hyphen]phase faults involving protection system
single points of failure. This concern (the study of protection
system single points of failure) is appropriately addressed as an
extreme event in TPL-001-4 Part 4.5. From TPL-001-4, Part 4.5: If
the analysis concludes there is Cascading caused by the occurrence
of extreme events, an evaluation of possible actions designed to
reduce the likelihood or mitigate the consequences and adverse
impacts of the event(s) shall be conducted.\18\
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    \18\ Id.
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C. Order No. 786

    9. In Order No. 786, the Commission approved the currently-
effective version of the transmission system planning standard,
Reliability Standard TPL-001-4. In that Order, the Commission also
issued several directives to NERC, including two relating to future
standard modifications that are addressed in proposed Reliability
Standard TPL-001-5. First, the Commission expressed concern that the
six-month outage duration threshold in Reliability Standard TPL-001-4,
Requirement R1 could exclude planned maintenance outages of significant
facilities from future planning assessments.\19\ The Commission
determined that planned maintenance outages of less than six months in
duration may result in relevant impacts during one or both of the
seasonal off-peak periods, and that prudent transmission planning
should consider maintenance outages at those load levels when planned
outages are performed to allow for a single element to be taken out of
service for maintenance without compromising the ability of the system
to meet demand without loss of load. The Commission further determined
that a properly planned transmission system should ensure the known,
planned removal of facilities (i.e., generation, transmission or
protection system facilities) for maintenance purposes without the loss
of nonconsequential load or detrimental impacts to system reliability
such as cascading, voltage instability or uncontrolled islanding. The
Commission directed NERC to modify the Reliability Standards to address
this concern.
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    \19\ Order No. 786, 145 FERC ] 61,051 at PP 40-45.
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    10. Second, while stating that NERC had met the Commission's Order
No. 693 directive to include a spare equipment strategy for steady
state analysis in Reliability Standard TPL-001-4, the Commission
determined that a spare equipment strategy for stability analysis was
not addressed in the standard. The Commission stated that a similar
spare equipment strategy for stability analysis should exist that
requires studies to be performed for P0, P1, and P2 categories with the
conditions that the system is expected to experience during the
possible unavailability of the long lead time equipment. Rather than
direct a change at that time, however, the Commission directed NERC to
consider the issue during the next review cycle of Reliability Standard
TPL-001-4.\20\
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    \20\ Id. PP 88-89.
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D. NERC Petition and Proposed Reliability Standard TPL-001-5

    11. On December 7, 2018, NERC submitted proposed Reliability
Standard TPL-001-5 for Commission approval.\21\ NERC maintains that the
proposed Reliability Standard addresses potential system contingencies
including the protection system single point of failure issue and Order
No. 786 directives.

With regard to protection system single points of failure, NERC
indicates that Table 1 of the proposed Reliability Standard describes
system performance requirements for a range of potential system
contingencies required to be evaluated by the planner. Table 1 includes
three parts: (1) Steady State & Stability Performance Planning Events,
(2) Steady State & Stability Performance Extreme Events, and (3) Steady
State & Stability Performance Footnotes. Table 1 describes system
performance requirements for a range of potential system contingencies
required to be evaluated by the planner. The table categorizes the
events as either ``planning events'' or ``extreme events.'' The table
lists seven contingency planning events (P1 through P7) that require
steady-state and stability analysis as well as five extreme event
contingencies: three for steady-state and two for stability. NERC
asserts that proposed Reliability Standard TPL-001-5 also includes
certain modifications to better ensure that planning entities are
performing a more complete analysis of potential protection system
single points of failure on their systems and taking appropriate action
to address these concerns. NERC explains that the proposed Reliability
Standard contains revisions to both the Table 1 planning event
(Category P5) and extreme events (Stability 2.a-h) and the associated
footnote 13 to provide for more comprehensive study of the potential
impacts of protection system single points of failure.
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    \21\ Proposed Reliability Standard TPL-001-5 is not attached to
this notice of proposed rulemaking (NOPR). The proposed Reliability
Standard is available on the Commission's eLibrary document
retrieval system in Docket No. RM19-10-000 and on the NERC website,
www.nerc.com.
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    12. NERC states that if the study of a protection system single
point of failure for a single-line-to-ground fault (i.e., Category P5
event) results in cascading, a corrective action plan is required.\22\
NERC considers this a relatively commonplace scenario, and it explains
that an entity would be required to develop a corrective action plan if
it determines that its system would be unable to meet the performance
requirements of Table 1 for the Category P5 event.
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    \22\ Proposed TPL-001-5 Reliability Standard, Table 1 (Steady
State and Stability Performance Planning Events), Category P5
requires the study of a single-line-to-ground faulted element (e.g.,
generator, transmission circuit or transformer) along with a failure
to operate of a non-redundant component of the protection system
(i.e., a single point of failure) protecting the faulted element.
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    13. In contrast, NERC proposes revisions to Table 1 to include the
study of a protection system single point of failure in combination
with a three-phase fault as an extreme event, which does not require a
corrective action plan. NERC avers in its petition that the three-phase
fault scenario is much rarer (compared to the single-line-to-ground
fault). According to NERC, like the other extreme events in the
proposed Reliability Standard, this scenario, while rare, could result
in more significant impacts to an entity's system.\23\ Under this
approach, NERC asserts that, if an entity determines that its system
will experience cascading as a result of a three-phase fault scenario,
an evaluation of possible actions designed to reduce the likelihood or
mitigate the consequences of the event will be conducted but a
corrective action plan is not required.
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    \23\ See Mandatory Reliability Standards for the Bulk-Power
System, Order No. 693, 118 FERC ] 61,218, at P 1826, order on reh'g,
Order No. 693-A, 120 FERC ] 61,053 (2007) (describing extreme events
as ``events resulting in loss of two or more elements or Cascading''
that do not require a corrective action plan rather than assigning a
quantitative probability to the event).
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    14. Based on a historical analysis of NERC data on protection
system misoperations, NERC asserts that the expected likelihood of a
three-phase fault event occurring and resulting in the most severe
impacts would be small. NERC states that it reviewed over 12,000
protection system misoperations in its Misoperation Information Data
Analysis System (MIDAS) database reported since 2011, of which only 28
involved three-phase faults. Of those, NERC states that 10 involved
breakers that failed to operate, and the remaining 18 involved breakers
that were slow to operate.\24\ NERC explains that a failure to operate
potentially indicates instances of a protection system single point of
failure. While the potential for severe impacts from such events
remains, NERC states that none of the 10 failure to trip scenarios
reported since 2011 resulted in events that reached the threshold for
reporting under Reliability Standard EOP-004 (Event Reporting).\25\
With regard to the Order No. 786 directives, NERC states that proposed
Reliability Standard TPL-001-5 provides for a more complete
consideration of factors for selecting which known outages will be
included in near-term transmission planning horizon studies.
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    \24\ NERC Petition at 26, n.55 (``The ERO began to collect
misoperations data in a common format beginning in 2011. Applicable
entities are currently required to report information on Protection
System misoperations to NERC pursuant to a request for data or
information under Section 1600 of the NERC Rules of Procedure
approved by the NERC Board of Trustees on August 14, 2014.
Previously, the PRC-004 standard contained requirements for
misoperation reporting.''); see also North American Electric
Reliability Corp., 151 FERC ] 61,129, at P 6 (2015) (``PRC-004-3,
and the parallel Section 1600 Data Request provides means to
accomplish this systematic analysis and correction'').
    \25\ Reliability Standard EOP-004-3 (Event Reporting),
Attachment 1: Reportable Events, contains a list of various
thresholds for reporting certain events to NERC. Examples of
reporting thresholds include: Loss of firm load for 15 minutes or
more if 300 MW or greater for entities with a previous year's demand
of at least 3,000 MW, or 200 MW or greater for all other entities,
and total generation loss within one minute 2,000 MW or greater for
entities in the Eastern or Western Interconnection, or 1,000 MW for
entities in the ERCOT or Quebec Interconnection.
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II. Discussion

