[Federal Register: May 11, 2006 (Volume 71, Number 91)]
[Notices]
[Page 27480]
[DOCID:fr11my06-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP03-12-001]

Egan Hub Storage, LLC; Notice of Application

May 4, 2006.
    Take notice that on April 26, 2006, Egan Hub Storage, LLC, 5400
Westheimer Court, Houston, Texas 77056-5310, filed in Docket No. CP03-
12-001 an application pursuant to section 7 of the Natural Gas Act
(NGA), as amended, to amend its certificate authorization by
reconfiguring its certificated compression units and installing related
facilities at the Egan Gas Storage Facility in Acadia Parish,
Louisiana, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. 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 to access the document.
For assistance, call<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Steven E. Tillman, General Manager, Regulatory Affairs, Egan Hub
Storage, LLC, 5400 Westheimer Court, Houston, Texas 77251 at (713) 627-
5113.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments
protests and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
(http://www.ferc.gov) site under the ``e-Filing'' link.

    Comment Date: May 25, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-7164 Filed 5-10-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 18, 2007 (Volume 72, Number 242)]
[Notices]
[Page 71725-71726]
[DOCID:fr18de07-80]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of: Xiiva Holdings Inc.; Order of Suspension of
Trading

December 14, 2007.
    It appears to the Securities and Exchange Commission that the
market for the securities of Xiiva Holdings, Inc. (``Xiiva,'' trading
symbol XIVAF), may be reacting to manipulative forces or deceptive
practices and that there is insufficient current public information
about the issuer upon which an informed investment decision may be
made, particularly concerning (1) the identity of and prior securities
fraud judgments against persons who appear to be involved in the offer
and sale of

Xiiva shares; (2) the financial performance and business prospects of
Xiiva; and (3) offerings to foreign investors and any restrictions on
the resale of shares.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to section 12(k) of the
Securities Exchange Act of 1934, that trading in the above-listed
company is suspended for the period of 9:30 a.m. EST, December 14, 2007
through 11:59 p.m. EST, on December 28, 2007.

    By the Commission.
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 07-6097 Filed 12-14-07; 12:26 pm]

BILLING CODE 8011-01-P


[Federal Register: October 21, 2009 (Volume 74, Number 202)]
[Notices]
[Page 54110-54111]
[DOCID:fr21oc09-108]

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SECURITIES AND EXCHANGE COMMISSION

[Rule 38a-1; SEC File No. 270-522; OMB Control No. 3235-0586]

Submission for OMB Review; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget a request for extension of the previously
approved collection of information discussed below.
    Rule 38a-1 (17 CFR 270.38a-1) under the Investment Company Act of
1940 (15 U.S.C. 80a) (``Investment Company Act'') is intended to
protect investors by fostering better fund compliance with securities
laws. The rule requires every registered investment company and
business development company (``fund'') to: (i) Adopt and implement
written policies and procedures reasonably designed to prevent
violations of the Federal securities laws by the fund, including
procedures for oversight of compliance by each investment adviser,
principal underwriter, administrator, and transfer agent of the fund;
(ii) obtain the fund board of director's approval of those policies and
procedures; (iii) annually review the adequacy of those policies and
procedures and the policies and procedures of each investment adviser,
principal underwriter, administrator, and transfer agent of the fund,
and the effectiveness of their implementation; (iv) designate a chief
compliance officer to administer the fund's policies and procedures and
prepare an annual report to the board that addresses certain specified
items relating to the policies and procedures; and (v) maintain for
five years the compliance policies and procedures and the chief
compliance officer's annual report to the board.
    The rule contains certain information collection requirements that
are designed to ensure that funds establish and maintain comprehensive,
written internal compliance programs. The information collections also
assist the Commission's examination staff in assessing the adequacy of
funds' compliance programs.
    While Rule 38a-1 requires each fund to maintain written policies
and procedures, most funds are located within a fund complex. The
experience of the Commission's examination and oversight staff suggests
that each fund in a complex is able to draw extensively from the fund
complex's ``master'' compliance program to assemble appropriate
compliance policies and procedures. Many fund complexes already have
written policies and procedures documenting their compliance programs.
Further, a fund needing to develop or revise policies and procedures on
one or more topics in order to achieve a comprehensive compliance
program can draw on a number or outlines and model programs available
from a variety of industry representatives, commentators, and
organizations.
    There are approximately 4638 funds subject to Rule 38a-1. Among
these funds, 105 were newly registered in the past year. These 105
funds, therefore, were required to adopt and document the policies and
procedures that make up their compliance programs. Commission staff
estimates that the average annual hour burden for a fund to adopt and
document these policies and procedures is 80 hours. Thus, we estimate
that the aggregate annual burden hours associated with the

adoption and documentation requirement is 8,400 hours.
    All funds are required to conduct an annual review of the adequacy
of their existing policies and procedures and the policies and
procedures of each investment adviser, principal underwriter,
administrator, and transfer agent of the fund, and the effectiveness of
their implementation. In addition, each fund chief compliance officer
is required to prepare an annual report that addresses the operation of
the policies and procedures of the fund and the policies and procedures
of each investment adviser, principal underwriter, administrator, and
transfer agent of the fund, any material changes made to those policies
and procedures since the date of the last report, any material changes
to the policies and procedures recommended as a result of the annual
review, and certain compliance matters that occurred since the date of
the last report. The staff estimates that each fund spends 42 hours per
year, on average, conducting the annual review and preparing the annual
report to the board of directors. Thus, we estimate that the annual
aggregate burden hours associated with the annual review and annual
report requirement is 194,796 hours.
    Finally, the staff estimates that each fund spends 11 hours
annually, on average, maintaining the records required by proposed Rule
38a-1. Thus, the annual aggregate burden hours associated with the
recordkeeping requirement is 51,018 hours.
    In total, the staff estimates that the aggregate annual information
collection burden of Rule 38a-1 is 254,214 hours. The estimate of
burden hours is made solely for the purposes of the Paperwork Reduction
Act. The estimate is not derived from a comprehensive or even a
representative survey or study of the costs of Commission rules.
Complying with this collection of information requirement is mandatory.
Responses will not be kept confidential. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid control number.
    Please direct general comments regarding the above information to
the following persons: (i) Desk Officer for the Securities and Exchange
Commission, Office of Management and Budget, Room 10102, New Executive
Office Building, Washington, DC 20503 or send an e-mail to Shagufta
Ahmed at<EMAIL_ADDRESS>and (ii) Charles Boucher,
Director/CIO, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: October 14, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-25208 Filed 10-20-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Proposed Rules]
[Pages 5748-5749]
[FR Doc No: 2018-02143]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-1089; Airspace Docket No. 17-AEA-21]

Proposed Amendment of Class E Airspace, Hamilton, NY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Hamilton
Municipal Airport (formerly Elisha Payne Airport), Hamilton, NY, to
accommodate airspace reconfiguration due to the decommissioning of the
Georgetown VHF omni-directional radio range tactical air navigation aid
(VORTAC), and cancellation of the VORTAC approach. Controlled airspace
is necessary for the safety and management of instrument flight rules
(IFR) operations at the airport. This action also would update the
geographic coordinates of the airport, and update the airport name.

DATES: Comments must be received on or before March 26, 2018.

