[Federal Register Volume 88, Number 233 (Wednesday, December 6, 2023)]
[Notices]
[Pages 84816-84817]
[FR Doc No: 2023-26763]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: PR24-15-000.
    Applicants: Columbia Gas of Pennsylvania.
    Description: Sec.  284.123 Rate Filing: Columbia Gas of
Pennsylvania, Inc. Statement of Operating Conditions to be effective
11/29/2023.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5132.
    Comment Date: 5 p.m. ET 12/20/23.

    Docket Numbers: PR24-16-000.
    Applicants: Columbia Gas of Virginia Inc.
    Description: Sec.  284.123 Rate Filing: Columbia Gas of Virginia,
Inc. Statement of Operating Conditions to be effective 11/29/2023.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5134.
    Comment Date: 5 p.m. ET 12/20/23.

    Docket Numbers: PR24-17-000.
    Applicants: Southern California Gas Company.
    Description: Sec.  284.123(g) Rate Filing: Offshore Delivery
Service Rate Revision November 2023 to be effective 11/1/2023.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5151.
    Comment Date: 5 p.m. ET 12/20/23.
    Sec.  284.123(g) Protest: 5 p.m. ET 1/29/24.

    Docket Numbers: RP24-181-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Agreement
Filing (ASARCO) to be effective 1/1/2024.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5125.
    Comment Date: 5 p.m. ET 12/11/23.

    Docket Numbers: RP24-182-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreements
Update (Red Willow_Sempra) to be effective 1/1/2024.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5129.
    Comment Date: 5 p.m. ET 12/11/23.

    Docket Numbers: RP24-183-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement--12/
1/2023 to be effective 12/1/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5024.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-184-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Remove Expired Agreements eff
11-30-2023 to be effective 11/30/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5047.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-185-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Housekeeping Filing for
Agreements Volume and Volume 1 Tariff eff 11-30-23 to be effective 11/
30/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5048.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-186-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: 2023 Leap Year Rate Filing to
be effective 1/1/2024.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5056.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-187-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: 2023 Special Pool Filing to be
effective 1/1/2024.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5057.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-188-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various Dec
1 2023 Releases to be effective 12/1/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5086.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-189-000.

    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreements
Filing (TMV and EcoEnergy) to be effective 12/1/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5091.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-190-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: CIG Qtrly LUF True-up Nov 2023
to be effective 1/1/2024.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5101.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-191-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20231130 Negotiated Rate to be
effective 12/1/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5102.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-192-000.
    Applicants: Kinder Morgan Louisiana Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Periodic Rate Adjustment--Fuel
and L&U Retention Percentages December 2023 to be effective 1/1/2024.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5105.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-193-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Annual Fuel and L&U Filing
2024 to be effective 1/1/2024.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5108.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-194-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Update
(Hartree 615843_610670_614700 Dec 2023) to be effective 12/1/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5110.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-195-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Northern to
NRG Business 3049 eff 12-1-23 to be effective 12/1/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5135.
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-196-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various
Releases eff 12-1-23 to be effective 12/1/2023.
    Filed Date: 11/30/23.
    Accession Number: 20231130-5145.
    Comment Date: 5 p.m. ET 12/12/23.

    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.

Filings in Existing Proceedings

    Docket Numbers: RP19-78-012
    Applicants: Panhandle Eastern Pipe Line Company, LP
    Description: Refund Report: RP19-78-000 Refund Report to be
effective N/A.
    Filed Date: 11/30/23
    Accession Number: 20231130-5066
    Comment Date: 5 p.m. ET 12/12/23.

