[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Notices]
[Page 64523]
[FR Doc No: 2013-25626]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Notice of Maximum Amount of Assistance Under the Individuals and
Households Program

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: FEMA gives notice of the maximum amount for assistance under
the Individuals and Households Program for emergencies and major
disasters declared on or after October 1, 2013.

DATES: Effective Date: October 1, 2013, and applies to emergencies and
major disasters declared on or after October 1, 2013.

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

SUPPLEMENTARY INFORMATION: Section 408 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act (the Stafford Act), 42
U.S.C. 5174, prescribes that FEMA must annually adjust the maximum
amount for assistance provided under the Individuals and Households
Program (IHP). FEMA gives notice that the maximum amount of IHP
financial assistance provided to an individual or household under
section 408 of the Stafford Act with respect to any single emergency or
major disaster is $32,400. The increase in award amount as stated above
is for any single emergency or major disaster declared on or after
October 1, 2013. In addition, in accordance with 44 CFR 61.17(c), this
adjustment includes the maximum amount of available coverage under any
Group Flood Insurance Policy (GFIP) issued for those disasters.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.5 percent for the 12-month period,
which ended in August 2013. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 17, 2013.

    Catalog of Federal Domestic Assistance No. 97.048, Federal
Disaster 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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-25626 Filed 10-28-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 103 (Thursday, May 28, 2020)]
[Notices]
[Page 32035]
[FR Doc No: 2020-11435]

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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:

    Docket Number: PR20-61-000.
    Applicants: Enable Oklahoma Intrastate Transmission, LLC.
    Description: Tariff filing per 284.123(b),(e)+(g): Enable Oklahoma
Storage Statement of Operating Conditions--PALS to be effective 5/19/
2020.
    Filed Date: 5/19/2020.
    Accession Number:<PHONE_NUMBER>68.
    Comments Due: 5 p.m. ET 6/9/2020.
    284.123(g) Protests Due: 5 p.m. ET 7/20/2020.

    Docket Numbers: RP20-880-000.
    Applicants: Elba Express Company, L.L.C.
    Description: Compliance filing Annual Cashout True-up 2020.
    Filed Date: 5/21/20.
    Accession Number: 20200521-5025.
    Comments Due: 5 p.m. ET 6/2/20.

    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: May 21, 2020..
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-11435 Filed 5-27-20; 8:45 am]
BILLING CODE 6717-01-P


                 2015 Ozone Transport EEI Stakeholder Meeting
Title:	GNP Comment review
Date/Time: July 27[th], 2022 @ 3:00PM EST
Agenda/Meeting Summary:
Discussed comments EEI filed on the Good Neighbor Plan proposal, particularly regarding changes to daily backstop rates, dynamic budgeting, and the role of allowance banking in market liquidity. EEI also mentioned supply chain issues for pollution control reagents.
Participants/Affiliations:
Name
Affiliation
Venu Ghanta
Duke Energy
Alexander Bond
EEI
Eric Holdsworth
EEI
Rona Birnbaum
EPA
Jeb Stenhouse
EPA
William Ruzicka
EPA
David Lifland
EPA
Brian Fisher
EPA
Jeremy Mark
EPA
Holly Dejong
EPA
Megan Lundequam
EPA


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on February 9, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-14057

________________________________________________________________________
________________________________________________________

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

Joint Application:  Aerovias Nacionales de Colombia, S.A. (Avianca) &
Delta Air Lines, Inc.

										Date Filed:  November 23, 2004

Relief requested:

Avianca:  Amend existing exemption from 49 U.S.C. § 41301 to conduct
foreign air transportation of persons, property and mail between
currently authorized points in Colombia, via currently authorized U.S.
gateways, and New York, New York, on a code-share basis only.

Avianca:  Amend existing statement of authorization under 14 CFR Part
212 to the extent necessary to permit Avianca to display Delta’s
designator code on flights operated by Avianca between its authorized
Colombian gateway points (rather than just Bogota) and any of the points
in Colombia and Ecuador authorized by Avianca’s existing statement of
authorization.

Delta:  Amend existing statement of authorization under Part 212 to the
extent necessary to permit Delta to display Avianca’s designator code
on flights operated by Delta between Avianca’s authorized U.S.
gateways, and New York, New York

Applicant representatives:	Richard D. Mathias<PHONE_NUMBER> (Avianca)

				Robert E. Cohn & Alexander Van der Bellen<PHONE_NUMBER> (Delta)

DOT Analyst:  Shelita A. Smith<PHONE_NUMBER>

Responsive pleadings:  None filed

DISPOSITION

Action: Approved									Action date:  February 9, 2005

Effective dates of the amended exemption authority granted Avianca:
February 9, 2005 – February 17, 2005 (coextensive with the exemption
authority granted Avianca on February 17, 2004, in this Docket)

Effective dates of the amended statements of authorization granted Delta
and Avianca:  February 9, 2005-for an indefinite duration

Basis for approval (bilateral agreement/reciprocity):  The authority is
encompassed by the United States-Colombia Air Transport Agreement

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

X  Standard exemption conditions (attached)         X  Foreign air
carrier permit conditions for Avianca (Order 86-9-36)

X  Code-share conditions imposed on Avianca and Delta on August 13,
2003, in this docket.

Special conditions/Partial grant/Denial basis/Remarks:  None

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

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

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

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

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

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

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

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

  Avianca’s existing exemption authorizes it to conduct foreign air
transportation of persons, property and mail between currently
authorized points in Colombia via currently authorized U.S. gateways to
Atlanta, Boston, Chicago, Dallas/Ft. Worth, Denver, Houston, Orlando,
Philadelphia, Tampa and Washington, D.C. on a code-share basis only (see
Notice of Action Taken issued February 17, 2004, in the present docket).
 Under its existing foreign air carrier permit Avianca is  authorized to
serve between any point or points in Colombia, and the coterminal points
Miami and New York, and between any point or points in Colombia and the
terminal point San Francisco or Los Angeles.  Although Avianca’s
permit thus authorizes service between points in Colombia and the
coterminal point New York, the permit does not include all of
Avianca’s current U.S. gateways as coterminal points (see Order
86-9-36).

  Avianca’s existing statement of authorization permits Avianca to
display Delta’s designator code on flights operated by Avianca between
Bogota, Colombia, and Armenia, Barranquilla, Bucaramanga, Cali,
Cartagena de Indias, Cucuta, Manizales, Medellin, Pereira, and San
Andres Island, Colombia; and Guayaquil and Quito, Ecuador (see Notice of
Action Taken issued August 13, 2003, in this present docket).

  Delta’s existing statement of authorization permits Delta to display
Avianca’s designator code of flights operated by Delta between
Avianca’s authorized U.S. gateways and Atlanta, Boston, Chicago,
Dallas/Ft. Worth, Denver, Houston, Orlando, Philadelphia, Tampa, and
Washington, D.C. (see Notice of Action taken issued February 3, 2003, in
the present docket).

