[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29717-29719]
[FR Doc No: 2015-12512]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pharmacy Compounding Advisory Committee.
    General Function of the Committee: To provide advice on scientific,
technical, and medical issues concerning drug compounding under
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), and, as required, any other product for which FDA has
regulatory responsibility, and make appropriate recommendations to the
Commissioner of Food and Drugs.
    Date and Time: The meeting will be held on June 17, 2015, from 8:30
a.m. to 5 p.m., and on June 18, 2015, from 8:30 a.m. to 11:30 a.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/
AdvisoryCommittees/

AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Jayne E. Peterson, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes
the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist or licensed physician to be exempt
from the following three sections of the FD&C Act: (1) Section
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use);
and (3) section 505 (21 U.S.C. 355) (concerning the approval of human
drug products under new drug applications (NDAs) or abbreviated new
drug applications (ANDAs)).
    The Drug Quality and Security Act adds a new section, 503B, to the
FD&C Act (21 U.S.C. 353b) that creates a new category of ``outsourcing
facilities.'' Outsourcing facilities, as defined in section 503B of the
FD&C Act, are facilities that meet certain conditions described in
section 503B, including registration with FDA as an outsourcing
facility. If these conditions are satisfied, a drug product compounded
for human use by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from three sections of
the FD&C Act: (1) Section 502(f)(1), (2) section 505, and (3) section
582 (21 U.S.C. 360eee-1), but not section 501(a)(2)(B).
    One of the conditions that must be satisfied to qualify for the
exemptions under both sections 503A and 503B of the FD&C Act is that
the drug that is compounded does not appear on a list published by the
Secretary of drugs that have been withdrawn or removed from the market
because such drug products or components of such drug products have
been found to be unsafe or not effective (``withdrawn or removed
list'') (see sections 503A(b)(1)(C) and 503B(a)(4) of the FD&C Act).
    Another condition that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that a bulk drug
substance (active pharmaceutical ingredient) used in a compounded drug
must meet one of the following criteria: (1) Complies with the
standards of an applicable United States Pharmacopoeia (USP) or
National Formulary monograph, if a monograph exists, and the USP
chapter on pharmacy compounding; (2) if an applicable monograph does
not exist, is a component of a drug approved by the Secretary of Health
and Human Services (the Secretary); or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, appears on a list (``section 503A bulk drug substances
list'') developed by the Secretary through regulations issued by the
Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act).
    Another condition that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that the compounded
drug product is not a drug product identified by the Secretary by
regulation as a drug product that presents demonstrable difficulties
for compounding that reasonably demonstrate an adverse effect on the
safety or effectiveness of that drug product (see section 503A(b)(3)(A)
of the FD&C Act).
    Another condition that must be satisfied to qualify for the
exemptions in section 503B of the FD&C Act is that the compounded drug
is not identified (directly or as part of a category of drugs) on a
list published by the Secretary of drugs or categories of drugs that
present demonstrable difficulties for compounding that are reasonably
likely to lead to an adverse effect on the safety or effectiveness of
the drug or category of drugs, taking into account the risks and
benefits to patients, or the drug is compounded in accordance with all
applicable conditions that are necessary to prevent the drug or
category of drugs from presenting such demonstrable difficulties (see
section 503B(a)(6)(A) and (B) of the FD&C Act).
    FDA will discuss with the committee drugs proposed for inclusion on
the withdrawn or removed list pursuant to sections 503A and 503B and on
the section 503A bulk drug substances list. FDA will also discuss with
the committee the criteria FDA proposes to use to evaluate candidates
to be identified as difficult to compound pursuant to sections 503A and
503B.
    Agenda: On June 17, 2015, during the morning session, the committee
will receive updates on certain issues to follow up on discussions from
the last meeting including the options for obtaining access to
investigational new drugs and the processes FDA plans to use to add or
remove drugs from the section 503A bulk drug substances list. During
this session, the committee will also discuss revisions FDA is
considering to the list of drug products that may not be compounded
under the exemptions provided by the FD&C Act because the drug products
have been withdrawn or removed from the market because such drug
products or components of such drug products have been found to be
unsafe or not effective. The list of those drug products is currently
codified at 21 CFR 216.24. FDA now is considering whether to amend the
rule to add four more drugs to the list: Aprotinin, ondansetron
hydrochloride, bromocriptine mesylate, and acetaminophen. As previously
explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689
through 37690), the list may specify that a drug may not be compounded
in any form, or, alternatively, may expressly exclude a particular
formulation, indication, dosage form, or route of administration from
an entry on the list because an approved drug containing the same
active ingredient(s) has not been withdrawn or removed from the market.
Moreover, a drug may be listed only with regard to certain
formulations, indications, routes of administration, or dosage forms
because it has been found to be unsafe or not effective in those
particular formulations, indications, routes of administration, or
dosage forms. FDA plans to seek the committee's advice concerning the
inclusion of these drug products.
    On June 17, 2015, during the afternoon session, the committee will
discuss four bulk drug substances nominated for inclusion on the
section 503A bulk drug substances list. FDA intends to discuss the
following nominated bulk drug substances: Brilliant Blue G, tranilast,
N-acetyl-D-glucosamine, and oxitriptan. The nominators of these
substances will be invited to make a short presentation supporting the
nomination. Other nominated substances will be discussed at future
committee meetings.
    During the morning session on June 18, 2015, the committee will
discuss the criteria FDA is proposing to use to evaluate drug products
or categories of