    Docket Numbers: RP24-158-001
    Applicants: Midwestern Gas Transmission Company
    Description: Tariff Amendment: Amendment to Tariff Part 5.0
Metadata Correction to be effective 11/1/2023.
    Filed Date: 11/30/23
    Accession Number: 20231130-5001
    Comment Date: 5 p.m. ET 12/12/23.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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: November 30, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-26763 Filed 12-5-23; 8:45 am]
BILLING CODE 6717-01-P


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="Microsoft Word - 8412fnl.doc">
<META name="creation-date" content="12/01/2009 10:56:52 ">
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Guidance for Industry
Q4B Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions
Annex 3
Test for Particulate Contamination:
Subvisible Particles General Chapter
Additional copies are available from:
Office of Training and Communication
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
1
090
3 New Hampshire Ave.
Bldg. 51, Room 2201
Silver Spring, MD 20993-0002
(Tel)<PHONE_NUMBER>
http://www.fda.gov/cder/guidance/index.htm
or
Office of Communication, Training and
Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
http://www.fda.gov/cber/guidelines.htm.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
January 2009
ICH

i
TABLE OF CONTENTS
I.
INTRODUCTION (1)....................................................................................................... 1
II.
Q4B OUTCOME (2)......................................................................................................... 2
A.
Analytical Procedures (2.1)...........................................................................................................2
B.
Acceptance Criteria (2.2)...............................................................................................................2
III.
TIMING OF ANNEX IMPLEMENTATION (3) .......................................................... 2
IV.
CONSIDERATIONS FOR IMPLEMENTATION (4).................................................. 2
A.
General Consideration (4.1)..........................................................................................................2
B.
FDA Consideration (4.2) ...............................................................................................................2
C.
EU Consideration (4.3) ..................................................................................................................3
D.
MHLW Consideration (4.4)..........................................................................................................3
V.
REFERENCES USED FOR THE Q4B EVALUATION (5) ........................................ 3
ATTACHMMENT........................................................................................................................ 4

Contains Nonbinding Recommendations
1
Guidance for Industry
1
Q4B Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions
Annex 3
Test for Particulate Contamination:  Subvisible Particles
General Chapter
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes
and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.
I. INTRODUCTION (1)
2
This annex is one in a series of guidance documents that describe the evaluations and
recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts
to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH
regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry.
For general information on the Q4B process, the reader is referred to the core guidance Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
3
This annex is the result of the Q4B process for the Test for Particulate Contamination: Subvisible
Particles General Chapter.  The proposed texts were submitted by the Pharmacopoeial
Discussion Group (PDG).
1
This guidance was developed within the Expert Working Group (Quality) of the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been
subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been
endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.  At Step 4 of the process, the final
draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States.
2
Arabic numbers reflect the organizational breakdown of the document endorsed by the ICH Steering Committee at
Step 4 of the ICH process, June 2008.
3
We update guidances periodically.  To make sure you have the most recent version of a guidance, check the CDER
guidance page at http://www.fda.gov/cder/guidance/index.htm or the CBER guidance page at
http://www.fda.gov/cber/guidelines.htm..

Contains Nonbinding Recommendations
2
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited.  The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II.
Q4B OUTCOME (2)
A.
Analytical Procedures (2.1)
The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group
(EWG), recommends that the official pharmacopoeial texts, Ph. Eur. 2.9.19. Particulate
Contamination: Sub-visible Particles, JP 6.07 Insoluble Particulate Matter Test for Injections,
and USP <788> Particulate Matter in Injections, can be used as interchangeable in the ICH
regions subject to the following condition:
•
Condition (2.1.1): Instrument calibration and system suitability measurements should
follow regional good manufacturing practice (GMP) requirements.
B.
Acceptance Criteria (2.2)
Except for nominal 100-milliliter (mL) parenteral products, the acceptance criteria are
interchangeable.  At the 100-mL nominal volume, the criteria specified in JP are more stringent
than those in the Ph. Eur. and the USP pharmacopoeias; therefore, the criteria are not
interchangeable in all three regions at that volume.
III.
TIMING OF ANNEX IMPLEMENTATION (3)
When this annex has been implemented (incorporated into the regulatory process at ICH Step 5)
in a region, it can be used in that region.  Timing might differ for each region.
IV.
CONSIDERATIONS FOR IMPLEMENTATION (4)
A. General Consideration (4.1)
When sponsors or manufacturers change their existing methods to the implemented Q4B-
evaluated pharmacopoeial texts that are referenced in section II.A (2.1) of this annex, any change
notification, variation, and/or prior approval procedures should be handled in accordance with
established regional regulatory mechanisms pertaining to compendial changes.
B.
FDA Consideration (4.2)

