[Federal Register: March 24, 2010 (Volume 75, Number 56)]
[Proposed Rules]
[Page 14097-14103]
[DOCID:fr24mr10-15]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 40

[Docket No. RM09-18-000; 130 FERC ] 61,204]

Revision to Electric Reliability Organization Definition of Bulk
Electric System

March 18, 2010.
AGENCY: Federal Energy Regulatory Commission, Energy.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Commission proposes to direct the Electric Reliability
Organization (ERO) to revise its definition of the term ``bulk electric
system'' to include all electric transmission facilities with a rating
of 100 kV or above. The Commission proposes that a Regional Entity must
seek ERO and Commission approval before exempting any facility rated at
100 kV or above from compliance with mandatory Reliability Standards.
The Commission believes that a 100 kV threshold for identifying bulk
electric system facilities will protect the reliability of the bulk
electric system. The proposal would also provide consistency across the
nation's reliability regions regarding the identification of bulk
electric system facilities.

DATES: Comments are due May 10, 2010.

ADDRESSES: You may submit comments, identified by docket number by any
of the following methods:
     Agency Web Site: http://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: Commenters unable to file comments
electronically must mail or hand deliver an original and 14 copies of
their comments to: Federal Energy Regulatory Commission, Office of the
Secretary, 888 First Street, NE., Washington, DC 20426.

FOR FURTHER INFORMATION CONTACT:
Kumar Agarwal (Technical Information), Office of Electric Reliability,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.<PHONE_NUMBER>.
Robert Snow (Technical Information), Office of Electric Reliability,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.<PHONE_NUMBER>.
Jonathan First (Legal Information), Office of General Counsel, 888
First Street, NE., Washington, DC 20426.<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Notice of Proposed Rulemaking

    1. The Commission proposes to direct the Electric Reliability
Organization (ERO) to revise its definition of the term ``bulk electric
system'' to include all electric transmission facilities with a rating
of 100 kV or above. The Commission proposes that a Regional Entity must
seek ERO and Commission approval before exempting any facility rated at
100 kV or above from compliance with mandatory Reliability Standards.
The Commission believes that a 100 kV threshold for identifying bulk
electric system facilities will protect the reliability of the bulk
electric system. The proposal would also provide consistency across the
nation's reliability regions regarding the identification of bulk
electric system facilities.\1\
---------------------------------------------------------------------------

    \1\ The Commission is not proposing any new or modified text to
its regulations.
---------------------------------------------------------------------------

I. Background

A. Section 215 of the Federal Power Act

    2. On August 8, 2005, the Energy Policy Act of 2005 (EPAct) was
enacted into law. Title XII of EPAct added a new section 215 to the
Federal Power Act (FPA),\2\ which requires a Commission-certified ERO
to develop mandatory and enforceable Reliability Standards, subject to
Commission review and approval. Once approved, the Reliability
Standards may be enforced by the ERO, subject to Commission oversight,
or by the Commission independently.\3\
---------------------------------------------------------------------------

    \2\ Public Law 109-58, Title XII, Subtitle A, 119 Stat. 594, 941
(2005) (codified at 16 U.S.C. 824o).
    \3\ See 16 U.S.C. 824o(e)(3).
---------------------------------------------------------------------------

    3. In February 2006, the Commission issued Order No. 672,\4\
implementing section 215 of the FPA. Pursuant to Order No. 672, the
Commission certified one organization, the North American Electric
Reliability Corporation (NERC), as the ERO.\5\
---------------------------------------------------------------------------

    \4\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, FERC
Stats. & Regs. ] 31,204 (2006), order on reh'g, Order No. 672-A,
FERC Stats. & Regs. ] 31,212 (2006).
    \5\ See North American Electric Reliability Corp., 116 FERC ]
61,062 (ERO Certification Order), order on reh'g and compliance, 117
FERC ] 61,126 (2006).
---------------------------------------------------------------------------

B. Order No. 693

    4. On March 16, 2007, in Order No. 693,\6\ pursuant to section
215(d) of the FPA,\7\ the Commission approved 83 Reliability Standards
proposed by the NERC, the Commission-certified ERO.\8\ In addition,
Order No. 693 addressed the applicability of mandatory Reliability
Standards to the Bulk-Power System.
---------------------------------------------------------------------------

    \6\ See Mandatory Reliability Standards for the Bulk-Power
System, Order No. 693, FERC Stats. & Regs. ] 31,242, order on reh'g,
Order No. 693-A, 120 FERC ] 61,053 (2007) (directing improvements to
56 of the 83 approved Reliability Standards and leaving 24
Reliability Standards as pending until further information is
provided).
    \7\ 16 U.S.C. 824o(d) (2006).
    \8\ 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, No. 06-1426 (DC Cir.) (certifying
NERC as the ERO responsible for the development and enforcement of
mandatory Reliability Standards).
---------------------------------------------------------------------------

    5. In Order No. 693, the Commission explained that section 215(a)
of the FPA defines Bulk-Power System as:

    (A) Facilities and control systems necessary for operating an
interconnected electric energy transmission network (or any portion
thereof) and
    (B) Electric energy from generating facilities needed to
maintain transmission system reliability. The term does not include
facilities used in the local distribution of electric energy.[\9\]

    \9\ 16 U.S.C. 824o(a).
---------------------------------------------------------------------------

    The Commission observed that NERC defines ``bulk electric system''
as follows:

    As defined by the Regional Reliability Organization, the
electrical generation resources, transmission lines,
interconnections with neighboring systems, and associated equipment,
generally operated at voltages of 100 kV or higher. Radial
transmission facilities serving only load with

one transmission source are generally not included in this
definition.[\10\]
---------------------------------------------------------------------------

    \10\ Order No. 693, FERC Stats. & Regs. ] 31,242 at P 51.

    Additionally, the Commission recognized that this definition
provides discretion to define ``bulk electric system'' without any
stated limitation and without ERO oversight. Nevertheless, it accepted
the definition.
    6. The Commission stated in Order No. 693 that, ``at least for an
initial period, the Commission will rely on the NERC definition of bulk
electric system and NERC's registration process to provide as much
certainty as possible regarding the applicability to and the
responsibility of specific entities to comply with the Reliability
Standards * * *.'' \11\ Further, the Commission explained that some
regional definitions of bulk electric system exclude facilities below
230 kV and transmission lines that serve Washington, DC and New York
City:
---------------------------------------------------------------------------

    \11\ Id. P 75; see also Order No. 693-A, 120 FERC ] 61,053 at P
19 (``the Commission will continue to rely on NERC's definition of
bulk electric system, with the appropriate regional differences, and
the registration process until the Commission determines in future
proceedings the extent of the Bulk-Power System'').

    Although we are accepting the NERC definition of bulk electric
system and NERC's registration process for now, the Commission
remains concerned about the need to address the potential for gaps
in coverage of facilities. For example, some current regional
definitions of bulk electric system exclude facilities below 230 kV
and transmission lines that serve major load centers such as
Washington, DC and New York City. The Commission intends to address
this matter in a future proceeding.[\12\]
---------------------------------------------------------------------------

    \12\ Order No. 693, FERC Stats. & Regs. ] 31,242 at P 77
(footnotes omitted).

    The Commission directed NERC to submit an informational filing that
includes regional definitions of bulk electric system and any regional
documents that identify critical facilities to which the Reliability
Standards apply (i.e., facilities below 100 kV).

