[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Proposed Rules]
[Pages 30027-30031]
[FR Doc No: E9-14783]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 40

[Docket No. RM09-8-000]

Revised Mandatory Reliability Standards for Interchange
Scheduling and Coordination

June 18, 2009.
AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of proposed rulemaking.

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SUMMARY: Pursuant to section 215 of the Federal Power Act, the
Commission proposes to approve three updated Interchange Scheduling and
Coordination (INT) Reliability Standards developed by the North
American Electric Reliability Corporation. The proposed INT Reliability
Standards specify times for entities in the Western Interconnection to
review and respond to requests for interchange service, specifically,
on-time requests for service and requests for emergency interchange and
reliability adjustment interchange service. In addition, the revisions
set forth appropriate response times for all requests for on-time,
emergency and reliability adjustment interchange service.

DATES: Comments are due July 24, 2009.

ADDRESSES: You may submit comments, identified by docket number by any
of the following methods:
     Agency Web Site: http://ferc.gov. Documents created
electronically using word processing software should be filed in native
applications or print-to-PDF format and not in a scanned format.
     Mail/Hand Delivery: Commenters unable to file comments
electronically must mail or hand deliver an original and 14 copies of
their comments to: Federal Energy Regulatory Commission, Secretary of
the Commission, 888 First Street, NE., Washington, DC 20426.

FOR FURTHER INFORMATION CONTACT:

Danny Johnson (Technical Information), Office of Electric Reliability,
Division of Reliability Standards, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. (202) 502-
8892.
Rheta Johnson (Technical Information), Office of Electric Reliability,
Division of Reliability Standards, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. (202) 502-
6503.
Richard M. Wartchow (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    1. Pursuant to section 215 of the Federal Power Act (FPA), the
Commission proposes to approve three updated Interchange Scheduling and
Coordination (INT) Reliability Standards developed by the North
American Electric Reliability Corporation (NERC): INT-005-3,
Interchange Authority Distributes Arranged Interchange; INT-006-3,
Response to Interchange Authority; and INT-008-3, Interchange Authority
Distributes Status. The proposed INT Reliability Standards specify
response times for entities in the Western Interconnection to review
and respond to requests for interchange service. In addition, the
revisions set forth appropriate response times for all requests for on-
time, emergency and reliability adjustment interchange service.\1\
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    \1\ Requests for interchange service are also called ``RFI.''
The NERC glossary defines ``Interchange'' as, ``Energy transfers
that cross balancing authority boundaries.'' NERC Glossary of Terms
Used in Reliability Standards (as revised) (glossary), originally
filed with NERC's April 4, 2006 Request for Approval of Reliability
Standards, Docket No. RM06-16-000, and affirmed by Mandatory
Reliability Standards for the Bulk-Power System, Order No. 693, FERC
Stats. and Regs. ] 31,242 (2007), order on reh'g, Order No. 693-A,
120 FERC ] 61,053 (2007). The glossary is appended to the
Reliability Standards and is available on the NERC Web site, http://www.nerc.com.
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    2. The revised INT Reliability Standards update and replace version
2 of the INT Reliability Standards. NERC adopted these standards
pursuant to an urgent action request under NERC procedures, which
require that the standards be resubmitted for processing through NERC's
normal Reliability Standards development procedures.\2\ The proposed
rule would benefit the reliable operation of the Bulk-Power System by
clarifying how long the relevant entities have to respond to requests
for interchange service and providing entities in the Western
Interconnection with sufficient time to assess and respond to requests
for interchange service.\3\
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    \2\ See Modification of Interchange and Transmission Loading
Relief Reliability Standards; and Electric Reliability Organization
Interpretation of Specific Requirements of Four Reliability
Standards, Order No. 713, 73 FR 43613 (Jul. 28, 2008), 124 FERC ]
61,071, at P 67 (2008). Under NERC procedures, changes developed
pursuant to an urgent action request must be reviewed under the
normal Reliability Standards development process, by a panel having
the appropriate expertise, and balloted for final approval, with any
modifications, within one year, if no substantive changes are made,
or else within two years. NERC states that the current revisions are
not substantial enough to change the intent, scope or purpose of the
prior versions of the Reliability Standards.
    \3\ The Commission is not proposing any new or modified text to
its regulations. Rather, as set forth in 18 CFR Part 40, a proposed
Reliability Standard will not become effective until approved by the
Commission, and the Electric Reliability Organization (ERO) must
post on its Web site each effective Reliability Standard.
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I. Background

A. EPAct 2005 and Mandatory Reliability Standards

    3. On August 8, 2005, the Electricity Modernization Act of 2005 was
enacted as Title XII, Subtitle A, of the Energy Policy Act of 2005
(EPAct 2005).\4\ EPAct 2005 added section 215 to the FPA, requiring the
Commission-certified Electric Reliability Organization (ERO) to develop
mandatory and enforceable Reliability Standards to provide for the
reliable operation of the Bulk-Power System, subject to Commission
review and approval. Once approved, the Reliability Standards may be
enforced by the ERO, subject to Commission oversight, or by the
Commission independently.\5\
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    \4\ Energy Policy Act of 2005, Public Law 109-58, Title XII,
Subtitle A, 119 Stat. 594, 941 (2005), 16 U.S.C. 824o (2006).
    \5\ 16 U.S.C. 824o(e)(3).
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    4. On February 3, 2006, the Commission issued Order No. 672,
implementing section 215.\6\ Pursuant to Order No. 672, the Commission
certified NERC as the ERO.\7\ The ERO is required to develop
Reliability Standards, subject to Commission review and approval,
applicable to users, owners and operators of the Bulk-Power System, as
set forth in each Reliability Standard.
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    \6\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, FERC
Stats. & Regs. ] 31,204, order on reh'g, Order No. 672-A, FERC
Stats. & Regs. ] 31,212 (2006).
    \7\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g & compliance, 117 FERC ] 61,126 (2006).
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    5. Section 215(d)(2) of the FPA states that the Commission may
approve, by rule or order, a proposed Reliability Standard or
modification to a Reliability Standard if it determines that the
Standard is just, reasonable, not unduly discriminatory or
preferential, and in