ADDRESSES: Send comments on this proposal to: The U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2017-1089; Airspace Docket No. 17-AEA-21, at the
beginning of your comments. You may also submit comments through the
internet at http://www.regulations.gov.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC, 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT:  John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave., College Park, GA 30337; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace at Hamilton Municipal Airport,
Hamilton, NY, to support IFR operations at the airport.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire.

Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2017-1089 and Airspace Docket No. 17-AEA-21) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number.) You may also submit comments through the
internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2017-1089; Airspace Docket No. 17-AEA-21.'' The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays at the office
of the Eastern Service Center, Federal Aviation Administration, room
350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA proposes an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to increases Class E airspace extending
upward from 700 feet or more above the surface within an 11.2-mile
radius (increased from a 6.5-mile radius) of Hamilton Municipal
Airport, Hamilton, NY, due to the decommissioning of the Georgetown
VORTAC, and cancellation of the VOR approach. The changes would enhance
the safety and management of IFR operations at the airport. The
geographic coordinates of the airport also would be adjusted to
coincide with the FAAs aeronautical database, and the airport name
would be updated to Hamilton Municipal Airport from Elisha Payne
Airport.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.11B, Airspace Designations and Reporting
Points, dated August 3, 2017, and effective September 15, 2017, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA NY E5 Hamilton, NY [Amended]

Hamilton Municipal Airport, NY
    (Lat. 42[deg]50'36'' N, long. 75[deg]33'40'' W)

    That airspace extending upward from 700 feet above the surface
within an 11.2-mile radius of Hamilton Municipal Airport.

    Issued in College Park, Georgia, on January 29, 2018.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2018-02143 Filed 2-8-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Rules and Regulations]
[Pages 5659-5660]
[FR Doc No: 2022-02022]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 381

[Docket No. RM22-4-000]

Annual Update of Filing Fees

AGENCY: Federal Energy Regulatory Commission.

ACTION: Final rule; annual update of Commission filing fees.

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SUMMARY: In accordance with the Commission's regulations, the
Commission issues this update of its filing fees. This document
provides the yearly update using data in the Commission's Financial
System to calculate the new fees. The purpose of updating is to adjust
the fees on the basis of the Commission's costs for Fiscal Year 2021.

DATES: Effective March 4, 2022.

FOR FURTHER INFORMATION CONTACT: Maryam Khan, Office of the Executive
Director, Federal Energy Regulatory Commission, 999 North Capitol St.
NE, Room 22-02, Washington, DC 20426,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Document Availability: 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). At this time, the Commission has suspended access to the
Commission's Public Reference Room, due to the proclamation declaring a
National Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020.
    From FERC's website on the internet, this information is available
in the 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 and follow other directions on the search page.
    User assistance is available for eLibrary and other aspects of
FERC's website during normal business hours. For assistance, contact
FERC Online Support at [email protected] or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>.

Annual Update of Filing Fees

(January 24, 2022)

    The Federal Energy Regulatory Commission (Commission) is issuing
this document to update filing fees that the Commission assesses for
specific services and benefits provided to identifiable beneficiaries.
Pursuant to 18 CFR 381.104, the Commission is establishing updated fees
on the basis of the Commission's Fiscal Year 2021 costs. The adjusted
fees announced in this document are effective March 4, 2022. The
Commission has determined, with the concurrence of the Administrator of
the Office of Information and Regulatory Affairs of the Office of
Management and Budget, that this final rule is not a major rule within
the meaning of section 251 of Subtitle E of Small Business Regulatory
Enforcement Fairness Act, 5 U.S.C. 804(2). The Commission is submitting
this final rule to both houses of the United States Congress and to the
Comptroller General of the United States.
    The new fee schedule is as follows:

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

------------------------------------------------------------------------
              Fees Applicable to the Natural Gas Policy Act
------------------------------------------------------------------------
1. Petitions for rate approval pursuant to 18 CFR                $16,770
 284.123(b)(2). (18 CFR 381.403)........................
------------------------------------------------------------------------
                  Fees Applicable to General Activities
------------------------------------------------------------------------
1. Petition for issuance of a declaratory order (except           33,690
 under Part I of the Federal Power Act). (18 CFR
 381.302(a))............................................
2. Review of a Department of Energy remedial order:
    Amount in controversy
        $0-9,999. (18 CFR 381.303(b))...................             100
        $10,000-29,999. (18 CFR 381.303(b)).............             600
        $ 30,000 or more. (18 CFR 381.303(a))...........          49,170
3. Review of a Department of Energy denial of
 adjustment:
    Amount in controversy
        $0-9,999. (18 CFR 381.304(b))...................             100
        $10,000-29,999. (18 CFR 381.304(b)).............             600
        $30,000 or more. (18 CFR 381.304(a))............          25,780
4. Written legal interpretations by the Office of                  9,660
 General Counsel. (18 CFR 381.305(a))...................
------------------------------------------------------------------------
                Fees Applicable to Natural Gas Pipelines
------------------------------------------------------------------------
1. Pipeline certificate applications pursuant to 18 CFR          * 1,000
 284.224. (18 CFR 381.207(b))...........................
------------------------------------------------------------------------
        Fees Applicable to Cogenerators and Small Power Producers
------------------------------------------------------------------------
1. Certification of qualifying status as a small power            28,970
 production facility. (18 CFR 381.505(a))...............
2. Certification of qualifying status as a cogeneration           32,790
 facility. (18 CFR 381.505(a))..........................
------------------------------------------------------------------------
* This fee has not been changed.

List of Subjects in 18 CFR Part 381

    Electric power plants, Electric utilities, Natural gas, Reporting
and recordkeeping requirements.

    Issued: January 24, 2022.
Anton C. Porter,
Executive Director, Office of the Executive Director.

    In consideration of the foregoing, the Commission amends part 381,
chapter I, title 18, Code of Federal Regulations, as set forth below.

PART 381--FEES

0
1. The authority citation for part 381 continues to read as follows:

    Authority:  15 U.S.C. 717-717w; 16 U.S.C. 791-828c, 2601-2645;
31 U.S.C. 9701; 42 U.S.C. 7101-7352; 49 U.S.C. 60502; 49 App. U.S.C.
1-85.

Sec.  381.302  [Amended]

0
2. In Sec.  381.302, paragraph (a) is amended by removing ``$ 31,160''
and adding ``$ 33,690'' in its place.

Sec.  381.303  [Amended]

0
3. In Sec.  381.303, paragraph (a) is amended by removing ``$ 45,480''
and adding ``$ 49,170'' in its place.

Sec.  381.304  [Amended]

0
4. In Sec.  381.304, paragraph (a) is amended by removing ``$ 23,850''
and adding ``$ 25,780'' in its place.

Sec.  381.305  [Amended]

0
5. In Sec.  381.305, paragraph (a) is amended by removing ``$ 8,940''
and adding ``$ 9,660'' in its place.

Sec.  381.403  [Amended]

0
6. Section Sec.  381.403 is amended by removing ``$ 15,510'' and adding
``$ 16,770'' in its place.

Sec.  381.505  [Amended]

0
7. In Sec.  381.505, paragraph (a) is amended by removing ``$ 26,790''
and adding ``$ 28,970'' in its place and by removing ``$ 30,330'' and
adding ``$ 32,790'' in its place.