drug products for identification as demonstrably difficult to compound.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
9, 2015. Oral presentations from the public will be scheduled between
approximately 11 a.m. to 11:15 a.m. and 3:45 p.m. to 4 p.m. on June 17,
2015, and between approximately 9:15 a.m. to 9:45 a.m. on June 18,
2015. Those individuals interested in making formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before June
4, 2015. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by June 8, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Jayne E. Peterson at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 19, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-12512 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 113 (Monday, June 13, 2011)]
[Notices]
[Pages 34243-34244]
[FR Doc No: 2011-14562]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1971-DR; Docket ID FEMA-2011-0001]

Alabama; Amendment No. 14 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster for the
State of Alabama (FEMA-1971-DR), dated April 28, 2011, and related
determinations.

DATES: Effective Date: May 5, 2011.

FOR FURTHER INFORMATION CONTACT: Tod Wells, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, on May 5, 2011,
the President amended the cost-sharing arrangements regarding Federal
funds provided under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I authorize as a pilot project a 90 percent Federal cost share
until June 12, 2011 (45 days from the date of declaration) for
Direct Federal Assistance for debris removal for those areas within
counties designated for Public Assistance that are within, Or
immediately adjacent to, areas of ``extensive'' or ``catastrophic''
damage as determined and depicted by the National Geospatial
Intelligence Agency. Further, under this pilot program, FEMA shall
obtain any applicable private insurance payments for debris removal
to reimburse Federal costs to the fullest extent of the law.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-14562 Filed 6-10-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Rules and Regulations]
[Pages 58101-58103]
[FR Doc No: 2011-24088]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 40

[Docket No. RM10-29-000; Order No. 753]

Electric Reliability Organization Interpretation of Transmission
Operations Reliability Standard

September 15, 2011.
AGENCY: Federal Energy Regulatory Commission.

ACTION: Final rule.

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SUMMARY: Under section 215 of the Federal Power Act (FPA), the Federal
Energy Regulatory Commission approves the North American Electric
Reliability Corporation's proposed interpretation of Reliability
Standard, TOP-001-1, Requirement R8, which pertains to the restoration
of real and reactive power during a system emergency.

DATES: Effective Date: This rule will become effective November 21,
2011.

FOR FURTHER INFORMATION CONTACT:
Robert T. Stroh (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, Telephone:<PHONE_NUMBER>.
Eugene Blick (Technical Information), Office of Electric Reliability,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, Telephone:<PHONE_NUMBER>.
David O'Connor (Technical Information), Office of Electric Reliability,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Before Commissioners: Jon Wellinghoff,
Chairman; Marc Spitzer, Philip D. Moeller, John R. Norris, and Cheryl
A. LaFleur.