05/2004


[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19477-19478]
[FR Doc No: 2013-07418]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project No. 2351-017]

Public Service Company of Colorado; Notice of Settlement
Agreement and Soliciting Comments

    Take notice that the following settlement agreement has been filed
with the Commission and is available for public inspection.
    a. Type of Application: Settlement Agreement.
    b. Project No.: P-2351-017.
    c. Date filed: March 22, 2013.
    d. Applicant: Public Service Company of Colorado.
    e. Name of Project: Cabin Creek Pumped Storage Hydroelectric
Project.

    f. Location: The existing project is located on the South Clear
Creek and its tributary Cabin Creek in Clear Creek County, Colorado.
The project, as currently licensed, is located on 267 acres of U.S.
Forest Service lands within the Arapaho National Forest.
    g. Filed Pursuant to: Rule 602 of the Commission's Rules of
Practice and Procedure, 18 CFR 385.602.
    h. Applicant Contact: Christine E. Johnston, Xcel Energy, 4653
Table Mountain Drive, Golden, CO 80403;<PHONE_NUMBER>.
    i. FERC Contact: Ryan Hansen,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments: 20 days from the filing of the
Settlement Agreement; reply comments are due 30 days from the filing of
the Settlement Agreement.
    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 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: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person 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. The Public Service Company of Colorado (PSCo) filed the
Settlement Agreement on behalf of itself and the U.S. Forest Service.
The purpose of the Settlement Agreement is to resolve among the
signatories all issues associated with issuance of a new license for
the project regarding instream flows, water quality, aquatic habitat,
terrestrial habitat, recreation, aesthetics, and cultural resources.
PSCo requests that the Commission accept and incorporate, without
material modification, as license articles in the new license to be
issued for the project all of the proposed license articles set forth
in Attachment 1 to the Settlement Agreement.
    l. A copy of the settlement agreement is available for review at
the Commission in the Public Reference Room or may 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 to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    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, contact FERC
Online Support.

    Dated: March 25, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-07418 Filed 3-29-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 28, 2006 (Volume 71, Number 145)]
[Rules and Regulations]
[Page 42750-42756]
[DOCID:fr28jy06-2]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 366

[Docket No. RM05-32-002, Order No. 667-B]

Repeal of the Public Utility Holding Company Act of 1935 and
Enactment of the Public Utility Holding Company Act of 2005

Issued July 20, 2006.
AGENCY: Federal Energy Regulatory Commission, DoE.

ACTION: Final Order; Order on Rehearing.

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SUMMARY: By this order, the Federal Energy Regulatory Commission
(Commission) grants clarification and rehearing in part of Order No.
667-A. Order No. 667-A granted rehearing in part and denied rehearing
in part of Order No. 667, which amended the Commission's regulations to
implement repeal of the Public Utility Holding Company Act of 1935 and
enactment of the Public Utility Holding Company Act of 2005.

DATES: Effective Date: This order is effective on August 28, 2006.

FOR FURTHER INFORMATION CONTACT:

Lawrence Greenfield (Legal Information), Federal Energy

Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202) 502-6415.
Andrew Lyon (Legal Information), Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426.<PHONE_NUMBER>.
Laura Wilson (Legal Information), Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426.<PHONE_NUMBER>.
James Guest (Technical Information), Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. (202) 502-
6614.

SUPPLEMENTARY INFORMATION:
Before Commissioners: Joseph T. Kelliher, Chairman; Nora Mead
Brownell, and Suedeen G. Kelly.

Order on Rehearing

    1. Subtitle F of Title XII of the Energy Policy Act of 2005 (EPAct
2005) repealed the Public Utility Holding Company Act of 1935 (PUHCA
1935) and enacted the Public Utility Holding Company Act of 2005 (PUHCA
2005).\1\ In Order No. 667, the Federal Energy Regulatory Commission
(Commission) amended Subchapter U of its regulations to implement
Subtitle F.\2\ In Order No. 667-A, the Commission denied rehearing in
part and granted rehearing in part of Order No. 667.\3\ In the present
order, we grant clarification and rehearing in part of Order No. 667-A
and amend our regulations accordingly.
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    \1\ Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 594
(2005).
    \2\ Repeal of the Public Utility Holding Company Act of 1935 and
Enactment of the Public Utility Holding Company Act of 2005, Order
No. 667, 70 FR 75592 (Dec. 20, 2005), FERC Stats. & Regs. ] 31,197
(2005).
    \3\ Repeal of the Public Utility Holding Company Act of 1935 and
Enactment of the Public Utility Holding Company Act of 2005, Order
No. 667-A, 71 FR 28446 (May 16, 2006), FERC Stats. & Regs. ] 31,213
(2006).
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Introduction

    2. On rehearing of Order No. 667-A, commenters \4\ raise five
issues. First, National Grid, EEI, Duke, and Consumers seek
clarification and/or rehearing of changes in the regulatory text that
could be construed to place conditions on the effectiveness of status
as an exempt wholesale generator (EWG) or foreign utility company
(FUCO). Under the Commission's PUHCA 2005 regulations, a person that is
a holding company solely with respect to an EWG or FUCO is eligible for
exemption from books-and-records, accounting, record retention and
reporting requirements.\5\ In Order No. 667-A, the Commission modified
the regulatory text governing procedures for obtaining EWG status to
state that self-certification (or a Commission determination) would not
become effective until the relevant state commissions had made certain
determinations under section 32(c) of PUHCA 1935 in those cases where
such determinations were necessary under section 32(c) of PUHCA 1935.
Similar language was included with respect to FUCO self-certifications
(and Commission determinations); i.e., that such status would not
become effective until the relevant state commissions had provided
certain certifications under section 33(a)(2) of PUHCA 1935. National
Grid, EEI, Duke, and Consumers suggest that the Commission cannot and
should not require those determinations and certifications, and they
seek clarification or rehearing. As discussed below, we reaffirm that
EWGs are subject to section 32(c) of PUHCA 1935.\6 \However, we clarify
that we did not intend that an entity that meets the definition of a
FUCO would not have FUCO status until a state commission certification
is also provided. Accordingly, we revise the regulatory text that
created this confusion.
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    \4\ Commenters in this second rehearing phase include: AES
Corporation (AES); ALCOA Inc. (ALCOA); Consumers Energy Company and
CMS Energy Corporation (Consumers); Duke Energy Corporation (Duke);
Edison Electric Institute (EEI); Edison International (Edison);
Interstate Natural Gas Association of America (INGAA); Invenergy
Investment Company LLC and Mayflower Management Services LLC
(Invenergy); National Grid USA (National Grid); PPL Corporation
(PPL); and Sempra Energy (Sempra).
    \5\ 18 CFR 366.7(a).
    \6\ We note that, in practice, section 32(c) of PUHCA only
applies to EWGs whose generation facilities' costs were included in
state-regulated rates and rate base as of the date of enactment of
the Energy Policy Act of 1992 (October 24, 1992). Where it does not
apply and therefore where State commission determinations are not
necessary, an EWG need merely inform us of that fact.
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    3. Second, EEI, Sempra, Edison, PPL, and AES ask for clarification
or rehearing of the Commission's definition of ``single-state holding
company system.'' Under the Commission's PUHCA 2005 regulations, a
single-state holding company system is eligible for waiver of
accounting, record retention and reporting requirements.\7\ In Order
No. 667-A, for purposes of such waiver, the Commission defined
``single-state holding company system'' as a system that derives no
more than thirteen percent of its ``public-utility company'' revenues
from outside of a state. The Commission also defined ``public-utility
company'' and ``electric utility company'' to include EWGs, FUCOs, and
qualifying facilities (QFs).\8\ As a result, interests in out-of-state
EWGs, FUCOs or QFs might make a system ineligible for waiver. EEI,
Sempra, Edison, PPL, and AES suggest that this result is unnecessary
and would discourage investment. We grant clarification as discussed
below, and modify the regulatory text to reflect this clarification.
---------------------------------------------------------------------------