[FR Doc. 2022-02022 Filed 2-1-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Notices]
[Pages 15478-15479]
[FR Doc No: 2020-05617]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0567]

Restricted Delivery Systems: Flow Restrictors for Oral Liquid
Drug Products; Draft 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 draft guidance for industry entitled ``Restricted
Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.''
This guidance provides recommendations regarding the use of restricted
delivery systems to limit unintentional ingestion of oral liquid drug
products (e.g., oral solution, oral suspension) by children. The
recommendations in this guidance apply broadly to oral liquid drug and
biological products. FDA's recommendations are intended to minimize the
potential for harm due to unintentional ingestions.

DATES: Submit either electronic or written comments on the draft
guidance by May 18, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 Division of
Dockets Management, FDA will post your

comment, as well as any attachments, except for information submitted,
marked and identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-0567 for ``Restricted Delivery Systems: Flow Restrictors for
Oral Liquid Drug Products.'' 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.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft 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; or
the Office of Policy, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Rhiannon Leutner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD, 20993-0002,<PHONE_NUMBER>, 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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Restricted Delivery Systems: Flow Restrictors for Oral
Liquid Drug Products.'' This guidance provides recommendations
regarding the use of restricted delivery systems to limit unintentional
ingestion of oral liquid drug products (e.g., oral solution, oral
suspension) by children. The recommendations in this guidance apply
broadly to oral liquid drug and biological products.
    A restricted delivery system, according to USP General Chapter
<659> Packaging and Storage Requirements, is a packaging system that is
designed or constructed to restrict (control) the amount of drug
product that is delivered. Manufacturers should consider a restricted
delivery system, such as a flow restrictor, as an additional measure to
further reduce the risk that unintended ingestions of oral liquid drug
products pose to public health. FDA is issuing this guidance to
describe the elements that should be considered in developing
restricted delivery systems for oral liquid drug products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Restricted
Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.'' 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. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 314, including the submission
of new drug and abbreviated new drug applications and supplements, have
been approved under OMB control number 0910-0001; the collections of
information in 21 CFR part 601, including the submission of biologics
license applications and supplements, have been approved under OMB
control number 0910-0338; the collections of information in 21 CFR
201.66 for format and content requirements for over-the-counter drug
product labeling have been approved under OMB control number 0910-0340;
and the collections of information in 21 CFR 201.56 and 201.57 for
format and content requirements for human prescription drug and
biological product labeling have been approved under OMB control number
0910-0572.

III. Electronic Access

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

    Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05617 Filed 3-17-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Rules and Regulations]
[Pages 64733-64738]
[FR Doc No: 2019-25450]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 211

[Release No. SAB 119]

Staff Accounting Bulletin No. 119

AGENCY: Securities and Exchange Commission.

ACTION: Publication of Staff Accounting Bulletin.

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

SUMMARY: This staff accounting bulletin updates portions of the
interpretive guidance included in the Staff Accounting Bulletin Series
in order to align the staff's guidance with Financial Accounting
Standards Board (``FASB'') Accounting Standards Codification (``ASC'')
Topic 326, Financial Instruments--Credit Losses (``Topic 326'').

DATES: Effective: November 25, 2019.

FOR FURTHER INFORMATION CONTACT: Rachel Mincin, Associate Chief
Accountant, Office of the Chief Accountant at<PHONE_NUMBER>, or
Stephanie Sullivan, Associate Chief Accountant, Division of Corporation
Finance at<PHONE_NUMBER>, Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549.

SUPPLEMENTARY INFORMATION: In 2016, the FASB adopted ASC Topic 326
through its issuance of Accounting Standards Update No. 2016-13,
Financial Instruments--Credit Losses (Topic 326): Measurement of Credit
Losses on Financial Instruments.\1\ Upon its effective date, this
standard will replace the existing incurred loss model for determining
the allowance for loan losses with an expected credit loss model. The
staff is publishing this staff accounting bulletin to update existing
staff guidance \2\ with respect to methodologies and supporting
documentation for measuring credit losses. This updated guidance
continues to focus on the documentation the staff would normally expect
registrants engaged in lending transactions to prepare and maintain to
support estimates of current expected credit losses for loan
transactions. This update is applicable upon a registrant's adoption of
Topic 326.
---------------------------------------------------------------------------

    \1\ ASC Topic 326 was subsequently amended through the issuances
of Accounting Standards Update (``ASU'') No. 2018-19, Codification
Improvements to Topic 326, Financial Instruments--Credit Losses, ASU
No. 2019-04, Codification Improvements to Topic 326, Financial
Instruments--Credit Losses, Topic 815, Derivatives and Hedging, and
Topic 825, Financial Instruments, ASU No. 2019-05, Financial
Instruments--Credit Losses, Topic 326: Targeted Transition Relief,
and ASU No. 2019-10, Financial Instruments--Credit Losses (Topic
326), Derivatives and Hedging (Topic 815), and Leases (Topic 842):
Effective Dates.
    \2\ See Codification of SABs Topic 6, Section L: Financial
Reporting Release No. 28--Accounting for Loan Losses by Registrants
Engaged in Lending Activities, which codified SAB No. 102--Selected
Loan Loss Allowance Methodology and Documentation Issues, 66 FR
36457 (July 12, 2001).
---------------------------------------------------------------------------

    On November 15, 2019, the FASB delayed the effective date of the
standard for certain small public companies and other private
companies.\3\ As amended, the effective date of ASC Topic 326 was
delayed until fiscal years beginning after December 15, 2022 for SEC
filers that are eligible to be smaller reporting companies under the
SEC's definition, as well as private companies and not-for-profit
entities. Nothing in this staff accounting bulletin should be read to
accelerate or delay the effective dates of the standard as modified by
the FASB.
---------------------------------------------------------------------------

    \3\ See ASU No. 2019-10, Financial Instruments--Credit Losses
(Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic
842): Effective Dates
---------------------------------------------------------------------------

    The statements in SABs are not rules or interpretations of the
Commission, nor are they published as bearing the Commission's official
approval. They represent staff interpretations and practices followed
by the staff in the Division of Corporation Finance and the Office of
the Chief Accountant in administering the disclosure requirements of
the federal securities laws.

List of Subjects in 17 CFR Part 211

    Accounting, Reporting and recordkeeping requirements, Securities.

    Dated: November 19, 2019.
Vanessa A. Countryman,
Secretary.

    Accordingly, part 211 of title 17 of the Code of Federal
Regulations is amended as follows:

PART 211--INTERPRETATIONS RELATING TO FINANCIAL REPORTING MATTERS

0
1. The authority citation for 17 CFR part 211 continues as follows:

    Authority: 15 U.S.C. 77g, 15 U.S.C. 77s(a), 15 U.S.C. 77aa(25)
and (26), 15 U.S.C. 78c(b), 17 CFR 78l(b) and 13(b), 17 CFR 78m(b)
and 15 U.S.C. 80a-8, 30(e) 15 U.S.C. 80a-29(e), 15 U.S.C. 80a-30,
and 15 U.S.C. 80a-37(a).

