[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30748-30751]
[FR Doc No: 2018-14005]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1903]

Modernizing Pharmaceutical Quality Systems; Studying Quality
Metrics and Quality Culture; Quality Metrics Feedback Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) Center
for Drug Evaluation and Research (CDER) is announcing two new efforts
to gather feedback on the use of quality metrics to modernize
pharmaceutical quality systems and advance innovation based on
stakeholder feedback. These efforts include Type C formal meeting
requests and pre-abbreviated new drug application (pre-ANDA) meeting
requests, and a pilot study to gain feedback from those establishments
for which Type C formal meetings or pre-ANDA meetings do not apply
(e.g., active pharmaceutical ingredients (API) establishments, contract
manufacturing organizations, over-the-counter (OTC) monograph products
establishments, or marketed unapproved finished drug products
establishments). Participation in either of these efforts is voluntary
and the programs are intended to foster the joint efforts of FDA and
stakeholders to further develop an FDA Quality Metrics Program. The FDA
Quality Metrics Program aims to evaluate a new approach for regulatory
oversight of pharmaceutical products through the collection of certain
quality information developed and maintained in the course of
manufacturing drugs under current good manufacturing practices. FDA
intends to use quality metrics data to further develop the Agency's
risk-based inspection scheduling (e.g., decreased surveillance
inspection frequency for certain establishments) to improve the
efficiency and effectiveness of establishment inspections, improve
FDA's evaluation of drug manufacturing and control operations, and
identify situations in which there may be a risk for drug supply
disruption.

DATES: Submit a written request to participate in the program by July
29, 2019. See sections II and III.B of this notice for information to
include in such requests. FDA will start accepting requests beginning
July 30, 2018.

FOR FURTHER INFORMATION CONTACT: Tara Gooen Bizjak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993, 301-796-
3257, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    More than a decade ago, FDA launched an initiative to encourage the
implementation of a modern, risk-based pharmaceutical quality
assessment system. As part of this initiative, and in recognition of
the increasing complexity of pharmaceutical manufacturing, FDA
developed a 21st century vision for manufacturing and quality with
input from academia and industry. The desired state was described as
follows: ``A maximally efficient, agile, flexible pharmaceutical
manufacturing sector that reliably produces high-quality drug products
without extensive regulatory oversight.'' \1\
---------------------------------------------------------------------------

    \1\ See ``FDA Pharmaceutical Quality Oversight: One Quality
Voice'' at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf.
---------------------------------------------------------------------------

    There has been significant progress toward this vision in the
intervening years, as evidenced by programs and guidance from FDA
around major initiatives such as pharmaceutical development and quality
by design, quality risk management and pharmaceutical quality systems,
process validation, and process analytical technology, among other
initiatives. These programs and guidances are intended to promote
effective use of the most current pharmaceutical science and
engineering principles and knowledge throughout the life cycle of a
product.
    While much progress has been made, we have not fully realized our
21st century vision for manufacturing and quality. Rather than focusing
on use of science- and risk-based principles as described in current
good manufacturing practices, many establishments continue to focus on
minimum requirements (e.g., check-box approach). Recalls and drug
shortages, which are often indications of serious product quality
defects caused by drug

manufacturing issues, continue to occur.2 3 The Agency has
found that most drug shortages stem from quality issues (e.g.,
substandard manufacturing facilities or processes, or significant
quality defects are identified in the finished product). These
situations necessitate remediation efforts to fix the issue, which in
turn may interrupt production and cause a shortage of drugs. Taking
action to reduce drug shortages remains a top priority for FDA.
---------------------------------------------------------------------------

    \2\ Refer to https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm for more information on drug recalls.
    \3\ In 2012, for example, based on information collected from
manufacturers, FDA determined that 66 percent of disruptions in drug
manufacturing were the result of either efforts to address product-
specific quality failures or broader efforts to remediate or improve
an unsafe manufacturing facility. FDA's ``Strategic Plan for
Preventing and Mitigating Drug Shortages,'' see figure 2, at https://www.fda.gov/downloads/drugs/drugsafety/drugshortages/ucm372566.pdf.
---------------------------------------------------------------------------

