			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on June 17, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST 2000-7150

________________________________________________________________________
_____________This serves as notice to the public of the action described
below, taken by the Department official indicated (no additional
confirming order will be issued in this matter).

Application of  AMERICAN AIRLINES, INC.,  filed 5/28/2004, for:

XX  Renewal of exemption under 49 U.S.C. §40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between points in the United States and points in Turkey, with the right
to integrate such authority with American’s existing certificates of
public convenience and necessity and other exemptions.  American states
that it uses the authority to engage in code-sharing services with
Turkish Airlines.

Applicant rep:   Carl B. Nelson, Jr.<PHONE_NUMBER>     DOT Analyst:
Linda Senese<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken:   June 17, 2004,  through
June 17, 2006.                                     .

Action taken by:   Paul L. Gretch, Director

                               Office of International Aviation

XX   The authority granted is consistent with the aviation agreement
between the United States and Turkey.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

	XX  Holder’s certificates of public convenience and necessity

	XX  Standard exemption conditions (attached)

XX  Statement of authorization approving American/Turkish Airlines
code-share operations dated July 20, 2000

________________________

Conditions:  The route integration authority granted is subject to the
condition that any service provided under this exemption shall be
consistent with all applicable agreements between the United States and
the foreign countries involved.  Furthermore, (a) nothing in the award
of the route integration authority requested should be construed as
conferring upon American additional rights (including fifth-freedom,
intermediate, and/or beyond rights), to serve markets where U.S. carrier
entry is limited unless American notifies the Department of American’s
intent to serve such a market and unless and until the Department has

(See Next Page)2

completed any necessary carrier selection procedures to determine which
carrier(s) should be authorized to exercise such rights; and (b) should
there be a request by any carrier to use the limited-entry route rights
that are included in American’s authority by virtue of the route
integration authority granted here, but that are not then being used by
American, the holding of such authority by route integration will not be
construed as providing any preference for American in a competitive
carrier selection proceeding to determine which carrier(s) should be
entitled to use the authority at issue.

________________________________________________________________________
_____________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/report_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										05/2004


[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16238-16240]
[FR Doc No: 2016-06746]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77412; File No. SR-ISEMercury-2016-06]

Self-Regulatory Organizations; ISE Mercury, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Schedule of Fees

March 21, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 10, 2016, ISE Mercury, LLC (the ``Exchange'' or ``ISE
Mercury'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change, as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    ISE Mercury proposes to amend its Schedule of Fees to count 100% of
eligible traded volume preferenced to a Market Maker towards that
member's volume tiers. The text of the proposed rule change is
available on the Exchange's Internet Web site at http://www.ise.com, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The self-regulatory organization has prepared summaries,
set forth in Sections A, B and C below, of the most significant aspects
of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On March 10, 2016, ISE Mercury filed a proposed rule change to
introduce fee and rebate tiers for Market Maker \3\ and Priority
Customer \4\ orders based on the average daily volume (``ADV'') that a
member executes in Priority Customer orders.\5\ Pursuant to that
proposed rule change, the Exchange will assess fees and rebates for
Market Maker and Priority Customer orders based on five tiers of Total
Affiliated Priority Customer ADV: \6\ 0-19,999 contracts (``Tier 1''),
20,000-39,999 contracts (``Tier 2''), 40,000-59,999 contracts (``Tier
3''), 60,000-79,999 contracts (``Tier 4''), and 80,000 or more
contracts (``Tier 5'').\7\ As is the case on ISE Mercury's affiliated
exchanges--the International Securities Exchange, LLC (``ISE'') and ISE
Gemini, LLC (``ISE Gemini'')--the Exchange's ADV calculation will also
include volume executed by affiliated members. In particular, the
Exchange will aggregate all eligible volume from affiliated members in
determining applicable tiers, provided that there is at least 75%
common ownership between the members as reflected on the member's Form
BD, Schedule A. While this method of aggregating volume is beneficial
to large firms with multiple affiliated members, the Exchange believes
that it is important to give smaller firms the ability to compete for
more favorable fees and rebates. The Exchange therefore proposes to
adopt ADV tiers that are based on preferenced volume--i.e., volume
directed to a specific Market Maker as provided in Supplementary
Material .03 to Rule 713.\8\ In particular, the Exchange proposes to
give Market Makers volume credit for 100% of eligible traded volume
preferenced to that member,\9\ regardless of the actual allocation that
the Market Maker receives. For example, assume Market Maker ABC is
quoting at the national best bid or offer (``NBBO'') and receives a
Preferenced Order for 10 contracts from an unaffiliated firm for the
account of a Priority Customer. If there are other Market Makers
quoting at the NBBO, Market Maker ABC may receive an allocation of 4
contracts--i.e., 40% of the order. Rather than counting only the 4
contracts executed towards

the Market Maker's volume total, the Exchange now proposes to give that
Market Maker credit for the full 10 contracts preferenced to it. This
is the same credit the member would receive if the 10 contracts were
sent to the exchange by an affiliated member, and the Exchange believes
that this will put smaller Market Makers on more equal footing with
large firms that benefit from affiliated volume.
---------------------------------------------------------------------------

    \3\ The term Market Makers refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively.
    \4\ A ``Priority Customer'' is a person or entity that is not a
broker/dealer in securities, and does not place more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s), as defined in ISE Mercury Rule
100(a)(37A).
    \5\ See ISE Mercury-2016-05.
    \6\ The Total Affiliated Priority Customer ADV category includes
all Priority Customer volume executed on the Exchange in all symbols
and order types, including volume executed in the PIM, Facilitation,
and QCC mechanisms.
    \7\ The highest tier threshold attained applies retroactively in
a given month to all eligible traded contracts and applies to all
eligible market participants. Any day that the market is not open
for the entire trading day or the Exchange instructs members in
writing to route their orders to other markets may be excluded from
the ADV calculation; provided that the Exchange will only remove the
day for members that would have a lower ADV with the day included.
    \8\ An Electronic Access Member (``EAM'') may designate a
``Preferred Market Maker'' on orders it enters into the System
(``Preferenced Orders''). Supplementary Material .03 to Rule 713
describes the Exchange's rules concerning Preferenced Orders.
    \9\ ``Eligible volume'' refers to volume that would otherwise
count towards to applicable volume tier. In the case of ADV
thresholds based on Total Affiliated Priority Customer ADV, as
currently implemented on ISE Mercury, all Priority Customer volume
would be ``eligible.'' See note 6 supra.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\10\ in general, and
Section 6(b)(4) of the Act,\11\ in particular, in that it is designed
to provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
The Exchange believes that the proposed fee change is reasonable and
equitable as it provides an additional way for members to increase
volume used to qualify for lower fees and higher rebates. The Exchange
has adopted volume based fees and rebates in another proposed rule
change filed with the Commission. While volume based fees and rebates
based on affiliated volume benefit Market Makers that have affiliated
order routers, the Exchange believes that smaller Market Makers that
attract order flow from non-affiliated firms should similarly be able
to compete for more favorable fees and rebates. Preferred Market Makers
attract order flow by establishing appropriate relationships with one
or more EAMs that send Preferenced Orders to the Exchange. Although
Preferred Market Makers may not be allocated the full volume orders
preferenced to them, the Exchange believes that it is reasonable and
equitable to give these Market Makers full credit for the volume of
orders that they have attracted to ISE Mercury. This will put smaller
Market Makers that are not affiliated with an order routing firm on
more equal footing with large firms that benefit from affiliated volume
today. In addition, the Exchange does not believe that it is unfairly
discriminatory to provide this incentive specifically to Preferred
Market Makers. As explained above, Preferred Market Makers attract
order flow to the Exchange by establishing relationships with EAMs that
direct Preferenced Orders to them. Moreover, all Market Makers are
eligible to become Preferred Market Makers provided that they meet the
quoting obligations expected of such firms.\12\
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    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
    \12\ Preferred Competitive Market Makers have quoting
obligations that mirror those for Primary Market Makers. See
Supplementary Material .03(d) to Rule 713 and Rule 804(e)(2)(iii).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\13\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. To the contrary,
the Exchange believes that the proposed rule change will increase
competition by allowing smaller Market Makers to compete for more
favorable fees and rebates. As currently implemented, Market Makers
that are affiliated with an order router are advantaged relative to
other firms in achieving volume based fees and rebates. Although the
Exchange continues to believe that counting volume across affiliated
members is appropriate,\14\ the Exchange also believes that Market
Makers whose relationships attract Preference Orders should also
receive similar benefits. As explained above, these Market Makers
attract significant volume to the Exchange but currently only receive
volume credit for a portion of that volume. The proposed rule change is
designed to level the playing field between these members and their
competitors that already benefit from affiliated volume. The Exchange
operates in a highly competitive market in which market participants
can readily direct their order flow to competing venues. For the
reasons described above, the Exchange believes that the proposed fee
change reflects this competitive environment.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b)(8).
    \14\ See note 5 supra.
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\15\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\16\ because it establishes a due, fee, or other charge
imposed by ISE Mercury.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \16\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISEMercury-2016-06 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISEMercury-2016-06. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of