    \7\ 18 CFR 366.3(c)(1).
    \8\ See 18 CFR 366.1.
---------------------------------------------------------------------------

    4. Third, ALCOA expresses concern as to the requirement in Order
No. 667-A that, when a subsidiary owns jurisdictional transmission
facilities, the parent company must apply for exemption from the
Commission's PUHCA 2005 regulations rather than being eligible for
exemption upon the provision of notice. ALCOA suggests that, if the
subsidiary is not primarily engaged in the provision of transmission
service, the parent company should be eligible for exemption upon
provision of notice. We deny rehearing as discussed below.
    5. Fourth, INGAA requests clarification of the Commission's
definition of ``gas utility company.'' Under Order No. 667-A, a natural
gas pipeline company that makes only incidental retail sales is a ``gas
utility company.'' An upstream owner of the pipeline company is
therefore subject to regulation under the Commission's PUHCA 2005
regulations. It asserts that this result imposes unnecessary burdens
and should be avoided through adoption of a de minimis standard for
retail sales. We grant clarification and revise the relevant regulatory
text to add an additional exemption to address this circumstance as
discussed below.
    6. Finally, we clarify (1) in response to a concern raised by EEI
and Duke, a subsidiary holding company may be eligible for an exemption
or waiver even if an upstream holding company is not; and (2) in
response to a concern raised by Invenergy, service companies within an
exempt holding company system are themselves exempt from the
requirements of sections 366.2, 366.22, and 366.23.

Discussion

1. EWG and FUCO Status

Background
    7. PUHCA 2005 requires the Commission to exempt from its books-and-
records requirements companies that are holding companies solely with
respect to an ``exempt wholesale generator'' or ``foreign utility

company.'' \9\ PUHCA 2005 gives the term ``exempt wholesale generator''
the same meaning as in section 32 of PUHCA 1935 and gives the term
``foreign utility company'' the same meaning as in section 33 of PUHCA
1935.\10\
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    \9\ EPAct 2005 1266. See also EPAct 2005 1264.
    \10\ EPAct 2005 1262(6).
---------------------------------------------------------------------------

    8. In the regulations implementing PUHCA 2005, the Commission
restated the definition of EWG in section 32(a)(1) of PUHCA 1935. Under
that definition, an EWG is a person that owns or operates an ``eligible
facility,'' which is a facility that, with minor exception, is
dedicated to wholesale sales.\11\
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    \11\ 18 CFR 366.1; 15 U.S.C. 79z-5(a)(1) and (2).
---------------------------------------------------------------------------

    9. The Commission also incorporated into the definition of EWG the
requirement for state commission determinations in section 32(c) of
PUHCA 1935.\12\ Section 32(c) applies to generation facilities whose
costs were included in state-regulated rates and rate base as of the
date of enactment of the Energy Policy Act of 1992 (October 24,
1992).\13\ Under section 32(c), for such a facility to be considered an
``eligible facility,'' the relevant state commission must determine
that dedication of the facility to wholesale sales will benefit
consumers, will be in the public interest and will not violate state
law.\14\ Because, by definition, an EWG can only own or operate
eligible facilities, a person seeking EWG status whose generation
facilities' costs were included in state-regulated rates and rate base
as of the date of enactment of the Energy Policy Act of 1992 (October
24, 1992) would not qualify as an EWG until the relevant state
commission issues the specified determinations.\15\
---------------------------------------------------------------------------

    \12\ 18 CFR 366.1, definition of ``exempt wholesale generator''
(1). See also 18 CFR 366.1, definition of ``exempt wholesale
generator'' (2); 18 CFR 366.7 (conditioning EWG status on State
determinations under section 32(c) of PUHCA 1935).
    \13\ Pub. L. 102-486, 106 Stat. 2776 (1992). To the extent that
the facilities that are at issue are not encompassed within section
32(c) of PUHCA 1935, e.g., the facilities are new facilities, then
section 32(c) would not apply and the state commission
determinations provided for in section 32(c) would not be necessary.
The regulations state that, in such circumstances, the EWG need
simply inform the Commission of that fact.
    \14\ 15 U.S.C. 79z-5a(a)(2) and (c).
    \15\ As noted supra note 13, to the extent that section 32(c) of
PUHCA 1935 does not apply in a particular instance, the person
seeking EWG status need simply inform the Commission of that fact.
---------------------------------------------------------------------------

    10. In implementing PUHCA 2005, the Commission adopted the
definition of ``foreign utility company'' in section 33(a)(3) of PUHCA
1935.\16\ Under this definition, a FUCO is a company that owns or
operates electricity or natural or manufactured gas facilities that are
not located in the United States, that does not derive income from the
generation, transmission or distribution of electricity or the
distribution at retail of natural or manufactured gas in the United
States, and that is not and has no subsidiary that is a public-utility
company operating in the United States.
---------------------------------------------------------------------------

    \16\ 18 CFR 366.1, definition of ``foreign utility company.''
See also 15 U.S.C. 79z-5b(a)(3)(B).
---------------------------------------------------------------------------

    11. In modifications to the regulatory text adopted on rehearing,
the Commission included in the definition of ``foreign utility
company'' a provision that exempts FUCOs from all sections but section
366.7 of the Commission's PUHCA 2005 regulations; \17\ section 366.7
provides that FUCO status does not become effective until the FUCO has
obtained state commission certification consistent with section
33(a)(2) of PUHCA 1935.\18\ Section 33(a)(2) of PUHCA 1935, in turn,
required state certification as a condition on exemption of a FUCO's
parent company from public utility holding company regulation under
PUHCA 1935. For the exemption to be effective, each state commission
with jurisdiction over associated retail electricity and natural gas
suppliers needed to certify that the state commission could adequately
protect retail ratepayers.\19\
---------------------------------------------------------------------------

    \17\ Id.
    \18\ 18 CFR 366.7.
    \19\ See 15 U.S.C. 79z-5b(a)(1) and (2).
---------------------------------------------------------------------------