the public interest.\8\ If the Commission disapproves of the proposed
Standard in whole or in part, it must remand the proposed Standard to
the ERO for further consideration.\9\ Section 215(d)(5) grants the
Commission authority, upon its own motion or upon complaint, to order
the ERO to submit to the Commission a proposed Reliability Standard or
a modification to a Reliability Standard that addresses a specific
matter if the Commission considers such a modified Reliability Standard
appropriate to carry out section 215.
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    \8\ 16 U.S.C. 824o(d)(2).
    \9\ 16 U.S.C. 824o(d)(4).
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B. Order No. 713

    6. In Order No. 713, the Commission accepted a prior NERC proposal
to provide additional time for entities in the Western Interconnection
to assess requests for interchange service needed in less than an
hour.\10\ The resulting changes were incorporated into the prior INT
Reliability Standards, designated INT-005-2, INT-006-2 and INT-008-2,
which were accepted by the Commission.\11\ The Commission found that,
due to the limited assessment time available, some requested
transactions were being denied because they were not reviewed and acted
upon in the allotted time.\12\ NERC's proposal was developed in
response to an urgent action request from the Western Electricity
Coordinating Council (WECC) to reinstate a ten-minute assessment
period, consistent with WECC's historical practice.
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    \10\ The INT Reliability Standards apply to interchange
authorities, balancing authorities, and transmission service
providers.
    \11\ Order No. 713, 124 FERC ] 61,071 at P 67.
    \12\ Upon expiration of the assessment time, the related e-Tags
are denied and must be resubmitted. In industry parlance, this is
called ``passive denial.'' Order No. 713, 124 FERC ] 61,071 at P 62-
63.
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    7. In its current petition, NERC finalizes the revisions that were
initially developed pursuant to the urgent action request.

C. NERC's Proposed INT Reliability Standard Revisions

    8. On February 5, 2009, NERC filed its petition for Commission
approval of the revised INT Reliability Standards, designated INT-005-
3; INT-006-3 and INT-008-3.\13\ In the revised INT Reliability
Standards, NERC proposes to establish separate timing tables for the
Western Interconnection and the Eastern Interconnection, including
Electric Reliability Council of Texas and Hydro-Quebec; affirm and
clarify the increase in the reliability assessment times for WECC from
five minutes to ten minutes for requests submitted more than 60 minutes
and no less than 15 minutes prior to ramp start time, and also permit
on-time submittal of e-Tags \14\ up to 20 minutes prior to the
operating hour; specify the timing for responses to requests for the
Western Interconnection; and modify Requirement R1 of INT-006-002 to
clarify that balancing authorities and transmission service providers
in all Interconnections must respond to ``on-time'' requests for
interchange service, as well as to requests for emergency and
reliability adjustment interchange services. NERC also proposes to add
three related definitions to its glossary: ``After the Fact,''
``Emergency Request for Interchange (RFI),'' and ``Reliability
Adjustment RFI,'' and specifies appropriate responses for ``Late,''
``On-time'' and ``After the Fact'' requests for service to the timing
tables.
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    \13\ The revised INT Reliability Standards are provided in the
petition and are available on the Commission's eLibrary document
retrieval system in Docket No. RM09-8-000 and also on NERC's Web
site, http://www.nerc.com.
    \14\ Electronic Tagging, or e-Tag, is a request to implement a
new interchange transaction as a physical energy flow, i.e., an RFI.
The e-Tag documents the requested physical interchange transaction
and identifies participants. E-Tags include expected flows, and the
information provided may be used in mitigating constraints, when
needed. See NERC's Joint Interchange Scheduling Work Group,
Electronic Tagging Functional Specification Version 1.8.0 (Nov. 7,
2007).
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    9. NERC states that the revised INT Reliability Standards (INT-005-
3, INT-006-3, and INT-008-3) ensure the safe and reliable operation of
the Bulk-Power System. According to NERC, the Reliability Standards
improve Bulk-Power System reliability by providing WECC entities
sufficient time to assess and respond to requests for interchange
service. Establishing a separate timing table for WECC will clarify the
timing requirements for the Western Interconnection. The timing
requirements for the Eastern Interconnections, including ERCOT and
Hydro-Quebec, are also modified by adopting the on-time, late and
after-the-fact classifications. NERC reports that the new terms
incorporated in the timing tables are consistent with existing industry
e-Tag specifications used to request and arrange interchange service,
and use of these terms will ensure uniform treatment for all entities
subject to the INT Reliability Standards.
1. Proposed NERC Glossary Definitions
    10. To implement the revisions to the INT Reliability Standards,
NERC proposes to add three terms to its glossary: \15\
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    \15\ As with Reliability Standards, the Commission also reviews
and approves revisions to the NERC glossary pursuant to FPA section
215(d)(2). Further, the Commission may direct a modification to
address a specific matter identified by the Commission pursuant to
section 215(d)(5). See, e.g., Order No. 693, FERC Stats. and Regs. ]
31,242 at P 1893-98.

    After the Fact: A time classification assigned to a Request for
Interchange (RFI) when the submittal time is greater than one hour
after the start time of the RFI.
    Emergency Request for Interchange: RFI to be initiated [for]
Emergency or Energy Emergency conditions.
    Reliability Adjustment RFI: Request to modify an Implemented
Interchange Schedule for reliability purposes.