    FDA sought input from industry on the establishment of an FDA
Quality Metrics Program as another mechanism to promote continual
improvement in manufacturing quality. FDA has also consulted with other
stakeholders to identify mutually useful and objective quality metrics.
The Agency learned that it should perform further studies of the FDA
Quality Metrics Program through a pilot program and additional
discussions with stakeholders. Based on this input, FDA is initiating
this Quality Metrics Feedback Program to assist the Agency in the
development of a Quality Metrics Program. Stakeholders are encouraged
to participate in these efforts by using the two feedback procedures
described below. Additional references may be found at the FDA web
page, Quality Metrics for Drug Manufacturing, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm526869.htm.
    Based on stakeholder feedback, FDA is presenting two new methods
for engaging industry. The approaches announced in this notice provide
industry stakeholders with an opportunity to provide information to
further the development of the Quality Metrics Program. CDER will also
continue to engage with trade associations to gather feedback for
industry subsectors.
    FDA does not intend to publicly disclose information submitted to
the Agency as part of this Quality Metrics Feedback Program that is
exempt from disclosure under disclosure laws and regulations. The
following types of information may be exempt from public disclosure if
not made public by the owner: (1) Commercial relationships; (2)
production and sales volume; (3) business plans; and (4) unapproved
applications.

II. Type C Formal Meetings and Pre-ANDA Meetings

    Applicants who have an interest in participating in this method of
the FDA Quality Metrics Feedback Program should submit a written
request. New drug application (NDA) applicants or sponsors should
follow the procedures for submitting Type C meeting requests as
described in the draft guidance for industry entitled ``Formal Meetings
Between the FDA and Sponsors or Applicants of PDUFA Products (December
2017).'' \4\ The requests should be labeled as ``Type C Meeting--
Request to Participate in the Quality Metrics Feedback Program.'' Pre-
ANDA applicants or sponsors planning to submit an original or
supplemental pre-ANDA should submit a pre-ANDA meeting request to OPQ-
OS-Quality [email protected] and label it as ``Pre-ANDA Meeting--
Request to Participate in the Quality Metrics Feedback Program.''
---------------------------------------------------------------------------

    \4\ We update guidances periodically. To make sure you have the
most recent version of a guidance, check the FDA Drugs guidance web
page at https://www.fda.gov/Drugs/GuidancecomplianceRegulatoryInformation/Guidances/default.htm.
---------------------------------------------------------------------------

    In addition to the procedures and items outlined in the referenced
guidances, a request for a meeting should include the following items:
    1. A description of the quality metrics currently used for the
product and process in the facility(ies) that are specific to the risks
of the facility(ies), products, manufacturing processes, supply chain,
and current business decisions (e.g., amount of product held in
inventory or days on hand). That is, the metrics which have been
determined by the applicant to be most meaningful to product quality
and for patient impact.
    2. A statement on whether the following quality metrics are
measured using consistent definitions: Lot acceptance rate per product
or rejection rate, invalidated out-of-specification rate per product,
product quality complaint rate, process performance and process
capability per product, corrective action and preventive action
effectiveness, quality system timeliness, and on-time-in-full
fulfillment of orders.
    3. A statement that suitably detailed technical definitions for the
quality metrics data elements in the previously mentioned items (1) and
(2) are established to enable consistent measurement and comparison.
    4. A description of the routine assessment and management oversight
of quality culture. This assessment should include all levels of staff,
from senior management to base level employees, to gauge and shape the
behaviors, beliefs, values, morals, conventions, goals, and practices
that characterize or are associated with manufacturing at the
facility(ies).
    5. A description of the ongoing site management and senior
management review of the quality metrics program, including
identification of areas for continual improvement.
    To maximize the benefits of an in-person meeting, FDA prefers that
the applicant or sponsor provide a statement of willingness for one or
more of the following: (1) To provide access to certain current and
historical product-specific measures and the data supporting the
measures, including lot acceptance rate or rejection rate, product
quality complaint rate, and invalidated out-of-specification rate; (2)
to share available information supporting the categories (product
specific measurements), where applicable, of process performance and
process capability (product specific), corrective and preventive
actions (CAPA) effectiveness, quality culture, quality system metrics
(e.g., periodic product report on-time rate), and on-time-in-full
fulfillment of orders (product specific); and (3) to discuss details of
their quality metrics program, including quality metrics data
definitions and methods of analyzing available data.
    We intend to accept as many meeting requests as Agency resources
allow and to focus on establishments that show an interest in engaging
in robust discussions regarding their quality metrics programs. FDA
expects to notify companies in writing of its decision regarding
meeting acceptance within 60 days of receipt of their requests.
Although incomplete and/or unclear requests will generally be denied,
FDA may contact the applicant to request additional information. Once a
meeting is granted, the participant can engage with the Quality Metrics
Program team in accordance with existing meeting procedures and
guidance(s). FDA anticipates that discussions with stakeholders will
help to further develop the Quality Metrics Program and will provide
the Agency with information on existing industry practices using modern
pharmaceutical quality systems.