0
2. Amend the table in subpart B by adding an entry for Staff Accounting
Bulletin No. 119 at the end of the table to read as follows:

Subpart B--Staff Accounting Bulletins

----------------------------------------------------------------------------------------------------------------
            Subject                  Release No.           Date                    FR vol. and page
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Publication of Staff            SAB119..............      11/25/2019  [INSERT FEDERAL REGISTER CITATION].
 Accounting Bulletin No. 119.
----------------------------------------------------------------------------------------------------------------

    Note: The text of Staff Accounting Bulletin No. 119 will not
appear in the Code of Federal Regulations.

Staff Accounting Bulletin No. 119

    The staff hereby adds Section M to Topic 6 of the Staff Accounting
Bulletin Series. Accordingly, the staff hereby amends the Staff
Accounting Bulletin Series as follows:
* * * * *

Topic 6: Interpretations of Accounting Series Releases and Financial
Reporting Releases

* * * * *

M. Financial Reporting Release No. 28--Accounting for Loan Losses by
Registrants Engaged in Lending Activities Subject to FASB ASC Topic 326

1. Measuring Current Expected Credit Losses
    General: This staff interpretation applies to all registrants that
are creditors in loan transactions that, individually or in the
aggregate, have a material effect on the registrant's financial
condition.\4\
---------------------------------------------------------------------------

    \4\ This staff interpretation relates to Financial Reporting
Release No. 28--Accounting for Loan Losses by Registrants Engaged in
Lending Activities, Release No. 33-6679 (Dec. 1, 1986), (hereinafter
``FRR 28'').
---------------------------------------------------------------------------

    FASB ASC Subtopic 326-20 addresses the measurement of current
expected credit losses for financial assets measured at amortized cost
basis, net investments in leases recognized by lessors, reinsurance
recoverables, and certain off-balance-sheet credit exposures.\5\
---------------------------------------------------------------------------

    \5\ See ASC paragraphs 326-20-15-2 and 326-20-15-3.
---------------------------------------------------------------------------

    At each reporting date, an entity shall record an allowance for
credit losses on financial assets measured at amortized cost basis and
net investments in leases recognized by lessors and shall record a
liability for credit losses on certain off-balance-sheet exposures not
accounted for as insurance or derivatives, including loan commitments,
standby letters of credit, and financial guarantees.\6\
---------------------------------------------------------------------------

    \6\ Ibid.
---------------------------------------------------------------------------

    For financial asset(s), the allowance for credit losses is a
valuation account that is deducted from, or added to, the amortized
cost basis of the financial asset(s) to present the net amount expected
to be collected on the financial asset(s).\7\
---------------------------------------------------------------------------

    \7\ See ASC paragraph 326-20-30-1.
---------------------------------------------------------------------------

    The allowance for credit losses is an estimate of current expected
credit losses considering available information relevant to assessing
collectibility of cash flows over the contractual term of the financial
asset(s).\8\
---------------------------------------------------------------------------

    \8\ As indicated in ASC paragraph 326-20-30-11, the liability
for expected credit losses for off-balance-sheet credit exposures
shall be based on the contractual period in which the entity is
exposed to credit risk via a present obligation to extend credit,
unless the obligation is unconditionally cancellable by the issuer.
---------------------------------------------------------------------------

    Information relevant to establishing an estimate of current
expected credit losses includes historical credit loss experience on
financial assets with similar risk characteristics, current conditions,
and reasonable and supportable forecasts that affect the collectability
of the remaining cash flows over the contractual term of the financial
assets. An entity shall report in net income (as a credit loss expense)
the amount necessary to adjust the allowance for credit losses and
liabilities for credit losses on off-balance-sheet credit exposures for
management's current estimate of expected credit losses.\9\
---------------------------------------------------------------------------

    \9\ See ASC paragraphs 326-20-30-1, 326-20-30-6, 326-20-30-7 and
326-20-30-11.
---------------------------------------------------------------------------

    This staff guidance is applicable upon a registrant's adoption of
FASB ASC Topic 326.\10\ Upon a registrant's adoption of FASB ASC Topic
326, the staff guidance in SAB Topic 6, Section L: Financial Reporting
Release No. 28--Accounting for Loan Losses by Registrants Engaged in
Lending Activities \11\ will no longer be applicable.
---------------------------------------------------------------------------

    \10\ See ASC paragraphs 326-10-65-1, 326-10-65-2, and 326-10-65-
3.
    \11\ Originally added to the Codification of SABs in Topic 6,
Section L, by SAB No. 102--Selected Loan Loss Allowance Methodology
and Documentation Issues, 66 FR 36457 (July 12, 2001).
---------------------------------------------------------------------------

    On November 15, 2019, the FASB delayed the effective date of FASB
ASC Topic 326 for certain small public companies and other private
companies. As amended, the effective date of ASC Topic 326 was delayed
until fiscal years beginning after December 15, 2022 for SEC filers
that are eligible to be smaller reporting companies under the SEC's
definition, as well as private companies and not-for-profit entities.
Nothing in this staff interpretation should be read to accelerate or
delay the effective dates of the standard as modified by the FASB.
2. Development, Governance, and Documentation of a Systematic
Methodology
    Facts: Registrant A is developing (or subsequently reviewing) its
allowance for credit losses methodology for its loan portfolio.
    Question 1: What are some of the factors or elements that the staff
normally would expect Registrant A to consider when developing (or
subsequently performing an assessment of) its methodology for
determining its allowance for credit losses under GAAP?
    Interpretive Response: The staff normally would expect a registrant
to have a systematic methodology to address the development,
governance, and documentation to determine its provision and allowance
for credit losses.
    It is critical that allowance for credit losses methodologies
incorporate management's current judgments about

the credit losses expected from the existing loan portfolio, including
reasonable and supportable forecasts about changes in credit quality of
these portfolios, on a disciplined and consistently-applied basis.
    A registrant's allowance for credit losses methodology is
influenced by entity-specific factors, such as an entity's size,
organizational structure, access to information, business environment
and strategy, management's risk assessment, complexity of the loan
portfolio, loan administration procedures, and management information
systems. Management is responsible for the estimate of expected credit
losses, and therefore also responsible for determining whether any
allowance methodologies developed by third parties are consistent with
GAAP.
    While different registrants may use different methods,\12\ there
are certain common elements that the staff would expect in any
methodology:
---------------------------------------------------------------------------

    \12\ ASC paragraph 326-20-30-3 states that ``[t]he allowance for
credit losses may be determined using various methods. For example,
an entity may use discounted cash flow methods, loss-rate methods,
roll-rate methods, probability-of-default methods, or methods that
utilize an aging schedule.''
---------------------------------------------------------------------------

     Identify relevant risk characteristics and pool loans on
the basis of similar risk characteristics; \13\
---------------------------------------------------------------------------

    \13\ See ASC paragraph 326-20-55-5 for a list of risk
characteristics that may be applicable.
---------------------------------------------------------------------------

     Consider available information relevant to assessing the
collectibility of cash flows; \14\
---------------------------------------------------------------------------

    \14\ See ASC paragraph 326-20-30-7.
---------------------------------------------------------------------------

     Consider expected credit losses over the contractual term
\15\ of all existing loans (whether on an individual or group basis),
and measure expected credit losses on loans on a collective (pool)
basis when similar risk characteristics exist; \16\
---------------------------------------------------------------------------

    \15\ See ASC paragraph 326-20-30-6.
    \16\ See ASC paragraph 326-20-30-2
---------------------------------------------------------------------------