    15. Pursuant to section 215(d)(2) of the FPA, the Commission
proposes to approve proposed Reliability Standard TPL-001-5 as just,
reasonable, not unduly discriminatory or preferential, and in the
public interest. The proposed Reliability Standard will improve Bulk-
Power System reliability by requiring enhanced transmission system
planning with regard to the study of protection system single points of
failure in combination with a single-line-to-ground fault, as discussed
in Order No. 754. The Commission also proposes to approve the
associated violation risk factors, violation severity levels and
implementation plan.
    16. With respect to the Order No. 786 directives, regarding planned
maintenance outages and stability analysis for spare equipment
strategy, the Commission proposes to determine that the revisions
satisfy the directives. First, proposed Reliability Standard TPL-001-5
provides for a more complete consideration of factors for selecting
which known outages will be included in near-term transmission planning
horizon studies. In particular, the modifications reflected in proposed
Reliability Standard TPL-001-5 address the Commission's concern that
the exclusion of known outages of less than six months in currently-
effective Reliability Standard TPL-001-4 could result in outages of
significant facilities not being studied. Second, the proposed
Reliability Standard modifies requirements for stability analysis to
require an entity to assess the impact of the possible unavailability
of long lead time equipment, consistent with the entity's spare
equipment strategy.
    17. In addition, the Commission, pursuant to section 215(d)(5) of
the FPA, proposes to direct that NERC develop modifications to the
Reliability Standards because certain protection system single points
of failure may not be fully addressed even with the implementation of
proposed Reliability Standard TPL-001-5. As discussed below, the
Commission is concerned that the proposed Reliability Standard does not
require responsible entities to develop corrective action plans to
address protection system single points

of failure in combination with a three-phase fault if planning studies
indicate potential cascading. Accordingly, the Commission proposes to
direct that NERC develop modifications to the Reliability Standards to
require corrective action plans for protection system single points of
failure in combination with three-phase faults if planning studies
indicate potential cascading.

A. The Record Indicates There Is a Reliability Gap for a Protection
System Single Point of Failure in Combination With a Three-Phase Fault