III. Pilot Program

A. Participation

    Establishments eligible to participate in this voluntary Quality
Metrics Pilot

Program are limited to nine or fewer firms that follow the procedures
set forth in section III.B and meet the following selection criteria:
    1. The company must be a covered establishment. A covered
establishment is an owner or operator of an establishment that is
engaged in the manufacture, preparation, propagation, compounding, or
processing of a covered drug product, or an API used in the manufacture
of a covered drug product. A covered drug product is: (1) Subject to an
approved application under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) or under section 351 of the Public Health
Service Act (42 U.S.C. 262); (2) marketed pursuant to an OTC monograph;
or (3) a marketed unapproved finished drug product. A covered
establishment does not need to be involved in the physical manipulation
of a drug.
    2. The company must have a quality metrics program that has been
developed and implemented by the quality unit and that is used to
support product and process quality improvement. The established
quality metrics program must include product-specific measurements and
include at a minimum: (1) Lot acceptance rate or rejection rate, (2)
invalidated out-of-specification rate, and (3) product quality
complaint rate. If a product is manufactured at more than one location,
these product specific metrics could be limited to operations at the
participating covered establishment. To provide feedback on recommended
changes in the metrics definitions, send an email to OPQ-OS-
Quality[email protected].
    The ideal participant in the Quality Metrics Pilot Program will
have the following elements in their quality metrics program:
    1. Quantitative measurement of quality metrics for the products and
processes in the facility(ies) that are specific to the risks of the
facility(ies), products, manufacturing processes, supply chain, and
current business decisions (e.g., amount of product held in inventory
or days on hand);
    2. Certain quality metrics measured, such as lot acceptance rate or
rejection rate per product, invalidated out-of-specification rate per
product, product quality complaint rate, process performance and
process capability per product, CAPA effectiveness, quality system
timeliness, and on-time-in-full fulfillment of orders;
    3. Suitably detailed technical definitions for the quality metrics
data elements to enable consistent measurement and comparison;
    4. routine assessment and management oversight of quality culture
at multiple levels of staff, such as senior management to base level
employees, to assess and shape the behaviors, beliefs, values, morals,
conventions, goals, and practices that characterize or are associated
with manufacturing at the facility(ies); and
    5. Ongoing site management and senior management review of the
quality metrics with identification of areas for continual improvement.
    The establishments that will likely benefit most from the Quality
Metrics Pilot Program and discussions with FDA are those that are able
to: (1) Provide access to certain current and historical product-
specific measures and the data supporting the measures, including lot
acceptance rate or rejection rate, product quality complaint rate, and
invalidated out-of-specification rate; (2) share available information
supporting the following categories (product specific measurements),
where applicable, of process performance and process capability
(product specific), CAPA effectiveness, quality culture, quality system
metrics (e.g., periodic product report on-time rate), and on-time-in-
full fulfillment of orders (product-specific); (3) discuss details of
their quality metrics program, including quality metrics data
definitions and methods of analyzing available data (for comparison
purposes, we are interested in establishments that are willing to
provide data based on definitions in the draft guidance as well as
their preferred definitions); (4) be available for real-time
consultations with FDA; (5) provide information about the firm's
quality management system related to the quality metrics program; and
(6) comment on and discuss their experiences with this Quality Metrics
Pilot process.