C. NERC's June 14, 2007 Filing

    7. In a June 14, 2007 filing, NERC submitted the regional
definitions of bulk electric system.\13\ NERC represented that ``[e]ach
Regional Entity utilizes the definition of bulk electric system in the
NERC Glossary of Terms Used in Reliability Standards (NERC Glossary);
however, as permitted by that definition * * * several Regional
Entities define specific characteristics or criteria that the Regional
Entity uses to identify the bulk electric system facilities for its
members. In addition, the Reliability Standards apply to load shedding
and special protection relay facilities below 100 kV, which are
monitored by Regional Entities, in compliance with NERC's Reliability
Standards.'' \14\
---------------------------------------------------------------------------

    \13\ NERC Informational Filing, Docket No. RM06-16-000 (June 14,
2007) (June 2007 Filing).
    \14\ Id. at 7.
---------------------------------------------------------------------------

    8. In the June 2007 Filing, NERC indicated that four Regional
Entities, Texas Regional Entity, Florida Reliability Coordinating
Council (FRCC), Midwest Reliability Organization, and SERC Reliability
Corporation, use the NERC definition of bulk electric system without
modification. In a supplemental filing, NERC informed the Commission
that Western Electricity Coordinating Council (WECC) uses the NERC
definition alone in its implementation of Regional Entity
activities.\15\
---------------------------------------------------------------------------

    \15\ NERC Supplemental Informational Compliance Filing, Docket
No. RM06-16-000 (March 6, 2009).
---------------------------------------------------------------------------

    9. Three other Regional Entities, ReliabilityFirst Corporation
(ReliabilityFirst), Southwest Power Pool (SPP Regional Entity) and
Northeast Power Coordinating Council, Inc. (NPCC) stated that they use
the NERC definition supplemented with additional criteria. For example,
SPP Regional Entity indicated that it uses the criteria specified in
the NERC Statement of Registry Criteria (with one exception).
ReliabilityFirst supplemented the NERC definition with specific
voltage-based inclusions and exclusions. For example, ReliabilityFirst
includes ``lines operated at voltage of 100 kV or higher.'' \16\
ReliabilityFirst excludes certain radial facilities, balance of
generating plant control and operation functions, and ``all other
facilities operated at voltages below 100 kV.''
---------------------------------------------------------------------------

    \16\ June 2007 Filing at 10.
---------------------------------------------------------------------------

    10. NERC's June 2007 Filing indicated that NPCC also asserts that
it uses the NERC definition of bulk electric system supplemented by
additional criteria. Unlike the supplemental criteria of other Regional
Entities, however, NPCC utilizes a significantly different approach to
identifying bulk electric system elements. According to NERC, NPCC
identifies elements of the bulk electric system using an impact-based
methodology, not a voltage-based methodology. Further, as part of its
approach to defining the bulk electric system, NPCC includes its own
definition of ``bulk power system'' as follows:

    The interconnected electrical systems within northeastern North
America comprised of system elements on which faults or disturbances
can have a significant adverse impact outside of the local area.

    According to NERC, NPCC analyzes all system elements within its
footprint regardless of size (voltage) to determine impact based on
this definition. NERC's filing included NPCC's ``Classification of Bulk
Power System Elements,'' which provides further information on the
above definition and how it is applied.\17\ Each balancing authority
conducts studies in accordance with NPCC Document A-10 to develop a
list of Bulk-Power System assets, which must be approved by NPCC's Task
Force on System Studies.
---------------------------------------------------------------------------

    \17\ NERC June 2007 Filing, Attachment 1 (NPCC Document A-10,
Classification of Bulk Power System Elements (April 28, 2007)).
---------------------------------------------------------------------------

D. NPCC Identification of Bulk Electric System Facilities

    11. In a December 2008 order, the Commission directed NERC and NPCC
to submit to the Commission a comprehensive list of bulk electric
system facilities located within the United States portion of the NPCC
region.\18\ The Commission explained that there appeared to be
conflicting lists of bulk electric system elements developed by one of
the balancing authorities in the United States portion of the NPCC
region. Further, it was not clear which, if any, of the lists developed
using NPCC's document A-10 were submitted to NPCC or approved by NPCC's
Task Force on System Studies. The December 2008 Order also stated that
``[t]he Commission believes that to best achieve reliability, the
applicable NPCC list should be consistent with both the NPCC impact-
based methodology and with the interpretations of bulk electric system
elements in other regional entities.'' \19\
---------------------------------------------------------------------------

    \18\ North American Electric Reliability Corp., 125 FERC ]
61,295 (2008) (December 2008 Order).
    \19\ Id. P 13.
---------------------------------------------------------------------------

    12. In response, NERC and NPCC submitted a compliance filing on
February 20, 2009, as supplemented on April 21, 2009. The compliance
filing indicated that the ``NPCC Approved BES List'' of June 2007 is
the only listing of bulk electric system facilities approved by NPCC
and is the current list of facilities within the U.S. portion of NPCC
to which the NERC Reliability Standards apply.\20\ The filing indicated
that a majority of the 115 kV and 138 kV transmission facilities in the
NYISO Balancing Authority Area of the NPCC

region are excluded from the bulk electric system and, hence,
compliance with mandatory Reliability Standards. In addition, NPCC
excludes approximately seven higher voltage (e.g., 230 kV, 345 kV and
500 kV) transmission facilities, some connecting to nuclear power
plants.
---------------------------------------------------------------------------

    \20\ NERC and NPCC Compliance Filing at 5 (February 20, 2009),
Docket No. RC09-3-000. The February 20 Compliance Filing also
indicated that the NPCC approved list of bulk electric system
elements was not developed pursuant to NPCC's Document A-10,
Classification of Bulk Power System Elements, identified in NERC's
June 2007 Filing. Rather, the approved NPCC list was developed
pursuant to an earlier version of the NPCC impact-based methodology.
---------------------------------------------------------------------------

    13. NERC and NPCC also provided information on generation
facilities in the U.S. portion of NPCC that are subject to compliance
with mandatory Reliability Standards. According to the filing, 92
percent of the total gross megavolt-ampere (MVA) in the NYISO Balancing
Authority Area, and 97 percent of the total gross MVA in the NE-ISO
Balancing Authority Area, are subject to compliance with mandatory
Reliability Standards. That information also indicates that numerous
transmission lines at 100 kV and above that interconnect with the
registered generation facilities are excluded from NPCC's list of bulk
electric system facilities.
    14. In September 2009, NERC and NPCC submitted a compliance filing
in which NPCC evaluated the impact and usefulness of a 100 kV ``bright-
line'' bulk electric system definition as well as another optional
method which utilizes Transmission Distribution Factor calculations to
determine reliability impacts. The NPCC definition would exclude radial
portions of the transmission system.\21\ However, NPCC states that it
continues to believe that its current impact-based approach provides an
adequate level of reliability and, therefore, intends to continue to
apply the impact-based approach in classifying its bulk-electric system
elements.\22\
---------------------------------------------------------------------------

    \21\ NERC and NPCC Compliance Filing and Assessment of Bulk
Electric System Report (September 21, 2009), Docket No. RC09-3-000.
NPCC would define ``radial portions of the transmission system to
include (1) an area serving load that is connected to the rest of
the network at a single transmission substation at a single
transmission voltage by one or more transmission circuits; (2) tap
lines and associated facilities which are required to serve local
load only; (3) transmission lines that are operated open for normal
operation; or (4) additionally as an option, those portions of the
NPCC transmission system operated at 100 kV or higher not explicitly
designated as a BES path for generation which have a one percent or
less participation in area, regional or inter regional power
transfers. Id. at 11.
    \22\ Id. at 7-8. See also id. at 14 (``[i]f directed by the
Commission to adopt the developed [bulk electric system] definition
for U.S. registered entities within the NPCC footprint, NPCC would
need additional time to carefully consider and develop a more
extensive and detailed implementation plan'').
---------------------------------------------------------------------------