     Require that analyses, estimates, reviews, and other
allowance for credit losses methodology functions be performed by
competent and well-trained personnel;
     Be based on reliable and relevant data and an analysis of
current conditions and reasonable and supportable forecasts;
     Include a systematic and logical method to consolidate the
loss estimates that allows for the allowance for credit losses balance
to be recorded in accordance with GAAP.
    The staff believes an entity's management should review, on a
periodic basis, whether its methodology for determining its allowance
for credit losses is appropriate. Additionally, for registrants that
have audit committees, the staff believes that oversight of the
financial reporting and auditing of the allowance for credit losses by
the audit committee can strengthen the registrant's process for
determining its allowance for credit losses.
    A systematic methodology that is properly designed and implemented
should result in a registrant's best estimate of its allowance for
credit losses.\17\ Accordingly, the staff normally would expect
registrants to adjust their allowance for credit losses balance, either
upward or downward, in each period for differences between the results
of the systematic methodology and the unadjusted allowance for credit
losses balance in the general ledger.\18\
---------------------------------------------------------------------------

    \17\ ASU 2016-13, BC63 states that ``the Board decided that an
entity should determine at the reporting date an estimate of credit
loss that best reflects its expectations (or its best estimate of
expected credit loss).''
    \18\ See ASC paragraph 326-20-35-1 and 326-20-35-3. Registrants
should also refer to the guidance on materiality in SAB Topic 1.M.
---------------------------------------------------------------------------

    Question 2: In the staff's view, what aspects of a registrant's
allowance for credit losses internal accounting controls would need to
be appropriately addressed in its written policies and procedures?
    Interpretive Response: Registrants may utilize a wide range of
policies, procedures, and control systems in their allowance for credit
losses processes, and these policies, procedures, and systems are
tailored to the size and complexity of the registrant and its loan
portfolio.
    However, the staff believes that, in order for a registrant's
allowance for credit losses methodology to be effective, the
registrant's written policies and procedures for the systems and
controls that maintain an appropriate allowance for credit losses would
likely address the following:
     The roles and responsibilities of the registrant's
departments and personnel (including the lending function, credit
review, financial reporting, internal audit, senior management, audit
committee, board of directors, and others, as applicable) who determine
or review, as applicable, the allowance for credit losses to be
reported in the financial statements;
     The registrant's selected methods and policies for
developing the allowance for credit losses and determining significant
judgments;
     The description of the registrant's systematic
methodology, which should be consistent with the registrant's
accounting policies for determining its allowance for credit losses
(see Question 4 below for further discussion); and
     How the system of internal controls related to the
allowance for credit losses process provides reasonable assurance that
the allowance for credit losses is in accordance with GAAP.
    The staff normally would expect internal accounting controls \19\
for the allowance for credit losses estimation process to:
---------------------------------------------------------------------------

    \19\ Public companies are required to comply with the books and
records and internal controls provisions of the Exchange Act. See
Sections 13(b)(2)-(7) of the Exchange Act.
---------------------------------------------------------------------------

     Include measures to provide reasonable assurance regarding
the reliability and integrity of information and compliance with laws,
regulations, and internal policies and procedures; \20\ and
---------------------------------------------------------------------------

    \20\ Section 13(b)(2)-(7) of the Exchange Act.
---------------------------------------------------------------------------

     Operate at a level of precision sufficient to provide
reasonable assurance that the registrant's financial statements are
prepared in accordance with GAAP.
    Question 3: Assume the same facts as in Question 1. What would the
staff normally expect Registrant A to include in its documentation of
its allowance for credit losses methodology?
    Interpretive Response: In FRR 28, the Commission provided guidance
for documentation of loan loss provisions and allowances for
registrants engaged in lending activities. The staff believes that
appropriate written supporting documentation for the provision and
allowance for credit losses facilitates review of the allowance for
credit losses process and reported amounts, builds discipline and
consistency into the allowance for credit losses methodology, and helps
to evaluate whether relevant factors are appropriately considered in
the allowance analysis.
    The staff, therefore, normally would expect a registrant to
document the relationship between its detailed analysis of the
characteristics and credit quality of the portfolio and the amount of
the allowance for credit losses reported in each period.\21\
---------------------------------------------------------------------------

    \21\ FRR 28, Section II states that ``[t]he specific rationale
upon which the [loan loss allowance and provision] amount actually
reported in each individual period is based--i.e., the bridge
between the findings of the detailed review [of the loan portfolio]
and the amount actually reported in each period--would be documented
to help ensure the adequacy of the reported amount, to improve
auditability, and to serve as a benchmark for exercise of prudent
judgment in future periods.''
---------------------------------------------------------------------------

    The staff normally would expect registrants to maintain written
supporting documentation for the following decisions and processes:
     Policies and procedures over the systems and controls that
maintain an appropriate allowance for credit losses;

     Allowance for credit losses methodology and key judgments,
including the data used, assessment of risk, and identification of
significant assumptions in the allowance estimation process;
     Summary or consolidation of the allowance for credit
losses balance;
     Validation of the allowance for credit losses methodology;
and
     Periodic adjustments to the allowance for credit losses.
    Question 4: What elements of a registrant's allowance for credit
losses methodology would the staff normally expect to be described in
the registrant's written policies and procedures?
    Interpretive Response: The staff normally would expect a
registrant's written policies and procedures to describe the primary
elements of its allowance for credit losses methodology. The staff
normally would expect that, in order for a registrant's allowance for
credit losses methodology to be effective, the registrant's written
policies and procedures would describe all primary elements needed to
support a disciplined and consistently-applied methodology, which may
include, but is not limited to: \22\
---------------------------------------------------------------------------

    \22\ See also, ASC paragraph 326-20-55-6 for additional
judgments a registrant may make.
---------------------------------------------------------------------------

     How portfolio segments are determined (e.g., by loan type,
industry, risk rating, etc.) \23\ and the methodology used for each
portfolio segment; \24\
---------------------------------------------------------------------------

    \23\ FASB ASC Subtopic 326-20-20 defines a portfolio segment as
the ``level at which an entity develops and documents a systematic
methodology to determine its allowance for credit losses.''
    \24\ See ASC paragraph 326-20-30-3 for examples of expected loss
estimation methods that may be used.
---------------------------------------------------------------------------

     The approach used to pool loans based on similar risk
characteristics;
     For accounting policy or practical expedient elections set
forth in FASB ASC Subtopic 326-20, documentation of the elections made;
     The method(s) used to determine the contractual term of
the financial assets, including consideration of prepayments and when
the contractual term is extended; \25\
---------------------------------------------------------------------------

    \25\ See ASC paragraph 326-20-30-6.
---------------------------------------------------------------------------

     If a loss-rate method is used, the historical data used to
develop the components of the loss rate and how that rate is applied to
the amortized cost basis of the financial asset as of the reporting
date; \26\
---------------------------------------------------------------------------

    \26\ See ASC paragraph 326-20-30-5.
---------------------------------------------------------------------------

     The method for estimating expected recoveries when
measuring the allowance for credit losses; \27\
---------------------------------------------------------------------------

    \27\ See ASC paragraph 326-20-30-1.
---------------------------------------------------------------------------

     The approach used to determine the appropriate historical
period for estimating expected credit loss statistics;
     The approach used to determine the reasonable and
supportable period;
     The approach used to adjust historical information for
current conditions and reasonable and supportable forecasts; \28\
---------------------------------------------------------------------------