2. Revised INT Reliability Standard Requirements
    11. NERC proposes a separate interchange response timing table for
WECC, while responsible entities in the Eastern Interconnections,
including ERCOT and Hydro-Quebec, will continue to follow a table
largely based on the prior versions. The tables set forth the response
times for various requests for interchange service according to
priority and time of submittal. The WECC-specific table reflects the
increased reliability assessment time that was approved in Order No.
713. The expanded review time provides WECC entities ten minutes to
respond to requests for interchange service submitted more than 60
minutes and no less than 15 minutes prior to ramp start time and also
permits on-time submittal of e-Tags up to 20 minutes prior to the
operating hour. NERC also makes minor textual modifications to clarify
that all entities subject to the INT Reliability Standards must respond
to ``on-time'' requests, as well as to all requests for emergency and
reliability adjustment interchange service,\16\ revises the tables to
accommodate regions in which a response to arranged interchange is
required, and clarifies INT-006-3, Measure M1 to correspond more
closely to Requirement R1.
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    \16\ INT-006-003, Requirement R1.
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    12. NERC requests that the revised INT Reliability Standards be
effective on the first day of the quarter three months after regulatory
approval is granted.\17\
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    \17\ The petition makes no modification to the violation risk
factors or violation severity levels for the revised INT Reliability
Standards. Therefore, the currently effective violation risk factors
and violation severity levels will continue to apply.
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3. Revised INT Reliability Standard Development
    13. In response to WECC's February 7, 2007 urgent action request,
NERC

developed the version 2 INT Reliability Standards that were approved by
the Commission in Order No. 713. Shortly after receiving the urgent
action request, WECC and a joint NERC/NAESB \18\ work group submitted a
Standards Authorization Request to NERC seeking permanent revisions to
the INT Reliability Standards to accommodate the expanded WECC timing
requirements. In developing the permanent revision, the version 2 INT
Reliability Standard proposal was modified to incorporate the changes
discussed above and the proposed glossary terms. After those revisions
were made, the proposed INT Reliability Standards were approved by
industry ballot and the NERC Board.
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    \18\ North American Energy Standards Board.
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II. Discussion

    14. The Commission proposes to approve Reliability Standards INT-
005-3, INT-006-3 and INT-008-3 and related glossary terms, effective as
proposed by NERC, as discussed below. INT-006-3, Requirement R1
requires communication between balancing authorities, transmission
service providers and interchange authority regarding when to respond
to a request for interchange service:

    Requirement R1: Prior to the expiration of the reliability
assessment period defined in the timing requirements tables in this
standard, Column B, the Balancing Authority and the Transmission
Service Provider shall respond to each On-time Request for
Interchange (RFI), and to each Emergency RFI and Reliability
Adjustment RFI from an Interchange Authority to transition an
Arranged Interchange to a Confirmed Interchange.

    15. INT-006-3 Requirement R1 cited above explicitly requires
balancing authorities and transmission service providers to coordinate
with interchange authorities concerning requests for interchange
service. Balancing authorities and transmission operators must review
proposed interchange transactions to ensure that transmission service
is available and system limits will not be violated and inform the
interchange authority whether a request may be confirmed.\19\
Reliability coordinators and transmission service providers must review
composite energy interchange transaction information to ensure that
their systems can accommodate the energy, generation is available based
on start-up characteristics, and the scheduling path is available on
both the local and adjacent systems.
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    \19\ See INT-005-3, Requirement R1; INT-006-3, Requirement R1
(Response to Interchange Authority).
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    16. The revised INT Reliability Standards facilitate the reliable
operation of the Bulk-Power System by providing WECC entities
sufficient time to assess and respond to requests for interchange
service and by clarifying timing requirements for all affected
entities. The revisions finalize and improve upon the version 2 changes
approved in Order No. 713. The Commission agrees that separating the
WECC- and Eastern-Interconnection/ERCOT requirements in the timing
tables adds clarity for entities operating in the WECC system. NERC's
proposal retains slightly modified versions of the prior tables
containing timing requirements for the Eastern Interconnection and
ERCOT.
    17. NERC's proposal incorporates one important change from the
version 2 requirements. As written, INT-006-002, Requirement R1
requires responsible entities to ``respond to a request from an
Interchange Authority to transition an Arranged Interchange to a
Confirmed Interchange,'' suggesting that a response is required for all
requests within the designated time periods. In version 3, the
requirement clarifies that the applicable entity must respond to ``on-
time'' requests for interchange service within a given time period, and
also to all requests for Emergency interchange service and Reliability
Adjustment interchange service.\20\ Entities are required to respond to
each of these latter two requests regardless of the timelines
identified in the timing tables, with paperwork to follow later. Time
classifications and deadlines apply to both initial arranged
interchange submittals and any subsequent modifications to the arranged
interchange.
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    \20\ See INT-006-3, Measure M1.
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    18. In light of the fact that the revised INT Reliability Standards
were developed to address the problem that it was impossible for WECC
entities to respond to certain requests for interchange service in the
given time frame, and that the underlying e-Tags for these requests
would expire, the Commission finds the clarification acceptable.
Responsible entities are still required to respond to all on-time
requests for interchange service, as well as all requests for Emergency
interchange service and Reliability Adjustment interchange service.
Balancing authorities and transmission service providers do not have to
respond to any other interchange service requests.
    19. In Order No. 713, the Commission approved version 2 of the INT
Reliability Standards, noting that NERC's compliance with the Order No.
693 directive to modify Reliability Standard INT-006-1, is ongoing.\21\
While we propose to accept the current changes in light of NERC's
efforts to modify the Reliability Standard, we remind NERC to ensure
that the Commission's outstanding directives are addressed in future
changes to the INT Reliability Standards. With this understanding, the
Commission proposes to accept the revised INT Reliability Standards and
associated glossary terms.
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    \21\ Order No. 713, 124 FERC ] 61,071 at P 67 (citing Order No.
693, FERC Stats. & Regs. ] 31,242 at P 866).
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    20. The Commission seeks comment on its proposal.