Comments
    12. National Grid, EEI, Duke, and Consumers seek clarification and/
or rehearing of the requirements for state commission determinations
and certifications. They assert that the requirements violate PUHCA
2005 by incorporating operative provisions of PUHCA 1935. They add that
state involvement is unnecessary because the Commission may prevent
cross-subsidization between EWGs and FUCOs and retail suppliers.
Finally, they assert that, if the Commission conditions FUCO status on
state commission certification, it will prevent companies from
representing that they have FUCO status until state commission
certification has been obtained, and also will be inconsistent with
such companies' ability to rely on FUCO status under PUHCA 1935.
According to these commenters, the associated uncertainty and delay
will put companies with United States affiliates at a disadvantage in
bidding for foreign utility companies.
Decision
    13. We will deny rehearing with respect to EWGs, but grant relief
with respect to FUCOs.
    14. For some entities, EWG status does not take effect until state
commission determinations have been obtained consistent with section
32(c) of PUHCA 1935.\20\ PUHCA 2005 gives the term ``exempt wholesale
generator'' the same meaning as in section 32 of PUHCA 1935.\21\
Section 32(a)(1) of PUHCA 1935 defines ``exempt wholesale generator''
as a person that owns or operates an ``eligible facility.'' Section
32(c) of PUHCA 1935 states that certain facilities, i.e., those whose
costs were included in state-regulated rates and rate base as of the
date of enactment of the Energy Policy Act of 1992 (October 24, 1992),
are not eligible facilities until specified state commission
determinations are obtained.\22\ Thus, because, by definition, an EWG
can only own or operate eligible facilities, and certain facilities can
only be eligible facilities with state commission determinations, a
person cannot be an EWG if it owns or operates such facilities (i.e.,
if it owns or operates generation facilities whose costs were included
in state-regulated rates and rate base as of the date of enactment of
the Energy Policy Act of 1992 (October 24, 1992)) without having
obtained the necessary State commission determinations.
---------------------------------------------------------------------------

    \20\ As noted supra note 13, to the extent that section 32(c) of
PUHCA 1935 does not apply in a particular instance, the person
seeking EWG status need simply inform the Commission of that fact.
    \21\ EPAct 2005 1262.
    \22\ See 15 U.S.C. 79z-5a(a)(1) and (c).
---------------------------------------------------------------------------

    15. With respect to FUCOs, we clarify that the Commission did not
intend to establish a requirement that an entity cannot meet the
definition of a FUCO without first obtaining state commission
certification. In contrast to the statutory definition of EWG in
section 32 of PUHCA 1935, the statutory definition of FUCO in section
33 of PUHCA 1935 is not tied to state commission certification, and
PUHCA 2005 gives the term ``foreign utility company'' the same meaning
as in section 33 of PUHCA 1935. Under section 33 of PUHCA 1935, state
commission certification affected only the availability of an exemption
from public utility holding company regulation under PUHCA 1935, but
was not part of the definition of ``foreign utility company.'' \23\ As
a result, state commission certification is not required by PUHCA 2005
as a condition of FUCO status, and we will eliminate the reference to
such state commission certification in the regulatory text.
---------------------------------------------------------------------------

    \23\ See 15 U.S.C. 79z-5b(a).
---------------------------------------------------------------------------

    16. Consistent with the foregoing, we also will move paragraph (2)
of the definitions of EWG and FUCO to a new section 366.7(e).

2. Single-State Holding Companies

Background
    17. In implementing PUHCA 2005, the Commission provided for waiver
of accounting, recordkeeping and reporting requirements for single
state holding company systems.\24\ The waiver reflects the principle
that, when a system operates substantially within a single state,
ratepayers are adequately protected by state oversight as well as by
federal oversight under the Federal Power Act, 16 U.S.C. 824 et seq.
---------------------------------------------------------------------------

    \24\ 18 CFR 366.3(c).
---------------------------------------------------------------------------

    18. In Order No. 667-A, the Commission defined ``single-state
holding company system'' with reference to revenues from in-state
versus out-of-state activities. For purposes of waiver from the
Commission's accounting, record-keeping and reporting requirements, the
Commission defined a single-state holding company system as a system
that derives no more than thirteen percent of its ``public-utility
company revenues'' from outside of a single state.\25\ The Commission
also defined ``public-utility company'' and ``electric utility
company'' to include EWGs, FUCOs and QFs.\26\ As a result, a system
whose traditional utility operations are largely confined to a single
state might be subject to federal accounting, record-keeping and
reporting requirements as a result of owning out-of-state EWGs, FUCOs
or QFs.
---------------------------------------------------------------------------

    \25\ 18 CFR 366.3(c)(1).
    \26\ 18 CFR 366.1.
---------------------------------------------------------------------------

Comments
    19. EEI, Sempra, Edison, PPL, and AES suggest that ownership of
out-of-state EWGs, FUCOs or QFs should not affect a system's
eligibility for waiver of federal accounting, recordkeeping and
reporting requirements. They state that ownership of out-of-state EWGs,
FUCOs and QFs did not affect a system's eligibility for the single-
state exemption from public utility holding company regulation under
PUHCA 1935. They suggest that considering ownership of out-of-state
EWGs, FUCOs and QFs now would subject holding company systems to new
obligations and would therefore contradict Congress's goal in PUHCA
2005 of removing regulatory obstacles to investment.
Decision
    20. The Commission's intent in adopting the 13 percent of revenues
standard to identify who is a single state holding company system
entitled to a waiver was to use the same 13 percent standard applied by
the SEC under PUHCA 1935. Although we have defined ``public-utility
company'' and ``electric utility company'' to include EWGs, FUCOs, and
QFs, we clarify that we did not intend to include such entities'
revenues for purposes of applying the 13 percent of revenues standard
to identify who is a single state holding company system entitled to
waiver. We will revise the relevant regulatory text in 18 CFR
366.3(c)(1) accordingly.
    21. This approach is similar to the section 3(a) exemption under
PUHCA 1935, which exempted single-state holding company systems from
plenary federal oversight of the system's corporate and financial
structure.\27\ The section 3(a) exemption of PUHCA 1935 reflected
Congress's assessment that the states and the federal government,
through corporate and rate regulation, could otherwise effectively
oversee a single-state system without the necessity of public utility
holding company regulation. Existing state and federal regulation
should continue to be sufficient to protect against any abuses
associated with ownership of out-of-state EWGs, FUCOs and QFs.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 79c(a).
---------------------------------------------------------------------------

    22. Accordingly, we will amend our regulations to provide that, for
purposes of waiver under section 366.3(c)(1), revenues derived from
EWGs, FUCOs and QFs will not be considered to be ``public-utility
company'' revenues and therefore will not affect the availability of
waiver of federal accounting and related requirements.\28\
---------------------------------------------------------------------------

    \28\ In the separate context of the statutory exemption of PUHCA
2005 section 1275(d), as reflected in 18 CFR 366.5, involving cost
allocation for non-power goods and services in the case of a holding
company system whose public utility operations are confined
substantially to a single state, EEI asks that the Commission not
require that a holding company file a petition for declaratory order
in order to obtain a Commission determination that the holding
company's public utility operations are confined substantially to a
single state. EEI Rehearing Request at 4, 12-13. As a Commission
determination that a holding company's public utility operations are
confined substantially to a single state would be a declaratory
order, the appropriate vehicle to seek such a determination would be
a petition for a declaratory order.
---------------------------------------------------------------------------