    18. While protection system single points of failure in combination
with a three-phase fault must be studied under the proposed Reliability
Standard to determine the impact of failure, the Commission believes
that the record may not support NERC's contention that corrective
action plans should not be required even when studies of the event
indicate the potential for cascading. Specifically, NERC asserts that
protection system single points of failure in combination with a three-
phase fault is an extreme event that does not require a corrective
action plan, even in cases where the study results indicate potential
cascading. NERC claims that protection system single points of failure
in combination with a three-phase fault are rare and, ``[l]ike all of
the `extreme events' scenarios in this [TPL-001 Standard risk-based]
framework, the impacts of a protection system single point of failure
in combination with a three phase fault could be severe in some cases,
but are very unlikely.'' \26\ Based on the present record, it is
unclear whether such contingencies are as rare as NERC maintains.
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    \26\ NERC Petition at 26.
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    19. A 2009 NERC Industry Advisory reported three system
disturbances that occurred during a five-year period that were
initiated by a protection system single point of failure in combination
with a single-line-to-ground fault.\27\ According to the Industry
Advisory and supporting documentation, all three events evolved into
either a multi-phase fault or a three-phase fault with cascading.\28\
Moreover, in the 2012 Informational Filing, NERC reported that it is
not uncommon for a single-line-to-ground fault to evolve into a multi-
phase fault, and NERC stated that studies solely on single-line-to-
ground faults may understate the reliability risk of single points of
failure of protection systems.\29\ As mentioned below, the NERC
standard drafting team pointed to the likelihood of a single-line-to-
ground fault evolving into a multi-phase fault when responding to
stakeholder comments that a single-line-to-ground fault was a rare
event.
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    \27\ NERC, Industry Advisory: Protection System Single Point of
Failure (March 30, 2009) (2009 NERC Industry Advisory).
    \28\ Id. at 2 (``Three system disturbances were caused by
failure of a single component (lockout or auxiliary relay) of a
protection system.'').
    \29\ 2012 NERC Informational Filing at 3, 10 (``identif[ying]
five events between 2004 and 2010 in which a single point of failure
on a protection system caused, in whole or in part, an event on the
Bulk-Power System . . .'').
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    20. NERC indicates that it reviewed over 12,000 protection system
misoperations and determined that only 28 involved three-phase faults
from 2011 through 2018. However that averages to approximately one
three-phase fault event every three months. NERC, moreover, indicates
that ten of those 28 misoperations involved breakers that failed to
operate that could reasonably be assumed to be representative of
protection system single points of failure, which averages to about one
event every 8 months.\30\ Although we recognize that three-phase faults
constitute a relatively small subset of all protection system
operations, under the following measure of one protection system single
point of failure every 8 months, the occurrence of three-phase faults
with misoperations could reasonably be viewed as regular occurrences.
Thus, based on the information currently before us, we are not
persuaded by NERC's analysis that three-phase faults are rare events
that should be categorized with other extreme events in proposed
Reliability Standard TPL-001-5 and should be studied but not have
corrective action plans.
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    \30\ NERC Petition at 26-27. NERC stated that none of the ten
failure to trip scenarios reached the threshold for reporting under
Reliability Standard EOP-004. Although NERC did not offer further
explanation, system conditions such as off-peak load conditions
could have contributed to whether Reliability Standard EOP-004
thresholds were met.
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    21. The record of development for proposed Reliability Standard
TPL-001-5 also supports our concerns with the absence of a corrective
action plan requirement. The development record evidences a standard
drafting team repeatedly expressing concerns regarding the reliability
risks of three-phase faults involving protection system single points
of failure. Indeed, the standard drafting team evaluated and initially
adopted more robust options to mitigate protection system single points
of failure in combination with three-phase faults if studies indicated
cascading, including requiring a corrective action plan or some
variation of a corrective action plan.
    22. In the first draft of proposed Reliability Standard TPL-001-5,
the standard drafting team included a draft requirement (Requirement
R4.6) that would have addressed protection system single points of
failure in combination with a three-phase fault, including a specific
requirement for the development of a corrective action plan.\31\ After
reviewing the unofficial comments on the proposal, the standard
drafting team provided the following response:
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    \31\ NERC Petition, Ex. G (Summary of Development and Complete
Record of Development) at page 372-373 of pdf (``If the analysis
concludes there is Cascading caused by the occurrence of Table 1
extreme events listed in the stability column for events 2e-2h, a
Corrective Action Plan shall be developed.'').

    The [standard drafting team (SDT)] recognized that the industry
comments . . . were particularly negative. The SDT would like to
address the most common comment received: Requiring Corrective
Action Plans as part of Requirement R4.6 goes beyond the scope of
the SAR, was not part of the recommendations from the SPCS/SAMS
report titled ``Order No. 754 Assessment of Protection System Single
Points of Failure Based on the Section 1600 Data Request'', and/or
is not justifiable given the low likelihood of occurrence. . . .
While it is clear that a [single point of failure (SPF)] for a
Protection System component may lead to significantly longer Delayed
Clearing and notably worse system response than typically analyzed
breaker failure conditions, the industry has indicated that the
probability of simultaneous SPF occurrence with a bolted three-phase
fault is low. Therefore the SDT has restored the assessment of SPF
for a Protection System component with a three-phase fault to
language consistent with TPL-001-4 Requirement 4.5.\32\
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    \32\ Id. at page 810 of pdf.

    While the standard drafting team agreed to remove the corrective
action plan provision in response to the stakeholder comments, the
following language from the standard drafting team's response stressed
the reliability concerns posed by protection system single points of
failure in combination with a three-phase fault, and suggested that the
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related risks are ``underappreciated'':

    The SPF for a Protection System component is an important topic
that, the SDT believes, may involve risks that are underappreciated.
The SDT considered using Corrective Action Plan changes in proposed
Requirement 4.6 or a new Table 1 Planning Events Category P8 to
emphasize the importance of this issue, but given the industry
comments and lack of a FERC directive did not ``raise the bar'' at
this time. The SDT would like to document an important
considerations (sic) it considered, that the fault conditions and
system performance requirement, referred to as Performance Measure,
of the Order 754 data

request were very similar to those of Extreme Events of TPL-001-4
Table 1, namely three-phase fault application and conditions that
can indicate Cascading. The primary conclusive finding of the SPCS/
SAMS report was: ``analysis of the data demonstrates the existence
of a reliability risk associated with single points of failure in
protection systems that warrants further action.'' Further, the
SPCS/SAMS report concluded that: ``additional emphasis in planning
studies should be placed on assessment of three-phase faults
involving protection system single points of failure.'' \33\
---------------------------------------------------------------------------

    \33\ Id.