III. Information Collection Statement

    21. The Office of Management and Budget (OMB) regulations require
approval of certain information collection requirements imposed by
agency rules.\22\ Upon approval of a collection(s) of information, OMB
will assign an OMB control number and an expiration date. Respondents
subject to the filing requirements of this rule will not be penalized
for failing to respond to these collections of information unless the
collections of information display a valid OMB control number. The
Paperwork Reduction Act (PRA) \23\ requires each federal agency to seek
and obtain OMB approval before undertaking a collection of information
directed to ten or more persons, or continuing a collection for which
OMB approval and validity of the control number are about to
expire.\24\ The PRA defines the phrase ``collection of information'' to
be the ``obtaining, causing to be obtained, soliciting, or requiring
the disclosure to third parties or the public, of facts or opinions by
or for an agency, regardless of form or format, calling for either--(i)
Answers to identical questions posed to, or identical reporting or
recordkeeping requirements imposed on ten or more persons, other than
agencies, instrumentalities, or employees of the United States; or (ii)
answers to questions posed to agencies, instrumentalities, or employees
of the United States which are to be used for general statistical
purposes.'' \25\
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    \22\ 5 CFR 1320.11.
    \23\ 44 U.S.C. 3501-20.
    \24\ 44 U.S.C. 3502(3)(A)(i), 44 U.S.C. 3507(a)(3).
    \25\ 44 U.S.C. 3502(3)(A).
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    22. This NOPR proposes to approve the revised INT Reliability
Standards developed by NERC as the ERO. Section

215 of the FPA authorizes the ERO to develop and enforce Reliability
Standards that provide for an adequate level of reliability of the
Bulk-Power System. Pursuant to the statute, the ERO must submit each
Reliability Standard that it proposes to be made effective to the
Commission for approval.\26\ The proposed Reliability Standard
revisions do not require responsible entities to file information with
the Commission. But the Reliability Standards do require responsible
entities to develop and maintain certain information for a specified
period of time, subject to inspection by the ERO or Regional Entities.
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    \26\ See 16 U.S.C. 824o(d).
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    23. The proposed requirements are mainly concerned with the timing
of responses to requests for service rather than the required
documentation. The existing documentation requirements were established
pursuant to OMB control number 1902-0244.\27\ Under the existing
requirements, affected entities were required to respond to all
requests for service covered by the INT Reliability Standards. The
proposed rule would clarify that entities need not respond to late
requests for service (with exceptions for services needed for emergency
or reliability purposes). Thus, the proposed rule does not establish
any significant reporting obligations, but relieves affected entities
of the burden of responding to late requests for service, other than
requests for emergency or reliability service. The Commission does not
consider this a significant burden.
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    \27\ This OMB control number was issued in Docket No. RM06-16-
000, Order No. 693, FERC Stats. and Regs. ] 31,242 at P 1907.
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    24. The Commission is submitting these reporting and recordkeeping
requirements to OMB for its review and approval under section 3507(d)
of the PRA. Comments are solicited on the Commission's need for this
information, whether the information will have practical utility, the
accuracy of provided burden estimates, ways to enhance the quality,
utility, and clarity of the information to be collected, and any
suggested methods for minimizing the respondent's burden, including the
use of automated information techniques.
    Title: Revised Mandatory Reliability Standards for Interchange
Scheduling and Coordination.
    Action: Proposed Collection.
    OMB Control No.: 1902-0244.
    Respondents: Businesses or other for-profit institutions; not-for-
profit institutions.
    Frequency of Responses: On occasion.
    Necessity of the Information: This proposed rule would approve
revised Reliability Standards to specify the times for entities to
respond to requests for interchange service, and clarify that entities
need not respond to late requests other than requests for emergency or
reliability related service. The proposed rule would find the revisions
just, reasonable, not unduly discriminatory or preferential, and in the
public interest. In addition, this proposed rule would approve new
glossary terms.
    Internal Review: The Commission has reviewed the requirements
pertaining to the revised Reliability Standards for the Bulk-Power
System and determined that the proposed requirements are necessary to
meet the statutory provisions of the Energy Policy Act of 2005. These
requirements conform to the Commission's plan for efficient information
collection, communication and management within the energy industry.
The Commission has assured itself, by means of internal review, that
the revised requirements are not likely to increase the informational
burden and that any resulting increase over existing requirements would
be insignificant.
    25. Interested persons may obtain information on the reporting
requirements by contacting the following: Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426 [Attention:
Michael Miller, Office of the Executive Director, Phone: (202) 502-
8415, fax:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>    26. For submitting comments concerning the collection(s) of
information and the associated burden estimate(s), please send your
comments to the contact listed above and to the Office of Management
and Budget, Office of Information and Regulatory Affairs, Washington,
DC 20503 [Attention: Desk Officer for the Federal Energy Regulatory
Commission, phone<PHONE_NUMBER>, fax:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
IV. Environmental Analysis

    27. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human environment.\28\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. The actions proposed here fall within the categorical
exclusion in the Commission's regulations for rules that are
clarifying, corrective or procedural, for information gathering,
analysis, and dissemination.\29\ Accordingly, neither an environmental
impact statement nor environmental assessment is required.
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    \28\ Regulations Implementing the National Environmental Policy
Act, Order No. 486, FERC Stats. & Regs., Regs. Preambles 1986-1990 ]
30,783 (1987).
    \29\ 18 CFR 380.4(a)(5).
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V. Regulatory Flexibility Act Certification