10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISEMercury-2016-06, and
should be submitted on or before April 15, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-06746 Filed 3-24-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Pages 71612-71620]
[FR Doc No: 2022-25589]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RD22-4-000]

Before Commissioners: Richard Glick, Chairman; James P. Danly,
Allison Clements, Mark C. Christie, and Willie L. Phillips;
Registration of Inverter-Based Resources; Registration of Inverter-
Based Resources

    1. In order to address concerns regarding the reliability impacts
of

inverter-based resources (IBR) \1\ on the Bulk-Power System,\2\ the
Commission directs the North American Electric Reliability Corporation
(NERC) to submit a work plan within 90 days of the issuance of this
order describing, in detail, how it plans to identify and register
owners and operators of IBRs that are connected to the Bulk-Power
System, but are not currently required to register with NERC under the
bulk electric system (BES) definition \3\ (referred to as
``unregistered IBRs'' throughout this order) that have an aggregate,\4\
material impact on the reliable operation of the Bulk-Power System. The
work plan should explain how NERC will modify its processes to address
unregistered IBRs (whether by working with stakeholders to change the
BES definition, a change to its registration program, or some other
solution) within 12 months of approval of the work plan. The work plan
should also include implementation milestones ensuring that owners and
operators meeting the new registration criteria are identified within
24 months of the approval date of the work plan, and that they are
registered and required to comply with applicable Reliability Standards
within 36 months of the approval date of the work plan. The work plan
will be noticed for public comment. Once the Commission approves the
proposed work plan, we direct NERC to file progress updates every 90
days thereafter detailing NERC's progress towards identifying and
registering owners and operators of unregistered IBRs.
---------------------------------------------------------------------------

    \1\ This order uses the term IBRs to include all generating
facilities that connect to the electric power system using power
electronic devices that change direct current (DC) power produced by
a resource to alternating current (AC) power compatible with
distribution and transmission systems. This order does not address
IBRs connected to the distribution system.
    \2\ The Bulk-Power System is defined in the Federal Power Act
(FPA) as facilities and control systems necessary for operating an
interconnected electric energy transmission network (or any portion
thereof), and 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. 16
U.S.C. 824o(a)(1).
    \3\ NERC's Commission-approved BES definition is a subset of the
Bulk-Power System and defines the scope of the Reliability Standards
and the entities subject to NERC compliance. Revisions to Elec.
Reliability Org. Definition of Bulk Elec. Sys. & Rules of Proc.,
Order No. 773, 78 FR 804 (Jan. 4, 2013), 141 FERC ] 61,236 (2012),
order on reh'g, Order No. 773-A, 78 FR 29209 (May 17, 2013), 143
FERC ] 61,053 (2013) rev'd sub nom. People of the State of N.Y. v.
FERC, 783 F.3d 946 (2d Cir. 2015) (rejecting New York's challenge to
the presumptive threshold for local distribution lines at 100 kV,
adopted for implementing Reliability Standards for the Bulk-Power
System); NERC, Glossary of Terms Used in NERC Reliability Standards,
5-7 (Mar. 29, 2022), https://www.nerc.com/pa/Stand/Glossary%20of%20Terms/Glossary_of_Terms.pdf (NERC Glossary).
    \4\ This order focuses on unregistered IBRs that may have
smaller individual capacities but which, when considered together or
in the aggregate, have a material impact on the reliability of the
Bulk-Power System. Pursuant to its registration program, NERC may
already register resources that have an individual material impact.
---------------------------------------------------------------------------

    2. The Bulk-Power System generation resource mix is undergoing a
rapid change, including the projected addition over the next decade of
an ``unprecedented proportion of nonsynchronous resources,'' \5\ i.e.,
IBRs. According to NERC, the rapid integration of IBRs is ``the most
significant driver of grid transformation'' on the Bulk-Power
System.\6\ However, despite the potential for IBRs to have a
significant aggregate impact on the Bulk-Power System, many of the
owners and operators of these individual resources are not required to
register with NERC or comply with NERC's mandatory Reliability
Standards.
---------------------------------------------------------------------------

    \5\ NERC, 2020 Long Term Reliability Assessment Report, 9 (Dec.
2020), https://www.nerc.com/pa/RAPA/ra/Reliability%20Assessments%20DL/NERC_LTRA_2020.pdf.
    \6\ NERC, Inverter-Based Resource Strategy: Ensuring Reliability
of the Bulk Power System with Increased Levels of BPS-Connected
IBRs, 1 (Sep. 14, 2022), https://www.nerc.com/comm/Documents/NERC_IBR_Strategy.pdf (NERC IBR Strategy).
---------------------------------------------------------------------------

    3. To identify which Bulk-Power System users, owners, and operators
must register with NERC and comply with mandatory Reliability
Standards, NERC applies its Commission-approved definition of BES. This
definition identifies elements \7\ and groups of elements, including
generation elements, that are necessary for the reliable planning and
operation of the Bulk-Power System. The BES definition includes a
``bright line'' for identifying all transmission elements operated at
100 kV or higher and real and reactive power resources connected at 100
kV or higher. After applying the bright line, the BES definition also
lists a series of exceptions to the bright line that NERC may apply to
either include within the BES elements that fall below the bright line
(inclusions), or to exclude elements from the BES that meet the bright
line (exclusions). The BES definition does not include facilities used
in the local distribution of electric energy. Entities that use, own,
or operate elements of NERC's approved definition of BES are users,
owners, and operators of the Bulk-Power System and candidates for
registration.\8\
---------------------------------------------------------------------------

    \7\ ``Element'' is defined in the NERC Glossary as: ``Any
electrical device with terminals that may be connected to other
electrical devices such as a generator, transformer, circuit
breaker, bus section, or transmission line. An element may be
comprised of one or more components.'' NERC Glossary at 11.
    \8\ NERC Rules of Procedure, App. 5B (Statement of Compliance
Registry) at 4.
---------------------------------------------------------------------------

    4. Unregistered IBRs connecting to the Bulk-Power System do not
meet the current BES definition, are not registered with NERC, and are
not required to comply with Reliability Standards.\9\ While NERC has
the capability to individually register unregistered IBRs connected to
the Bulk-Power System through its materiality test, a non-exclusive
series of factors used to assess whether an element has a material
impact on reliability,\10\ NERC's materiality test is typically used to
assess an individual entity's material impact and not the aggregate
impact of a class of facilities. NERC has not, to date, applied the
materiality test to unregistered IBRs to determine whether they have an
aggregate material impact on the reliable operation of the Bulk-Power
System.
---------------------------------------------------------------------------

    \9\ NERC, Improvements to Interconnection Requirements for BPS-
Connected Inverter-Based Resources, at 1, (Sept. 2019) (IBR
Interconnection Requirements Guideline) (reporting that the majority
of newly interconnecting IBRs are either connecting at voltages less
than 100 kV or with capacity less than 75 MVA and therefore do not
meet the size criteria in the BES definition). All NERC Guidelines
referenced in this order are available on NERC's website at https://www.nerc.com/comm/Pages/Reliability-and-Security-Guidelines.aspx.
    \10\ See NERC Rules of Procedure, App. 5B at 7-8 (listing a non-
exclusive set of factors (materiality test) for consideration in
registration decisions).
---------------------------------------------------------------------------

    5. In a series of reports detailing grid disturbances over the past
six years, NERC has determined that the operational characteristics of
IBRs, regardless of size, coupled with their equipment settings, may
cause IBRs to reduce power output, whether by tripping offline \11\ or
ceasing operation without tripping offline (known as ``momentary
cessation''),\12\ both individually and in the aggregate, in response
to a single fault on a transmission or sub-transmission system.\13\ For
example, in the San