    \28\ See ASC paragraph 326-20-30-8 and 326-20-30-9.
---------------------------------------------------------------------------

     How the entity plans to revert to historical credit loss
information for periods beyond which the entity is able to make or
obtain reasonable and supportable forecasts of expected credit losses;
\29\ and
---------------------------------------------------------------------------

    \29\ See ASC paragraph 326-20-30-9
---------------------------------------------------------------------------

     The approach used to determine when a purchased financial
asset would qualify to be accounted for as a purchased financial asset
with credit deterioration.\30\
---------------------------------------------------------------------------

    \30\ See ASC paragraph 326-20-30-13 through 326-20-30-15.
---------------------------------------------------------------------------

3. Documenting the Results of a Systematic Methodology
    Question 5: What documentation would the staff normally expect a
registrant to prepare to support its allowance for credit losses for
its loans under FASB ASC Subtopic 326-20?
    Interpretive Response: Regardless of the method used to determine
the allowance for credit losses under FASB ASC Subtopic 326-20, the
staff normally would expect a registrant to demonstrate in its
documentation that the loss measurement methods and assumptions used to
estimate the allowance for credit losses for its loan portfolio are
determined in accordance with GAAP as of the financial statement date.
    The staff normally would expect a registrant to maintain as
sufficient evidence written documentation to support its measurement of
expected credit losses under FASB ASC Subtopic 326-20. That
documentation should reflect the method(s) used to estimate expected
credit losses for each portfolio segment.\31\
---------------------------------------------------------------------------

    \31\ See supra note 20.
---------------------------------------------------------------------------

    The staff normally would expect registrants to follow a systematic
and consistently-applied approach to select the most appropriate
expected credit loss measurement methods and support its conclusions
and rationale with written documentation. Typically, registrants decide
the methods to use based on many factors, which vary with their
business strategies as well as their information system capabilities.
    As economic and other business conditions change, registrants often
modify their business strategies, which may necessitate adjustments to
the methods used to estimate expected credit losses. The staff normally
would expect a registrant to maintain a process to evaluate whether
adjustments to the methodology are necessary and, if so, maintain
documentation to support adjustments to the methodology used.
    A registrant's methodology should produce an estimate that is
consistent with GAAP. The staff normally would expect that, before
employing an expected loss method, a registrant would evaluate and
modify, as needed, the method's assumptions related to the current
estimate of expected credit losses. Also, the staff expects that
registrants would typically document the evaluation, the conclusions
regarding the appropriateness of estimating expected credit losses with
that method, and the objective support for adjustments to the method or
its results.
    A registrant shall measure expected credit losses on a collective
(pool) basis when similar risk characteristic(s) exist.\32\ The staff
normally would expect a registrant to maintain documentation to support
its conclusion that the loans in each pool have similar
characteristics.
---------------------------------------------------------------------------

    \32\ See ASC paragraph 326-20-30-2. Also refer to ASC paragraph
326-20-55-5 for a list of risk characteristics that may be
applicable.
---------------------------------------------------------------------------

    One method of estimating expected credit losses for a pool of loans
is through the application of loss rates to the pool's aggregate loan
balances.\33\ Such loss rates should generally reflect the registrant's
historical credit loss experience consistent with the remaining
contractual terms \34\ for each pool of loans, adjusted to reflect the
extent to which management expects current conditions and reasonable
and supportable forecasts to differ from the conditions that existed
for the period over which historical information was evaluated.\35\
---------------------------------------------------------------------------

    \33\ See ASC paragraph 326-20-55-18 through 326-20-55-22 for an
example illustrating one way an entity may estimate expected credit
losses on a portfolio of loans with similar risk characteristics
using a loss-rate approach.
    \34\ See ASC paragraph 326-20-30-6 for guidance on determining
the contractual term.
    \35\ See ASC paragraph 326-20-30-9 for guidance related to
adjusting historical loss information.
---------------------------------------------------------------------------

    If a registrant utilizes external data, the staff normally would
expect that the registrant would demonstrate in its documentation the
relevance and reliability of the external data. The registrant should
consider whether the external loss experience data comes from loans
with credit attributes similar to those of the loans included in the
registrant's portfolio and is consistent with the registrant's
assumptions regarding current and forecasted

economic conditions.\36\ The staff normally would expect a registrant
to maintain supporting documentation for assumptions and data used to
develop its loss rates, including its evaluation of the relevance and
reliability of any external data.
---------------------------------------------------------------------------

    \36\ See ASC paragraph 326-20-30-8.
---------------------------------------------------------------------------

    If a registrant uses the present value of expected future cash
flows to measure expected credit losses,\37\ the staff normally would
expect supporting documentation for the assumptions and data used to
develop the amount and timing of expected cash flows and the effective
interest rate used to discount expected cash flows.
---------------------------------------------------------------------------

    \37\ See ASC paragraph 326-20-30-4.
---------------------------------------------------------------------------

    If a registrant uses the fair value of collateral to measure
expected credit losses, the staff normally would expect the registrant
to document:
     The basis for its conclusion that the loan qualifies under
GAAP for measurement of expected credit losses based on the fair value
of the collateral; \38\
---------------------------------------------------------------------------

    \38\ See ASC paragraph 326-20-35-4 through 326-20-35-6 for
guidance regarding when it is appropriate to measure expected credit
losses based on the fair value of the collateral as of the reporting
date.
---------------------------------------------------------------------------

     How it determined the fair value of the collateral,
including policies relating to the use of appraisals, valuation
assumptions and calculations, the supporting rationale for adjustments
to appraised values, if any, and the determination of costs to sell, if
applicable; and
     The recency and reliability of the appraisal or other
valuation.
    Regardless of the method used, the underlying assumptions used by
registrants to develop expected credit loss measurements should
consider current conditions and reasonable and supportable forecasts.
The staff normally would expect a registrant to document the factors
used in the development of the assumptions and how those factors
affected the expected credit loss measurements.\39\ Factors to be
considered include the following:
---------------------------------------------------------------------------

    \39\ See ASC paragraph 326-20-55-4 for examples of factors to
consider.
---------------------------------------------------------------------------

     Levels of and trends in delinquencies and performance of
loans;
     Levels of and trends in write-offs and recoveries
collected;
     Trends in volume and terms of loans;
     Effects of any changes in reasonable and supportable
economic forecasts;
     Effects of any changes in risk selection and underwriting
standards, and other changes in lending policies, procedures, and
practices;
     Experience, ability, and depth of lending management and
other relevant staff;
     Available relevant information sources that support or
contradict the registrant's own forecast;
     Effects of changes in prepayment expectations or other
factors affecting assessments of loan contractual term;
     Industry conditions; and
     Effects of changes in credit concentrations.
    Factors affecting collectibility that are not reflected in the
registrant's historical loss information should be evaluated to
determine whether an adjustment is necessary so that the expected
credit loss measurement considers those factors.\40\ For any adjustment
of loss measurements based on current conditions and reasonable and
supportable forecasts, the staff normally would expect a registrant to
maintain sufficient evidence to (a) support the amount of the
adjustment and (b) explain why the adjustment is necessary to reflect
current conditions and reasonable and supportable forecasts in the
expected credit loss measurements. Supporting documentation for
adjustments may include relevant economic reports, economic data, and
information from individual borrowers.
---------------------------------------------------------------------------