3. Companies That Are Not Primarily Engaged in Transmission

Background
    23. In Order No. 667-A, the Commission exempted from its PUHCA 2005
regulations persons that are holding companies with respect to
Commission-jurisdictional utilities when (1) neither the utility nor an
affiliate has captive customers and (2) neither the utility nor an
affiliate owns Commission-jurisdictional transmission facilities or
provides Commission-jurisdictional transmission services.\29\
---------------------------------------------------------------------------

    \29\ See 18 CFR 366.3(b)(2)(ii).
---------------------------------------------------------------------------

Comments
    24. ALCOA suggests that the Commission should exempt, under 18 CFR
366.3(b)(2) and 366.4(b)(1), i.e., by way of FERC-65A, companies whose
subsidiaries have no captive customers and are not primarily engaged in
transmission in interstate commerce, regardless of whether a subsidiary
owns transmission facilities. According to ALCOA, the Commission's
regulations as they stand require companies such as ALCOA to instead
apply for exemption, under 18 CFR 366.3(d) and 366.4(b)(3), when a
subsidiary owns discrete transmission facilities and acquired those
facilities by what it characterizes as historical coincidence. ALCOA
suggests that there is no regulatory interest in oversight of the
parent company in those circumstances and that, therefore, the parent
company should not be required to apply for exemption.
    25. ALCOA also suggests that the Commission must make the exemption
process provided in 18 CFR 366.3(b)(2) and 366.4(b)(1), i.e., by way of
FERC-65A, available to companies such as ALCOA because (1) those
companies were exempted from public utility holding company regulation
under PUHCA 1935, (2) the Commission's notice of proposed rulemaking in
this proceeding suggested that the Commission did not intend to impose
burdens beyond those in PUHCA 1935, and (3) the Commission did not make
the parent company of a transmission owner ineligible for the
notification process until rehearing of the Commission's initial order
in this proceeding. According to ALCOA, to now require ALCOA to apply
for exemption would violate notice requirements of the Administrative
Procedure Act, 5 U.S.C. 551-59, and ALCOA's constitutional right to the
equal protection of the laws.
Decision
    26. At issue is not whether ALCOA and similar companies are
eligible for exemption from the Commission's PUHCA 2005 regulations but
whether those companies must individually and formally apply for
exemption under 18 CFR 366.3(d) and 366.4(b)(3), rather than submitting
an exemption notification, i.e., a FERC-65A, under 18 CFR 366.4(b)(1).
Contrary to ALCOA's suggestion, at this early stage in our
implementation of PUHCA 2005, there is a strong regulatory interest in

requiring holding companies that do not qualify for the exemptions or
waivers identified in 18 CFR 366.3(b)(2) and 366.3(c) to apply formally
for exemption. As relevant here, that would include, where no other
exemption or waiver applies, where the company or a subsidiary owns
jurisdictional transmission facilities or provides jurisdictional
transmission service. We do not mean to suggest that on the facts and
circumstances of a particular case an exemption or waiver might not be
appropriate. Rather, at this point in time, the formal application
process gives the Commission the opportunity to make such
determinations on the facts and circumstances of each case. For
example, the process gives the Commission the opportunity to determine
whether there might be significant potential for transmission service
customers to subsidize wholesale sales and, if so, whether the cross-
subsidies could be adequately addressed through rate regulation. Based
on that analysis, the Commission would or would not, as the facts and
circumstances dictate, permit exemption from oversight under the
Commission's PUHCA 2005 regulations.\30\
---------------------------------------------------------------------------

    \30\ In fact, ALCOA has made a formal filing, in Docket No.
EL06-75-000, seeking an exemption. That filing is presently pending.
---------------------------------------------------------------------------

    27. Moreover, the requirement does not impose undue regulatory
burdens. In its request for rehearing, ALCOA cites cases in which the
SEC determined that ALCOA was exempt from holding company regulation
under PUHCA 1935. In light of the SEC's past, active involvement in
determining eligibility for exemption under PUHCA 1935, our requirement
that companies formally apply to us for exemption under the
Commission's PUHCA 2005 regulations (rather than obtaining exemption by
filing a FERC-65A) is unexceptional. It is true that companies like
ALCOA must apply anew for exemption rather than relying on prior SEC
determinations. That obligation flows directly from Congress's decision
to change the governing law and is not an unreasonable cost of doing
business.
    28. Finally, the Administrative Procedure Act does not require us
to issue a new notice of proposed rulemaking every time that we make a
change to a proposed rule. The express purpose of the comment,
decision, and rehearing process is to allow the Commission to make
changes to a proposed rule. As evidenced by ALCOA's request for
rehearing, moreover, ALCOA had actual and timely notice and opportunity
to address provisions and changes that affected ALCOA.

4. Pipeline Companies That Make Incidental Retail Gas Sales

Background
    29. Pursuant to PUHCA 1935, and specifically section 2(a)(4) of
PUHCA 1935, a natural gas pipeline that was not ``primarily engaged''
in the sale of natural gas at retail was not considered to be a ``gas
utility company.'' \31\ As a result, under PUHCA 1935, a holding
company with interests in that pipeline would not, by virtue of those
interests, be subject to public utility holding company regulation.\32\
---------------------------------------------------------------------------

    \31\ 15 U.S.C. 79b(a)(4).
    \32\ 15 U.S.C. 79b(a)(7); see also 17 CFR 250.7(a) (a pipeline
company was not ``primarily engaged'' in the sale of natural gas at
retail if gross revenues from retail sales were less than an
average, annual amount of $5,000,000 over the preceding three
calendar years).
---------------------------------------------------------------------------

    30. PUHCA 2005 defines ``gas utility company'' without regard to
whether a company is primarily engaged in the retail sale of natural
gas.\33\ In implementing PUHCA 2005, the Commission adopted the
statutory definition of ``gas utility company,'' with the added
clarification that an entity that is engaged only in the marketing of
natural gas is not a ``gas utility company'':
---------------------------------------------------------------------------

    \33\ EPAct 2005 1262(7).

    The term ``gas utility company'' means any company that owns or
operates facilities used for distribution at retail (other than the
distribution only in enclosed portable containers or distribution to
tenants or employees of the company operating such facilities for
their own use and not for resale) of natural or manufactured gas for
heat, light, or power. For the purposes of this subchapter, ``gas
utility company'' shall not include entities that engage only in
marketing of natural and manufactured gas.\34\
---------------------------------------------------------------------------

    \34\ 18 CFR 366.1.