    28. The Regulatory Flexibility Act of 1980 (RFA) \30\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
Most of the entities to which the requirements of this rule would
apply, i.e., interchange authorities, balancing authorities and
transmission service providers, do not fall within the definition of
small entities.\31\
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    \30\ 5 U.S.C. 601-12.
    \31\ The RFA definition of ``small entity'' refers to the
definition provided in the Small Business Act, which defines a
``small business concern'' as a business that is independently owned
and operated and that is not dominant in its field of operation. See
15 U.S.C. 632 (2000). According to the SBA, a small electric utility
is defined as one that has a total electric output of less than four
million MWh in the preceding year.
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    29. The proposed Reliability Standard revisions will not be a
burden on the industry since most, if not all, of the applicable
entities currently coordinate interchange information and the proposed
Reliability Standard will simply provide a common framework for such
coordination and responding to requests for service. Many, if not all,
of the affected entities already have procedures in place to respond to
requests for service and document such responses. Accordingly, the
Commission certifies that the proposed INT Reliability Standard
revisions will not have a significant adverse impact on a substantial
number of small entities.
    30. Based on this understanding, the Commission certifies that this
rule will not have a significant economic impact on a substantial
number of small entities. Accordingly, no regulatory flexibility
analysis is required.

VI. Comment Procedures

    31. The Commission invites interested persons to submit comments on
the matters and issues proposed to be adopted in this notice, including
any related matters or alternative proposals that commenters may wish
to discuss. Comments are due July 24, 2009. Comments must refer to
Docket No. RM09-8-000, and must include the commenter's name, the
organization

they represent, if applicable, and their address in their comments.
    32. The Commission encourages comments to be filed electronically
via the eFiling link on the Commission's Web site at http://www.ferc.gov. The Commission accepts most standard word processing
formats. Documents created electronically using word processing
software should be filed in native applications or print-to-PDF format
and not in a scanned format. Commenters filing electronically do not
need to make a paper filing.
    33. Commenters unable to file electronically must send an original
and 14 copies of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street, NE.,
Washington, DC 20426.
    34. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commenters on this proposal are
not required to serve copies of their comments on other commenters.

VII. Document Availability

    35. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's
Public Reference Room during normal business hours (8:30 a.m. to 5 p.m.
Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.
    36. From FERC's Home Page on the Internet, this information is
available on eLibrary. The full text of this document is available on
eLibrary in PDF and Microsoft Word format for viewing, printing, and/or
downloading. To access this document in eLibrary, type the docket
number excluding the last three digits of this document in the docket
number field.
    37. User assistance is available for eLibrary and the FERC's Web
site during normal business hours from FERC Online Support at 202-502-
6652 (toll free at 1-866-208-3676) or e-mail at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. E-mail the Public Reference Room at
<EMAIL_ADDRESS>
List of Subjects in 18 CFR Part 40

    Electric power; Reporting and recordkeeping requirements.

    By direction of the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-14783 Filed 6-23-09; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 30, 2007 (Volume 72, Number 230)]
[Notices]
[Page 67768-67770]
[DOCID:fr30no07-98]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-28065; File No. 812-13414]

John Hancock Life Insurance Company, et al., Notice of
Application

November 26, 2007.
AGENCY: The Securities and Exchange Commission (``Commission'').

ACTION: Notice of application for an order of exemption pursuant to
Section 17(b) of the Investment Company Act of 1940, as amended (the
``1940 Act'' or ``Act'').

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    Applicants: John Hancock Life Insurance Company (U.S.A.) (``John
Hancock USA''), John Hancock Life Insurance Company (U.S.A.) Separate
Account H (``Account H''), John Hancock Life Insurance Company of New
York (``John Hancock New York''), John Hancock Life Insurance Company
of New York Separate Account A (``Account A'') and John Hancock Trust
(``JHT'') (collectively the ``Applicants'').
SUMMARY: The Applicants hereby apply for an order of exemption pursuant
to Section 17(b) of the 1940 Act to permit in-kind purchases in
connection with a substitution as described herein.
    Filing Date: The application was filed on August 6, 2007 and
amended and restated on November 19, 2007.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Secretary of
the Commission and serving Applicants with a copy of the request
personally or by mail. Hearing requests must be received by the
Commission by 5:30 p.m. on December 20, 2007, and should be accompanied
by proof of service on Applicants in the form of an affidavit or, for
lawyers, a certificate of service. Hearing requests should state the
nature of the requester's interest, the reason for the request, and the
issues contested. Persons who wish to be notified of a hearing may
request notification by writing to the Secretary of the Commission.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-1090. Applicants, John Hancock Life Insurance
Company (U.S.A.), 601 Congress Street, Boston, MA 02210.

FOR FURTHER INFORMATION CONTACT: Alison T. White, Senior Counsel, or
Joyce M. Pickholz, Branch Chief, Office of Insurance Products, Division
of Investment Management, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The following is a summary of the
Application. The complete Application is available for a fee from the
Public Reference Branch of the Commission, 100 F Street, NE., Room
1580, Washington, DC 20549<PHONE_NUMBER>).