II. Discussion

    15. As discussed in further detail below, based on our experience
in implementing FPA section 215 over the past four years and events
that have either caused or contributed to significant bulk electric
system disturbances and cascading outages, the Commission has
reevaluated the definition of ``bulk electric system'' contained in
Commission-approved NERC Glossary and has determined that the
definition needs to be modified in order to protect the reliability of
the Nation's Bulk-Power System.\23\ Accordingly, the Commission
proposes to direct the ERO to revise, within 90 days of the effective
date of a final rule in this proceeding, the ERO's definition of the
term ``bulk electric system'' to include all electric transmission
facilities with a rating of 100 kV or above.\24\
---------------------------------------------------------------------------

    \23\ As with Reliability Standards, the Commission reviews and
approves revisions to the NERC glossary pursuant to FPA section
215(d)(2). Further, the Commission may direct a modification to
address a specific matter identified by the Commission pursuant to
section 215(d)(5). See Order No. 693, FERC Stats. & Regs. ] 31,242
at P 1893-98.
    \24\ While the Commission indicated in Order No. 693, FERC
Stats. & Regs. ] 31,242 at P 77, that the Commission may reconsider
the scope of the statutory term Bulk Power System in a future
proceeding, in this proceeding we are addressing only the ERO's
definition of the term bulk electric system.
---------------------------------------------------------------------------

    16. This proposal would eliminate the discretion provided in the
current definition for a Regional Entity to define ``bulk electric
system'' within a region. Importantly, however, we emphasize that we
are not proposing to eliminate all regional variations and we do not
anticipate that the proposed change would affect most entities. The
goal of the proposal is to eliminate significant inconsistencies across
regions and provide a backstop review to ensure that any regional
variations do not compromise reliability and that facilities that could
significantly impact reliability are subject to mandatory rules. Simply
put, if the Commission does not take this step, we are concerned that
we would not be fulfilling the intent of Congress in enacting section
215 to protect reliability of the Nation's Bulk-Power System, including
reliability in major cities. The proposed change in definition and our
rationale and technical support for a new definition, are discussed in
more detail below.
    17. The current ERO definition provides a ``general'' 100 kV
threshold for identifying ``bulk electric system'' facilities:

    As defined by the Regional Reliability Organization, the
electrical generation resources, transmission lines,
interconnections with neighboring systems, and associated equipment,
generally operated at voltages of 100 kV or higher. Radial
transmission facilities serving only load with one transmission
source are generally not included in this definition.\25\
---------------------------------------------------------------------------

    \25\ Order No. 693, FERC Stats. & Regs. ] 31,242 at P 51.

    The definition, however, as noted above, also provides discretion
for a Regional Entity \26\ to define ``bulk electric system'' without
any stated limitation or ERO oversight. Although the Commission
accepted this definition in our early implementation of FPA section
215, in Order No. 672,\27\ we also expressed certain reservations about
the definition and in particular a preference for uniformity of
Reliability Standards. More recently, we have repeated our preference
for a uniformity of definitions used by the ERO and the Regional
Entities.\28\ Similarly, the Commission believes that there should be
uniformity in the definition of bulk electric system and the
identification of facilities that are subject to mandatory Reliability
Standards. Without such uniformity, and assurance of a strong
justification for not complying with a uniform definition, the risk is
that the reliability of the electric system could be compromised.
---------------------------------------------------------------------------

    \26\ In Order No. 693, the Commission recognized the Regional
Entities as the appropriate statutory regional body, and directed
the ERO to substitute ``Regional Entity'' for ``Regional Reliability
Organization'' in mandatory Reliability Standards. Id. at P 157,
321.
    \27\ Order No. 672, FERC Stats. & Regs. ] 31,204 at P 290
(``[t]he Commission believes that uniformity of Reliability
Standards should be the goal and practice, the rule rather than the
exception'').
    \28\ Western Electricity Coordinating Council Regional
Reliability Standard Regarding Automatic Time Error Correction,
Order No. 723, 127 FERC ] 61,176, at P 39 (2009) (``the Commission
believes NERC, as a rule, should develop definitions that apply
uniformly across the different regions. As a general goal, NERC
should work to minimize the use of regional definitions and
terminology * * *.'').
---------------------------------------------------------------------------

    18. The Commission recognizes that there may be limited
circumstances when a variation from the proposed uniform 100 kV
threshold is appropriate. The Commission proposes that a Regional
Entity must seek ERO approval before it exempts any transmission
facility rated at 100 kV or above from compliance with mandatory
Reliability Standards. Pursuant to this proposal, the ERO must submit
to the Commission for review on a facility-by-facility basis any ERO-
approved exception to the proposed threshold that all transmission
facilities at 100 kV or above, except for radial transmission
facilities serving only load, are subject to compliance with mandatory
Reliability Standards. Any such submission must also include adequate
supporting information explaining why

it is appropriate to exempt a specific transmission facility that would
otherwise satisfy the proposed 100 kV threshold. Only after Commission
approval would the proposed exclusion take effect. Such review would
allow flexibility where warranted while providing appropriate oversight
to assure that there is a legitimate need for an exemption. The
Commission seeks comment whether a corresponding revision to the ERO's
Rules of Procedure to accommodate the proposed process is warranted.
    19. Further, the Commission does not propose to change the ERO's
statement that ``[r]adial transmission facilities serving only load
with one transmission source are generally not included in this
definition.'' Likewise, as is currently the case, Regional Entities may
identify ``critical'' facilities, rated at less than the 100 kV, that
are subject to mandatory Reliability Standards, without seeking
approval from the ERO and the Commission.\29\
---------------------------------------------------------------------------

    \29\ See NERC June 2007 Filing at 14.
---------------------------------------------------------------------------

    20. The Commission believes that the proposed 100 kV threshold for
identifying bulk electric system facilities is consistent with current
reliability criteria. Most notably, NERC has applied a definition of
bulk electric system that includes a 100 kV ``general'' threshold for
decades.\30\ As discussed above, seven of eight Regional Entities have
adopted NERC's definition, including the 100 kV threshold, either
verbatim or with limited additional criteria.\31\ Significantly,
ReliabilityFirst Regional Entity, which resulted from a merger of three
historical reliability regions, successfully replaced three ``legacy''
definitions with a 100 kV threshold for defining bulk electric system
facilities.\32\ Moreover, the NERC Statement of Compliance Registry
Criteria, which the ERO and Regional Entities use to determine which
entities should be registered to comply with mandatory Reliability
Standards, also utilizes a 100 kV threshold.\33\ In fact, the Registry
Criteria provide that a load serving entity should be subject to
registration if its peak load exceeds 25 MW ``and is directly connected
to the bulk power (>100 kV) system * * *.'' \34\ Likewise, the Registry
Criteria provide that a transmission owner or transmission operator
should be registered if it owns or operates ``an integrated
transmission element associated with the bulk power system 100 kV and
above * * *.'' \35\
---------------------------------------------------------------------------