Fernando Disturbance Report, NERC found that many of the facilities
that unexpectedly and adversely responded to the fault events were
``non-BES solar PV [IBRs] that had a noticeable effect on [Bulk-Power
System] performance in aggregate.'' \14\ This aggregate impact may
occur when individual IBRs' controls and equipment protection settings
are not configured or programmed to ride through \15\ system
disturbances.\16\ These reports demonstrate that the potential for IBRs
to have a material impact on the Bulk-Power System is not limited to
larger IBRs that are typically required to register with NERC or to the
IBRs within an individual balancing authority area. Additionally,
simulations indicate that aggregate IBRs experiencing momentary
cessation can lead to instability, uncontrolled separation, and voltage
collapse.\17\ In areas of high IBR saturation, simulations indicate
that this type of response may have an impact much greater than the
most severe single contingency (i.e., the traditional worst-case N-1
contingency) \18\ of a balancing authority area, potentially impacting
a widespread area.\19\
---------------------------------------------------------------------------

    \11\ Tripping offline is a mode of operation during which part
of or the entire IBR disconnects from the Bulk-Power System and
therefore cannot supply real and reactive power.
    \12\ Momentary cessation is a mode of operation during which the
inverter remains electrically connected to the Bulk-Power System,
but the inverter does not inject current during low or high voltage
conditions outside the continuous operating range. As a result,
there is no current injection from the inverter and therefore no
active or reactive current (and no active or reactive power). NERC,
Reliability Guideline BPS-Connected Inverter-Based Resource
Performance, 11 (Sept. 2018) (IBR Performance Guideline).
    \13\ NERC's IBR disturbance event reports indicate that
unregistered Bulk-Power System connected solar and wind IBRs
(unregistered IBRs) experience identical power reduction and power
loss issues. All NERC event reports referenced in this order are
available on NERC's website at https://www.nerc.com/pa/rrm/ea/Pages/Major-Event-Reports.aspx.
    \14\ NERC and WECC, San Fernando Disturbance, 23 (Nov. 2020)
(San Fernando Disturbance Report). While various NERC reports refer
to ``non-BES'' to describe IBRs that fall below the BES definition
threshold, we understand this term to be synonymous with
``unregistered IBRs.''
    \15\ See Standardization of Generator Interconnection Agreements
and Procedures, Order No. 2003, 68 FR 49846 (Aug. 19, 2003), 104
FERC ] 61,103, at P 562 n.88 (2003) (defining ride through as ``a
Generating Facility staying connected to and synchronized with the
Transmission System during system disturbances within a range of
over- and under-frequency[/voltage] conditions, in accordance with
Good Utility Practice.'').
    \16\ See e.g., NERC and WECC, 900 MW Fault Induced Solar
Photovoltaic Resource Interruption Disturbance Report, 19 (Feb.
2018) (Canyon 2 Fire Event Report) (finding momentary cessation as a
major cause for the loss of IBRs when voltages rose above 1.1 per
unit or decreased below 0.9 per unit).
    \17\ NERC, Resource Loss Protection Criteria Assessment
Whitepaper, at 1-2, key findings 4, 7, 8 (Feb. 2018), https://www.nerc.com/comm/PC/InverterBased%20Resource%20Performance%20Task%20Force%20IRPT/IRPTF_RLPC_Assessment.pdf.
    \18\ The most severe single contingency or the N-1 contingency
generally refers to the concept that a system must be able to
withstand an unexpected failure or outage of a single system
component and maintain reliable service at all times. See NERC
Glossary at 17 (defining ``most severe single contingency'').
    \19\ See, e.g., San Fernando Disturbance Report at vi (stating
that ``[t]his event, as with past events, involved a significant
number of solar photovoltaic (PV) resources reducing power output
(either due to momentary cessation or inverter tripping) as a result
of normally-cleared [Bulk-Power System] faults. The widespread
nature of power reduction across many facilities poses risks to
[Bulk-Power System] performance and reliability.'').
---------------------------------------------------------------------------

    6. Therefore, we find that it is necessary to ensure that
unregistered IBRs that may have an aggregate material impact on the
reliable operation of the Bulk-Power System are required to: (1)
register with NERC, and (2) comply with NERC Reliability Standards.
Hence, we direct NERC, pursuant to our authority under FPA section
215,\20\ to submit for Commission approval within 90 days a work plan
describing in detail how NERC plans to identify and register
unregistered IBRs that, in the aggregate, have a material impact on the
reliable operation of the Bulk-Power System. The work plan should
explain how NERC will modify its processes to encompass unregistered
IBRs (whether by working with stakeholders to change the BES
definition, a change to its registration program, or some other
solution) within 12 months of approval of the work plan. The work plan
should also include implementation milestones ensuring that
unregistered IBR owners and operators meeting the new registration
criteria are identified within 24 months of the approval date of the
work plan, and that they are registered and required to comply with
applicable Reliability Standards within 36 months of the approval date
of the work plan. The work plan will be noticed for public comment.
Once the Commission approves the work plan, NERC must file updates
every 90 days thereafter detailing its progress towards identifying and
registering owners and operators of IBRs (e.g., the number or
percentage of entities identified and/or registered and anticipated
completion date if changed, with an explanation of any such change).
---------------------------------------------------------------------------

    \20\ 16 U.S.C. 824o(b)(1). See also 18 CFR 39.2(d) (2021) (the
ERO shall provide the Commission information as necessary to
implement section 215 of the FPA).
---------------------------------------------------------------------------

    7. In view of the rapid growth of IBRs and their potential to
materially impact the reliability of the Bulk-Power System (including
the potential for unregistered IBRs to materially impact the
reliability of the Bulk-Power System in the aggregate), we are issuing
this order concurrently with a notice of proposed rulemaking that
preliminary finds that the Reliability Standards do not fully address
the impacts of IBRs on the reliable operation of the Bulk-Power System
and that proposes to direct NERC to create new or modified Reliability
Standards that address reliability concerns pertaining to IBRs.\21\
Together, these actions are necessary to ensure that the ongoing
integration of IBRs does not adversely impact the reliable operation of
the Bulk-Power System.
---------------------------------------------------------------------------

    \21\ Reliability Standards to Address Inverter-based Resources,
181 FERC ] 61,125 (2022).
---------------------------------------------------------------------------

I. Background

A. Section 215 of the FPA

    8. Section 215 of the FPA provides that the Commission may certify
an Electric Reliability Organization (ERO), the purpose of which is to
establish and enforce Reliability Standards, subject to Commission
review and approval.\22\ Once approved, the Reliability Standards may
be enforced by the ERO, subject to Commission oversight, or by the
Commission independently.\23\ Pursuant to section 215 of the FPA, the
Commission established a process to select and certify an ERO,\24\ and
subsequently certified NERC.\25\
---------------------------------------------------------------------------

    \22\ 16 U.S.C. 824o.
    \23\ Id. 824o(e)(3).
    \24\ Rules Concerning Certification of the Elec. Reliability
Org.; and Procs. for the Establishment, Approval, & Enforcement of
Elec. Reliability Standards, Order No. 672, 71 FR 8662 (Feb. 17,
2006), 114 FERC ] 61,104, order on reh'g, Order No. 672-A, 71 FR
19814 (Apr. 18, 2006), 114 FERC ] 61,328 (2006).
    \25\ N. Am. Elec. Reliability Corp., 116 FERC ] 61,062 (2006),
order on reh'g and compliance, 117 FERC ] 61,126 (2006) aff'd sub
nom. Alcoa Inc. v. FERC, 564 F.3d 1342 (D.C. Cir. 2009) (certifying
NERC as the ERO responsible for the development and enforcement of
mandatory Reliability Standards).
---------------------------------------------------------------------------

B. NERC Registration

    9. The Commission's regulations require each user, owner, and
operator of the Bulk-Power System to be registered with the ERO and to
comply with applicable Reliability Standards.\26\ NERC registers users,
owners, and operators of the Bulk-Power System through either
application of its BES definition or its materiality test.\27\ As
explained by NERC's Rules of Procedure, ``any entity reasonably deemed
material to the reliability of the [Bulk-Power System] will be
registered, irrespective of other considerations.'' \28\ NERC
determines whether an entity is ``deemed material'' through either
application of its BES definition or its materiality test to an
entity's facilities and elements. Once an entity is identified as a
candidate for registration, the functions it normally performs are
compared to a list of function type definitions.\29\ NERC registers
these Bulk-Power System users, owners, and operators by the reliability
functions they perform (e.g., generator owner or

generator operator),\30\ and to which specific requirements of the
mandatory Reliability Standards are applicable.\31\
---------------------------------------------------------------------------