Applicants' Representations

    1. John Hancock USA, formerly known as The Manufacturers Life
Insurance Company (U.S.A.), is a stock life insurance company
originally organized under the laws of Maine on August 20, 1955 by a
special act of the Maine legislature. John Hancock USA redomesticated
under the laws of Michigan on December 30, 1992.
    2. Account H is registered under the Act as a unit investment trust
(File No. 811-4113). The variable annuity contracts funded by Account H
that are affected by this Application are Scudder Wealthmark Annuity
(File Nos. 333-70728 and 333-70730) and Scudder Wealthmark ML3 Annuity
(File No. 333-70850).
    3. John Hancock New York, formerly known as The Manufacturers Life
Insurance Company of New York, is a wholly-owned subsidiary of John
Hancock USA and is a stock life insurance company organized under the
laws of New York on February 10, 1992.
    4. Account A is registered under the Act as a unit investment trust
(File No. 811-6584). It is used to fund variable annuity contracts of
John Hancock New York. The variable annuity contracts funded by Account
A that are affected by this application are Scudder Wealthmark Annuity
for New York (File Nos. 33-79112 and 33-46217) and Scudder Wealthmark
ML3 Annuity for New York (File No. 333-83558).
    5. The individual and group variable annuity contracts affected by
this Application are collectively referred to as the ``Contracts.''
    6. Each of the Contracts permits its owners to allocate the
Contract's accumulated value among numerous available Subaccounts, each
of which invests in a different investment portfolio (``Fund'') of an
underlying mutual fund.
    7. Shares of JHT are sold exclusively to insurance company separate
accounts to fund benefits under variable annuity contracts and variable
life insurance policies sponsored by the Insurance Companies or their
affiliates, and to employer pension and profit sharing plans. JHT is
registered under the Act as an open-end management investment company
of the series type, and its securities are registered under the
Securities Act of 1933, File Nos. 002-94157 and 811-04146. John Hancock
Investment Management Services, LLC (formerly, Manufacturers Securities
Services, LLC) (``JHIMS''), is the investment adviser to JHT, and each
series has its own subadviser.
    8. John Hancock USA and John Hancock New York (collectively the
``Insurance Companies'') and Account H and Account A (collectively the
``Separate Accounts'') previously applied for and were granted an Order
of the Commission pursuant to Section 26(c) of the Act (Inv. Co. Act
Rel. No. 27781, the ``Section 26(c) Order'') approving the substitution
of shares of certain series of JHT for shares of comparable series of
various registered investment companies, the majority of which were
series of DWS Variable Series II. The Section 26(c) Order approved,
among others, the substitution of shares of JHT Investment Quality Bond
Trust--Series II of JHT (such series being referred to herein as the
``Replacement Fund'') for shares of DWS Core Fixed Income VIP--Series
II, Class B of DWS Variable Series II (such series being referred to
herein as the ``Existing Fund''). All of the substitutions approved in
the Section 26(c) Order, except that involving the Existing Fund and
the Replacement Fund, were completed or are in the process of being
completed.
    9. The reason that the substitution involving the Existing Fund and
the Replacement Fund has not been completed is that Deutsche Investment
Management Americas Inc. (``DeIM''), the investment advisor of the
Existing Fund, has informed the Insurance Companies that the redemption
of the shares of the Existing Fund that are held by the Separate
Accounts may be effected partly in cash and partly in-kind.
    10. The Insurance Companies, on behalf of the Separate Accounts,
propose to redeem the shares held by the Separate Accounts in the
Existing Fund for a combination of cash and securities. The redemption
will be done on a pro-rata basis. The in-kind redemption from the
Existing Fund will be effected in accordance with the conditions set
forth in the Commission's no-action letter issued to Signature
Financial Group, Inc. (available December 28, 1999).
    11. The Insurance Companies, after redeeming the shares held by the
Separate Accounts in the Existing Fund for a combination of cash and
securities, will then use such redemption proceeds to purchase shares
of the Replacement Fund.
    12. The Applicants request an order under Section 17(b) exempting
them from the provisions of Section 17(a) to