Contains Nonbinding Recommendations
3
Based on the recommendation above, and with reference to the conditions set forth in this annex,
the pharmacopoeial texts referenced in section II.A (2.1) of this annex can be considered
interchangeable.  However, FDA might request that a company demonstrate that the chosen
method is acceptable and suitable for a specific material or product, irrespective of the origin of
the method.  For nominal 100-mL parenteral products, the FDA considers testing criteria from all
three pharmacopoeias as interchangeable.
C.
EU Consideration (4.3)
For the European Union, the monographs of the Ph. Eur. have mandatory applicability.
Regulatory authorities can accept the reference in a marketing authorization application, renewal
or variation application citing the use of the corresponding text from another pharmacopoeia as
referenced in section II.A (2.1), in accordance with the conditions set out in this annex, as
fulfilling the requirements for compliance with the Ph. Eur. Chapter, Particulate Contamination:
Sub-visible Particles: 2.9.19., on the basis of the declaration of interchangeability made above.
For nominal 100-mL parenteral products, the EU considers testing criteria from all three
pharmacopoeias as interchangeable.
D.
MHLW Consideration (4.4)
The pharmacopoeial texts referenced in section II.A (2.1) of this annex can be used as
interchangeable in accordance with the conditions set out in this annex.  Details of
implementation requirements will be provided in the notification by MHLW when this annex is
implemented.
V.
REFERENCES USED FOR THE Q4B EVALUATION (5)
A. (5.1)  The PDG Stage 5B sign-off document:  Japanese Pharmacopoeial Forum,
Volume 13, Number 3 (August 2004).
B. (5.2) The pharmacopoeial references for Particulate Matter for this annex are:
1. (5.2.1) European Pharmacopoeia (Ph. Eur.):  5
th
Edition (official on January
2005), Particulate Contamination: Sub-visible Particles (reference 01/2005:20919).
2. (5.2.2) Japanese Pharmacopoeia (JP):  6.07 Insoluble Particulate Matter Test for
Injections as it appears in the JP Fifteenth Edition (March 31, 2006, The Ministry of
Health, Labour and Welfare Ministerial Notification No. 285). The method was
changed in September 2007 to correct a sentence in the introduction as underlined in the text
that is provided by MHLW which is attached.
3. (5.2.3) United States Pharmacopeia (USP): <788> Particulate Matter in Injections,
Revision Bulletin, April 4, 2007.

Contains Nonbinding Recommendations
4
ATTACHMMENT

Contains Nonbinding Recommendations
5

Contains Nonbinding Recommendations
6


[Federal Register: September 16, 2008 (Volume 73, Number 180)]
[Notices]
[Page 53411-53412]
[DOCID:fr16se08-31]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13272-000]

Alaska Village Electric Cooperative; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

September 10, 2008.
    On August 6, 2008, Alaska Village Electric Cooperative filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Old Harbor Hydroelectric
Project (Old Harbor). Old Harbor would be located on the east fork of
Mountain Creek, in Kodiak Island Borough, Alaska.

    The proposed Old Harbor project would consist of: (1) A 4-foot-
high, 30-foot-long concrete diversion; (2) a proposed 6,200-foot-long,
varying in diameter from 16-inches to 12-inches steel penstock; (3) a
proposed powerhouse containing a 300-kilowatt generator; (4) a proposed
tailrace; (5) a proposed 10,700-foot-long transmission line; and
appurtenant facilities. The Old Harbor Hydroelectric Project is
estimated to have an annual generation of 2.2-gigawatt-hours, which
would be sold to a local utility.
    Applicant Contact: Mr. Brent Petrie, Alaska Village Electric
Cooperative, 4831 Eagle Street, Anchorage, AK 99503; phone (907) 565-
5358.
    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13272) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-21585 Filed 9-15-08; 8:45 am]

BILLING CODE 6717-01-P