    \26\ 18 CFR 39.2 (c).
    \27\ NERC Rules of Procedure, App. 5B at 3. See id. at 7-8
(listing the criteria for determining which entities that have a
``material impact'').
    \28\ Id.
    \29\ Id. at 5.
    \30\ See NERC, Active Entities List (updated Oct. 3, 2022),
https://www.nerc.com/pa/comp/Registration%20and%20Certification%20DL/NERC_Compliance_Registry_Matrix_Excel.xlsx.
    \31\ Each Reliability Standard includes an applicability section
that identifies the specific functional entity or subset of
functional entities responsible for compliance with that standard.
---------------------------------------------------------------------------

    10. NERC's registration criteria also allow NERC to limit the
compliance obligations of a given entity registered for a particular
function or of a similarly-situated class of entities, as warranted
based on the particular facts and circumstances, to a subset of
Reliability Standards or requirements.\32\ For example, an entity that
owns underfrequency load shedding (UFLS) protection equipment needed to
implement a required UFLS program designed for the protection of the
BES, but that does not meet any of the other registration criteria for
a distribution provider, would be registered as a ``UFLS-only
distribution provider'' and only be required to comply with a subset of
the Reliability Standards normally required for registered distribution
providers.\33\
---------------------------------------------------------------------------

    \32\ NERC Rules of Procedure, App. 5B at 8.
    \33\ Id. at 7.
---------------------------------------------------------------------------

C. Bulk Electric System Definition

    11. On March 16, 2007, in Order No. 693, pursuant to section 215(d)
of the FPA, the Commission approved 83 of 107 proposed Reliability
Standards and the Glossary of Terms Used in NERC Reliability Standards
(NERC Glossary), which included an early version of NERC's BES
definition.\34\ The Commission observed that the NERC BES definition
omitted ``significant portions of the transmission system component[s]
of the Bulk-Power System'' \35\ but declined to direct NERC at that
time to revise its BES definition. The Commission stated that it would,
for at least an initial period, rely on the NERC BES definition to
determine the applicability of the Reliability Standards; however, the
Commission noted that it ``remains concerned about the need to address
the potential for gaps in coverage of facilities.'' \36\
---------------------------------------------------------------------------

    \34\ Mandatory Reliability Standards for the Bulk-Power Sys.,
Order No. 693, 72 FR 16416 (Apr. 4, 2007), 118 FERC ] 61,218 order
on reh'g, Order No. 693-A, 72 FR 40717 (July 25, 2007), 120 FERC ]
61,053 (2007).
    \35\ Order No. 693, 118 FERC ] 61,218 at P 54.
    \36\ Id. PP 75-76.
---------------------------------------------------------------------------

    12. On November 18, 2010, in Order No. 743, the Commission directed
NERC to revise its definition of the term BES to ensure that the
definition encompasses all facilities necessary for operating an
interconnected transmission network.\37\ The Commission concluded that
the best way to accomplish this was to eliminate the Regional Entity
discretion to define the BES without NERC or Commission review,
maintain a bright-line threshold that includes all facilities operated
at or above 100 kV except radial facilities,\38\ and adopt an exemption
process and criteria for removing from the BES facilities that are not
necessary for operating the interconnected transmission network. In
Order No. 743, the Commission allowed NERC to ``propose a different
solution that is as effective as, or superior to, the Commission's
proposed approach in addressing the Commission's technical and other
concerns so as to ensure that all necessary facilities are included
within the scope of the definition.'' \39\
---------------------------------------------------------------------------

    \37\ Revision to Elec. Reliability Org. Definition of Bulk Elec.
System, Order No. 743, 75 FR 72910 (Nov. 26, 2010), 133 FERC ]
61,150, at P 16 (2010), order on reh'g, Order No. 743-A, 76 FR 16263
(Mar. 23, 2011), 134 FERC ] 61,210 (2011).
    \38\ Id. Order No. 743 uses ``defined radial facilities'' to
mean those radial transmission facilities serving only load with one
transmission source.
    \39\ Id.
---------------------------------------------------------------------------

    13. On January 25, 2012, NERC submitted two petitions to revise its
BES definition and Rules of Procedure pursuant to the directives in
Order No. 743, including: (1) NERC's proposed revision to the
definition of BES with a ``core'' definition (i.e., the 100 kV bright
line) and provisions that include and exclude specific categories of
facilities within the BES irrespective of the bright line; \40\ and (2)
revisions to NERC's Rules of Procedure to add an exception process to
classify or de-classify an element as part of the BES on a case-by-case
basis.\41\ On December 20, 2012, in Order No. 773, the Commission
approved the revisions to the BES definition and the NERC Rules of
Procedure exception process.\42\
---------------------------------------------------------------------------

    \40\ N. Am. Elec. Reliability Corp., Docket No. RM12-6-000
(filed Jan. 25, 2012).
    \41\ N. Am. Elec. Reliability Corp., Docket No. RM12-7-000
(filed Jan. 25, 2012).
    \42\ Order No. 773, 141 FERC ] 61,236.
---------------------------------------------------------------------------

    14. NERC uses the BES definition to identify which users, owners,
and operators of the Bulk-Power System should be registered by first
using the BES definition bright-line (i.e., all elements connected at
100 kV or higher). After the bright line, additional elements may be
identified as BES elements by applying one or more of the five
``Inclusions'' that make up the BES definition.\43\
---------------------------------------------------------------------------

    \43\ The five inclusions are: (1) I1--Transformers; (2) I2--
Generating Resources; (3) I3--Blackstart Resources; (4) I4--
Dispersed Power Producing Resources; and (5) Static or Dynamic
Devices. The NERC Glossary includes additional detail on what
specific configurations are covered by these inclusions. NERC
Glossary at 5-7.
---------------------------------------------------------------------------

    15. On December 13, 2013, NERC filed proposed revisions to the BES
definition to, among other things, address Commission directives in
Order Nos. 773 and 773-A to improve the BES definition inclusions and
exclusions.\44\ On March 20, 2014, the Commission approved
modifications to the BES definition inclusions and exclusions to ensure
that generator interconnection facilities at or above 100 kV connected
to BES generators identified in inclusion I2 (generating resources
connected at a voltage of 100 kV or above with either a gross
individual nameplate rating above 20 MVA or a gross plant/facility
nameplate rating greater than 75 MVA) are not excluded from the
BES.\45\ The Commission also approved revisions to inclusion I4 to
include collector systems from the point where the generation
aggregates to greater than 75 MVA to a common point of connection at a
voltage of 100 kV or above.\46\
---------------------------------------------------------------------------

    \44\ N. Am. Elec. Reliability Corp., Docket No. RD14-2-000, at 2
(filed Dec. 13, 2013).
    \45\ N. Am. Elec. Reliability Corp., 146 FERC ] 61,199, at P 8
(2014).
    \46\ Id. P 19.
---------------------------------------------------------------------------

    16. The inclusions relevant for IBRs are inclusions I2 (generating
resources) and I4 (dispersed power producing resources),\47\ which are
defined as follows:
---------------------------------------------------------------------------

    \47\ The Commission approved NERC's clarification that inclusion
I4's dispersed power producing resources includes variable
generation resources in light of ``the increasing presence of wind,
solar, and other non-traditional forms of generation.'' The
Commission recognized that these individual variable generation
units should be included within the scope of the BES ``where
necessary to support reliability.'' Id. P 47.
---------------------------------------------------------------------------

    I2--Generating resource(s) including the generator terminals
through the high-side of the step-up transformer(s) connected at a
voltage of 100 kV or above with: (a) Gross individual nameplate rating
greater than 20 MVA. Or, (b) Gross plant/facility aggregate nameplate
rating greater than 75 MVA.
    I4--Dispersed power producing resources that aggregate to a total
capacity greater than 75 MVA (gross nameplate rating), and that are
connected through a system designed primarily for delivering such
capacity to a common point of connection at a voltage of 100 kV or
above. Thus, the facilities designated as BES are: (a) The individual
resources, and (b) The system designed primarily for delivering
capacity from the point where those resources aggregate to greater than
75 MVA to a common point of connection at a voltage of 100 kV or above.
    17. Further, in approving revisions to NERC's BES definition in
Order No.