    \30\ See, e.g., NERC Board of Trustees, Minutes of the Meeting
at 2-3 (April 3-4, 1995) (noting adoption of definitions, including
a definition of bulk electric system: ``[t]he bulk electric system
is a term commonly applied to that portion of an electric utility
system, which encompasses the electrical generation resources,
transmission lines, interconnections with neighboring systems, and
associated equipment, generally operated at voltages of 100 kV or
higher'').
    \31\ We note that WECC has established a ``BES definition Task
Force,'' which is currently re-evaluating WECC's 100 kV threshold.
This Task Force has previously considered options that include
retaining WECC's current 100 kV threshold, adopting a 200 kV
threshold, or adopting a ``classification by voltage'' definition.
More recently, in December 2009, WECC's Task Force posted a proposal
to retain the 100 kV threshold, and also allow for the exclusion of
facilities with a rating above 100 kV based on a ``material impact''
assessment. Information regarding the Task Force's activities is
available on the WECC Web site at: http://www.wecc.biz/Standards/
Development/BES/default.aspx.
    \32\ See NERC June 2007 Filing at 11. One of the merged
reliability councils in the ReliabilityFirst footprint had
historically excluded transmission facilities with a rating below
230 kV from the definition of bulk electric system. Id. In an
October 1, 2007 letter, ReliabilityFirst informed NERC of its
transition plan to allow sufficient time for entities with
facilities at voltages less than 230 kV to become compliant with
mandatory Reliability Standards. Subsequently, ReliabilityFirst
informed NERC that, as of December 2008, it completed the
transition, and all entities within ReliabilityFirst ``now subscribe
to the stated bulk electric system definition and are required to
comply with the NERC Reliability Standards in accordance with the
new definition.'' NERC Supplemental Compliance Filing at 3 (March 6,
2009), Docket No. RM06-16-000.
    \33\ NERC Statement of Registry Criteria, Revision 5.0 (October
16, 2008) (Registry Criteria).
    \34\ Id. at 7.
    \35\ Id. at 9.
---------------------------------------------------------------------------

    21. In addition, the Commission believes that there is adequate
technical justification for the proposed 100 kV threshold for
identifying bulk electric system facilities for reliability-related
purposes. Events on facilities rated at 115 kV and 138 kV have either
caused or contributed to significant bulk electric system disturbances
and cascading outages. For example, a February 26, 2008 event in the
FRCC region, which resulted in widespread outages, originated from a
fault at a facility connected to the 138 kV transmission system. This
event resulted in the loss of 24 transmission lines and loss of 4,300
MW of generation, associated with thirteen generating units, and
disruption of electric service to more than three million customers for
several hours on average.
    22. Other recent events also evidence the impact of 115 and 138 kV
facilities on bulk electric system reliability. On June 13, 2008, the
electrical failure of a 138 kV motor operated switch on a 138 kV-13 kV
transformer located in the ReliabilityFirst region resulted in the
tripping of two transformers, one due to the electrical failure and the
second due to inappropriate operation of an adjacent protection system.
This event resulted in the tripping of three 138 kV-13kV transformers,
three 138 kV transmission lines, and an estimated loss of approximately
150 MW of firm load in a critical high population density area. A June
27, 2007 event on 138 kV transmission lines in the NPCC region resulted
in sequential tripping of the four 138 kV cable-circuits. The event
resulted in the interruption of service to about 137,000 customers as
well as the loss of five generators and six 138 kV transmission lines.
    23. Transmission lines with a rating of 100-200 kV represent a
significant portion of the total circuit miles of transmission within
the bulk electric system.\36\ As illustrated by the disturbances
described above, the 100-200 kV facilities are important to reliable
operations. Moreover, events that occur on the 100-200 kV facilities
can result in consequences, sometimes severe, to the reliability of the
higher kV system.
---------------------------------------------------------------------------

    \36\ In the Eastern Interconnection, there is a total of 182,288
transmission line circuit miles rated above 100 kV, of which
approximately 103,983 transmission line circuit miles are rated
between 100 kV and 200 kV, or 57 percent of the total. In the
Western Interconnection, approximately 27,318 (or 41 percent) of a
total 66,815 transmission line circuit miles consist of facilities
rated between 100 kV and 200 kV. (Based on information from publicly
available sources, including FERC Form 1. The figures exclude
transmission lines owned by Federal and local governmental
entities.)
---------------------------------------------------------------------------

    24. In addition, there are other compelling technical reasons for
proposing a 100 kV threshold. Certain transmission lines in the U.S.
portion of NPCC region are not identified as bulk electric system
although these transmission lines extend into the footprint of another
Regional Entity where they are considered bulk electric system
facilities. For example, NPCC does not identify two 115 kV transmission
lines--Falconer to Warren, and North Waverly to East Sayre--as part of
the bulk electric system in its region even though the sections of
these lines that connect to PJM's balancing authority area are
considered bulk electric system within the Reliability First
Corporation footprint.
    25. Moreover, reliability coordinators within NPCC have declared
transmission load relief (TLR) events, pursuant to Reliability Standard
IRO-006-4, on certain transmission lines to protect reliability of the
bulk electric system.\37\ Yet, NPCC does not classify the transmission
lines subject to the TLR events as bulk electric system

facilities. For example, the New York Independent System Operator has
declared TLR events on a flowgate named ``Central East ties,'' multiple
times, in some cases for more than twenty four hours, in a ninety-day
period during 2009. The Central East ties consist of ten transmission
elements, three of which operate at 115 kV, all of which were impacted
during the TLR event.\38\ Yet, the three 115 kV transmission elements
are not bulk electric system facilities pursuant to NPCC's current
regional definition of that term. This suggests that entities within
NPCC operate their systems as if certain facilities are important to
protect the reliability of the bulk electric system, even though NPCC
does not identify the same transmission facilities as bulk electric
system elements.
---------------------------------------------------------------------------

    \37\ Pursuant to Reliability Standard IRO-006-4, the TLR
procedure is used by reliability coordinators to prevent or manage
potential or actual violations of ``system operating limits'' and
``interconnection reliability operating limits'' to maintain
reliability of the bulk electric system.
    \38\ See North American Reliability Council, Transmission
Loading Relief Log (June 2009), https://www.crc.nerc.net/.
---------------------------------------------------------------------------

    26. Thus, the Commission believes that its proposal to direct the
ERO to consistently maintain a 100 kV threshold for identifying bulk
electric system facilities for reliability purposes, with exceptions
allowed only with ERO and Commission oversight, is justified based on
(1) the need to eliminate inappropriate inconsistencies among regions,
(2) the historical and current application of a 100 kV threshold to
identify the bulk electric system for reliability purposes, and (3) the
technical justification for a 100 kV threshold provided above,
including events on facilities rated at 115 kV and 138 kV that have
caused or contributed to significant bulk electric system disturbances
and cascading outages.
    27. As discussed above, information provided by the ERO indicates
that seven of eight Regional Entities currently have regional
definitions of ``bulk electric system'' that are consistent with the
ERO definition, either verbatim or with limited additional criteria.
Thus, the Commission does not believe that the proposal would have an
immediate effect on entities in any Regional Entity other than NPCC.
Based on NERC's and NPCC's responses to the Commission's December 2008
Order, it appears that a significant number of transmission lines in
the U.S. portion of the NPCC region rated at 115 kV and 138 kV are
currently excluded from NPCC's definition of bulk electric system. The
Commission recognizes that, similar to the transition that occurred in
the ReliabilityFirst region, entities within the U.S. portion of NPCC
would likely require a reasonable period of time to ensure that they
can comply with mandatory Reliability Standards for previously-exempt
facilities. Therefore, the Commission proposes to allow a Regional
Entity impacted by the Commission's final rule in this matter to submit
a transition plan that allows a reasonable period of time for affected
entities within that region to achieve compliance with respect to
facilities that are subject to mandatory Reliability Standards for the
first time.\39\
---------------------------------------------------------------------------