    Under that definition, a pipeline that makes incidental retail
sales of natural gas could be interpreted to be a ``gas utility
company,'' such that a parent of the pipeline would be subject to the
Commission's PUHCA 2005 regulations.\35\
---------------------------------------------------------------------------

    \35\ EPAct 2005 1262(8) and (13); 18 CFR 366.1.
---------------------------------------------------------------------------

Comments
    31. INGAA seeks clarification of the Commission's interpretation of
``gas utility company'' and asks us to find that a company that ``owns
an interstate natural gas pipeline company, which pipeline makes
deliveries to industrial customers and power plants and/or de minimis
deliveries to farmers and/or ranchers located adjacent to the
pipeline's rights-of-way is not, due to such ownership, a `holding
company' under the Commission's PUHCA [2005] regulations.'' INGAA
relies primarily on section 2(a)(4) of PUHCA 1935, which allowed the
SEC to except from the definition of ``gas utility company'' companies
that were not ``primarily engaged in'' retail sales of natural gas.
According to INGAA, section 2(a)(4) of PUHCA 1935 demonstrated
Congressional intent not to impose holding company regulation in the
context of pipeline companies that make incidental retail sales. INGAA
suggests there is no need to change that longstanding practice under
PUHCA 1935 and, in particular, to impose regulatory obligations under
PUHCA 2005 where none existed under PUHCA 1935. It also points out that
under PUHCA 1935 the SEC promulgated a regulation exempting entities
from the definition of ``gas utility company'' if their revenues from
retail distribution of natural gas were de minimis and that the most
recent monetary limit was an average annual amount of $5 million over
the preceding three calendar years.
Decision
    32. A holding company is defined in PUHCA 2005 and in the
Commission's PUHCA 2005 regulations based on its ownership of a public-
utility company. A public-utility company, in turn, includes a gas
utility company, but does not include a natural gas company. So, for a
public-utility company that is a gas utility company, its parent may
fall within the definition of a holding company. In contrast, for a
public-utility company that is a natural gas company and not a gas
utility company, its parent would not fall within the definition of a
holding company. INGAA's concern is that some pipelines may make
incidental sales of natural gas at retail. That fact would result in
their also being considered gas utility companies rather than solely
natural gas companies--thus resulting in regulation of their parent
companies as holding companies.
    33. The relevant language in PUHCA 2005 at issue here defining
``gas utility company'' and when exemptions would be warranted under
PUHCA 2005 is not identical to the corresponding language in PUHCA 1935
highlighted by INGAA above defining ``gas utility company'' and when
exemptions were warranted under PUHCA 1935. That fact notwithstanding,
we agree with INGAA and believe that the fact that a pipeline makes
sales of natural gas to end-use customers located adjacent to the
pipeline's right of way should not, on that basis alone, lead to the
pipeline's parent being considered a holding

company under PUHCA 2005.\36\ We will revise the regulatory text
accordingly to add an additional exemption to address such
circumstances.
---------------------------------------------------------------------------

    \36\ As we previously noted in both Order No. 667 and Order No.
667-A, we again note that we have independent authority under the
Natural Gas Act to obtain the books and records of regulated
companies and any person that controls such companies if relevant to
jurisdictional activities. 15 U.S.C. 717g.
---------------------------------------------------------------------------

5. Additional Clarifications

    34. We hereby grant two clarifications to Order No. 667-A. The
first clarification relates to the following statement in the narrative
preamble of Order No. 667-A:

    Where the parent holding company qualifies for an exemption or
waiver, the subsidiary holding company would necessarily equally
qualify; phrased differently, if the subsidiary did not qualify for
a particular exemption or waiver, then the parent would not qualify
for that same exemption or waiver either.\37\
---------------------------------------------------------------------------

    \37\ Order No. 667-A at P 20, n.41.

    EEI and Duke urge us to delete the latter portion of the quoted
sentence that begins with ``phrased differently'' on the grounds that
it creates unnecessary confusion. Upon further review, the first
portion of the above-quoted sentence is sufficiently clear on its own.
We therefore void the latter, ``phrased differently'' portion of the
sentence.
    The second clarification relates to section 366.3(a) of our
regulations, which states that holding companies that meet the
requirements of that section are exempt from specified provisions of
the Commission's PUHCA 2005 regulations:

    Any person that is a holding company solely with respect to one
or more of the following will be exempt from the requirements of
Sec.  366.2 and the accounting, record-retention, and reporting
requirements of Sec. Sec.  366.21, 366.22, and 366.23 * * * .\38\
---------------------------------------------------------------------------

    \38\ 18 CFR 366.3(a).

    35. The specified provisions include two provisions--sections
366.22 and 366.23--that apply to service companies. Invenergy requests
clarification that, if a holding company is exempt as provided in
section 366.3(a), service companies within the holding company system
are exempt from sections 366.22 and 366.23. We agree with the requested
clarification and will change section 366.3(a) accordingly.
Information Collection Statement
    36. The regulations of the Office of Management and Budget (OMB)
\39\ require that OMB approve information-collection burdens that are
imposed by an agency. OMB has approved the information-collection
burdens that were imposed in Order Nos. 667 and 667-A.\40\ The present
order clarifies those orders. Accordingly, OMB approval for this order
is not necessary. The Commission will send a copy of this order to OMB
for informational purposes.
---------------------------------------------------------------------------

    \39\ 5 CFR 1320.12.
    \40\ See OMB Control Nos. 1902-0166, 1902-0216.
---------------------------------------------------------------------------

    37. Interested persons may obtain information on the information
requirements by contacting the following: Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426 [Attention:
Michael Miller, Office of the Executive Director, ED-34], Phone: (202)
502-8415, Fax:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>The Commission Orders
    Rehearing and clarification is hereby granted in part and denied in
part as discussed in the body of this order.

    By the Commission.
Magalie R. Salas,
Secretary.

List of Subjects in 18 CFR Part 366

    Electric power, Natural gas, Public utility holding companies and
service companies, Reporting and recordkeeping requirements.

0
In consideration of the foregoing, under the authority of PUHCA 2005,
the Commission is amending Part 366 in Chapter I of Title 18 of the
Code of Federal Regulations, as set forth below:

Subchapter U--Regulations Under the Public Utility Holding Company Act
of 2005

PART 366--PUBLIC UTILITY HOLDING COMPANY ACT OF 2005

Subpart A--PUHCA 2005 Definitions and Provisions

0
1. The authority citation for part 366 continues to read as follows:

    Authority: Pub. L. 109-58, 1261 et seq., 119 Stat. 594, 972 et
seq.

0
2. Section 366.1 is amended by revising the definitions of ``exempt
wholesale generator'' and ``foreign utility company'' to read as
follows:

Subpart A--PUHCA 2005 Definitions and Provisions

Sec.  366.1  Definitions.