773, the Commission recognized its authority under section 215 of the
FPA to designate an element as part of the BES.\48\ The Commission went
on to explain that ``where an event analysis of a system disturbance
indicates the operational importance of sub-100 kV elements . . . to
reliability, the Commission may find it necessary for the reliable
operation of the interconnected transmission network to designate
facilities to be included in the bulk electric system.'' \49\ The
Commission also explained that it would expect in the normal course
that registered entities, Regional Entities, and NERC would proactively
identify and include those sub-100 kV elements (including generation
elements) in the BES.\50\ But in the case that another entity does not
initiate the registration of such facilities, the Commission stated it
would exercise its authority to do so.\51\
---------------------------------------------------------------------------

    \48\ Order No. 773, 141 FERC ] 61,236 at P 285 (citing authority
under FPA sections 215(a)(1) and (b)(1)).
    \49\ Id.
    \50\ Id. P 288.
    \51\ Id.
---------------------------------------------------------------------------

D. NERC Determination of Material Impact

    18. An entity that does not have elements that fall within the BES
definition may nevertheless be registered if it can be demonstrated
that the entity has a material impact on Bulk-Power System reliability.
To determine whether users, owners, and operators of facilities and
elements that fall outside the BES definition are material to Bulk-
Power System reliability and must be registered, NERC uses a non-
exclusive set of factors (materiality test).\52\ NERC recognizes that
only a subset of the materiality test factors may be applicable to
particular functional registration categories when determining whether
a facility should be registered or deregistered.\53\ All such
registration decisions regarding materiality must be made by a NERC-led
registration review panel.\54\
---------------------------------------------------------------------------

    \52\ NERC Rules of Procedure, App. 5B at 7-8.
    \53\ Id. at 7.
    \54\ Id. The NERC-led registration review panel is comprised of
a NERC lead with Regional Entity participants. The panel evaluates
requests to de-register entities meeting registration criteria,
requests to add an entity that does not meet registration criteria,
disputes regarding application of registration criteria, and
requests for subset lists of applicable Reliability Standards. NERC
Rules of Procedure, App. 5A (Organization Registration and
Certification Manual) at 10.
---------------------------------------------------------------------------

    19. Relevant to IBRs, the factors for determining material impact
include the following:
    Will intentional or inadvertent removal of an Element owned or
operated by the entity, or a common mode failure of two Elements as
identified in the Reliability Standards (for example, loss of two
Elements as a result of a breaker failure), lead to a reliability issue
on another entity's system (such as a neighboring entity's Element
exceeding an applicable rating, or loss of non-consequential load due
to a single contingency)? Conversely, will such contingencies on a
neighboring entity's system result in issues for Reliability Standards
compliance on the system of the entity in question?

. . . .

    Can the normal operation, misoperation, or malicious use of the
entity's Protection Systems (including UFLS [under frequency load
shedding], UVLS [under voltage load shedding], Special Protection
System, Remedial Action Schemes and other Protection Systems protecting
BES Facilities) cause an adverse impact on the operational reliability
of any associated Balancing Authority, Generator Operator or
Transmission Operator, or the automatic load shedding programs of a PC
[planning coordinator] or TP [transmission planner] (UFLS, UVLS)? \55\
---------------------------------------------------------------------------

    \55\ NERC Rules of Procedure, App. 5B at 7-8.
---------------------------------------------------------------------------

II. Discussion

    20. We are issuing this order to ensure that timely action is taken
to address the reliability challenges presented by IBRs because their
individual and aggregate impacts can exacerbate disturbances on the
Bulk-Power System. Such impacts are well documented in studies of Bulk-
Power System disturbances over the past six years, as discussed below.
The rapid growth of IBRs will make these impacts more acute over time
unless they are adequately addressed. Accordingly, we direct NERC
within 90 days of the date of issuance of this order to develop and
submit for Commission approval a work plan describing, in detail, how
NERC will identify and register owners and operators of unregistered
IBRs that in the aggregate materially impact the reliable operation of
the Bulk-Power System.
    21. NERC should explain in its work plan how NERC will modify its
processes to encompass unregistered IBRs (whether by working with
stakeholders to change the BES definition, a change to its registration
program, or some other solution) within 12 months of approval of the
work plan. The work plan should also include implementation milestones
ensuring that unregistered IBR owners and operators meeting the new
registration criteria are identified within 24 months of the approval
date of the work plan, and they are registered and required to comply
with applicable Reliability Standards within 36 months of the approval
date of the work plan. The work plan will be noticed for public
comment. Once the Commission approves the proposed work plan, we direct
NERC to file progress updates every 90 days thereafter detailing NERC's
progress towards modifying its processes and, once the modification is
complete, every 90 days thereafter detailing its progress towards
identifying and registering owners and operators of unregistered IBRs.
    22. IBRs are rapidly becoming a principal source of electric
power,\56\ and in certain areas of the Bulk-Power System the IBR
saturation is significant enough that their operations can materially
impact Bulk-Power System reliability. As their contribution to the
resource mix continues to increase, IBRs present new considerations for
transmission planning and operation of the Bulk-Power System, which was
designed primarily for synchronous generation.\57\ Like synchronous
generators, IBRs such as solar PV, wind, fuel cells, and battery
storage produce real and reactive power; however, they do not react to
disturbances on the transmission system in the same manner as
synchronous generators do. As discussed below, the operational
characteristics and equipment settings of IBRs have in some instances
exacerbated system disturbances both individually and in the aggregate,
and the status quo presents a risk to Bulk-Power System reliability.
---------------------------------------------------------------------------

    \56\ See NERC, 2021 Long Term Reliability Assessment Report, 29
(Dec. 2021). https://www.nerc.com/pa/RAPA/ra/Reliability%20Assessments%20DL/NERC_LTRA_2021.pdf. In the report,
NERC projects IBR nameplate capacity additions of approximately 504
GW of solar and 360 GW of wind (i.e., a total nameplate capacity of
864 GW) and cumulative retirements of approximately 60 GW of
nuclear, coal, natural gas, and biomass to the Bulk-Power System
over the next decade.
    \57\ See e.g., NERC, 2012 Special Assessment Interconnection
Requirements for Variable Generation, 1 (Sept. 2012), https://www.nerc.com/files/2012_IVGTF_Task_1-3.pdf (finding that ``many of
NERC's existing interconnection standards and procedures have been
based on technical characteristics and physical capabilities of
traditional power generation resources that employ synchronous
generators'').
---------------------------------------------------------------------------

    23. Unregistered IBRs often have small individual generation
capacities, are connected to the Bulk-Power System at less than 100 kV
transmission or sub-transmission voltages, and do not meet one of the
inclusions in the BES definition. NERC's materiality test \58\ includes
an assessment of material

impact for individual entities; however, it has not been used to
determine whether unregistered IBRs can, in the aggregate, have a
material impact on the Bulk-Power System such that their owners or
operators should be registered with NERC. As discussed below, the
aggregate impact of unregistered IBRs is not directly addressed by the
BES definition or the materiality test, meaning that the users, owners,
and operators of those unregistered IBRs are not required to register
with NERC and therefore are not required to comply with Reliability
Standards.
---------------------------------------------------------------------------

    \58\ NERC Rules of Procedure, App. 5B at 7-8.
---------------------------------------------------------------------------

A. Unregistered IBRs Continue To Exacerbate Disturbance Events on the
Bulk-Power System

    24. The first documented large-scale reliability issues related to
IBRs occurred in August of 2016 during the Blue Cut Fire event in
California. Until this event, the likelihood of IBRs tripping or
momentarily ceasing during faults on the Bulk-Power System was unclear.
Since the Blue Cut Fire, at least 11 additional NERC-documented events
\59\ have demonstrated common mode failures of IBRs acting unexpectedly
and adversely in response to normally cleared transmission line faults
on the Bulk-Power System.\60\ Most of the early NERC reports, however,
do not provide IBR nameplate capacity of the facilities involved.
Without a breakdown of unregistered IBR and IBR nameplate capacities we
are unable to determine what percentage of the elements involved were
unregistered IBRs. Later studies of IBR-related disturbance events
indicate that a loss of real power generation from unregistered IBRs
contributed to the total resource loss during these disturbances.\61\
---------------------------------------------------------------------------