    The standard drafting team's above response acknowledged the
importance of a corrective action plan and noted conclusive findings of
the SPCS/SAMS report that the reliability risk associated with
protection system single points of failure warrants further action. The
standard drafting team, nonetheless, indicated that ``lacking a FERC
directive'' it would remove the corrective action plan provision.
    23. The standard drafting team then developed a second draft of
proposed Reliability Standard TPL-001-5. The second draft did not
require a corrective action plan by name. Rather, the standard drafting
team developed and submitted for ballot a new provision requiring that,
when system studies show that a protection system single points of
failure in combination with a three-phase fault results in system
cascading, the entity must take specific actions, namely ``listing
system deficiencies, the associated actions needed to prevent the
system from Cascading and the associated timetable for
implementation.'' \34\ Further, the proposed provision would require
follow-up in annual planning assessments for ``continued validity and
implementation status.''
---------------------------------------------------------------------------

    \34\ Id. at page 824 of pdf (proposed Requirement 4.2.2).
---------------------------------------------------------------------------

    24. The standard drafting team developed a technical rationale
document that accompanied the second draft of the proposed Reliability
Standard.\35\ In the draft technical rationale document, the standard
drafting team explained the technical basis for draft Requirement
R4.2.2:
---------------------------------------------------------------------------

    \35\ Id. at page 942 of pdf.

    Given the risk to BES reliability, additional emphasis in
planning studies should be placed on assessment of three-phase
faults involving Protection System SPF. This concern (the study of
Protection System SPF) is appropriately addressed as an extreme
event in TPL-001-4, Requirement R4, Part 4.2. While less probable
than single-phase-to-ground faults, three-phase faults typically
initiate as single-phase-to-ground and often evolve into three-phase
faults, leading to Delayed Fault Clearing scenarios more severe than
the Table 1 P5 event. Therefore, TPL-001-4, Requirement R4, Part
4.5, which specifies that an evaluation of possible mitigating
actions be conducted if analysis concludes there is cascading caused
by the occurrence of this extreme event, is inadequate to address
the risk of Protection System component SPF to the reliability of
the BES.\36\
---------------------------------------------------------------------------

    \36\ Id. at page 950-951 of pdf (emphasis added).

    Again, the standard drafting team expressed its concerns regarding
the reliability risks associated with a protection system single point
of failure in combination with a three-phase fault. The standard
drafting team addressed the stakeholder comments regarding the
perceived low risk of such conditions by pointing out that ``[w]hile
less probable than single-phase-to-ground faults, three-phase faults
typically initiate as single-phase-to-ground and often evolve into
three-phase faults, leading to Delayed Fault Clearing scenarios more
severe than the Table 1 P5 event.'' \37\ Further, the standard drafting
team noted the inadequacy of simply conducting an ``evaluation'' as set
forth in the relevant provision of the current Reliability
Standard.\38\
---------------------------------------------------------------------------

    \37\ Id.
    \38\ The second draft of Reliability Standard TPL-001-5, was
voted down by stakeholders, with stakeholders suggesting the removal
of Requirement R4.2.2 again suggesting that three-phase fault
followed by a protection failure is a low probability event. Id. at
page 1327 of pdf.
---------------------------------------------------------------------------

    25. The standard drafting team developed a third draft of the
proposed Reliability Standard. This third draft removed the more robust
provision (proposed Requirement R4.2.2) in favor of the currently
proposed language in Requirement 4.2, which requires that ``[i]f the
analysis concludes there is Cascading caused by the occurrence of
extreme events, an evaluation of possible actions designed to reduce
the likelihood or mitigate the consequences of the event(s) shall be
conducted.'' Significantly, however, in the draft technical rationale
document associated with the second draft of the proposed Reliability
Standard, the standard drafting team stated that merely requiring that
``an evaluation of possible mitigating actions be conducted if analysis
concludes there is cascading caused by the occurrence of this extreme
event, is inadequate to address the risk of Protection System component
SPF to the reliability of the BES.'' \39\
---------------------------------------------------------------------------

    \39\ Id. at page 951 of pdf (emphasis added).
---------------------------------------------------------------------------

    26. The standard development history discussed above therefore
supports our concern that there is a potential reliability gap with
respect to the proposed Reliability Standard's treatment of protection
system single points of failure in combination with a three-phase
fault.\40\
---------------------------------------------------------------------------

    \40\ The standard development record indicates several
stakeholder comments in support of a corrective action plan
requirement for protection system single points of failure in
combination with a three-phase fault that was proposed in the third
draft. For example, one commenter suggested ``the best way to
achieve this [corrective action plan] requirement is through the
creation of a P8 [new category planning event] contingency rather
than extreme events.'' Another commenter stated it ``does not
believe though that the language . . . goes far enough . . . and
believes a corrective action plan should be required.'' Id. at pages
2283, 2291, 2415, and 2424 of pdf.
---------------------------------------------------------------------------

B. Commission Proposal

    27. The Commission, pursuant to section 215(d)(5) of the FPA,
proposes to direct that NERC develop modifications to require
corrective action plans for protection system single points of failure
in combination with three-phase faults if planning studies indicate
potential cascading. While we do not propose to prescribe how NERC
should respond to the proposed directive, we discuss below certain
possible alternatives.
    28. NERC could address the proposed directive by modifying the
current Category P5 proposal for single-line-to-ground faults (that
already includes a P5 corrective action plan) to include language, such
as, a footnote stating that the simulation of Delayed Fault Clearing
must consider that a single-line-to-ground faulted condition may evolve
to all three-phases before protection system action operates to clear
the fault. Alternatively, NERC could modify the Reliability Standard to
have a new Category planning event that would require a corrective
action plan for the study of a protection system single point of
failure in combination with a three-phase fault if the study indicates
cascading.\41\
---------------------------------------------------------------------------

    \41\ See id. at page 1506 and 1746 of pdf.
---------------------------------------------------------------------------

    29. In addition, we recognize that during the standard drafting
process for proposed Reliability Standard TPL-001-5 some stakeholders
were concerned with incurring significant costs to mitigate protection
system single points of failure in combination with a three-phase
fault, while others stated that such actions do not usually incur
significant costs.\42\ While we are aware of the potential for
increased cost under this proposal, we understand that there are likely
cost-effective actions that could be taken to mitigate a protection
system single point of failure in combination with a three-phase fault.