Final Rule

    1. Under section 215 of the Federal Power Act (FPA),\1\ the Federal
Energy Regulatory Commission approves the North American Electric
Reliability Corporation's (NERC) proposed interpretation of Requirement
R8 in Commission-approved NERC Reliability Standard TOP-001-1--
Reliability Responsibilities and Authorities.
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    \1\ 16 U.S.C. 824o (2006).
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I. Background

    2. Section 215 of the FPA requires a Commission-certified Electric
Reliability Organization (ERO) to develop mandatory and enforceable
Reliability Standards, which are subject to Commission review and
approval. Approved Reliability Standards are enforced by the ERO,
subject to Commission oversight, or by the Commission independently.
    3. Pursuant to section 215 of the FPA, the Commission established a
process to select and certify an ERO \2\ and, subsequently, certified
NERC as the ERO.\3\ On March 16, 2007, the Commission issued Order No.
693, approving 83 of the 107 Reliability Standards filed by NERC,
including Reliability Standard TOP-001-1.\4\
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    \2\ 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).
    \3\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g & compliance, 117 FERC ] 61,126 (2006), aff'd
sub nom. Alcoa, Inc. v. FERC, 564 F.3d 1342 (D.C. Cir. 2009).
    \4\ Mandatory Reliability Standards for the Bulk-Power System,
Order No. 693, FERC Stats. & Regs. ] 31,242, order on reh'g, Order
No. 693-A, 120 FERC ] 61,053 (2007).
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    4. NERC's Rules of Procedure provide that a person that is
``directly and materially affected'' by Bulk-Power System reliability
may request an interpretation of a Reliability Standard.\5\ The ERO's
``standards process manager'' will assemble a team with relevant
expertise to address the requested interpretation and also form a
ballot pool. NERC's Rules provide that, within 45 days, the team will
draft an interpretation of the Reliability Standard, with subsequent
balloting. If approved by ballot, the interpretation is appended to the
Reliability Standard and filed with the applicable regulatory authority
for regulatory approval.
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    \5\ NERC Rules of Procedure, Appendix 3A, Reliability Standards
Development Procedure, Version 6.1, at 27-29 (2010).
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A. Reliability Standard TOP-001-1

    5. Reliability Standard TOP-001-1 (Reliability Responsibilities and
Authorities) centers on the responsibilities of balancing authorities
and transmission operators during a system emergency. Specifically, the
stated purpose of Reliability Standard TOP-001-1 is to ensure
reliability entities have clear decision-making authority and
capabilities to take appropriate actions or direct the actions of
others to return the transmission system to normal conditions during an
emergency. Requirement R8 of the standard provides:

    During a system emergency, the Balancing Authority and
Transmission Operator shall immediately take action to restore the
Real and Reactive Power Balance. If the Balancing Authority or
Transmission Operator is unable to restore Real and Reactive Power
Balance it shall request emergency assistance from the Reliability
Coordinator. If corrective action or emergency assistance is not
adequate to mitigate the Real and Reactive Power Balance, then the
Reliability Coordinator, Balancing Authority, and Transmission
Operator shall implement firm load shedding.\6\
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    \6\ Reliability Standard TOP-001-1, Requirement R8.
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B. NERC Proposed Interpretation

    6. On July 16, 2010, NERC submitted its petition for approval for
an interpretation of Requirement R8 in Commission-approved Reliability
Standard TOP-001-1. The Petition explains that NERC received a request
from Florida Municipal Power Pool (FMPP) seeking an interpretation of
Reliability Standard TOP-001-1, Requirement R8. Specifically, FMPP
requested clarification on several aspects of Requirement R8. FMPP
asked the following:

    Balancing real power is not a function of a [Transmission
Operator] and balancing reactive power is not a function of a
[Balancing Authority]. For Requirement R8 is the Balancing Authority
responsibility to immediately take corrective action to restore Real
Power Balance and is the [Transmission Operator] responsibility to
immediately take corrective action to restore Reactive Power
Balance? \7\
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    \7\ NERC Petition at 5.

    7. Consistent with the NERC Rules of Procedure, NERC stated that it
assembled a team to respond to the request for interpretation and
presented the proposed interpretation to industry ballot, using a
process similar to the process it uses for the development of
Reliability Standards.\8\
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    \8\ NERC Reliability Standards Development Procedure at 27-29.
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    8. In response to FMPP's interpretation request, NERC provided the
following:

    The answer to both questions is yes. According to the NERC
Glossary of Terms Used in Reliability Standards, the Transmission
Operator is responsible for the reliability of its ``local''
transmission system, and operates or directs the operations of the
transmission facilities. Similarly, the Balancing Authority is
responsible for maintaining load-interchange-generation balance,
i.e., real power balance. In the context of this requirement, the
Transmission Operator is the functional entity that balances
reactive power. Reactive power balancing can be accomplished by
issuing instructions to the Balancing Authority or Generator
Operators to alter reactive power injection. Based on NERC
Reliability Standard BAL-005-1b Requirement R6, the Transmission
Operator has no requirement to

compute an Area Control Error (ACE) signal or to balance real power.
Based on NERC Reliability Standard VAR-001-1 Requirement R8, the
Balancing Authority is not required to resolve reactive power
balance issues. According to TOP-001-1[bsol] Requirement R3, the
Balancing Authority is only required to comply with Transmission
Operator or Reliability Coordinator instructions to change
injections of reactive power.\9\
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    \9\ Id. at 5-6.