    \40\ See ASC paragraph 326-20-30-9 for guidance on when it is
not appropriate to make adjustments to historical loss information
for forecasted economic conditions.
---------------------------------------------------------------------------

    The staff normally would expect that, as part of the registrant's
allowance for credit losses methodology, it would create a summary of
the amount and rationale for the adjustment factor for review by
management prior to the issuance of the financial statements. The staff
normally would expect the nature of the adjustments, how they were
measured or determined, and the underlying rationale for making the
changes to the allowance for credit losses balance to be documented.
The staff also normally would expect appropriate documentation of the
adjustments to be provided to management for review of the final
allowance for credit losses amount to be reported in the financial
statements.
    Similarly, the staff normally would expect that registrants would
maintain documentation to support the identified range and the
rationale used for determining which estimate is the best estimate
within the range of expected credit losses and that this documentation
would also be made available to the registrant's independent
accountants. If changes frequently occur during management or credit
committee reviews of the allowance for credit losses, management may
find it appropriate to analyze the reasons for the frequent changes and
to reassess the methodology the registrant uses.
    Facts: Registrant H has completed its estimation of its allowance
for credit losses for the current reporting period, in accordance with
GAAP, using its established systematic methodology.
    Question 6: What summary documentation would the staff normally
expect Registrant H to prepare to support the amount of its allowance
for credit losses to be reported in its financial statements?
    Interpretive Response: The staff normally would expect that, to
verify that the allowance for credit losses balances are presented
fairly in accordance with GAAP and are auditable, management would
prepare a document that summarizes the amount to be reported in the
financial statements for the allowance for credit losses,\41\ and that
such documentation also include sufficient evidence to support the
allowance and internal controls over the allowance. Common elements
that the staff normally would expect to find documented in allowance
for credit losses summaries include:
---------------------------------------------------------------------------

    \41\ See supra note 16.
---------------------------------------------------------------------------

     The reasonable and supportable economic forecasts used;
     The estimate of the expected credit losses using the
registrant's methodology or methodologies;
     A summary of the current allowance for credit losses
balance;
     The amount, if any, by which the allowance for credit
losses balance is to be adjusted; and
     Depending on the level of detail that supports the
allowance for credit losses analysis, detailed subschedules of loss
estimates that reconcile to the summary schedule.
    Generally, a registrant's review and approval process for the
allowance for credit losses relies upon the data provided in these
consolidated summaries. There may be instances in which individuals or
committees that review the allowance for credit losses methodology and
resulting allowance balance identify adjustments that need to be made
to the loss estimates to provide a better estimate of expected credit
losses. These changes may occur as a result of holistically evaluating
the individual components of the estimation process and considering the
overall estimate of the allowance for credit losses as a whole or due
to information not known at the time of the initial loss estimate. It
would be important that these adjustments be consistent with GAAP and
be reviewed

and approved by appropriate personnel. Additionally, it would typically
be appropriate for the summary to provide each subsequent reviewer with
an understanding of the support behind these adjustments. Therefore,
the staff normally would expect management to document the nature of
any adjustments and the underlying rationale for making the changes.
    The staff also normally would expect this documentation to be
provided to those among management making the final determination of
the allowance for credit losses amount.
4. Validating a Systematic Methodology
    Question 7: What is the staff's guidance to a registrant on
validating, and documenting the validation of, its systematic
methodology used to estimate allowance for credit losses?
    Interpretive Response: The staff believes that a registrant's
allowance for credit losses methodology is considered reasonable when
it results in a valuation account that adjusts the net amount of its
existing portfolio to cash flows expected to be collected.\42\
---------------------------------------------------------------------------

    \42\ See ASC paragraph 326-20-30-1.
---------------------------------------------------------------------------

    The staff normally would expect the registrant's systematic
methodology to include procedures to assess the continued relevance and
reliability of methods, data, and assumptions used to estimate expected
cash flows.
    To verify that the allowance for credit losses methodology is
reasonable and conforms to GAAP, the staff believes it would be
appropriate for management to establish internal control policies,
appropriate for the size of the registrant and the type and complexity
of its loan products and modeling methods.
    These policies may include procedures for a review, by a party who
is independent of the allowance for expected credit losses estimation
process, of the allowance methodology and its application in order to
confirm its effectiveness.
    While registrants may employ many different procedures when
assessing the reasonableness of the design and performance of its
allowance for credit losses methodology and appropriateness of the data
and assumptions used, the procedures should allow management to
determine whether there may be deficiencies in its overall methodology.
Examples of procedures may include:
     A review of how management's prior assumptions (including
expectations regarding loan delinquencies, troubled debt
restructurings, write-offs, and recoveries) have compared to actual
loan performance;
     A review of the allowance for credit losses process by a
party that is independent and possesses competencies on the subject
matter. This often involves the independent party reviewing, on a test
basis, source documents and underlying data and assumptions to
determine that the established methodology develops reasonable loss
estimates;
     A retrospective analysis of whether the models used
performed in a manner consistent with the intended purpose of
developing an estimate of expected credit losses; and
     When the fair value of collateral is used, an evaluation
of the appraisal process of the underlying collateral. This may be
accomplished by periodically comparing the appraised value to the
actual sales price on selected properties sold.
    The staff believes that management should support its validation
process with documentation of the specific validation procedures
performed, including any findings of an independent reviewer. The staff
normally would expect that, if the methodology is changed based upon
the findings of the validation process, documentation that describes
and supports the changes would be maintained.
    The staff encourages anyone with questions or suggestions regarding
this interpretation to contact the staff via email at<EMAIL_ADDRESS>or
phone at<PHONE_NUMBER>.

[FR Doc. 2019-25450 Filed 11-22-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Page 74489]
[FR Doc No: 2016-25826]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2016-104]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14, Code of Federal Regulations
(14 CFR). The purpose of this notice is to improve the public's
awareness of, and participation in, this aspect of the FAA's regulatory
activities. Neither publication of this notice nor the inclusion or
omission of information in the summary is intended to affect the legal
status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before November 15, 2016.

ADDRESSES: You may send comments identified by docket number FAA-2016-
6518 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments digitally.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility 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.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility 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.

FOR FURTHER INFORMATION CONTACT: Deana Stedman, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on October 6, 2016.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2016-6518.
    Petitioner: Lockheed Martin Aeronautics Company.
    Section of 14 CFR Affected: Sec. Sec.  25.335(e)(3) and
25.473(a)(2).
    Description of Relief Sought: Lockheed Martin Aeronautics Company
is requesting that the FAA allow the same airplane load derivation
equations and methods consistent with previous Model 382 airplane
design criteria for the current type design update of the Model 382J
Series airplane instead of strict compliance with Sec. Sec.
25.335(e)(3) and 25.473(a)(2).