    \39\ We note that for certain specific matters (such as
operating reserves and protection), NPCC has more stringent criteria
than NERC Reliability Standards, which NPCC refers to collectively
as ``NPCC Criteria.'' NPCC designates each Criteria with a
``Document A'' prefix, such as ``NPCC Document A-6.'' These NPCC
Criteria require the approval of two thirds of the NPCC membership,
but are not submitted to the ERO or Commission for approval. The
Commission's proposal here would not affect the applicability of
NPCC Criteria that are not submitted to the ERO and Commission for
approval. NPCC would not be required to apply NPCC Criteria based on
a 100 kV threshold and, rather, could continue to determine the
applicability of such criteria to facilities in the region based on
NPCC's impact-based methodology.
---------------------------------------------------------------------------

    28. In summary, the Commission proposes to direct the ERO to submit
to the Commission, within 90 days of the effective date of a final
rule, a revised ERO definition of bulk electric system that provides a
100 kV threshold for facilities that are included in the bulk electric
system and eliminates the currently-allowed discretion of a Regional
Entity to define bulk electric system within its system without ERO or
Commission oversight.\40\ The Commission proposes that a Regional
Entity must seek ERO and Commission approval before it exempts a
transmission facility rated at 100 kV or above from compliance with
mandatory Reliability Standards. A Regional Entity may develop a
transition plan that allows a reasonable period of time for affected
entities within that region to achieve compliance with respect to
facilities that are subject to mandatory Reliability Standards for the
first time.
---------------------------------------------------------------------------

    \40\ As discussed above, the Commission does not propose to
change the provision of the ERO's definition that ``[r]adial
transmission facilities serving only load with one transmission
source are generally not included in this definition.'' Likewise,
Regional Entities may identify ``critical'' facilities, rated at
less than the 100 kV, that are subject to mandatory Reliability
Standards, without application to the ERO and the Commission.
---------------------------------------------------------------------------

III. Information Collection Statement

    29. The Office of Management and Budget (OMB) regulations require
approval of certain information collection requirements imposed by
agency rules.\41\ Upon approval of a collection(s) of information, OMB
will assign an OMB control number and an 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
Paperwork Reduction Act (PRA) \42\ requires each federal agency to seek
and obtain OMB approval before undertaking a collection of information
directed to ten or more persons, or continuing a collection for which
OMB approval and validity of the control number are about to
expire.\43\ The PRA defines the phrase ``collection of information'' to
be the ``obtaining, causing to be obtained, soliciting, or requiring
the disclosure to third parties or the public, of facts or opinions by
or for an agency, regardless of form or format, calling for either--(i)
answers to identical questions posed to, or identical reporting or
recordkeeping requirements imposed on ten or more persons, other than
agencies, instrumentalities, or employees of the United States; or (ii)
answers to questions posed to agencies, instrumentalities, or employees
of the United States which are to be used for general statistical
purposes.'' \44\
---------------------------------------------------------------------------

    \41\ 5 CFR 1320.11.
    \42\ 44 U.S.C. 3501-20.
    \43\ 44 U.S.C. 3502(3)(A)(i), 44 U.S.C. 3507(a)(3).
    \44\ 44 U.S.C. 3502(3)(A).
---------------------------------------------------------------------------

    30. This NOPR proposes to direct the ERO to revise its definition
of the term bulk electric system to provide a 100 kV threshold for
identifying bulk electric system facilities and requiring ERO and
Commission approval of a Regional Entity definition of bulk electric
system that varies from the ERO's definition of the term. In Order No.
693, the Commission approved the ERO's definition of the term bulk
electric system. The Commission also approved 83 Reliability Standards
submitted by the ERO. The Commission's proposed action in this NOPR
does not specify any information collection requirements. However, the
proposal would likely result in certain responsible entities having to
comply with mandatory Reliability Standards with respect to certain
facilities in the 100 kV to 200 kV range for the first time. While the
previously-approved Reliability Standards do not require reporting to
the Commission, they do require responsible entities to develop and
maintain certain information for a specified period of time, subject to
inspection by the ERO or Regional Entities. Thus, the proposed revision
to the ERO's definition of bulk electric system in this proceeding
would likely increase the public reporting burden estimate provided in
Order No. 693.\45\
---------------------------------------------------------------------------

    \45\ See Order No. 693, FERC Stats. and Regs. ] 31,242 at P
1904.

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

    31. Public Reporting Burden: As discussed above, the Commission
believes that only one Regional Entity, NPCC, would be immediately
affected by the Commission's proposal. In particular, the Commission
believes that transmission owners, transmission operators and
transmission service providers in the U.S. portion of the NPCC region
would be affected by the Commission's proposal. Based on registration
information available on NPCC's Web site, it appears that approximately
33 transmission owners, transmission operators and transmission service
providers in the U.S. portion of the NPCC region would potentially be
affected by the Commission's proposal.\46\ These entities are currently
responsible for complying with applicable mandatory Reliability
Standards approved by the Commission in Order No. 693 and subsequent
orders. A final rule in this proceeding would result in the extension
of compliance under these Reliability Standards to additional
facilities within the U.S. portion of the NPCC region.
---------------------------------------------------------------------------

    \46\ ``NPPC Registered Entities as of January 13, 2010,''
available on the NPCC Web site: http://www.npcc.org/.
---------------------------------------------------------------------------

    32. Based on currently available information, the Commission
estimates that the increased Public Reporting Burden as follows:

----------------------------------------------------------------------------------------------------------------
                                      Number of       Number of
         Data collection             respondents      responses    Hours per respondent     Total annual hours
----------------------------------------------------------------------------------------------------------------
FERC-725-A
    Transmission Owners,                       33               1  Reporting: 0........  Reporting: 0.
     Transmission Operators and                                    Recordkeeping: 500..  Recordkeeping: 16,500.
     Transmission Service
     Providers in the U.S.
     portion of the NPCC Region.
                                  ------------------------------------------------------------------------------
        Total....................              33               1  500.................  16,500
----------------------------------------------------------------------------------------------------------------

     Total Annual Hours for Collection: (Reporting +
Recordkeeping) = 16,500 hours.
    Information Collection Costs: The Commission seeks comments on the
costs to comply with these requirements. It has projected the average
annualized cost to be the total annual hours.
    Recordkeeping = 16,500 @ $40/hour = $660,000.
    Labor (file/record clerk @ $17 an hour + supervisory @ $23 an
hour).
     Total costs = $ 660,000.
     Title: FERC-725-A Revision of Definition of Bulk Electric
System.
     Action: Proposed Collection of Information.
     OMB Control No.: 1902-0244.
     Respondents: Business or other for profit, and/or not for
profit institutions.
     Frequency of Responses: On Occasion.
     Necessity of the Information: The proposed revision to the
ERO's definition of the term bulk electric system, if adopted, would
implement the Congressional mandate of the Energy Policy Act of 2005 to
develop mandatory and enforceable Reliability Standards to better
ensure the reliability of the nation's Bulk-Power System. Specifically,
the proposal would ensure that certain facilities needed for the
reliable operation of the nation's bulk electric system are subject to
mandatory and enforceable Reliability Standards.
     Internal Review: The Commission has reviewed the proposed
directive that the ERO revise its current definition of bulk electric
system and determined that the proposal is necessary to meet the
statutory provisions of the Energy Policy Act of 2005. The Commission
has assured itself, by means of internal review, that there is
specific, objective support for the burden estimates associated with
the information requirements.
    33. Interested persons may obtain information on the reporting
requirements by contacting: Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426 [Attention: Michael Miller,
Office of the Executive Director, Phone:<PHONE_NUMBER>, fax: (202)
273-0873, e-mail<EMAIL_ADDRESS>Comments on the
requirements of the proposed rule may also be sent to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20503 [Attention: Desk Officer for the Federal Energy
Regulatory Commission], e-mail<EMAIL_ADDRESS>
IV. Environmental Analysis