    NERC stated that the interpretation was developed and approved by
industry stakeholders and approved by the NERC Board of Trustees
(Board).
    9. The NERC petition explained that the interpretation is
consistent with the stated purpose of the Reliability Standard, which
is to ensure reliability entities have clear decision-making authority
and capabilities to take appropriate actions or direct the actions of
others to return the transmission system to normal conditions during an
emergency. NERC added that the interpretation clarifies the
responsibilities of balancing authorities and transmission operators
during a system emergency by referencing the NERC Glossary of Terms
Used in Reliability Standards as well as other relevant Reliability
Standards.\10\
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    \10\ Id. at 6.
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    10. On February 14, 2011, NERC made a supplemental filing in
response to a Commission staff data request.\11\ With regard to whether
Requirement R8 obligates a joint response in a system emergency, NERC
explained that Requirement R8 does not use the word ``joint'' or
otherwise infer joint responsibility during system emergencies. Rather,
NERC responded that the balancing authority and transmission operator
have separate responsibilities to restore real and reactive power
balance during system emergencies. NERC also stated that the use of
``and'' between the two entities should not construe communication or
coordination. NERC added that the Blackout Report \12\ correctly
identifies communication and coordination issues as reliability issues
and that communication and coordination are addressed in the
Communications (COM) Reliability Standards.\13\
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    \11\ Response of the North American Electric Reliability
Corporation to Request for Additional Information Regarding
Interpretation to Reliability Standard TOP-001-1, Requirement R8
(NERC Response).
    \12\ Final Report on the August 14, 2003 Blackout in the United
States and Canada (Blackout Report).
    \13\ NERC Response at 4-7.
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II. Notice of Proposed Rulemaking

    11. On April 21, 2011, the Commission issued a Notice of Proposed
Rulemaking (NOPR) proposing to approve NERC's interpretation of
Reliability Standard TOP-001-1, Requirement R8.\14\ In the NOPR, the
Commission stated that it believed that the ERO has presented a
reasonable interpretation consistent with the language of the
Reliability Standard. In addition, the NOPR noted that a balancing
authority and transmission operator each have coordination and
communication functions that are necessary for maintaining real and
reactive power balance.
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    \14\ Electric Reliability Organization Interpretation of
Transmission Operations Reliability Standard, Notice of Proposed
Rulemaking, 76 FR 23222 (Apr. 26, 2011), FERC Stats. & Regs. ]
32,674 (2011) (NOPR).
---------------------------------------------------------------------------

    12. In response to the NOPR, NERC filed comments supporting the
Commission's proposed approval of the interpretation. No comments were
filed opposing the Commission's proposal to approve NERC's
interpretation.

III. Commission Determination

    13. The Commission adopts the NOPR proposal and approves the
interpretation of TOP-001-1, Requirement R8. The Commission finds that
NERC's interpretation is just, reasonable, not unduly discriminatory or
preferential, and in the public interest.
    14. The interpretation supports the stated purpose of the
Reliability Standard, i.e., ensuring that reliability entities have
clear decision-making authority and capabilities to take appropriate
actions or direct the actions of others to return the transmission
system to normal conditions during an emergency.\15\ The interpretation
also clarifies the responsibilities of a balancing authority and
transmission operator during a system emergency. Further, the language
is consistent with the language of the requirement. Accordingly, the
Commission approves the ERO's interpretation of TOP-001-1, Requirement
R8.
---------------------------------------------------------------------------

    \15\ Id. at 6.
---------------------------------------------------------------------------

    15. We agree, as discussed in the interpretation, that the
balancing authority is responsible for restoring real power balance
during a system emergency and the transmission operator is responsible
for restoring reactive power balance during a system emergency.
However, during a system emergency, communication and coordination
between the transmission operator and balancing authority can be
essential to restore real and reactive power balance. For example,
during an emergency, the balancing authority may rely on the real power
output of a generator to fulfill its responsibility, while the
transmission operator may expect the same generator unit to reduce real
power to generate greater reactive power output.\16\
---------------------------------------------------------------------------