the extent necessary to permit the Insurance Companies to carry out the
proposed substitution.
    13. Section 17(a)(1) of the Act, in relevant part, prohibits any
affiliated person of a registered investment company, or any affiliated
person of such person, acting as principal, from knowingly selling any
security or other property to that company. Section 17(a)(2) of the Act
generally prohibits the persons acting as principals, from knowingly
purchasing any security or other property from the registered company.
    14. Because shares held by a separate account of an insurance
company are legally owned by the insurance company, the Insurance
Companies and their affiliates collectively own of record substantially
all of the shares of JHT. Therefore, JHT and the Replacement Fund are
arguably under the control of the Insurance Companies notwithstanding
the fact that Contract owners may be considered the beneficial owners
of those shares held in the Separate Accounts. If JHT and the
Replacement Fund are under the control of the Insurance Companies, then
each Insurance Company is an affiliated person or an affiliated person
of an affiliated person of JHT and the Replacement Fund. If JHT and the
Replacement Fund are under the control of the Insurance Companies, then
JHT and the Replacement Fund are affiliated persons of the Insurance
Companies.
    15. Regardless of whether or not the Insurance Companies can be
considered to control JHT and the Replacement Fund, because the
Insurance Companies own of record more than 5% of the shares of each of
them and are under common control with the Replacement Funds'
investment adviser, the Insurance Companies are affiliated persons of
JHT and the Replacement Fund. Likewise, the Replacement Fund is an
affiliated person of the Insurance Companies.
    16. The Insurance Companies, through their Separate Accounts, in
the aggregate own more than 5% of the outstanding shares of the
Existing Fund. Therefore, each Insurance Company is an affiliated
person of the Existing Fund.
    17. Because the substitution may be effected, in whole or in part,
by means of in-kind redemptions and purchases, the substitution may be
deemed to involve one or more purchases or sales of securities or
property between affiliated persons. The proposed transactions will
involve a transfer of portfolio securities by the Existing Fund to the
Insurance Companies; immediately thereafter, the Insurance Companies,
on behalf of the Separate Accounts, will purchase shares of the
Replacement Fund with the portfolio securities received from the
Existing Fund. Accordingly, the Insurance Companies and the Existing
Fund, and the Insurance Companies and the Replacement Fund could be
viewed as affiliated persons of one another under Section 2(a)(3) of
the Act. It is conceivable that this aspect of the substitution could
be viewed as being prohibited by Section 17(a). Therefore, the
Applicants have determined to seek relief from Section 17(a) for the
in-kind purchases and sales of the shares of the Replacement Fund.
    18. Section 17(b) of the Act provides that the Commission may, upon
application, grant an order exempting any transaction from the
prohibitions of Section 17(a) if the evidence establishes that: (1) The
terms of the proposed transaction, including the consideration to be
paid or received, are reasonable and fair and do not involve
overreaching on the part of any person concerned; (2) the proposed
transaction is consistent with the policy of each registered investment
company concerned, as recited in its registration statement and records
filed under the Act; and (3) the proposed transaction is consistent
with the general purposes of the Act.
    19. The Applicants submit that the terms of the proposed in-kind
purchases of shares of the Replacement Fund, including the
consideration to be paid and received, as described in this
Application, are reasonable and fair and do not involve overreaching on
the part of any persons concerned. The Applicants also submit that the
proposed in-kind purchases by the Insurance Companies will be
consistent with the investment policies of the Replacement Fund. The
Insurance Companies' redemption of the shares held by the Separate
Accounts in the Existing Fund and the Insurance Companies' subsequent
purchase of shares of the Replacement Fund with such redemption
proceeds are scheduled to occur on the same day. The Replacement Fund
may opt to sell all or a portion of such in-kind securities received.
The Applicants submit that the proposed substitution is consistent with
the general purposes of the Act.
    20. Applicants assert that, to the extent that the in-kind
purchases are deemed to involve principal transactions among affiliated
persons, the procedures described below should be sufficient to assure
that the terms of the proposed transactions are reasonable and fair to
all participants. The Applicants maintain that the terms of the
proposed in-kind purchase transactions, including the consideration to
be paid and received by each fund involved, are reasonable, fair and do
not involve overreaching. Applicants represent that the transactions
will conform with all but one of the conditions enumerated in Rule 17a-
7. The proposed transactions will take place at relative net asset
value in conformity with the requirements of Section 22(c) of the Act
and Rule 22c-1 thereunder with no change in the amount of any Contract
owner's contract value or death benefit or in the dollar value of his
or her investment in any of the Separate Accounts. Contract owners will
not suffer any adverse tax consequences as a result of the
substitution. The fees and charges under the Contracts will not
increase because of the substitution. Even though the Separate
Accounts, the Insurance Companies and JHT may not rely on Rule 17a-7,
the Applicants believe that the Rule's conditions outline the type of
safeguards that result in transactions that are fair and reasonable to
registered investment company participants and preclude overreaching in
connection with an investment company by its affiliated persons.
    21. The board of JHT has adopted procedures, as required by
paragraph (e)(1) of Rule 17a-7, pursuant to which its series may
purchase and sell securities to and from their affiliates. The
Applicants will carry out the proposed Insurance Company in-kind
purchases in conformity with all of the conditions of Rule 17a-7 and
the Replacement Fund's procedures thereunder, except that the
consideration paid for the securities being purchased or sold may not
be entirely cash. Nevertheless, the circumstances surrounding the
proposed substitution will be such as to offer the same degree of
protection to the Replacement Fund from overreaching that Rule 17a-7
provides to it generally in connection with their purchase and sale of
securities under that Rule in the ordinary course of their business. In
particular, the proposed transactions will not be effected at a price
that is disadvantageous to the Replacement Fund. Although the
transactions may not be entirely for cash, each will be effected based
upon (1) the independent market price of the portfolio securities
valued as specified in paragraph (b) of Rule 17a-7, and (2) the net
asset value per share of each fund involved valued in accordance with
the procedures disclosed in its respective registration statement and
as

required by Rule 22c-1 under the Act. Any brokerage commission, fee, or
other cost incurred in connection with the proposed transactions will
be paid for by the Insurance Companies and not by the Contract owners.
    22. The sale of shares of the Replacement Fund for investment
securities, as contemplated by the proposed in-kind purchases, will be
consistent with the investment policy and restrictions of the
Replacement Fund because (1) the shares will be sold at their net asset
value, and (2) the portfolio securities will be of the type and quality
that the Replacement Fund could have acquired with the proceeds from
share sales had the shares been sold for cash. To assure that the
second of these conditions is met, the investment adviser and sub-
adviser of the Replacement Fund will examine the portfolio securities
being offered to the Replacement Fund and accept only those securities
as consideration for shares that they could have acquired for the
Replacement Fund in a cash transaction.
    23. The Applicants submit that the Insurance Companies' in-kind
purchases are consistent with the general purposes of the Act as stated
in the Findings and Declaration of Policy in Section 1 of the Act and
that the proposed transactions do not present any of the conditions or
abuses that the Act was designed to prevent.
    24. The Applicants represent that the proposed in-kind purchases
meet all of the requirements of Section 17(b) of the Act and request
that the Commission issue an order pursuant to Section 17(b) of the Act
exempting the Separate Accounts, the Insurance Companies, JHT, and the
Replacement Fund from the provisions of Section 17(a) of the Act to the
extent necessary to permit the Insurance Companies on behalf of the
Separate Accounts to carry out, as part of the substitution, the in-
kind purchases of shares of the Replacement Fund which may be deemed to
be prohibited by Section 17(a) of the Act.