    For purposes of this part:
* * * * *
    Exempt wholesale generator. The term ``exempt wholesale generator''
means any person engaged directly, or indirectly through one or more
affiliates as defined in this subchapter, and exclusively in the
business of owning or operating, or both owning and operating, all or
part of one or more eligible facilities and selling electric energy at
wholesale. For purposes of establishing or determining whether an
entity qualifies for exempt wholesale generator status, sections
32(a)(2) through (4), and sections 32(b) through (d) of the Public
Utility Holding Company Act of 1935 (15 U.S.C. 79z-5a(a)(2)-(4), 79z-
5a(b)-(d)) shall apply.
    Foreign utility company. The term ``foreign utility company'' means
any company that owns or operates facilities that are not located in
any state and that are used for the generation, transmission, or
distribution of electric energy for sale or the distribution at retail
of natural or manufactured gas for heat, light, or power, if such
company:
    (1) Derives no part of its income, directly or indirectly, from the
generation, transmission, or distribution of electric energy for sale
or the distribution at retail of natural or manufactured gas for heat,
light, or power, within the United States; and
    (2) Neither the company nor any of its subsidiary companies is a
public-utility company operating in the United States.
* * * * *

0
3. Section 366.3 is amended by revising paragraphs (a) introductory
text, (b)(2) introductory text, (c) introductory text, and (c)(1), and
by adding paragraph (b)(2)(vii) to read as follows:

Sec.  366.3  Exemption from Commission access to books and records;
waivers of accounting, record-retention, and reporting requirements.

    (a) Exempt classes of entities. Any person that is a holding
company solely with respect to one or more of the following will be
exempt from the requirements of Sec. Sec.  366.2 and 366.21 and any
associated service company will be exempt from the requirements of
Sec. Sec.  366.2, 366.22, and 366.23; such person need not make the
filings provided in Sec.  366.4(a) or (b):
* * * * *
    (b) * * *
    (2) Commission exemption of additional persons and classes of
transactions.
    The Commission has determined that the following persons and
classes of transactions satisfy the requirements of paragraph (b)(1) of
this section, and any person that is a holding company solely with
respect to one or more of the following may file to obtain an exemption
for that person or class of transactions, as appropriate, from the

requirements of Sec. Sec.  366.2 and 366.21 (applicable to holding
companies) and Sec. Sec.  366.2, 366.22, and 366.23 (applicable to the
holding companies' associated service companies), pursuant to the
notification procedure contained in Sec.  366.4(b):
* * * * *
    (vii) Natural gas companies that distribute natural or manufactured
gas at retail to industrial or electric generation customers and/or
distribute de minimis amounts of natural or manufactured gas at retail
to farmer or rancher customers located adjacent to the natural gas
company's rights-of-way.
    (c) Waivers. Any person that is a holding company solely with
respect to one or more of the following may file to obtain a waiver of
the accounting, record-retention, and reporting requirements of Sec.
366.21 (applicable to holding companies) and Sec. Sec.  366.22 and
366.23 (applicable to the holding companies' associated service
companies), pursuant to the notification procedures contained in Sec.
366.4(c):
    (1) Single-state holding company systems; for purposes of Sec.
366.3(c)(1), a holding company system will be deemed to be a single-
state holding company system if the holding company system derives no
more than 13 percent of its public-utility company revenues from
outside a single state (for purposes of this waiver, revenues derived
from exempt wholesale generators, foreign utility companies and
qualifying facilities will not be considered public-utility company
revenues);
* * * * *

0
4. In Sec.  366.7, paragraphs (a) and (b) are revised to read as
follows, and paragraph (e) is added to read as follows:

Sec.  366.7  Procedures for obtaining exempt wholesale generator and
foreign utility company status.

    (a) Self-certification notice procedure. An exempt wholesale
generator or a foreign utility company, or its representative, may file
with the Commission a notice of self-certification demonstrating that
it satisfies the definition of exempt wholesale generator or foreign
utility company (including stating the location of its generation);
such notices of self-certification must be subscribed, consistent with
Sec.  385.2005(a) of this chapter, but need not be verified. In the
case of exempt wholesale generators, the person filing a notice of
self-certification under this section must also file a copy of the
notice of self-certification with the state regulatory authority of the
state in which the facility is located, and that person must also
represent to this Commission in its submittal with this Commission that
it has filed a copy of the notice of self-certification with the state
regulatory authority of the state in which the facility is located.
Notice of the filing of a notice of self-certification will be
published in the Federal Register. Persons that file a notice of self-
certification must include a form of notice suitable for publication in
the Federal Register in accordance with the specifications in Sec.
385.203(d) of this chapter. A person filing a notice of self-
certification in good faith will be deemed to have temporary exempt
wholesale generator or foreign utility company status. If the
Commission takes no action within 60 days from the date of filing of
the notice of self-certification, the self-certification shall be
deemed to have been granted; however, consistent with section 32(c) of
the Public Utility Holding Company Act of 1935 (15 U.S.C. 79z-5a (c))
any self-certification of an exempt wholesale generator may not become
effective until the relevant state commissions have made the
determinations provided for therein if such determinations are
necessary (if such determinations are not necessary, the notice of
self-certification should state so). The Commission may toll the 60-day
period to request additional information, or for further consideration
of the request; in such cases, the person's exempt wholesale generator
or foreign utility company status will remain temporary until such time
as the Commission has determined whether to grant or deny exempt
wholesale generator or foreign utility company status; however,
consistent with section 32(c) of the Public Utility Holding Company Act
of 1935 (15 U.S.C. 79z-5a (c)), any self-certification of an exempt
wholesale generator may not become effective until the relevant state
commissions have made the determinations provided for therein if such
determinations are necessary (if such determinations are not necessary,
the notice of self-certification should state so). Authority to toll
the 60-day period is delegated to the Secretary or the Secretary's
designee, and authority to act on uncontested notices of self-
certification is delegated to the General Counsel or the General
Counsel's designee.
    (b) Optional procedure for Commission determination of exempt
wholesale generator status or foreign utility company status. A person
may file for a Commission determination of exempt wholesale generator
status or foreign utility company status under Sec.  366.1 by filing a
petition for declaratory order pursuant to Sec.  385.207(a) of this
chapter, justifying the request for such status; however, consistent
with section 32(c) of the Public Utility Holding Company Act of 1935
(15 U.S.C. 79z-5a (c)), a Commission determination of exempt wholesale
generator status may not become effective until the relevant state
commissions have made the determinations provided for therein if such
determinations are necessary. (If such determinations are not
necessary, the petition for declaratory order should state so.) Persons
that file petitions must include a form of notice suitable for
publication in the Federal Register in accordance with the
specifications in Sec.  385.203(d) of this chapter.
* * * * *
    (e) An exempt wholesale generator shall not be subject to any
requirements of this part other than Sec.  366.7, i.e., procedures for
obtaining exempt wholesale generator status. A foreign utility company
shall not be subject to any requirements of this part other than Sec.
366.7, i.e., procedures for obtaining foreign utility company status.
 [FR Doc. E6-12048 Filed 7-27-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Notices]
[Page 38021]
[FR Doc No: 2014-15631]

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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: RP13-957-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Resubmission of 9-9-13 Commencement of Service in
CP12-496-000.
    Filed Date: 6/24/14.
    Accession Number: 20140624-5099.
    Comments Due: 5 p.m. ET 7/7/14.