B. Procedures

    To be considered for the voluntary Quality Metrics Pilot Program, a
company should submit a statement of interest for participation to OPQ-
OS-Quality[email protected]. The statement of interest should include
agreement to the selection qualities listed in section III.A.
    The following captures the proposed process for the Quality Metrics
Pilot Program selection:
    1. FDA will collect statements of interest for participation in the
pilot program beginning July 30, 2018.
    2. FDA will select the first nine participants that submit a
statement of interest in participation meeting the selection criteria
in the first paragraph of section III.A. While any covered
establishment meeting the criteria may request inclusion in the pilot
program per the first paragraph of section III.A, FDA would prefer that
establishments for which Type C formal meetings and pre-ANDA meetings
are not applicable use this approach. Additionally, FDA is seeking
participants that represent different sectors of the pharmaceutical
industry, including companies that manufacture the following types of
products: Brand, generics, biotechnology, APIs, and non-application
products marketed under the OTC monograph system. Furthermore, we are
looking for representation from contract development and manufacturing
organizations, establishments with small and large portfolios, and
establishments with past or current product availability issues (e.g.,
history of a drug supply issue or recall).
    3. Lessons learned from the initial participants in the pilot
program (maximum of nine participants) will help inform FDA's thinking
as it refines the Quality Metrics Program.

IV. Beginning Date of the Quality Metrics Pilot Program and Type C
Formal Meetings and Pre-ANDA Meetings

    FDA intends to accept requests for participation in the voluntary
Quality Metrics Pilot Program and Type C formal meetings and Pre-ANDA
meetings beginning July 30, 2018. The pilot program will begin July 30,
2018 and will close July 29, 2019. The Type C formal meetings and pre-
ANDA meetings will be granted based on the schedules described in the
associated guidance documents.

V. Paperwork Reduction Act of 1995

    This notice 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 505 have been approved under
OMB control number 0910-0001 and the collections of information in 21
CFR parts 210 and 211 have been approved under OMB control number 0910-
0139.
    The collections of information to be included in a meeting request
for a product submitted in an NDA is approved under OMB control number
0910-0429. The collections of information to be included in a meeting
request for a product submitted in an ANDA is approved under OMB
control number 0910-0797.

    Dated: June 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14005 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Notices]
[Page 11573]
[FR Doc No: 2017-03562]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC17-47-000]

4C Acquisition, LLC; Notice of Request for Waiver

    Take notice that on February 10, 2017, pursuant to 18 CFR parts 41,
101 and 141 (2016) of the Federal Energy Regulatory Commission
(Commission) Regulations, 4C Acquisition, LLC filed a request for
waiver of accounting and financial reporting requirements for the
Fourth Quarter of 2016.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comments: 5:00 p.m. Eastern Time on March 3, 2017.

    Dated: February 16, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-03562 Filed 2-23-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Pages 34525-34526]
[FR Doc No: 2014-14138]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-495-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on June 2, 2014, Columbia Gas Transmission, LLC
(Columbia), 5151 San Felipe, Suite 2500, Houston, Texas 77056, filed in
Docket No. CP14-495-000, a prior notice request pursuant to sections
157.205, 157.208, 157.213, and 157.216 of the Commission's regulations
under the Natural Gas Act (NGA). Columbia seeks authorization to
construct, modify, replace, and abandon natural gas storage facilities
in its Rockport Storage Field, located in Wirt and Wood Counties, West
Virginia. Columbia proposes to perform these activities under its
blanket certificate issued in Docket No. CP83-76-000 [22 FERC ] 62,029
(1983)], all as more fully set forth in the application which is on
file with the Commission and open to public inspection.
    The filing may be viewed on the web at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Fredric J. George, Senior Counsel, Columbia Gas Transmission, LLC, P.O.
Box 1273, Charleston, West Virginia, 25325-1273, or by calling (304)
357-2359 (telephone) or<PHONE_NUMBER> (fax<EMAIL_ADDRESS>    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the NGA (18 CFR 157.205) a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the

day after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    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 commenters 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 commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters 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
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: June 11, 2014.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-14138 Filed 6-16-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Page 3672]
[FR Doc No: 2015-01075]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 11a-2; SEC File No. 270-267, OMB Control No. 3235-0272.