Conclusion

    Applicants assert that for the reasons summarized above the
proposed substitution and related transactions are consistent with the
standards of Section 17(b) of the Act and that the requested orders
should be granted.

    For the Commission, by the Division of Investment Management
pursuant to delegated authority.
Nancy M. Morris,
Secretary.
[FR Doc. E7-23205 Filed 11-29-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 6 (Monday, January 10, 2022)]
[Notices]
[Pages 1141-1142]
[FR Doc No: 2022-00185]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2842-044]

City of Idaho Falls; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Application for Non-Project Use of Project
Lands and Waters.
    b. Project No: 2842-044.
    c. Date Filed: September 23, 2021 and supplemented on October 18,
2021 and December 27, 2021.
    d. Applicant: City of Idaho Falls, Idaho (licensee).
    e. Name of Project: Idaho Falls Hydroelectric Project.
    f. Location: The project is located on the Snake River in
Bonneville County, Idaho.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Jason Cooper, Physical Engineer; Idaho Falls
Power; P.O. Box 50220; 140 South Capital; Idaho Falls, Idaho 83405-
0220; Phone:<PHONE_NUMBER>.
    i. FERC Contact: Alicia Burtner,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: February 4, 2022.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at https://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at https://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first

page of any filing should include the docket number P-2842-044.
Comments emailed to Commission staff are not considered part of the
Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee requests approval of a non-
project use of project lands and waters in support of a public park to
be located adjacent to and partially on project lands. The licensee
proposes a water withdrawal of 2.27 cubic feet per second (cfs) to be
taken from the right bank of the Snake River, upstream of the Lower
Development weir. The request includes provisions to construction an
intake structure and a series of pipes leading to a constructed,
educational stream and pond in the public park. Approximately 0.27 cfs
of the diverted water would be used for irrigation in the park, and the
remaining 2 cfs would be returned to the Snake River downstream of the
Lower Development weir. This would be the first water withdrawal at the
project, and it would not require any alterations of current project
operations.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at https://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. At this time, the Commission has suspended
access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: January 4, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-00185 Filed 1-7-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55616-55617]
[FR Doc No: 2021-21686]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1396]

Use of Data From Foreign Investigational Studies To Support
Effectiveness of New Animal Drugs; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry #265 entitled ``Use
of Data from Foreign Investigational Studies to Support Effectiveness
of New Animal Drugs.'' The guidance describes FDA's current thinking
with respect to assisting sponsors in incorporating data from foreign
countries into proposed clinical investigational protocols and
applications for new animal drugs under the Federal Food, Drug, and
Cosmetic Act.

DATES: The announcement of the guidance is published in the Federal
Register on October 6, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1396 for ``Use of Data from Foreign Investigational Studies
to Support Effectiveness of New Animal Drugs.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary
Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 15, 2020 (85 FR 42867), FDA
published the notice of availability for a draft guidance entitled
``Use of Data from Foreign Investigational Studies to Support
Effectiveness of New Animal Drugs,'' giving interested persons until
October 13, 2020, to comment on the draft guidance. This final guidance
describes principles for designing, conducting, and reporting the
results for investigations or studies, including data from foreign
countries, in submissions to FDA of investigational new animal drug
files, new animal drug applications (NADAs), and applications for
conditional approval of a new animal drug (CNADAs) to demonstrate
substantial evidence of effectiveness for NADAs or a reasonable
expectation of effectiveness for CNADAs. It also describes how sponsors
may obtain feedback from the Center for Veterinary Medicine regarding
the incorporation of data from foreign countries into investigations
and study protocols before the submission of an application.
    FDA received comments on the draft guidance and those comments were
considered as the guidance was finalized. Editorial changes were made
to this final guidance to improve clarity. For example, we revised the
language of the draft guidance to provide greater clarity regarding the
level of evidence that may be required under certain circumstances to
support effectiveness in clinical investigation protocols and
applications. The guidance announced in this notice finalizes the draft
guidance dated July 2020.
    This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``Use of Data from Foreign
Investigational Studies to Support Effectiveness of New Animal Drugs.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in FDA's guidance entitled ``Use of Data from Foreign
Investigational Studies to Support Effectiveness of New Animal Drugs''
have been approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21686 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Page 2471]
[FR Doc No: 2018-00738]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE:  Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, that the
Commission will co-host the SEC-NYU Dialogue on Securities Markets--
Shareholder Engagement on Friday, January 19, 2018, beginning at 9:10
a.m. (ET).

PLACE:  The meeting will be held at the New York University's Salomon
Center for the Study of Financial Institutions, 44 W. 4th Street, New
York, NY 10112.

STATUS:  This meeting will begin at 9:10 a.m. (ET) and will be open to
the public. Attendees can pre-register for in-person attendance or
webcast. The meeting will be webcast live by NYU and later archived on
the Commission's website at www.sec.gov.

MATTERS TO BE CONSIDERED:  The event is scheduled to include welcome
remarks by SEC Chairman Jay Clayton, concluding remarks by SEC
Commissioner Kara Stein, and panel discussions that Commissioners may
attend. The panel discussions will address, among other matters, the
increasing ownership of public companies by large institutional
investors, the influence of activist investors, the role of proxy
advisory services, and other changes in the way investors and public
companies engage with each other.
    This Sunshine Act notice is being issued because a majority of the
Commission may attend the meeting.

CONTACT PERSON FOR MORE INFORMATION:  For further information and to
ascertain what, if any, matters have been added, deleted or postponed;
please contact Brent J. Fields from the Office of the Secretary at
(202) 551-5400.

    Dated: January 11, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-00738 Filed 1-12-18; 11:15 am]
 BILLING CODE 8011-01-P