    Docket Numbers: RP14-1057-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: JP Morgan Ventures Energy Corp (RTS)--6025-46 to be
effective 7/1/2014.
    Filed Date: 6/24/14.
    Accession Number: 20140624-5036.
    Comments Due: 5 p.m. ET 7/7/14.

    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 comment date. 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: June 25, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-15631 Filed 7-2-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Notices]
[Pages 26775-26776]
[FR Doc No: 2022-09670]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0102]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number 1625-0023

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0023,
Barge Fleeting Facility Records; without change.
    Our ICR describes the information we seek to collect from the
public. Review and comments by OIRA ensure we only impose paperwork
burdens commensurate with our performance of duties.

DATES: You may submit comments to the Coast Guard and OIRA on or before
June 6, 2022.

ADDRESSES: Comments to the Coast Guard should be submitted using the
Federal eRulemaking Portal at https://www.regulations.gov. Search for
docket number [USCG-2022-0102]. Written comments and recommendations to
OIRA for the proposed information collection should be sent within 30
days of publication of this notice to https://www.reginfo.gov/public/do/PRAMain.
    Find this particular information collection by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. 3501 et seq., chapter 35, as amended. An ICR is an
application to OIRA seeking the approval, extension, or renewal of a
Coast Guard collection of information (Collection). The ICR contains
information describing the Collection's purpose, the Collection's
likely burden on the affected public, an explanation of the necessity
of the Collection, and other important information describing the
Collection. There is one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. These comments
will help OIRA determine whether to approve the ICR referred to in this
Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2022-0102], and must be received by June 6,
2022.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments to the Coast Guard will
be posted without change to https://www.regulations.gov and will
include any personal information you have provided. For more about
privacy and submissions to the Coast Guard in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020). For

more about privacy and submissions to OIRA in response to this
document, see the https://www.reginfo.gov, comment-submission web page.
OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0023.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (87 FR 7476, February 9, 2022)
required by 44 U.S.C. 3506(c)(2). That notice elicited no comments.
Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: Barge Fleeting Facility Records.
    OMB Control Number: 1625-0023.
    Summary: The regulations in 33 CFR 165.803 require the person in
charge of certain barge fleeting facilities to keep records of twice
daily inspections of barge moorings and movements of barges and
hazardous cargo in and out of a facility.
    Need: 33 CFR 165.803 requirements are intended to prevent barges
from breaking away from a fleeting facility and drifting downstream out
of control in the congested Lower Mississippi River waterway system.
    Forms: None.
    Respondents: Operators of barge fleeting facilities.
    Frequency: Daily.
    Hour Burden Estimate: The estimated burden has increased from 7,542
hours to 7,777 hours a year, due to an increase in the estimated annual
number of responses.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. et seq.,
chapter 35, as amended.

    Dated: April 26, 2022.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2022-09670 Filed 5-4-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Pages 23268-23269]
[FR Doc No: 2012-9325]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-E-0310 (previously FDA Docket No. 2005E-0245)]

Determination of Regulatory Review Period for Purposes of Patent
Extension; KEPIVANCE; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of April 2, 2007 (72 FR 15699).
The document concerned FDA's determination of the regulatory review
period for KEPIVANCE. The document cited an incorrect statute under
which the KEPIVANCE biologics license application was submitted. This
document corrects the citation.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,

10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. 2007-15699 on page 15700 in the
Federal Register of Monday, April 2, 2007, the following correction is
made:
    1. On page 15700, in the first column, in the first line, ``505(b)
of the act'' is corrected to read ``351 of the Public Health Service
Act (42 U.S.C. 262).''

    Dated: February 28, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-9325 Filed 4-17-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26043-26045]
[FR Doc No: 2021-09963]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1609]

Q12 Technical and Regulatory Considerations for Pharmaceutical
Product Lifecycle Management; International Council for Harmonisation;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, 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 entitled ``Q12
Technical and Regulatory Considerations for Pharmaceutical Product
Lifecycle Management.'' The guidance was prepared under the auspices of
the International Council for Harmonisation (ICH), formerly the
International Conference on Harmonisation. The guidance, which consists
of a Guidance and Annexes, provides a framework to facilitate the
management of postapproval chemistry, manufacturing, and controls
changes for new and marketed pharmaceutical drug substances and drug
products, including chemical and biotechnological/biological products.
This guidance finalizes the draft guidance of the same title issued on
May 31, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on May 12, 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-2018-D-1609 for ``Q12 Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management.'' 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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-

800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Mahesh
Ramanadham, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3272; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Q12 Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management.'' The guidance was
prepared under the auspices of ICH. ICH has the mission of achieving
greater regulatory harmonization worldwide to ensure that safe,
effective, high-quality medicines are developed, registered, and
maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In the Federal Register of May 31, 2018 (83 FR 25018), FDA
published a notice announcing the availability of a draft guidance
entitled ``Q12 Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management.'' The notice gave
interested persons an opportunity to submit comments by December 15,
2018.
    After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies in November 2019.
Changes from the draft to the final guideline include: revision of the
text regarding the compatibility of the guideline with regional legal
frameworks, removal of the terms ``implicit'' and ``explicit'' as they
referred to established conditions, removal of the term ``key process
parameter,'' and revisions to the text to better explain the concept of
critical process parameter and identification of established conditions
for manufacturing processes. Other changes included revision of the
description for identification of established conditions for analytical
methods and development of an illustrative example, revisions to the
recommended content of the product lifecycle management document and
its location within the common technical document, and revisions to
clarify the use of tools described in the guideline for master files.
In addition, editorial changes were made to improve clarity.
    The guidance provides guidance on postapproval chemistry,
manufacturing, and controls changes for new and marketed pharmaceutical
drug substances and drug products. The guidance describes regulatory
tools and enablers, along with associated guiding principles, that are
intended to enhance the management of postapproval changes and
transparency between industry and regulatory authorities, encouraging
innovation and continual improvement. The guidance is intended to
demonstrate how increased product and process knowledge can contribute
to a more precise and accurate understanding of which postapproval
changes require a regulatory submission as well as the definition of
the level of reporting categories for such changes (i.e., a better
understanding of risk to product quality). Increased knowledge and
effective implementation of the tools and enablers described in this
guidance should enhance industry's ability to manage many chemistry,
manufacturing, and controls changes effectively under the company's
Pharmaceutical Quality System (PQS) with less need for extensive
regulatory oversight prior to implementation. This approach can
incentivize continual improvement by providing an opportunity for
greater flexibility in making postapproval changes. It could also
result in fewer associated postapproval submissions to the Marketing
Authorization Application and less associated regulatory burden. The
extent of operational and regulatory flexibility and its adequate
implementation is subject to the regulatory framework in place as well
as product and process understanding (ICH Q8(R2) and Q11), application
of risk management principles (ICH Q9), and an effective PQS (ICH Q10).
    This 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 ``Q12 Technical and Regulatory
Considerations for Pharmaceutical Product Lifecycle Management.'' 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

    This guidance contains no collection 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.
    However, this guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in 21 CFR part 314 have been approved under OMB control

number 0910-0001 and in part 601 under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: May 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09963 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P