For example, a corrective action plan to eliminate a single point of
failure of protection system could add a redundant lockout relay in the
control circuitry of a protection system, which would eliminate
occurrence of those events reported in the 2009 NERC Industry
Advisory.\43\ As another option, an entity could add control center
monitoring and reporting functions to a DC battery bank or to a
communication system of a communication-aided protection scheme so that
system operators are aware of their failure.\44\ To better understand
the potential for increased costs and other implementation issues, the
Commission seeks comment on how many corrective action plans are
expected for protection system single points of failure in combination
with a three-phase fault if study results indicate cascading.
---------------------------------------------------------------------------

    \42\ See, e.g., id. at page 1016 (Seattle City Light), 1019
(Arizona Public Service), 1044 (Northeast Power Coordinating
Council), 1048 (Eversource Energy), 1331 and 1333 (Standard Drafting
Team Response to Commenters) of pdf.
    \43\ NERC Petition at 20 (``most, if not all, constituent parts
of the control circuitry are generally unmonitored, may fail, and
may remain undetected until periodic testing is conducted. This is
particularly significant for non-redundant auxiliary relays or
lockout relays within the control circuitry because they may be used
for multiple functions. . . .''). In addition, the standard drafting
team stated that ``[i]t is emphasized that Footnote 13 does not
prescribe any level of redundancy . . . . If, after proper
consideration and simulation, required System performance is
achieved, then there may be no impetus to make non-redundant
components of a Protection System redundant. On the other hand,
after proper consideration and simulation it is demonstrated that
required System performance is not achieved, making non-redundant
components of a Protection System redundant may be but one of many
alternatives for corrective actions to obtain required System
performance.'' Id., Ex. G at page 162 of pdf.
    \44\ NERC Petition at 18-19 (stating that ``[f]ootnote 13
provides that certain non-redundant components that are both
monitored and reported at a Control Center would not need to be
considered as part of planning studies. This includes the
communications systems identified in footnote 13.b. The standard
drafting team considered that the monitoring and reporting of a non-
redundant component to a centralized location (i.e., the Control
Center) would facilitate prompt identification and correction of
abnormal conditions to minimize the exposure to and consequence of
the failed component . . . Similar to footnote 13.b, monitoring and
reporting the status of the DC supply to a centralized location
[i.e., footnote 13.c] can be considered a sufficient alternative to
physical redundancy if the result is prompt notification and
remediation which minimizes the exposure to and consequence of DC
supply failure'').
---------------------------------------------------------------------------

    30. To ensure no delay and to align the effective date of the
proposed directive with the current implementation plan of proposed
Reliability Standard TPL-001-5, the Commission proposes to direct that
NERC address the directive within one year of the effective date of a
final rule.\45\ The Commission seeks comments on its proposals.
---------------------------------------------------------------------------

    \45\ NERC Petition, Exhibit B (Implementation Plan) at 2.
---------------------------------------------------------------------------

III. Information Collection Statement

    31. The FERC-725N information collection requirements contained in
this notice of proposed rulemaking are subject to review by the Office
of Management and Budget (OMB) under section 3507(d) of the Paperwork
Reduction Act of 1995.\46\ OMB's regulations require approval of
certain information collection requirements imposed by agency
rules.\47\ Upon approval of a collection of information, OMB will
assign an OMB control number and expiration date. Respondents subject
to the filing requirements of this rule will not be penalized for
failing to respond to these collections of information unless the
collections of information display a valid OMB control number. The
Commission solicits comments on the Commission's need for this
information, whether the information will have practical utility, the
accuracy of the burden estimates, ways to enhance the quality, utility,
and clarity of the information to be collected or retained, and any
suggested methods for minimizing respondents' burden, including the use
of automated information techniques.
---------------------------------------------------------------------------

    \46\ 44 U.S.C. 3507(d) (2012).
    \47\ 5 CFR 1320.11 (2018).
---------------------------------------------------------------------------

    32. The Commission bases its paperwork burden estimates on the
changes in paperwork burden presented by proposed Reliability Standard
TPL-001-5. The NERC Compliance Registry, as of May 10, 2019, identifies
approximately 144 planning coordinators and transmission planners in
the United States that are subject to mandatory compliance with this
proposed Regulatory Standard. Of the 144 entities 62 of the entities
are registered as both transmission planners and planning coordinators.
The register indicates there are seven entities registered as planning
coordinators and 137 entities registered as transmission planners.
    33. Burden Estimate: \48\ The estimated burden and cost for the
requirements contained in this proposed rule follows:
---------------------------------------------------------------------------