    \16\ The Blackout Report described such a scenario, explaining
that a generator unit tripped because the unit's protection system
detected the VAR output, i.e., reactive power, exceeded the unit's
capability. Blackout Report at 27. The Blackout Report also
explained that no generator units were asked to reduce their real
power output to produce more reactive power. Id. at 47.
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    16. NERC acknowledges the need for such communication and
coordination.\17\ NERC maintains that this coordination and
communication is required through two currently-effective Communication
Reliability Standards: (1) COM-001-1.1--Telecommunications and (2) COM-
002-2--Communication and Coordination.\18\
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    \17\ NERC Response at 6-7.
    \18\ NERC Response at 6-7. NERC also identifies several ongoing
Reliability Standards projects that are intended to strengthen the
requirements pertaining to communication and coordination between
entities.
---------------------------------------------------------------------------

    17. We agree with NERC that the currently effective COM Reliability
Standards provide for such communication and coordination. For example,
Reliability Standard COM-002-2, Requirement R1 provides that
transmission operators, balancing authorities and generator operators
must have communication links with one another and must be staffed to
address a real-time emergency. Reliability Standard EOP-001-0,
Requirements R3, R4.3, and R7 also contain provisions relevant to the
need for communication and coordination in emergencies.\19\ These
provisions require balancing authorities and transmission operators to
develop plans to mitigate operating emergencies including coordination
among adjacent transmission operators and balancing authorities.
---------------------------------------------------------------------------

    \19\ See NOPR, FERC Stats. & Regs. ] 32,674 at P 14. On July 13,
2011, the Commission approved EOP-001-2 Reliability Standard,
replacing EOP-001-0 effective July 1, 2013. Mandatory Reliability
Standards for Interconnection Reliability Operating Limits; System
Restoration Reliability Standards, 136 FERC ] 61,030 (2011). The
applicable Requirements in EOP-001-2 relevant to the need for
communication and coordination in emergencies are Requirements R2,
R3.3, and R6.
---------------------------------------------------------------------------

    18. Accordingly, for the reasons discussed above, we approve NERC's
proposed interpretation of TOP-001-1, Requirement R8.

IV. Information Collection Statement

    19. The Office of Management and Budget (OMB) regulations require
that OMB approve certain reporting and recordkeeping requirements
(collections of information) imposed by an agency.\20\ The information
contained here is also

subject to review under section 3507(d) of the Paperwork Reduction Act
of 1995.\21\
---------------------------------------------------------------------------

    \20\ 5 CFR 1320.11.
    \21\ 44 U.S.C. 3507(d).
---------------------------------------------------------------------------

    20. As stated above, the Commission approved, in Order No. 693,
Reliability Standard TOP-001-1 that is the subject of the current
rulemaking. This Final Rule approves the interpretation of the
previously approved Reliability Standard, which was developed by NERC
as the ERO. The interpretation, as clarified, relates to an existing
Reliability Standard, and the Commission does not expect it to affect
entities' current reporting burden.\22\ Accordingly, we will submit
this Final Rule to OMB for informational purposes only.
---------------------------------------------------------------------------

    \22\ See Order No. 693, FERC Stats. & Regs. ] 31,242 at P 1901-
1907.
---------------------------------------------------------------------------

    21. Interested persons may obtain information on the reporting
requirements by contacting the following: Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426 [Attention:
Ellen Brown, Office of the Executive Director, e-mail:
<EMAIL_ADDRESS>Phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>].

V. Environmental Analysis

    22. 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.\23\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. Included in the exclusion are rules that are clarifying,
corrective, or procedural or that do not substantially change the
effect of the regulations being amended.\24\ The actions proposed
herein fall within this categorical exclusion in the Commission's
regulations.
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    \23\ Regulations Implementing the National Environmental Policy
Act of 1969, Order No. 486, 52 FR 47897 (Dec. 17, 1987), FERC Stats.
& Regs. Preambles 1986-1990 ] 30,783 (1987).
    \24\ 18 CFR 380.4(a)(2)(ii).
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VI. Regulatory Flexibility Act