    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'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 11a-2 (17 CFR 270.11a-2) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) permits certain registered insurance
company separate accounts, subject to certain conditions, to make
exchange offers without prior approval by the Commission of the terms
of those offers. Rule 11a-2 requires disclosure, in certain
registration statements filed pursuant to the Securities Act of 1933
(15 U.S.C. 77a et seq.) of any administrative fee or sales load imposed
in connection with an exchange offer.
    There are currently 652 registrants governed by Rule 11a-2. The
Commission includes the estimated burden of complying with the
information collection required by Rule 11a-2 in the total number of
burden hours estimated for completing the relevant registration
statements and reports the burden of Rule 11a-2 in the separate
Paperwork Reduction Act (``PRA'') submissions for those registration
statements (see the separate PRA submissions for Form N-3 (17 CFR
274.11b), Form N-4 (17 CFR 274.11c) and Form N-6 (17 CFR 274.11d). The
Commission is requesting a burden of one hour for Rule 11a-2 for
administrative purposes.
    The estimate of average burden hours is made solely for the
purposes of the PRA, and is not derived from a comprehensive or even a
representative survey or study of the costs of Commission rules or
forms. With regard to Rule 11a-2, the Commission includes the estimate
of burden hours in the total number of burden hours estimated for
completing the relevant registration statements and reported on the
separate PRA submissions for those statements (see the separate PRA
submissions for Form N-3, Form N-4 and Form N-6). The information
collection requirements imposed by Rule 11a-2 are mandatory. Responses
to the collection of information will not be kept confidential.
    Written comments are invited on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burden of
the collection of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Pamela Dyson, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send
an email to<EMAIL_ADDRESS>
    Dated: January 16, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-01075 Filed 1-22-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 12, 2009 (Volume 74, Number 7)]
[Notices]
[Page 1203-1204]
[DOCID:fr12ja09-55]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-38-000]

Transcontinental Gas Pipe Line Corporation; Copano Field
Services/Central Gulf Coast, L.P.; Notice of Application

January 6, 2009.
    Take notice that on December 19, 2008, Transcontinental Gas Pipe
Line Corporation (Transco), PO Box 1396, Houston, Texas 77251-1396 and
Copano Field Services/Central Gulf Coast, L.P. (Copano), 2727 Allen
Parkway, Suite 1200, Houston, Texas 77019, filed in Docket No. CP09-38-
000 an application pursuant to section 7(b) of the Natural Gas Act
(NGA) requesting that the Commission grant Transco approval to abandon
by sale to Copano certain natural gas pipelines facilities in South
Texas, including the McMullen Lateral. Additionally, Copano requests
that the Commission finds that such facilities will perform gathering
function upon their abandonment by

sale from Transco to Copano and will be exempt from the Commission's
jurisdiction pursuant to section 1(b) of the NGA, as well as the two
natural gas pipelines Copano is proposing to construct to connect the
McMullen Lateral to its processing plant, all as more fully set forth
in the application which is on file with the Commission and open to
public inspection. The filing may also be viewed on the Web 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, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Scott
Turkington, Director, Rates & Regulatory, Transcontinental Gas Pipe
Line Corporation, PO Box 1396, Houston, Texas, 77251-1396 at (713) 215-
3391 or by e-mail at<EMAIL_ADDRESS>or to Brian D.
Eckhart, Senior Vice President, Transportation and Supply, Copano
Energy, 2727 Allen Parkway, Suite 1200, Houston, Texas 77019 at (713)
621-9547 or by e-mail at<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either complete
its environmental assessment (EA) and place it into the Commission's
public record (eLibrary) for this proceeding; or issue a Notice of
Schedule for Environmental Review. If a Notice of Schedule for
Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    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 in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: January 27, 2009.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-333 Filed 1-9-09; 8:45 am]

BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

																																													OFFICE OF PREVENTION,
PESTICIDES

																																														AND TOXIC SUBSTANCES

MEMORANDUM

	06-November-2008

Subject: 	S-Metolachlor:  Docket ID Number: EPA-HQ-OPP-2007-0445,
Federal Register / Vol. 72, No. 152 / Wednesday, August 08, 2007 /
Proposed Rules, Syngenta comments on Proposed Rule to modify certain
tolerances for the herbicide.