    \48\ ``Burden'' is 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 CFR 1320.3.
    \49\ We consider the filing of an application to be a
``response.''
    \50\ Hourly costs are based on the Bureau of Labor Statistics
(BLS) figures for May 2017 (Sector 22, Utilities) for wages (https://www.bls.gov/oes/current/naics2_22.htm) and benefits for December
2019 (https://www.bls.gov/news.release/ecec.nr0.htm). We estimate
that an Office and Administrative Support (Occupation code: 43-0000)
would perform the functions associated with recordkeeping
requirements, at an average hourly cost (for wages and benefits) of
$41.34. The functions associated with reporting requirements, we
estimate, would be performed by an Electrical Engineer (Occupation
code: 17-2051) at an average hourly cost of $68.10 including wages
and benefits. These occupational categories' wage figures are
averaged and weighted equally as follows: ($41.34 hour + 68.10 hour)
/ 2 = $54.72/hour. The resulting wage figure is rounded to $55.00/
hour for use in calculating wage figures in the NOPR in Docket No.
RM19-10-000.
    \51\ Entity count based on May 10, 2019 NERC Registration: 7
entities register as Planning Coordinators (PC), 137 entities
register as Transmission Planners (TP), and 62 entities register as
both PCs and TPs.

                                           RM19-10-000 NOPR--FERC-725N
                        [Mandatory reliability standards: Reliability standard TPL-001-5]
----------------------------------------------------------------------------------------------------------------
                                                Annual number                                      Total annual
                                  Number of     of responses    Total number   Average burden &   burden hours &
    Areas of modification        respondents      \49\ per      of responses       cost per        total annual
                                                 respondent                      response \50\         cost
                                          (1)             (2)     (1) * (2) =  (4).............  (3) * (4) = (5)
                                                                          (3)
----------------------------------------------------------------------------------------------------------------
Single Point of Failure (one-   \51\ 206 (PC/               1             206  16 hrs.           3,296 hrs;
 time).                                   TP)                                   (reporting: 12    $181,280.
                                                                                hrs.;
                                                                                recordkeeping:
                                                                                4 hrs.); $880.
Spare Equipment Strategy (one-    206 (PC/TP)               1             206  4 hrs.            824 hrs;
 time).                                                                         (reporting: 2     $45,320.
                                                                                hrs.;
                                                                                recordkeeping:
                                                                                2 hrs.); $220.

Plan Maintenance Outage (one-     206 (PC/TP)               1             206  16 hrs.           3,296 hrs;
 time).                                                                         (reporting: 12    $181,280.
                                                                                hrs.;
                                                                                recordkeeping:
                                                                                4 hrs.) $880.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............             618  ................  7,416 hrs;
                                                                                $407,880.
----------------------------------------------------------------------------------------------------------------

    This notice of proposed rulemaking will not significantly change
existing burdens on an ongoing basis. The Commission estimates a one-
time burden increase for Year 1 only because Year 1 represents a one-
time task not repeated in subsequent years.
    The one-time burden for FERC-725N information collection can be
averaged over three years:
     7,416 hours / 3 = 2,472 (rounded) hours/year over three
years.
    34. Title: FERC-725N, Mandatory Reliability Standards: Transmission
Planning (TPL) Reliability Standards.
    Action: Proposed revision to FERC-725N information collection.
    OMB Control No.: 1902-0264.
    Respondents: Businesses or other for-profit institutions; not-for-
profit institutions.
    Frequency of Responses: One Time.
    Necessity of the Information: This notice of proposed rulemaking
proposes to approve the requested modifications to a Reliability
Standard pertaining to transmission planning. As discussed above, the
Commission proposes to approve proposed Reliability Standard TPL-001-5
pursuant to section 215(d)(2) of the FPA because it improves upon the
currently-effective Reliability Standard TPL-001-4.
    Internal Review: The Commission has reviewed proposed Reliability
Standard TPL-001-5 and made a determination that its action is
necessary to implement section 215 of the FPA. The Commission has
assured itself, by means of its internal review, that there is
specific, objective support for the burden estimates associated with
the information requirements.
    35. Interested persons may obtain information on the reporting
requirements by contacting the following: Federal Energy Regulatory
Commission, 888 First Street NE, Washington, DC 20426 [Attention: Ellen
Brown, Office of the Executive Director, email<EMAIL_ADDRESS>
phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>].
    36. For submitting comments concerning the collection(s) of
information and the associated burden estimate(s), please send your
comments to the Commission, and to the Office of Management and Budget,
Office of Information and Regulatory Affairs, 725 17th Street NW,
Washington, DC 20503, [Attention: Desk Officer for the Federal Energy
Regulatory Commission, phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>]. For
security reasons, comments to OMB should be submitted by email to:
<EMAIL_ADDRESS>Comments submitted to OMB should include
Docket Number RM19-10-000 and FERC-725N (OMB Control No. 1902-0264).

IV. Environmental Analysis

    37. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human environment.\52\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. Included in the exclusion are rules that are clarifying,
corrective, or procedural or that do not substantially change the
effect of the regulations being amended.\53\ The actions proposed
herein fall within this categorical exclusion in the Commission's
regulations.
---------------------------------------------------------------------------

    \52\ Regulations Implementing the National Environmental Policy
Act of 1969, Order No. 486, FERC Stats. & Regs. ] 30,783 (1987)
(cross-referenced at 41 FERC ] 61,284).
    \53\ 18 CFR 380.4(a)(2)(ii) (2018).
---------------------------------------------------------------------------

V. Regulatory Flexibility Act Analysis

    38. The Regulatory Flexibility Act of 1980 (RFA) \54\ generally
requires a description and analysis of proposed rules that will have
significant economic impact on a substantial number of small
entities.\55\ The Small Business Administration's (SBA) Office of Size
Standards develops the numerical definition of a small business.\56\
The SBA revised its size standard for electric utilities (effective
January 22, 2014) to a standard based on the number of employees,
including affiliates (from the prior standard based on megawatt hour
sales).\57\
---------------------------------------------------------------------------