    \59\ These 12 events report an average of approximately 1,000 MW
of IBRs entering into momentary cessation or tripping in the
aggregate. See Blue Cut Fire Event Report (covering the Blue Cut
Fire (August 16, 2016)); Canyon 2 Fire Event Report (covering the
Canyon 2 Fire (October 9, 2017)); NERC and WECC, April and May 2018
Fault Induced Solar Photovoltaic Resource Interruption Disturbances
Report (Jan. 2019) (Angeles Forest and Palmdale Roost Events Report)
(covering the Angeles Forest (April 20, 2018) and Palmdale Roost
(May 11, 2018) events); San Fernando Disturbance Report (covering
the San Fernando Event (July 7, 2020)); NERC and Texas RE, Odessa
Disturbance (Sept. 2021) (Odessa Disturbance Report) (covering
events in Odessa, Texas on May 9, 2021 and June 26, 2021); NERC and
WECC, Multiple Solar PV Disturbances in CAISO (April 2022) (2021
Solar PV Disturbances Report) (covering four events: Victorville
(June 24, 2021); Tumbleweed (July 4, 2021); Windhub (July 28, 2021);
and Lytle Creek (August 26, 2021)); and NERC and Texas RE, Panhandle
Wind Disturbance, Texas Event: March 22, 2022, (Aug. 2022)
(Panhandle Wind Disturbance Report).
    \60\ Smaller scale events have occurred as well. However, there
is less documentation of smaller scale events in part because NERC
only tracks ``Category 1'' events, which are unexpected outages of
three or more BES facilities, including interruptions of IBRs
aggregated to a 500 MW threshold (Category 1aii and Category 1i).
See, e.g., NERC, ERO Event Analysis Process--Version 4.0, at 2 (Dec.
2019), https://www.nerc.com/pa/rrm/ea/ERO_EAP_Documents%20DL/ERO_EAP_v4.0_final.pdf.
    \61\ As unregistered IBRs do not have to comply with Reliability
Standards or respond to NERC Alerts, it is difficult for NERC to
perform root cause analyses of IBR-disturbance events that fully
reflect unregistered IBR contributions to Bulk-Power System
disturbances. See e.g., 2021 Solar PV Disturbances Report at 13
(``non-BES facilities chose not to respond to the [requests for
information] nor participate in any follow-up discussions to perform
root cause analysis.'').
---------------------------------------------------------------------------

    25. On July 7, 2020, two consecutive faults in northern Los Angeles
county, California resulted in the wide-spread interruption of solar PV
IBRs across the Southern California region, referred to as the ``San
Fernando Disturbance.'' \62\ Those faults included an approximately 205
MW power reduction followed by a 1,000 MW power reduction, both
observed at Bulk-Power System-connected solar PV IBRs.\63\ In the San
Fernando Disturbance Report, NERC found that many of the facilities
that unexpectedly and adversely responded to the fault events were
``non-BES solar PV [IBR] that had a noticeable effect on [Bulk-Power
System] performance in aggregate.'' \64\ NERC explained that the
performance of these types of IBRs ``mirror the responses of the larger
solar PV [IBR] facilities; [and] this is to be expected since the
inverter manufacturer, make, and model are likely similar.'' \65\ The
San Fernando Disturbance Report showed that the active power output
response from two small solar PV IBRs during the disturbance responded
to the normally cleared faults with their inverters entering momentary
cessation and returning to service after several minutes.\66\ During
the event, about 1,000 MW of IBRs tripped or momentarily ceased
operation; 112 MW or about 11% of those IBRs were unregistered
IBRs.\67\
---------------------------------------------------------------------------

    \62\ San Fernando Disturbance Report at 2.
    \63\ Id. at vi.
    \64\ Id. at 23.
    \65\ Id.
    \66\ Id.
    \67\ Id. at app. B, tbl. B.1
---------------------------------------------------------------------------

    26. During the summer of 2021, California experienced four solar PV
IBR disturbance events. Similar to prior disturbances, these four
events involved normally cleared transmission line faults and the loss
of Bulk-Power System-connected solar PV IBRs.\68\ NERC and WECC found
that 13 non-BES connected solar PV IBRs contributed between almost 10%
(in Lytle Creek, 58 MW of 600 MW) and almost 30% (in Tumbleweed, 162 MW
of 566 MW) of the total losses. The report stated that the total number
of non-BES connected solar PV IBRs may have been underestimated because
the count only included solar PV IBRs with active power reduction of
more than 10 MW.\69\ As owners and operators of unregistered facilities
are not required to respond to NERC Alerts (and therefore do not
provide data to NERC), NERC was unable to perform a complete root cause
analysis that included these facilities.\70\
---------------------------------------------------------------------------

    \68\ 2021 Solar PV Disturbances Report at 2.
    \69\ Id. at 36, app. B (providing a detailed review of affected
facilities). NERC and WECC's analysis was limited to solar PV IBRs
that exhibited an active power reduction greater than 10 MW for the
four disturbances.
    \70\ Id. at 13 (noting that ``[n]on-BES facilities chose not to
respond to the [requests for information] nor participate in any
follow-up discussions to perform root cause analysis'').
---------------------------------------------------------------------------

    27. In its 2021 Solar PV Disturbances Report, NERC recognized the
risk posed by non-BES connected IBRs, finding that ``[t]he ongoing
widespread [power] reduction of solar PV [IBR] resources continues to
be a notable reliability risk to the [Bulk-Power System], particularly
when combined with the additional loss of other generating resources on
the [Bulk-Power System] and in aggregate on the distribution system.''
\71\ Further, NERC has stated that ``lack of data visibility and poor
data quality continue to be a concern for comprehensive event analysis
after large [Bulk-Power System] disturbances.'' \72\
---------------------------------------------------------------------------

    \71\ Id. at v.
    \72\ Angeles Forest and Palmdale Roost Events Report at 23.
---------------------------------------------------------------------------

    28. Since the discernment of reliability issues related to IBRs in
2016, NERC has taken the following actions to assess and mitigate the
impact of both registered and unregistered IBRs: (1) published seven
reports documenting 12 events; \73\ (2) issued two NERC Alerts; \74\
(3) issued three reliability guidelines regarding IBR data collection
and performance; \75\ (4) formed an IBR

performance task force (IRPTF) \76\ and system planning impacts from
distributed energy resources working group; (5) issued multiple
technical reports; \77\ and (6) issued an IBR strategy document.\78\
Nevertheless, NERC acknowledges that its actions to date have not
successfully addressed the most common reliability issues posed by
IBRs, like momentary cessation, nor have they resolved any modeling or
other IBR-related performance issues from unregistered IBRs.\79\
---------------------------------------------------------------------------

    \73\ Blue Cut Fire Event Report; Canyon 2 Fire Event Report; the
San Fernando Disturbance Report; the Angeles Forest and Palmdale
Roost Events Report; Odessa Disturbance Report; 2021 Solar PV
Disturbances Report; and the Panhandle Wind Disturbance Report.
    \74\ NERC, Loss of Solar Resources during Transmission
Disturbances due to Inverter Settings (June 2017) (Loss of Solar
Resources Alert I); NERC, Industry Recommendation Loss of Solar
Resources during Transmission Disturbances due to Inverter
Settings--II (May 2018) (Loss of Solar Resources Alert II). All NERC
Alerts referenced in this order are available on NERC's website at
https://www.nerc.com/pa/rrm/bpsa/Pages/Alerts.aspx.
    \75\ See NERC, Reliability Guideline BPS-Connected Inverter-
Based Resource Performance, (Sept. 2018); IBR Interconnection
Requirements Guideline; and NERC, Reliability Guideline Performance,
Modeling, and Simulations of BPS-Connected Battery Energy Storage
Systems and Hybrid Power Plants (Mar. 2021). NERC guidelines are a
collection of best practices and are provided to the industry as
voluntary guidance; they are not mandatory. All NERC guidelines
referenced in this order are available on NERC's website at https://www.nerc.com/comm/Pages/Reliability-and-Security-Guidelines.aspx.
    \76\ The task force became the IBR Performance Working Group in
October 2020, and most recently became the IBR Performance
Subcommittee in March 2022. For consistency, this order uses
``IRPTF'' to refer to all three iterations.
    \77\ See e.g., NERC, Technical Report, BPS-Connected Inverter-
Based Resource Modeling and Studies (May 2020) (Modeling and Studies
Report); NERC, WECC Base Case Review: Inverter-Based Resources (Aug.
2020), (WI Base Case IBR Review). All technical reports referenced
in this order are available on NERC's website at https://nerc.com/comm/PC/Pages/Inverter-Based-Resource-Performance-Task-Force.aspx.
    \78\ NERC IBR Strategy, supra note 6.
    \79\ See e.g., San Fernando Disturbance Report at 23; see also
Odessa Disturbance Report at vi (finding that industry is aware of
the guidance materials published by NERC yet are not comprehensively
adopting those recommendations); see also NERC, Agenda Member
Representatives Committee, at 16 (Apr. 2022) (stating that as NERC
``continue[s] to observe, significant amounts of inverter-based
resources cease or reduce energy production during system faults
just when needed--this increasingly risky behavior impacts the
reliable operation of the bulk power system'').
---------------------------------------------------------------------------