    23. The Regulatory Flexibility Act of 1980 (RFA) \25\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
The RFA mandates consideration of regulatory alternatives that
accomplish the stated objectives of a final rule and that minimize any
significant economic impact on a substantial number of small entities.
The Small Business Administration's (SBA) Office of Size Standards
develops the numerical definition of a small business.\26\ The SBA has
established a size standard for electric utilities, stating that a firm
is small if, including its affiliates, it is primarily engaged in the
transmission, generation and/or distribution of electric energy for
sale and its total electric output for the preceding twelve months did
not exceed four million megawatt hours.\27\ The RFA is not implicated
by this Final Rule because the interpretations discussed herein will
not have a significant economic impact on a substantial number of small
entities.
---------------------------------------------------------------------------

    \25\ 5 U.S.C. 601-612.
    \26\ 13 CFR 121.101.
    \27\ 13 CFR 121.201, Section 22, Utilities, & n.1.
---------------------------------------------------------------------------

    24. The Commission approved Reliability Standard TOP-001-1 in 2007
in Order No. 693. The Final Rule in the immediate docket addresses an
interpretation of Requirement R8 of previously-approved TOP-001-1. The
interpretation clarifies current compliance obligations of balancing
authorities and transmission operators and therefore, does not create
an additional regulatory impact on small entities.

VII. Document Availability

    25. 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.
    26. 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.
    27. User assistance is available for eLibrary and the FERC's
website 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>
VIII. Effective Date and Congressional Notification

    28. These regulations are effective November 21, 2011. The
Commission has determined, with the concurrence of the Administrator of
the Office of Information and Regulatory Affairs of OMB, that this rule
is not a ``major rule'' as defined in section 351 of the Small Business
Regulatory Enforcement Fairness Act of 1996.

List of Subjects in 18 CFR Part 40

    Electric power, Electric utilities, Reporting and recordkeeping
requirements.

    By the Commission.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-24088 Filed 9-19-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Notices]
[Page 21920]
[FR Doc No: 2013-08588]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2601-021]

Duke Energy Carolinas, LLC; 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: Shoreline Management Plan.
    b. Project No: 2601-021.
    c. Date Filed: August 13, 2012 and supplemented January 10, March
26, and April 4, 2013.
    d. Applicant: Duke Energy Carolinas, LLC.
    e. Name of Project: Bryson Hydroelectric Project.
    f. Location: The Bryson Hydroelectric Project is located on the
Oconaluftee River in Swain County, North Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Dennis Whitaker, Duke Energy--Lake Services,
526 S. Church St., Charlotte, NC 28202,<PHONE_NUMBER>.
    i. FERC Contact: Tara Perry at<PHONE_NUMBER>, or email:
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: May 9, 2013.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://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 http://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_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
Please include the project number (P-2601-021) on any comments,
motions, or recommendations filed.
    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: As required by article 407 of the July
22, 2011 license, Duke Energy Carolinas, LLC requests Commission
approval of a proposed shoreline management plan (SMP) for the project.
The SMP defines shoreline management classifications for the reservoir
shoreline within the project boundary, identifies allowable and
prohibited uses within the shoreline areas, and describes the shoreline
use permitting process.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field (P-2601) 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. For assistance, call 1-866-
208-3676 or email<EMAIL_ADDRESS>for TTY, call (202) 502-
8659. A copy is also available for inspection and reproduction at the
address in item (h) above. 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: April 8, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-08588 Filed 4-11-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Page 39765]
[FR Doc No: 2015-16886]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR15-35-001.
    Applicants: Southcross Alabama Pipeline LLC.
    Description: Submits tariff filing per 284.123(b), (e), (g):
Revised Tariff filing to be effective 5/1/2015; Filing Type: 1270.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5107.
    Comments Due: 5 p.m. ET 7/21/15.
    284.123(g) Protests Due: 5 p.m. ET 7/21/15.