PC Code: 108800	DP Barcode:  308245

Decision No.: 348979	Registration No.:  None

Petition No.: None	Regulatory Action: None

Risk Assessment Type: None	Case No.:  None

TXR No.: None	CAS No.: 87392-12-9

MRID Nos.: None	40 CFR: 180.368

From:		P. Yvonne Barnes, Chemist

		Reregistration Action Branch II

		Health Effects Division (7509P)

Through:		Felecia A. Fort, Chief

		Reregistration Action Branch II

		Health Effects Division (7509P)

To:		Jane Scott-Smith

								Special Review and Reregistration Division

		Registration Division (7505P)

THE ENVIRONMENTAL PROTECTION AGENCY, under 40 CFR Part 180, issued
[EPA–HQ–OPP–2007–0445; FRL–8138–8] on Acephate,
Chlorpyrifos, Fenbutatin-Oxide (Hexakis), Metolachlor, MCPA, Pyrethrins
and Triallate, Proposed Tolerance Actions: Proposed Rule for public
comment in the Federal Register / Vol. 72, No. 152 / Wednesday, August
08, 2007 / Proposed Rules.  Syngenta Incorporated submitted comments.

Background

DP Barcode: D296904, R. Loranger, 04/17/2006

S-Metolachlor (an isomer enriched form of Metolachlor) is a selective,
chloroacetanilide herbicide that is applied to a variety of crops as a
preplant, preplant-incorporated (PPI), pre-emergence, or post-emergence
application, primarily for the control of grass weeds.  S-Metolachlor is
registered to Syngenta Crop Protection, Incorporated for use on a wide
variety of crops with the intent of replacing the racemic mixture of
metolachlor. Following recommendations made in the revised Tolerance
Reassessment Eligibility Decision (TRED) for Metolachlor and
S-Metolachlor (DP Barcode: D292881, S. Kinard, 08/15/2003), tolerances
for metolachlor and s-metolachlor have been separated.

Based on the adequate metolachlor and S-metolachlor plant and animal
metabolism studies, the nature of S-Metolachlor residues in plants and
animals is understood. For both metolachlor and S-metolachlor the
residues of concern in plants and animals include the parent compound
(having both R and S-enantiomers with an estimated ratio of 12:88 for R:
S) and its metabolites, determined as the derivatives
2-[(2-ethyl-6-methylphenyl) amino]-1-propanol and
4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone (DP
Barcode: D226780, L. Kutney, 11/12/1996).  The residue definitions for
S-Metolachlor (parent and metabolites) which are regulated under the
“Pest Control Products Act” are equivalent between the United States
and Canada.

An excerpt highlighting the main issues from the FR notice is provided
for reference below:

ENVIRONMENTAL PROTECTION AGENCY {40 CFR Part 180, [EPA-HQ-OPP-2007-0445;
FRL-8138-8]}:   EPA is proposing to revoke certain tolerances for the
herbicide metolachlor… Also, EPA is proposing to modify certain
tolerances for the herbicide metolachlor… In addition, EPA is
proposing to establish new tolerances for the herbicides metolachlor…
The regulatory actions proposed in this document are in follow-up to the
Agency's reregistration program under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment
program under the Federal Food, Drug, and Cosmetic Act (FFDCA) section
408(q).  [[Page 44443]] 5. Metolachlor (including S-Metolachlor). The
Agency is also revising the commodity terminology for certain tolerances
to current Agency practice. Therefore, EPA proposes transferring
tolerances from 40 CFR 180.368(a) (1) to a new section designated 40 CFR
180.368 (d) (1) for the combined residues (free and bound) of the
herbicide metolachlor. [[Page 44444]] EPA is revising commodity
terminology to current Agency practice. The current terminology for seed
and pod vegetables (except soybean) crop group is vegetable, legume,
edible podded, subgroup 6A; pea and bean, succulent shelled, subgroup
6B; and pea and bean, dried shelled, except soybean, subgroup 6C.