    29. The NERC IRPTF May 2020 technical report explained that the
``[i]nformation from only about one-half of the installed capacity of
[Bulk-Power System]-connected solar PV resources (in the Western
Interconnection) was collected as part of the NERC Alert process based
on the size of resources and their designation as [BES] or non-BES
resources. The extent of model accuracy for those resources that did
not respond to the NERC Alert is unknown.'' \80\ Further, the report
found that ``[w]hile entities owning non-BES resources were requested
to provide data, only BES resources are required to respond to the data
requests in the NERC Alert.'' \81\ As a consequence of not having the
requested unregistered IBR data, the NERC IRPTF made modeling
assumptions that only included roughly half (i.e., approximately 7 GW)
of the existing solar PV IBRs in the WECC base case when performing
system reliability studies to identify potential IBR reliability
issues.\82\ In 2020, NERC and WECC conducted a review of the Western
Interconnection base case transmission planning model and found
numerous modeling errors and omissions regarding IBRs.\83\
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    \80\ Modeling and Studies Report at 2.
    \81\ Id. at 25 n.34.
    \82\ See id. at 24, 25 (finding that while the WECC base case
reflects around 14,500 MW of Bulk-Power System-connected non-BES
solar PV IBRs, only approximately 7,200 MW of Bulk-Power System-
connected non-BES solar PV IBRs submitted data during the NERC Alert
process).
    \83\ WI Base Case IBR Review Report. The WI base case has been
updated since the time of this report.
---------------------------------------------------------------------------

    30. In summary, events and disturbances have shown that IBRs,
regardless of size and transmission or sub-transmission voltage, have a
material impact on Bulk-Power System reliability. Further, while NERC
recognizes that action is necessary to address the most common
reliability issues posed by IBRs, these issues have not been resolved.
Finally, even when NERC does address IBR-specific gaps through its
Reliability Standards, until unregistered IBRs are registered, they
will not be required to comply with the Reliability Standards.

B. Generator Owners and Operators of Unregistered IBRs That Materially
Impact the Reliable Operation of the Bulk-Power System Must Be
Registered by NERC and Subject to Mandatory Reliability Standards

    31. As IBR saturation continues to increase on the Bulk-Power
System, we are concerned that, absent Commission action, larger numbers
of unregistered IBRs may pose increasing risk to reliable operation, as
demonstrated by the disturbance events described above. Therefore, we
find it necessary to ensure that NERC register the owners and operators
of those unregistered IBRs that, in the aggregate, have a material
impact on Bulk-Power System reliability, to ensure those entities are
subject to a relevant set of mandatory and enforceable Reliability
Standard requirements.
    32. Many IBRs have small individual generation capacities, are
connected to the Bulk-Power System at less than 100 kV transmission or
sub-transmission voltage, or do not meet one of the inclusions in the
NERC BES definition, and therefore are not registered. Similarly, while
NERC's materiality test can be used to assess whether an individual
entity that does not meet the NERC BES definition has a material impact
on the reliable operation of the Bulk-Power System, and thus should be
registered with NERC and subject to its mandatory Reliability
Standards, NERC has not, to date, applied the materiality test to
unregistered IBRs to determine whether they, in the aggregate, have a
material impact on the reliable operation of the Bulk-Power System.
Therefore, NERC has not addressed through either its BES definition or
the materiality test the impact of unregistered IBRs that, in the
aggregate, materially impact the reliable operation Bulk-Power System.
As a result, these potentially impactful unregistered IBRs are not
required to comply with any Reliability Standards. To address this
concern, we find that unregistered IBRs connected to the Bulk-Power
System, regardless of size and transmission or sub-transmission
voltage, that in the aggregate have a material impact on Bulk-Power
System performance should be registered.
    33. Based on the record of IBR facilities materially impacting the
reliability of the Bulk-Power System discussed above, we find that the
current BES definition and NERC's application of the materiality test
to individual entities do not address the potential impacts to the
reliability of the Bulk-Power System of the increasing numbers of
smaller non-BES Bulk-Power System-connected IBRs. Therefore, we direct
NERC to develop and file a work plan within 90 days of the date of this
order explaining how it will identify and register unregistered IBRs
that, in the aggregate, have a material impact on the reliable
operation of the Bulk-Power System, but that are not currently required
to be registered with NERC under the BES definition. The work plan
should explain how NERC will modify its processes to encompass
unregistered IBRs (whether by working with stakeholders to change the
BES definition, changing its Rules of Procedure related to
registration, or some other solution) within 12 months of approval of
the work plan. The work plan should also include implementation
milestones ensuring that unregistered IBR owners and operators meeting
the new registration criteria are identified within 24 months of the
approval date of the work plan, and that they are registered and
required to comply with applicable Reliability Standards within 36
months of the approval date of the work plan. The work plan will be
noticed for public comment.
    34. We recognize that the currently unregistered IBRs may not
present the same impact in all circumstances as IBRs that fall under
the current BES definition. Accordingly, NERC may determine that the
full set of Reliability Standard Requirements otherwise applicable to
generator owners and operators need not apply to currently

unregistered IBR generator owners and operators when they are
registered.\84\ For example, NERC may determine that currently
unregistered IBR generator owners and operators that must register as a
result of this order need comply only with provisions pertaining to
facility interconnections and studies, protection systems, modeling,
voltage support, and frequency response, as well as any new or modified
standards developed through the rulemaking in Docket No. RM22-12-000.
While we provide the above by way of example, NERC may, subject to
Commission review and approval, determine whether specific provisions
from the full set of Reliability Standard Requirements otherwise
applicable to generator owners and operators need not apply to
generator owners and operators when they are registered that currently
only own unregistered IBRs.
---------------------------------------------------------------------------

    \84\ See, e.g., New Harquahala Generating Co., LLC, 123 FERC ]
61,173 (2008).
---------------------------------------------------------------------------

    35. Accordingly, consistent with the discussion in this order, we
direct NERC to file the work plan within 90 days of the date of this
order for Commission approval. The work plan filed by NERC will be
noticed for public comment. Once the Commission approves the work plan,
we direct NERC to file progress updates every 90 days from the date of
approval documenting NERC's progress. We direct NERC to complete
implementation of the work plan (whether by working with stakeholders
to change the BES definition, changes to its registration program, or
some other solution) within 12 months from the date of Commission
approval of the work plan and to complete the identification of
unregistered IBR owners and operators within 24 months from the date of
Commission approval, so that they are registered and required to comply
with applicable Reliability Standards within 36 months from the date of
Commission approval of the work plan.

III. Information Collection Statement

    36. The Paperwork Reduction Act (PRA) \85\ requires each federal
agency to seek and obtain approval by the Office of Management and
Budget (OMB) before undertaking a collection of information (including
reporting, record keeping, and public disclosure requirements) directed
to ten or more persons or contained in a rule of general applicability.
OMB regulations \86\ require approval of certain information collection
requirements (including deletion or revision of existing requirements,
or implementation of new requirements). Upon approval of a collection
of information, OMB will assign an OMB Control Number and an expiration
date. Respondents subject to the filing requirements will not be
penalized for failing to respond to the collection of information
unless the collection of information displays a valid OMB control
number.
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    \85\ 44 U.S.C. 3501-3521.
    \86\ 5 CFR pt. 1320 (2021).
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    37. The information collection affected by this order is FERC-725,
``Certification of Electric Reliability Organization; Procedures for
Electric Reliability Standards'' (OMB Control Number 1902-0225). The
information collection requirements in this order are covered by and
included in, the existing OMB-approved FERC-725.\87\
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    \87\ FERC-725 includes the burden, reporting, and recordkeeping
requirements associated with Reliability Standards Development,
Reliability Assessments, Self-Assessment and ERO Application,
Reliability Compliance, Stakeholder Survey, and Other Reporting.
---------------------------------------------------------------------------