    \54\ 5 U.S.C. 601-612 (2012).
    \55\ Id. 601-12.
    \56\ 13 CFR 121.101 (2018).
    \57\ Id. 121.201.
---------------------------------------------------------------------------

    39. Proposed Reliability Standard TPL-001-5 is expected to impose
an additional burden on 206 entities \58\ (planning coordinators and
transmission planners).
---------------------------------------------------------------------------

    \58\ Public utilities may fall under one of several different
categories, each with a size threshold based on the company's number
of employees, including affiliates, the parent company, and
subsidiaries. For the analysis in this NOPR, we are using a 500
employee threshold due to each affected entity falling within the
role of Electric Bulk Power Transmission and Control (NAISC Code:
221121).
---------------------------------------------------------------------------

    40. Of the 206 affected entities discussed above, we estimate that
approximately 10 percent of the affected entities are small entities.
We estimate that each of the 21 small entities to whom the proposed
modifications to proposed Reliability Standard TPL-001-5 apply will
incur one-time costs of approximately $1,980 per entity to implement
the proposed Reliability Standard. We do not consider the estimated
costs for these 21 small entities to be a significant economic impact.
Accordingly, we propose to certify that proposed Reliability Standard
TPL-001-5 will not have a significant economic impact on a substantial
number of small entities.

VI. Comment Procedures

    41. The Commission invites interested persons to submit comments on
the matters and issues proposed in this notice to be adopted, including
any related matters or alternative proposals that commenters may wish
to discuss. Comments are due August 26, 2019. Comments must refer to
Docket No.

RM19-10-000, and must include the commenter's name, the organization
they represent, if applicable, and address.
    42. The Commission encourages comments to be filed electronically
via the eFiling link on the Commission's website at http://www.ferc.gov. The Commission accepts most standard word processing
formats. Documents created electronically using word processing
software should be filed in native applications or print-to-PDF format
and not in a scanned format. Commenters filing electronically do not
need to make a paper filing.
    43. Commenters that are not able to file comments electronically
must send an original of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    44. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commenters on this proposal are
not required to serve copies of their comments on other commenters.

VII. Document Availability

    45. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) and
in the Commission's Public Reference Room during normal business hours
(8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE, Room 2A,
Washington, DC 20426.
    46. From the Commission's Home Page on the internet, this
information is available on eLibrary. The full text of this document is
available on eLibrary in PDF and Microsoft Word format for viewing,
printing, and/or downloading. To access this document in eLibrary, type
the docket number of this document, excluding the last three digits, in
the docket number field.User assistance is available for eLibrary and
the Commission's website during normal business hours from the
Commission's Online Support at<PHONE_NUMBER> (toll free at 1-866-208-
3676) or email at<EMAIL_ADDRESS>or the Public Reference
Room at<PHONE_NUMBER>, TTY<PHONE_NUMBER>. Email the Public Reference
Room at<EMAIL_ADDRESS>
    By direction of the Commission.

    Issued: June 20, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-13582 Filed 6-26-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 1, 2009 (Volume 74, Number 168)]
[Notices]
[Page 45222-45223]
[DOCID:fr01se09-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0429] (formerly Docket No. 2007D-0496]

Guidance for Industry on Labeling of Nonprescription Human Drug
Products Marketed Without an Approved Application as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act:
Questions and Answers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Labeling of Nonprescription Human
Drug Products Marketed Without an Approved Application as Required by
the Dietary Supplement and Nonprescription Drug Consumer Protection
Act: Questions and Answers.'' This guidance is intended to assist
industry in complying with the labeling requirements for
nonprescription (over-the-counter (OTC)) human drugs marketed without
an approved application established by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate
guidance, issued by the Center for Food Safety and Applied Nutrition on
complying with the labeling requirements for dietary supplements, is
announced elsewhere in this issue of the Federal Register.

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
51, rm. 2201, Rockville, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Walter Ellenberg, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5488, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Labeling of Nonprescription Human Drug Products Marketed
Without an Approved Application as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act: Questions and
Answers.'' On December 22, 2006, the President signed into law DSNDCPA
(Public Law 109-462, 120 Stat. 3469). This law amends the Federal Food,
Drug, and Cosmetic Act (the act) with respect to serious adverse event
reporting for dietary supplements and nonprescription drugs marketed
without an approved application. The law also amended the act to add
section 502(x) (21 U.S.C. 352(x)), which requires the label of an OTC
drug product marketed in the United States without an approved
application to include a domestic address or domestic telephone number
through which the product's manufacturer, packer, or distributor may
receive reports of serious adverse events associated with its use.
    In the Federal Register of January 2, 2008 (73 FR 196), FDA
announced the availability of a draft version of the guidance
containing questions and answers relating to the new labeling
requirements under Public Law 109-462 for OTC drugs marketed without an
approved application. In addition to providing guidance for industry on
how to comply with the labeling requirements in section 502(x) of the
act, the draft guidance stated that FDA intended to begin enforcing the
requirements of section 502(x) for OTC human drugs marketed without an
approved application labeled on or after January 1, 2009. Although
interested parties can comment on any guidance at any time, to ensure
that the agency would have the opportunity to consider comments on the
draft guidance before beginning work on the final version of the
guidance, FDA requested that interested parties submit comments by
March 3, 2008. On December 11, 2008 (73 FR 75436), FDA announced the
availability of a revised draft guidance to notify industry and other
members of the public that it intended to exercise enforcement
discretion with regard to the labeling requirements of section 502(x)
of the act for an additional 1-year period (i.e., for OTC drug products
marketed without an approved