    Docket Numbers: RP15-1090-000.
    Applicants: Monroe Gas Storage Company, LLC.
    Description: Compliance filing Compliance Filing--FERC Order No.
801 System Maps to be effective 6/30/2015.
    Filed Date: 6/30/15
    Accession Number: 20150630-5136.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1091-000.
    Applicants: Cadeville Gas Storage LLC.
    Description: Compliance filing Compliance Filing--FERC Order No.
801 System Maps to be effective 6/30/2015
    Filed Date: 6/30/15.
    Accession Number: 20150630-5141.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1092-000.
    Applicants: Perryville Gas Storage LLC, Perryville Gas Storage LLC.
    Description: Compliance filing Compliance Filing--FERC Order No.
801 System Maps to be effective 6/30/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5144.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1093-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Section 4(d) Rate Filing: Amendment to Neg Rate Agmt
(FPL 40097-14) to be effective 7/1/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5184.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1094-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Section 4(d) Rate Filing: Non-Conforming Agreement
Update Filing to be effective 8/1/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5190.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1095-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Measurement Variance/Fuel Use Factors of Iroquois Gas
Transmission System, L.P.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5194.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1096-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Section 4(d) Rate Filing: Negotiated Rates--Cherokee
AGL--Replacement Shippers--Jul 2015 to be effective 7/1/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5199.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1097-000.
    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Section 4(d) Rate Filing: Non-Conforming Agreement
Update to be effective 8/1/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5202.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1098-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Section 4(d) Rate Filing: Negotiated Rate Filing--June
30 2015--Entergy 8791 LER 8744 and SWEPCO 6888 to be effective 7/1/
2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5243.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1099-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Section 4(d) Rate Filing: Neg Rate 2015-06-30 Mieco,
Exelon, BP, Tenaska to be effective 7/1/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5258.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1100-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Section 4(d) Rate Filing: Decoupled Releases to be
effective 8/1/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5262.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1101-000.
    Applicants: Big Sandy Pipeline, LLC.
    Description: Section 4(d) Rate Filing: Big Sandy EPC 2015 to be
effective 8/1/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5271.
    Comments Due: 5 p.m. ET 7/13/15.

    Docket Numbers: RP15-1102-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Section 4(d) Rate Filing: EPC AUG 2015 FILING to be
effective 8/1/2015.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5274.
    Comments Due: 5 p.m. ET 7/13/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 1, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-16886 Filed 7-9-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 155 (Monday, August 12, 2013)]
[Notices]
[Pages 48925-48926]
[FR Doc No: 2013-19449]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2013-0684]

Agency Information Collection Activities: Requests for Comments;
Clearance of a New Approval of Information Collection: Helicopter Air
Ambulance Operator Reports; Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a new information collection.
This notice corrects a notice published in the Federal Register on July
31, 2013 (78 FR 46405) to include additional background information, to
include the docket number FAA-2013-0684, which contains supplementary
documentation on the subject information collection, and to extend the
comment period. The FAA Modernization and Reform Act of 2012 included a
mandate to begin collection of operational data from Air Ambulance
operators. FAA is to summarize the data and report to Congress no later
than February 14, 2014, and annually thereafter.

DATES: Written comments should be submitted by October 11, 2013.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-XXXX.
    Title: Helicopter Air Ambulance Operator Reports.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Clearance of a new information collection.
    Background: The FAA Modernization and Reform Act of 2012 mandates
that all helicopter air ambulance operators must begin reporting the
number of flights and hours flown, along with other specified
information, during which helicopters operated by the certificate
holder were providing

helicopter air ambulance services. See 49 U.S.C. 44731. The helicopter
air ambulance operational data provided to the FAA will be used by the
agency as background information useful in the development of risk
mitigation strategies to reduce the currently unacceptably high
helicopter air ambulance accident rate, and to meet the mandates set by
Congress. Upon approval of this information collection the FAA intends
to amend helicopter air ambulance operators' Operations Specifications
to require submission of the data, mandated by Congress, to the FAA.
    The FAA notes that prior to issuance of this notice representatives
from the Flight Standards Service, Office of Accident Investigation and
Prevention, and the Office of the Chief Counsel met with
representatives from the Air Medical Operators Association (AMOA) to
discuss the FAA's approach to this data collection. Meetings were held
on October 15, 2012 and May 17, 2013. On June 28, 2013 AMOA submitted a
response to the FAA discussing its view of the method to collect the
data being pursued by the FAA. A copy of that letter has been placed in
the docket and will be considered by the agency.
    Respondents: 73 helicopter air ambulance certificate holders.
    Frequency: Information is collected quarterly.
    Estimated Average Burden per Response: 6 hours.
    Estimated Total Annual Burden: 2,352 hours.

ADDRESSES: Send comments identified by docket number to the FAA at the
following address: Ms. Kathy DePaepe, Room 126B, Federal Aviation
Administration, AES-200, 6500 S. MacArthur Blvd., Oklahoma City, OK
73169. Comments may also be submitted electronically by going to http://www.regulations.gov and following the online instructions.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    The supplementary materials placed in the docket may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue
SE.,Washington, DC between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

    Issued in Washington, DC on August 5, 2013.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2013-19449 Filed 8-9-13; 8:45 am]
BILLING CODE 4910-13-P