    38. This order directs the ERO to develop and submit to the
Commission for approval within 90 days of the date of this order a work
plan describing, in detail, how the ERO plans to modify its
registration processes to identify and register owners and operators of
unregistered IBRs that in the aggregate, materially impact the reliable
operation of the Bulk-Power System, as discussed in the body of this
order. NERC is required to submit progress updates every 90 days after
approval of the work plan.
    39. In this order, NERC is directed to: (1) complete modifications
to its registration process within 12 months of Commission approval of
the work plan; (2) complete identification of owners and operators of
IBRs that are connected to the Bulk Power System and that, in the
aggregate, materially impact the reliable operation of the Bulk-Power
System within 24 months of Commission approval of the work plan; and
(3) complete registration of unregistered IBR owners and operators so
they are required to comply with applicable Reliability Standards
within 36 months of Commission approval of the work plan, as discussed
in the body of this order.
    40. The Commission solicits comments on the Commission's need for
the revision of the information collection, whether the information
will have practical utility, the accuracy of the burden estimates, ways
to enhance the quality, utility, and clarity of the information to be
collected or retained.
    41. Interested persons may submit questions about this information
collection by contacting Ellen Brown, Office of the Executive Director,
at [email protected], or<PHONE_NUMBER>. Please send comments
concerning the collection of information and the associated burden
estimates to: Office of Information and Regulatory Affairs, Office of
Management and Budget [Attention: Federal Energy Regulatory Commission
Desk Officer]. Due to security concerns, comments should be submitted
at www.reginfo.gov/public/do/PRAMain. Comments submitted to OMB should
be sent within 60 days of publication of this notice in the Federal
Register and refer to FERC-725 and OMB Control No. 1902-0225.
    The Commission orders:
    (A) NERC is hereby directed to submit a work plan within 90 days of
the date of this order describing, in detail, how it plans to modify
with stakeholder input its BES definition, registration program, or
some other solution to identify and register owners and operators of
unregistered IBRs that are connected to the Bulk-Power System and that,
in the aggregate, materially impact the reliable operation of the Bulk-
Power System, as discussed in the body of this order.
    (B) NERC is hereby directed to complete modifications in accordance
with its work plan within 12 months of Commission approval of the work
plan, complete identification of owners and operators of IBRs that in
the aggregate, materially impact the reliable operation of the Bulk-
Power System within 24 months of Commission approval of the work plan,
and complete registration of IBR owners and operators so they are
required to comply with applicable Reliability Standards within 36
months of Commission approval of the work plan, as discussed in the
body of this order.
    (C) NERC is hereby directed to file detailed progress updates on
the status of its workplan, completed implementation milestones, and
any delays, every 90 days from the date of Commission approval of the
work plan, as discussed in the body of this order.

    By the Commission. Commissioner Danly is concurring with a
separate statement attached.

    Issued: November 17, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.

United States of America

Federal Energy Regulatory Commission

Registration of Inverter-based Resources.
Docket No. RD22-4-000 (Issued November 17, 2022)

    DANLY, Commissioner, concurring:

    1. I concur in today's order.\1\ I remain gravely concerned about
the North American Electric Reliability Corporation's (NERC) inability
to act swiftly and nimbly in response to emerging risks that threaten
the reliability of the Bulk-Power System (BPS). This is due in no small
part to the statutory framework of Federal Power Act (FPA) section
215.\2\ According to NERC's Inverter-Based Resource (IBR) Strategy
document,\3\ ``[t]he [Electric Reliability Organization (ERO)]
Enterprise has analyzed numerous widespread IBR loss events and
identified many systemic performance issues with the inverter-based
fleet over the past six years.'' \4\ NERC explains that ``[t]he
disturbance reports, alerts, guidelines, and other deliverables
developed by the ERO thus far have highlighted that abnormal IBR
performance issues pose a significant risk to BPS reliability.'' \5\
Our actions today in this and another proceeding \6\ propose firm
deadlines by which NERC must act to register and hold IBR entities
accountable for failure to comply with mandatory and enforceable
Reliability Standards.
---------------------------------------------------------------------------

    \1\ Registration of Inverter-based Resources, 181 FERC ] 61,124
(2022).
    \2\ 16 U.S.C. 824o.
    \3\ NERC, Inverter-Based Resource Strategy: Ensuring Reliability
of the Bulk Power System with Increased Levels of BPS-Connected IBRs
(Issued Sep. 14, 2022), https://www.nerc.com/comm/Documents/NERC_IBR_Strategy.pdf.
    \4\ Id. at 3.
    \5\ Id. at 5.
    \6\ Reliability Standards to Address Inverter-Based Resources,
181 FERC ] 61,125 (2022).
---------------------------------------------------------------------------

    2. Better late than never, I suppose. Nevertheless, it could be at
least four years before certain of the IBR entities are registered and
another five years before the full suite of contemplated requirements
are mandatory and enforceable. So, it will be about ten or eleven years
after the significant reliability risk was definitively identified that
we will have required registration and Reliability Standards in place.
The reliability consequences that attend the rapid deployment of an
unprecedented number of IBRs are, at this point, unarguable. As NERC's
President and CEO explained last week: ``the pace of the transformation
of the electric system needs to be managed and that transition needs to
occur in an orderly way.'' \7\ Mandatory reliability standards must be
implemented as quickly as possible to ensure the reliable operation of
the BPS. We at FERC are responsible for the reliability of the BPS
under FPA section 215. I fear we may be taking too long to address
reliability challenges that urgently need our attention.
---------------------------------------------------------------------------

    \7\ Statement of James B. Robb, Annual Commissioner-led
Reliability Technical Conference (Nov. 10, 2022), https://www.ferc.gov/news-events/events/annual-commissioner-led-reliability-technical-conference-11102022.
---------------------------------------------------------------------------

    For these reasons, I respectfully concur.

James P. Danly,

Commissioner.

[FR Doc. 2022-25589 Filed 11-22-22; 8:45 am]
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[Federal Register: June 3, 2009 (Volume 74, Number 105)]
[Notices]
[Page 26703]
[DOCID:fr03jn09-76]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0125]

Draft Guidance for Industry and Researchers on the Radioactive
Drug Research Committee: Human Research Without an Investigational New
Drug Application; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and researchers entitled
``The Radioactive Drug Research Committee: Human Research Without an
Investigational New Drug Application.'' This draft guidance provides
information to those using radioactive drugs for certain research
purposes to help determine whether research studies may be conducted
under an FDA-approved radioactive drug research committee, or whether
research studies must be conducted under an investigational new drug
application (IND). It also offers answers to frequently asked questions
on conducting research with radioactive drugs, and provides information
on the membership, functions, and reporting requirements of a
radioactive drug research committee approved by FDA.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by September 1, 2009.

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

FOR FURTHER INFORMATION CONTACT:  Orhan Suleiman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 2206, Silver Spring, MD 20993-0002, 301-
796-1471.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and researchers entitled ``The Radioactive Drug Research Committee:
Human Research Without an Investigational New Drug Application.''
    On July 25, 1975 (40 FR 31298), FDA changed the conditions under
which new radioactive drug and biological products could be used. The
Agency terminated a 1963 order from the Commissioner of Food and Drugs
(28 FR 183; January 8, 1963) that had exempted radioactive new drug and
biological products for investigational use in humans from new drug
requirements (part 312 (21 CFR part 312)), as long as they were shipped
consistent with regulations issued by the Atomic Energy Commission
(AEC). FDA and AEC had agreed that all radioactive drugs and biological
products should now become subject to the same requirements for
investigational use as other new drugs under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) and section 351 of the
Public Health Service Act (42 U.S.C. 262). Simultaneously, the agency
issued regulations (Sec.  361.1 (21 CFR 361.1)) explaining when
radioactive drugs for basic science and medical research would not be
subject to the same requirements for investigational use as other new
drugs.
    Today, research studies with a radioactive drug or biological
products may be conducted in a number of ways: (1) Under an IND (part
312), (2) exempt from IND requirements (Sec.  312.2), or (3) under
certain conditions, with the supervision and approval of an FDA-
approved Radioactive Drugs Research Committee (RDRC) (Sec.  361.1).
    This guidance discusses the conditions under which research with a
radioactive drug may be conducted under Sec.  361.1. Appendices to the
guidance answer frequently asked questions about those conditions and
provide additional information on RDRCs. Appendix A of the draft
guidance answers questions on basic science research with radioactive
drugs. Appendix B addresses approval by the RDRC and the information
that must be submitted by investigators to the RDRC. Appendix C
discusses the limits on the pharmacological dose, and Appendix D
discusses the limits on the radiation dose. Each of these appendices
also includes a summary of the regulations. Appendix E provides
information on the membership, functions, reports, and monitoring of an
RDRC. The final appendix, Appendix F, is an RDRC review criteria
checklist, indicating the areas on which the RDRC will focus when
considering a proposed research study.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on determining
whether human research with a radioactive drug can be conducted under a
radioactive drug research committee. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 361.1 have been approved under OMB
control number 0910-0053.

III. Comments

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

IV. Electronic Access

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

    Dated: May 14, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12832 Filed 6-2-09; 8:45 am]

BILLING CODE 4160-01-S