Syngenta Crop Protection commented on the proposed rule to modify
certain tolerances for the herbicide S-Metolachlor. Syngenta comments on
five maximum residue levels (MRLs) tolerance differences between Canada
and the U.S., referencing Docket ID Number: EPA-HQ-OPP-2007-0445
(Federal Register Notice of 08-Aug-2007 (Volume 72, Number 152)).  Note
that HED’s responses are combined for items #2 and #3 and also for
items #4 and #5 due to their respective similarities.

Syngenta’s comments (item 1):

Item #1: Revocation of tolerance in stone fruit – Use of S-Metolachlor
in stone fruit is an important tool for Canadian fruit producers and
therefore, it would be beneficial to maintain U.S. tolerances to avoid
any trade irritant issues for these crops being exported from Canada to
the U.S. Canada currently has a tolerance of 0.1 ppm for S-Metolachlor
in apples, apricots, cherries, peaches/nectarines, pears and plums.

HED responds to Item #1:  There are no reported tolerances for
S-Metolachlor in/on fruit, stone group 12; 40CFR §180.368 (2000 to
present).  However, it is the Agency’s understanding that the
registrant has previously proposed (DP Barcode: D282607, C. Jarvis,
05/23/2002) to revoke tolerances (0.1) in/on fruit, stone group 12 for
Metolachlor and HED  agreed to remove all references to stone fruit from
its disciplinary chapters.  However, HED concurs that there is a
Canadian MRL (0.1 ppm) for S-Metolachlor on apples, apricots, cherries,
peaches/nectarines, pears and plums.   No proposals/petitions have been
submitted to the Agency by the registrant for an S-Metolachlor tolerance
in/on fruit, stone group 12. Therefore, the registrant should submit to
the Agency a proposal/petition for a tolerance on fruit, stone group 12
for S-Metolachlor.

Syngenta’s comments (items 2 and 3):

Item #2:  Increase in tolerance for Crop Group 6A from 0.3 ppm to 0.5
ppm - Canada currently has a tolerance of 0.3 ppm for S-Metolachlor in
peas and snap beans.  An increase in the U.S. tolerance could result in
a trade irritant for these crops exported from the U.S. to Canada.

Item #3: Decrease in tolerance for Crop Group 6C from 0.3 ppm to 0.1
ppm - Canada currently has a tolerance of 0.3 ppm for S-Metolachlor in
dry beans.  A decrease in the U.S. tolerance could result in a trade
irritant for these crops exported from Canada to the U.S.

HED’s response to Items #2 and #3: 	The legume vegetable field trial
data (DP Barcode: D350492, D. McNeilly, 10/21/2008) indicate that
combined S-Metolachlor residues in/on beans and peas resulting from the
three types of applications are similar within each crop subgroup and
within the crop group. For the legume vegetable crop subgroups 6A, 6B
and 6C, the maximum observed residues from the trials using the
broadcast foliar application were used to determine recommended
tolerances. These data indicate that a 0.3 ppm tolerance for residues on
crop group 6 is appropriate. HED concludes that Crop Group 6A, 6B and 6C
tolerances/MRLs remain harmonized with Canada at 0.3 ppm for
S-Metolachlor.

Syngenta’s comments (items 4 and 5):

Item #4:  Increase in tolerance for egg and meat from 0.02 pm to 0.04
ppm - Canada currently has a tolerance of 0.02 ppm for S-Metolachlor in
eggs, meat of cattle, goats, hogs, poultry and sheep.  An increase in
the U.S. tolerance could result in a trade irritant for these animal
products exported from the U.S. to Canada.

Item #5: Increase tolerance in animal liver from 0.05 ppm to 0.1 ppm –
Canada currently has a tolerance of 0.05 ppm for S-Metolachlor in liver
of cattle and poultry.  An increase in the U.S. tolerance could result
in a trade irritant for these animal products exported from the U.S. to
Canada.