    34. 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.\47\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. The actions proposed here fall within the categorical
exclusion in the Commission's regulations for rules that are
clarifying, corrective or procedural, for information gathering,
analysis, and dissemination.\48\ Accordingly, neither an environmental
impact statement nor environmental assessment is required.
---------------------------------------------------------------------------

    \47\ Regulations Implementing the National Environmental Policy
Act, Order No. 486, 52 FR 47897 (Dec. 17, 1987), FERC Stats. &
Regs., Regs. Preambles 1986-1990 30,783 (1987).
    \48\ 18 CFR 380.4(a)(5).
---------------------------------------------------------------------------

V. Regulatory Flexibility Act Certification

    35. The Regulatory Flexibility Act of 1980 (RFA) \49\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
As discussed above, the Commission believes that the immediate effect
of the proposed directive that the ERO revise its current definition of
bulk electric system to establish a 100 kV threshold would likely be
limited to certain transmission owners, transmission operators and
transmission service providers in the U.S. portion of the NPCC region.
Most transmission owners, transmission operators and transmission
service providers do not fall within the definition of small
entities.\50\ The Commission estimates that approximately four of the
33 transmission owners, transmission operators and transmission
services providers may fall within the definition of small entities.
---------------------------------------------------------------------------

    \49\ 5 U.S.C. 601-612.
    \50\ The RFA definition of ``small entity'' refers to the
definition provided in the Small Business Act (SBA), which defines a
``small business concern'' as a business that is independently owned
and operated and that is not dominant in its field of operation. See
15 U.S.C. 632 (2006). According to the SBA, a small electric utility
is defined as one that has a total electric output of less than four
million MWh in the preceding year.
---------------------------------------------------------------------------

    36. Based on this understanding, the Commission certifies that this
rule will not have a significant economic impact on a substantial
number of small

entities. Accordingly, no regulatory flexibility analysis is required.

VI. Comment Procedures

    37. 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 May 10, 2010. Comments must refer to
Docket No. RM09-18-000, and must include the commenter's name, the
organization they represent, if applicable, and their address in their
comments.
    38. The Commission encourages comments to be filed electronically
via the eFiling link on the Commission's Web site 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.
    39. Commenters that are not able to file comments electronically
must send an original and 14 copies of their comments to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street, NE., Washington, DC 20426.
    40. 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

    41. 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 FERC's Home Page (http://www.ferc.gov) and in FERC's
Public Reference Room during normal business hours (8:30 a.m. to 5 p.m.
Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.
    42. From FERC'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 excluding the last three digits of this document in the docket
number field.
    43. User assistance is available for eLibrary and the FERC's Web
site during normal business hours from FERC Online Support at 202-502-
6652 (toll free at 1-866-208-3676) or e-mail at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. E-mail the Public Reference Room at
<EMAIL_ADDRESS>
List of Subjects in 18 CFR Part 40

    Electric power; Reporting and recordkeeping requirements.

    By direction of the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-6479 Filed 3-23-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30131-30133]
[FR Doc No: 2023-09982]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1661]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Expanded Access to
Investigational Drugs for Treatment Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget

(OMB) for review and clearance under the Paperwork Reduction Act of
1995.

DATES: Submit written comments (including recommendations) on the
collection of information by June 9, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0814. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Expanded Access to Investigational Drugs for Treatment Use

OMB Control Number 0910-0814--Revision

    Sometimes called ``compassionate use,'' expanded access (EA) is a
potential pathway for a patient with a serious or immediately life-
threatening disease or condition to gain access to an investigational
medical product (drug, biologic, or medical device) for treatment
outside of clinical trials when no comparable or satisfactory
alternative therapy options are available. Agency regulations in 21 CFR
part 312 provide for individual patient EA and associated procedures
for those submitting EA requests to FDA. We provide resource
information on our website at https://www.fda.gov/news-events/public-health-focus/expanded-access regarding our EA program, including
information for patients, physicians, and industry. We also provide
information pertaining to forms and processes for submitting EA
requests to FDA. Specifically, we have developed electronic Form FDA
3926 ``Individual Patient Expanded Access Investigational New Drug
Application (IND).'' Upon accessing the online form, users may need to
follow certain technical instructions to save the document in a
portable document format (PDF). Form FDA 3926 requires the completion
of data fields that enable FDA to uniformly collect the minimum
information necessary from licensed physicians who want to request EA
as prescribed in the applicable regulations.
    Description of Respondents: Respondents to the collection of
information are licensed physicians who request individual patient
access to investigational drugs.
    In the Federal Register of December 14, 2021 (86 FR 71069), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. However, on our
own initiative, we are proposing the following revisions to associated
Form FDA 3926:

                        Table 1--Summary of Proposed Data Field Changes to Form FDA 3926
----------------------------------------------------------------------------------------------------------------
                                   Includes proposed                              With accompanying instruction
        Current field:                changes to:         Becoming new field:                  to:
----------------------------------------------------------------------------------------------------------------
8. Physician Name, Address,     Delete ``Physician's    1. Physician Name,      Enter the physician's name, name
 and Contact Information.        IND number, if          Name of Institution     of institution or clinical
                                 known'' from this       or Clinical Practice,   practice, and the physician's
                                 field and move to       Address, and Contact    contact information, including
                                 proposed Field 4.a.     Information.            the physical address, email
                                Add ``Name of           Remaining fields         address, telephone number, and
                                 Institution or          become renumbered.      facsimile (FAX) number.
                                 Clinical Practice''
                                 to the title of the
                                 field.
3.a. Initial Submission.......  Add ``enter the         4.a. Initial            If the submission is an initial
                                 Physician's IND         Submission.             (original) submission for an
                                 Number, if previously  [ballot] Select this     individual patient expanded
                                 issued by FDA,''.       box if this form is     access IND (including for
                                                         an initial submission   emergency use), select the box
                                                         for an individual       provided in field 4.a., enter
                                                         patient expanded        the physician's IND number, if
                                                         access IND, enter the   previously issued by FDA, and
                                                         Physician's IND         complete only fields 5 through
                                                         Number, if previously   8, and fields 10 and 11. Do not
                                                         issued by FDA, and      include commercial sponsor's
                                                         complete only fields    IND number.
                                                         5 through 8, and
                                                         fields 10 and 11.
4. Clinical Information.......  Add ``or                5. Clinical             Provide the indication (proposed
Brief Clinical History           sensitivities, race     Information.            treatment use) and a brief
 (Patient's age, gender,         and ethnicity          Brief Clinical History   clinical history of the
 weight, allergies, diagnosis,   (optional)'' after      (Patient's age,         patient. The clinical history
 prior therapy, response to      allergies.              gender, weight,         includes age, gender, weight,
 prior therapy, reason for      Add ``Ethnicity (check   allergies or            allergies or sensitivities
 request, including an           one)'' and list         sensitivities, race     (general (e.g., soy) and drug
 explanation of why the          choice options          and ethnicity           specific) and other optional
 patient lacks other             (Hispanic/Latino or     (optional),             demographic and clinical
 therapeutic options).           Not Hispanic/Latino).   diagnosis, prior        information (e.g., race (as
                                Add ``Race (check all    therapy, response to    reported by the patient; you
                                 that apply)'' and       prior therapy, reason   may choose multiple answers)
                                 list choice options     for request,            and ethnicity (choose only one
                                 (American Indian/       including an            response)), diagnosis (e.g., a
                                 Alaska Native or        explanation of why      brief summary (with dates) of
                                 Asian or Black/         the patient lacks       relevant past medical and
                                 African American or     other therapeutic       surgical history, diagnostic
                                 Native Hawaiian/Other   options).               procedures, current stage/
                                 Pacific Islander or    Ethnicity (check one).   severity of disease, and
                                 White).                [ballot] Hispanic/       functional status), prior
                                                         Latino.                 therapy, response to prior
                                                        [ballot] Not Hispanic/   therapy (e.g., patient was
                                                         Latino.                 treated with drug X and
                                                        Race (check all that     subsequently developed lung
                                                         apply).                 metastasis), and the reason for
                                                        [ballot] American        requesting the proposed
                                                         Indian/Alaska Native.   treatment, including an
                                                        [ballot] Asian........   explanation of why the patient
                                                        [ballot] Black or        lacks other therapeutic options
                                                         African American.       (e.g., patient has failed or is
                                                        [ballot] Native          intolerant to currently
                                                         Hawaiian/Other          available therapy, or is not
                                                         Pacific Islander.       eligible for any clinical
                                                        [ballot] White........   trials registered at
                                                                                ClinicalTrials.gov).