application that are labeled on or after January 1, 2010), because the
agency was still in the process of finalizing the guidance. The agency
has now completed its review and evaluation of the comments received
and has modified the guidance where appropriate.
    The document provides guidance to industry on the following topics:
(1) The meaning of ``domestic address'' for purposes of the labeling
requirements of section 502(x) of the act; (2) FDA's recommendation for
the use of an introductory statement before the domestic address or
domestic telephone number that is required to appear on the product
labeling under section 502(x) of the act (21 U.S.C. 352(x)); and (3)
that FDA intends to begin enforcing the labeling requirements of
section 502(x) of the act for products labeled on or after September
30, 2010.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance were approved under OMB
control no. 0190-0640.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments are available for
public examination in the Division of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ default.htm or
http://www.regulations.gov.

    Dated: August 26, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21093 Filed 8-31-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Rules and Regulations]
[Pages 58158-58159]
[FR Doc No: 2013-22840]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Docket No. FAA-2013-0528; Airspace Docket No. 13-ANM-16

Establishment of Class E Airspace; Wasatch, UT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at the Wasatch VHF
Omni-Directional Radio Range Tactical Air Navigational Aid (VORTAC)
navigation aid, Wasatch, UT, to facilitate vectoring of Instrument
Flight Rules (IFR) aircraft under control of Salt Lake City Air Route
Traffic Control Center (ARTCC). This improves the safety and management
of IFR operations within the National Airspace System. This action also
makes a minor adjustment to the geographic coordinates of the Wasatch
VORTAC navigation aid.

DATES: Effective date, 0901 UTC, December 12, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On July 10, 2013, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend controlled airspace at
Wasatch, UT (78 FR 41336). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received. Subsequent to
publication, the FAA's Aeronautical

Products office found the geographic coordinates of the Wasatch VORTAC
needed to be corrected. This action makes the correction.
    Class E airspace designations are published in paragraph 6006, of
FAA Order 7400.9X dated August 7, 2013, and effective September 15,
2013, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by establishing Class E en route domestic airspace extending
upward from 1,200 feet above the surface, at the Wasatch VORTAC
navigation aid, Wasatch, UT, to accommodate IFR aircraft under control
of Salt Lake City ARTCC by vectoring aircraft from en route airspace to
terminal areas. This action is necessary for the safety and management
of IFR operations. The geographic coordinates of the VORTAC are
adjusted from (Lat. 40[deg]51'10'' N., long. 111[deg]58'55'' W.) to
(Lat. 40[deg]51'01'' N., long. 111[deg]58'55'' W.) in accordance with
the FAA's aeronautical database. Except for administrative changes, and
the changes listed above, this rule is the same as that proposed in the
NPRM.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act. The FAA's authority to issue rules
regarding aviation safety is found in Title 49 of the U.S. Code.
Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it establishes
controlled airspace at the Wasatch VORTAC, Wasatch, UT.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

     Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9X, Airspace Designations and
Reporting Points, dated August 7, 2013, and effective September 15,
2013 is amended as follows:

Paragraph 6006 En Route Domestic Airspace Areas.

* * * * *

ANM UT E6 Wasatch, UT [New]

Wasatch VORTAC, UT
    (Lat. 40[deg]51'01'' N., long. 111[deg]58'55'' W.)

    That airspace extending upward from 1,200 feet above the surface
within an area bounded by Lat. 42[deg]27'00'' N., long.
113[deg]22'00'' W.; to Lat. 41[deg]41'49'' N., long. 109[deg]29'35''
W.; to Lat. 41[deg]26'15'' N., long. 109[deg]19'46'' W.; to Lat.
41[deg]10'22'' N., long. 109[deg]42'26'' W.; to Lat. 40[deg]21'23''
N., long. 109[deg]42'25'' W.; to Lat. 39[deg]59'03'' N., long.
110[deg]43'27'' W.; to Lat. 39[deg]37'44'' N., long. 111[deg]07'28''
W.; to Lat. 39[deg]03'55'' N., long. 110[deg]37'49'' W.; to Lat.
38[deg]28'51'' N., long. 110[deg]38'05'' W.; to Lat. 38[deg]10'56''
N., long. 111[deg]24'19'' W.; to Lat. 37[deg]50'39'' N., long.
112[deg]24'51'' W.; to Lat. 37[deg]30'00'' N., long. 112[deg]03'30''
W.; to Lat. 37[deg]30'00'' N., long. 113[deg]00'00'' W.; to Lat.
37[deg]32'02'' N., long. 113[deg]07'15'' W.; to Lat. 37[deg]48'00''
N., long. 113[deg]30'00'' W.; to Lat. 38[deg]23'43'' N., long.
113[deg]12'48'' W.; to Lat. 38[deg]19'56'' N., long. 114[deg]09'07''
W.; to Lat. 38[deg]28'04'' N., long. 114[deg]21'28'' W.; to Lat.
39[deg]38'25'' N., long. 114[deg]42'19'' W.; to Lat. 40[deg]06'57''
N., long. 114[deg]37'44'' W.; to Lat. 40[deg]40'40'' N., long.
114[deg]28'45'' W.; to Lat. 41[deg]08'22'' N., long. 114[deg]57'44''
W.; to Lat. 42[deg]00'00'' N., long. 114[deg]42'42'' W., thence to
the point of beginning.

    Issued in Seattle, Washington, on September 11, 2013.
Christopher Ramirez,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-22840 Filed 9-20-13; 8:45 am]
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