[FR Doc. 2016-25826 Filed 10-25-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50861-50862]
[FR Doc No: 2023-16473]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG23-242-000.
    Applicants: Eleven Mile Solar Center, LLC.
    Description: Eleven Mile Solar Center, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5106.
    Comment Date: 5 p.m. ET 8/17/23.
    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:
    Docket Numbers: EL23-84-000; QF18-1454-001; QF18-1455-001; QF18-
1456-001.
    Applicants: ALLCO FINANCE LIMITED, ALLCO FINANCE LIMITED, ALLCO
FINANCE LIMITED, ALLCO FINANCE LIMITED.
    Description: Petition for Enforcement Pursuant to Section 210(h) of
the Public Utility Regulatory Policies Act of 1978 of Allco Finance
Limited.
    Filed Date: 7/24/23.
    Accession Number: 20230724-5096.
    Comment Date: 5 p.m. ET 8/14/23.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-1427-006; ER10-2917-025; ER10-2922-025; ER11-
2383-021; ER12-161-027; ER14-25-022; ER14-1964-017; ER16-287-011; ER17-
482-011; ER19-529-012; ER19-1074-012; ER19-1075-012; ER20-1447-007;
ER20-2028-002; ER22-192-006; ER22-1010-004.
    Applicants: TerraForm IWG Acquisition Holdings II, LLC, Evolugen
Trading and Marketing LP, Bitter Ridge Wind Farm, LLC, Brookfield
Energy Marketing U.S. LLC, Brookfield Renewable Energy Marketing U.S.
LLC, Brookfield Energy Marketing Inc., Brookfield Renewable Trading and
Marketing LP, BREG Aggregator LLC, BIF III Holtwood LLC, BIF II Safe
Harbor Holdings, LLC, Prairie Breeze Wind Energy LLC, Bishop Hill
Energy LLC, Safe Harbor Water Power Corporation, Hawks Nest Hydro LLC,
Brookfield Power Piney & Deep Creek LLC, Brookfield Energy Marketing
LP.
    Description: Notice of Non-Material Change in Status of Brookfield
Energy Marketing LP, et al.
    Filed Date: 7/26/23.
    Accession Number: 20230726-5127.
    Comment Date: 5 p.m. ET 8/16/23.

    Docket Numbers: ER23-2494-000.
    Applicants: ISO New England Inc., The Narragansett Electric
Company.
    Description: Sec.  205(d) Rate Filing: ISO New England Inc. submits
tariff filing per 35.13(a)(2)(iii): ISO-NE/The Narragansett Electric
Company; Second Revised LGIA-ISONE/NEP-15-03 to be effective 1/1/2023.
    Filed Date: 7/26/23.
    Accession Number: 20230726-5136.
    Comment Date: 5 p.m. ET 8/16/23.

    Docket Numbers: ER23-2495-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3317R2 WAPA & East River
Electric Power Interconnection Agr to be effective 7/26/2023.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5005.
    Comment Date: 5 p.m. ET 8/17/23.

    Docket Numbers: ER23-2496-000.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: Niagara Mohawk Power
Corporation submits tariff filing per 35.13(a)(2)(iii): Niagara Mohawk
205: E&P Agreement between NMPC and Sithe SA2791 to be effective 7/12/
2023.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5054.
    Comment Date: 5 p.m. ET 8/17/23.

    Docket Numbers: ER23-2497-000.
    Applicants: Midcontinent Independent System Operator, Inc., Great
River Energy.
    Description: Sec.  205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per 35.13(a)(2)(iii): 2023-
07-27_SA 3741 GRE-MRES-WMMPA Amendment No. 1 to be effective 9/26/2023.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5068.
    Comment Date: 5 p.m. ET 8/17/23.

    Docket Numbers: ER23-2498-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No.

7012; Queue No. AF1-098 to be effective 6/27/2023.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5082.
    Comment Date: 5 p.m. ET 8/17/23.

    Docket Numbers: ER23-2499-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions to Extend Tariff
Administration between SPP and SPA through 12/31/2024 to be effective
7/1/2023.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5087.
    Comment Date: 5 p.m. ET 8/17/23.

    Docket Numbers: ER23-2500-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA, SA No.
5958; Queue No. AC1-074/AC2-075 to be effective 9/26/2023.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5101.
    Comment Date: 5 p.m. ET 8/17/23.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) 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>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 27, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-16473 Filed 8-1-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 2, 2008 (Volume 73, Number 106)]
[Notices]
[Page 31492-31493]
[DOCID:fr02jn08-89]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0364] (formerly Docket No. 2007D-0080)

Guidance for Industry on Indexing Structured Product Labeling;
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Indexing Structured
Product Labeling.'' This guidance explains that the Center for
Biologics Evaluation and Research (CBER) and the Center for Drug
Evaluation and Research (CDER) will index structured product labeling
(SPL) in the product labeling for human drug and biologic products.
This guidance also makes recommendations to industry on how to submit
input regarding the indexing information in the SPL.

DATES: Submit written or electronic comments on agency guidance
documents at any time.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring MD 20993-0003, or the
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your requests. The guidance can also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. Submit written comments
on the guidance to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://www.regulations.gov. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT:  Laurie Burke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6462, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>or
     Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Indexing Structured Product Labeling.'' This guidance
explains that CBER and CDER will index SPL in the product labeling for
human drug and biological products. This guidance also makes
recommendations to industry on how to submit input regarding the
indexing information in the SPL.
    A Health Level Seven (HL7) standard, SPL enables the electronic
exchange of the content of labeling and other regulated product
information using the extensible markup language. The SPL standard
enables the inclusion of indexing elements with product labeling. These
machine readable identifiers enable users with clinical decision
support tools and electronic prescribing systems to rapidly search and
sort product information found in product labeling. Indexing the
content of labeling with SPL will greatly facilitate the efficient
communication of important drug information to the public, helping
create a more robust nationwide system for promoting the safe and
effective use of drugs.
    After completing a 6-month pilot project evaluating how best to add
indexing elements, FDA determined that the most efficient strategy is
for FDA, not individual applicants, to index the SPL using a phased
approach. We will index the pharmacological class during the first
phase. We are adding

the pharmacologic class first because: (1) It is important for the safe
use of drugs; (2) it is necessary for making future indexing meaningful
(e.g., drug interactions); and (3) this choice leverages existing FDA
resources. After pharmacologic class, we will be seeking public input
on which indexing elements should be added in future phases.
    The guidance also recommends that applicants submit any questions
regarding existing indexing, including any requests to add or revise an
indexing element, to FDA by e-mail at<EMAIL_ADDRESS>Inquiries and
requests will be forwarded to the appropriate FDA personnel, who will
consider them and make any appropriate change in the SPL.
    In the Federal Register of March 19, 2007, FDA announced a draft
version of this guidance entitled ``Indexing Structured Product
Labeling'' (72 FR 12807). A number of comments were received, and FDA
considered them carefully during finalization of the guidance. For
example, applicants expressed a desire to recommend indexing terms to
FDA; the guidance now provides advice on this topic. Applicants also
indicated that they would like to see the indexing terms that FDA has
selected prior to indexing. The guidance describes a high level process
for sharing indexing terms before FDA actually indexes the SPL decision
for a specific element, e.g., pharmacologic class. The guidance also
clarifies various points set forth in the draft guidance that the
public suggested needed clarification. This guidance is being issued as
a joint CDER-CBER guidance in preparation for CBER to implement SPL in
the future.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on indexing SPL. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Comments on agency guidances are welcome at any time. Interested
persons may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/
cber/guidelines.htm, or http://www.fda.regulations.

    Dated: May 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12158 Filed 5-30-08; 8:45 am]

BILLING CODE 4160-01-S