5: Treatment Information......  Add ``(including        Field 6...............  Provide treatment information,
                                 rationale for dose)''.                          including the investigational
                                Add ``(e.g.,                                     drug's name and the name of the
                                 assessment criteria/                            entity supplying the drug
                                 procedure(s) for                                (generally the manufacturer),
                                 monitoring and                                  the applicable FDA review
                                 frequency)''.                                   division (if known), and a
                                Add ``(e.g., criteria                            concise statement regarding the
                                 for adjusting dose if                           treatment plan. This includes
                                 dose reduction or                               the planned dose, route and
                                 escalation is                                   schedule of administration of
                                 planned, criteria for                           the investigational drug
                                 stopping the                                    (including rationale for dose),
                                 treatment),''.                                  planned duration of treatment,
                                Add ``(e.g.,                                     monitoring procedures (e.g.,
                                 concomitant                                     assessment criteria/
                                 medication)''.                                  procedure(s) for monitoring and
                                Add ``You may choose                             frequency), planned
                                 to attach an                                    modifications to the treatment
                                 Investigator                                    plan in the event of toxicity
                                 Brochure, scientific                            (e.g., criteria for adjusting
                                 publication(s), or                              dose if dose reduction or
                                 other supporting                                escalation is planned, criteria
                                 documents, if                                   for stopping the treatment),
                                 needed.''.                                      and other relevant information
                                                                                (e.g., concomitant medication).
                                                                                The information should be
                                                                                entered within the space
                                                                                provided. You may choose to
                                                                                attach an Investigator
                                                                                Brochure, scientific
                                                                                publication(s), or other
                                                                                supporting documents, if
                                                                                needed.
None..........................  Add a box option for    9. Contents of          Field 9: Contents of Submission
                                 ``Request for           Submission.             (Follow-up/Additional
                                 Withdrawal'' under     ......................   Submissions Only).
                                 ``Summary of Expanded  [ballot] Request for    Request for Withdrawal: A
                                 Access Use (treatment   Withdrawal.             submission describing the
                                 completed)''.                                   intent to withdraw an effective
                                                                                IND (21 CFR 312.38).
None..........................  Add ``When a waiver is  Field 10.b.: Request    Select this box to request under
                                 requested in this       for Authorization to    21 CFR 56.105, authorization to
                                 manner, the physician   Use Alternative IRB     obtain concurrence by the IRB
                                 does not receive        Review Procedures.      chairperson or by a designated
                                 notice from FDA                                 IRB member, instead of at a
                                 indicating that the                             convened IRB meeting, before
                                 waiver is granted.''.                           the treatment use begins, in
                                                                                order to comply with FDA's
                                                                                requirements for IRB review and
                                                                                approval. When a waiver is
                                                                                requested in this manner, the
                                                                                physician does not receive
                                                                                notice from FDA indicating that
                                                                                the waiver is granted.
None..........................  Add ``Information on    Field 11:               Field 11: Certification
                                 where and how to        Certification           Statement and Signature of the
                                 submit this form is     Statement and           Physician Information on where
                                 available at Expanded   Signature of the        and how to submit this form is
                                 Access--How to          Physician.              available at Expanded Access--
                                 Submit''.                                       How to Submit.
[General Instruction?]........  Insert a statement      [General Instruction?]  Information on where and how to
                                 ``Information on                                submit this form is available
                                 where and how to                                at Expanded Access--How to
                                 submit this form is                             Submit a Request (Forms).
                                 available at Expanded
                                 Access--How to Submit
                                 a Request (Forms)''
                                 under ``Signature of
                                 Physician'' after
                                 Field 11.
----------------------------------------------------------------------------------------------------------------

    We retain the currently approved burden estimate of 13,910
responses and 255,326 hours annually for the information collection. We
anticipate no adjustment as a result of the proposed form updates and
have posted a draft of revised Form FDA 3926 to the docket, available
for public inspection through https://www.regulations.gov.

    Dated: May 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09982 Filed 5-9-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Proposed Rules]
[Pages 22944-22946]
[FR Doc No: 2016-09033]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2015-1127]
RIN 1625-AA00

Safety Zone; 2016 Wings Over Vermont Air Show, Lake Champlain,
Burlington, VT

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for an aerobatic demonstration over the navigable waters of Lake
Champlain along the shoreline in Burlington, VT. This temporary safety
zone will be necessary to protect spectators and vessels from hazards
associated with the air show. Entry into, transit through, mooring or
anchoring within this regulated area will be prohibited unless
authorized by the Captain of the Port (COTP) Sector Northern New
England (SNNE). We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 20, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-1127 using the Federal eRulemaking Portal http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Chief Marine Science Technician
Chris Bains, Waterways Management Division at Coast Guard Sector
Northern New England, telephone<PHONE_NUMBER>, or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On December 24, 2015, the Vermont National Guard notified the Coast
Guard that they will be holding the 2016 Wings over Vermont Air Show on
Lake Champlain along the shoreline of Burlington, VT from August 12,
2016 through August 14, 2016. The aeronautical box designed for the
performers will measure 12,000 feet long and 4,770 feet wide and will
be approximately 1,100 feet from shoreline. On water viewing locations
will be placed both east and west of the air show box to control vessel
traffic during the demonstration. Lake Champlain Transportation Company
will redirect the ferry route around the aeronautical box so not to
disrupt the safety zone during the enforcement period.
    The purpose of this rulemaking is to ensure the safety of the
spectator vessels and other traffic using the navigable waters near or
around the designated aeronautical box. The Coast Guard proposes this
rulemaking under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone for the Wings over
Vermont Air Show from 9 a.m. to 6 p.m. on August 12- 14, 2016 on Lake
Champlain, along the shoreline of Burlington, VT. The safety zone would
cover all navigable waters within an aeronautical box extending to and
including the breakwater bounded by the following coordinates:
44[deg]29'24'' N./073[deg]14'44'' W.; 44[deg]29'24'' N./073[deg]14'03''
W.; 44[deg]28'56'' N./073[deg]14'03'' W.; 44[deg]28'50'' N./
073[deg]13'48'' W.; 44[deg]28'12'' N./073[deg]13'33'' W.;
44[deg]27'47'' N./073[deg]14'03'' W.; 44[deg]27'25'' N./073[deg]14'03''
W.; 44[deg]27'25'' N./073[deg]14'44'' W. The duration of the zone is
intended to ensure the safety of vessels and these navigable waters
before, during, and after the scheduled 10 a.m. to 5 p.m. aerobatic
displays. No vessel or person would be permitted to enter the safety
zone without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive Orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    The Coast Guard has determined that this rule is not a significant
regulatory action for the following reasons: The safety zone will be of
limited duration and will only be in effect during a portion of three
days, it will allow vessels to transit in waters directly adjacent to
the safety zone, and coordinated efforts have been made to direct the
ferry traffic around the safety zone so not to disrupt service on Lake
Champlain. Additionally, maritime advisories will be posted in the
Local Notice to Mariners and the Coast Guard will issue a Broadcast
Notice to Mariners via VHF-FM marine Channel 16 prior to and during the
entire duration of the enforcement period.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A this proposed rule would not have a significant economic impact on
any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person

listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard
will not retaliate against small entities that question or complain
about this proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under the Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it will not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting a portion of three days and would prohibit entry into
without permission from the COTP. Normally such actions are
categorically excluded from further review under paragraph 34 of figure
2-1 of Commandant Instruction M16475.1D. A preliminary environmental
analysis checklist supporting this is available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this notice, and all public comments, are in
our online docket at http://www.regulations.gov and can be viewed by
following that Web site's instructions. Additionally, if you go to the
online docket and sign up for email alerts, you will be notified when
comments are posted or a final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and record
keeping requirements, Security Measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5 and Department of Homeland Security Delegation No.
0170.1

0
2. Add Sec.  165.T01-1127 to read as follows:

Sec.  165.T01-1127  Safety Zone; 2016 Wings Over Vermont Air Show, Lake
Champlain; Burlington, VT

    (a) Location. The following area is a Safety Zone: All navigable
waters, from surface to bottom, of Lake Champlain, Burlington, VT,
within an aeronautical box extending to and including the breakwater
bounded by the following coordinates: 44[deg]29'24'' N./073[deg]14'44''
W.; 44[deg]29'24'' N./073[deg]14'03'' W.; 44[deg]28'56'' N./
073[deg]14'03'' W.; 44[deg]28'50'' N./073[deg]13'48'' W.;
44[deg]28'12'' N./073[deg]13'33'' W.; 44[deg]27'47'' N./073[deg]14'03''
W.; 44[deg]27'25'' N./073[deg]14'03'' W.; 44[deg]27'25'' N./
073[deg]14'44'' W.
    (b) Effective and enforcement period. This rule would be effective
and would be enforced with actual notice from 9 a.m. until 6 p.m. on
August 12-14, 2016.
    (c) Regulations. (1) The general regulations contained in 33 CFR
165.23 apply. During the enforcement period, entry into, transiting,
mooring, anchoring or remaining within this safety zone is prohibited
unless authorized by the Captain of the Port or his designated
representatives.
    (2) Vessel operators given permission to enter or operate in the
safety zone must comply with all directions given to them by the
Captain of the Port or his designated representatives.
    (3) Persons and vessels may request permission to enter the safety
zone by contacting the COTP or the COTP's designated representative on
VHF-16 or via phone at<PHONE_NUMBER>.

    (4) The ``designated representative'' is any Coast Guard
commissioned, warrant, or petty officer who has been designated by the
Captain of the Port to act on his behalf. The on-scene representative
may be on a Coast Guard vessel, a Coast Guard Auxiliary vessel, or
onboard a local or state agency vessel that is authorized to act in
support of the Coast Guard. Additionally, the Coast Guard Auxiliary may
be present to inform vessel operators of this regulation.
    (5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel must proceed
as directed.

    Dated: March 16, 2016.
M.A. Baroody,
Captain, U.S. Coast Guard, Captain of the Port, Sector Northern New
England.
[FR Doc. 2016-09033 Filed 4-18-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Notices]
[Page 47676-47677]
[DOCID:fr06au10-153]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms, and Record Keeping Requirements; Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collection and the expected
burden. The Federal Register Notice with a 60-day comment period was
published on May 12, 2010 (75 FR 26837-26838).

DATES: Comments must be submitted on or before [insert date 30 days
after publication].

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th

Street, NW., Washington, DC 20503, Attention NHTSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Randolph Atkins, PhD, Office of
Behavioral Safety Research, National Highway Traffic Safety
Administration, NTI-131, Room W46-500, 1200 New Jersey Ave, SE.,
Washington, DC 20590. Dr. Atkins' phone number is<PHONE_NUMBER> and his
e-mail address is<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Title: Investigate the Use and Feasibility of Speed Warning
Devices.
    Type of Request: New information collection request--debriefing
session follow-up with participants from an earlier on-road
instrumented vehicle study.
    Abstract: Speeding is one of the primary factors leading to vehicle
crashes. In 2008, 31% of all fatal crashes were speeding-related. The
estimated economic cost to society for speeding-related crashes is
$40.4 billion per year. Driving at higher speeds reduces the ability of
drivers to avoid obstacles or react to sudden changes in the roadway
environment and increases the severity of crashes. Of particular
concern are the habitual speeders and aggressive drivers for whom other
countermeasures, such as enforcement, licenses suspensions, and fines,
are not effective deterrents. The data collected in this study will
provide NHTSA with important information on a countermeasure with the
potential to address an especially challenging segment of the driving
population that poses an inordinately high safety risk to themselves
and other drivers who share the roads with them. In this pilot study,
NHTSA will be conducting on-road instrumented vehicle data collection
with drivers who have a history of speeding violations to examine the
impact of in-vehicle speed warning devices on their driving speed
patterns and speeding behavior. Participants will be asked to install a
speed warning device for eight weeks. The device will provide data on
travel speeds of participants' vehicles coupled with GPS information
that is linked to a database with speed limits for various sections of
roads in the study area. After completing their on-road phase of the
data collection, participating drivers will be asked to participate in
a short debriefing interview while the in-vehicle warning device is
removed from their vehicle. The debriefing sessions will focus on the
drivers' subjective experience regarding the speed warning device--how
it affected their driving behavior, any problems experienced with the
device, how they interacted with the device, and their opinion of the
device, as well as feedback on their experience as a participant in the
study. This subjective data will be coupled with the data from their
actual driving behavior to help NHTSA develop a better understanding of
speeding and speeders and the potential acceptance and effectiveness of
using speed warning devices as a countermeasure to alter the speeding
behavior of habitual speeders. The debriefing sessions are expected to
provide data relevant to implementation issues and concerns associated
with the device, as well as the key advantages and disadvantages
associated with the use of this device as a countermeasure.
    Affected Public: NHTSA plans to recruit 80 drivers from the
Rockville, MD area, with a driving history of at least three speeding
violations in the previous five years, through the MVA. The
participants will be stratified; with 20 male and 20 female drivers age
18-29 and 20 male and 20 female drivers age 30 and above. Participation
would be voluntary and confidential.
    Estimated Total Annual Burden: The total estimated annual burden is
40 hours for the debriefing session (80 x 30 minutes per session) while
the monitoring device is being removed from their vehicle. The
participants would not incur any reporting cost from the information
collection and will receive a $150 honorarium for data collection. The
participants would not incur any record keeping burden or record
keeping cost from the information collection.
    Comments are invited on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed information collection;
    (iii) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) Ways to minimize the burden of the collection of information
on respondents, including the use of automated collection techniques or
other forms of information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication.

    Authority: 44 U.S.C. 3506(c)(2)(A).

    Issued on: August 3, 2010.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2010-19352 Filed 8-5-10; 8:45 am]
BILLING CODE 4910-59-P