HED’s response to Items #4 and #5: As previously stated in the
“Revised Metolachlor and S-Metolachlor Residue Chemistry Chapter for
the Tolerance Reassessment Eligibility Decision (TRED)”, (DP Barcode:
D292881, S. Kinard, 08/15/2003).  In the available ruminant feeding
study, dairy cows were administered metolachlor at a level equivalent to
60 ppm in the feed for up to 28 consecutive days. Animals were dosed:
(1) by mixing the compound in the feed; (2) orally via gelatin capsules;
and (3) by intra-rumen injections. Milk samples for residue analysis
were collected on days 0, 1, 4, 7, 12, 14, 21, and 28, and cows were
sacrificed at 14, 21, and 28 days. There were no detectable residues of
CGA-37913 (<0.006 ppm) or CGA-49751 (<0.01 ppm) in any of the milk
samples, and there were no detectable residues of CGA-37913 (<0.02 ppm)
and CGA-49751 (<0.02 ppm) in any tissues except liver or kidney. If
residues in beef muscle are corrected for decline of CGA-37913 residues
during storage, the maximum combined residues in beef muscle would be
<0.06 ppm. At each sampling interval, residues in liver were comprised
of CGA-37913 at 0.11 ppm and CGA-49751 at 0.02 ppm, for combined
residues of 0.13 ppm.

Based upon a maximum reasonable balanced dietary burden (MRDB) of 11.4
ppm for cattle, the 60 ppm dose level in the ruminant feeding study is
equivalent to 5.3x the MRDB for cattle. Extrapolating the residue data
from the ruminant study to a 1x feeding level for cattle, the maximum
combined residues would be 0.01 ppm in fat, 0.01 ppm in meat and 0.03
ppm in liver. As these residue levels are below the method LOQ in fat
and meat, the MRLs/tolerances for these residues should remain at 0.02
ppm and are harmonized with Canada.  HED acknowledges the importance of
harmonizing MRLs/tolerances of S-Metolachlor with Canada in/on the liver
of cattle and will increase that tolerance to 0.05 ppm.

As previously stated in the “Revised Metolachlor and S-Metolachlor
Residue Chemistry Chapter for the Tolerance Reassessment Eligibility
Decision (TRED)”, (DP Barcode: D292881, S. Kinard, 08/15/2003), in the
available poultry feeding study, laying hens were fed metolachlor at
levels of 0, 0.1, 0.5, and 2.0 ppm in the diet. These feeding levels are
equivalent to 0.2x, 0.98x, and 3.9x the MRBD for poultry. Eggs samples
were taken on days 1, 3, 7, 10, 14, and 21, and birds were sacrificed
after 7, 14, 21, and 28 days for tissue analysis. Only tissues from the
two highest feeding levels (0.5 and 2.0 ppm) were analyzed. No
detectable residues were found in egg whites or egg yolks (<0.02 ppm for
CGA-37913), and no detectable residues of CGA-37913 (<0.02 ppm) were
found in any poultry tissues, meat or fat, except liver CGA-37913 (<0.02
to 0.03 ppm) and CGA-49751 (<0.05 ppm).

Based on the LOQ (0.02 ppm) for eggs and meat and the LOQ (0.05 ppm) for
liver of the tolerance enforcement method; HED concludes that the
MRL/tolerance for S-Metolachlor in/on egg and the meat of cattle, goats,
hogs, poultry and sheep, should remain harmonized with Canada at 0.02
ppm and the MRL/tolerance for S-Metolachlor in/on the liver of poultry
should remain harmonized with Canada at 0.05 ppm.

Table 1.	Calculation of Dietary Burdens of S-Metolachlor Residues to
Livestock (June 2008).

Feedstuff	Type1	% Dry Matter2	% Diet2	Tolerance (ppm)	Dietary
Contribution (ppm)3

Dairy Cattle

Sorghum grain	CC	86	40	0.3	0.1

Sunflower	PC	92	10	1.0	0.1

Sugar Beets Dried/Molasses 	 CC	75	5	2.0	0.1

Grasses Forage/Silage	RR	25	20	10.0	8.0

Corn Field, Silage	R	40	15		8.0	3.0

Cowpea	R	30	10	15.0	5.0

TOTAL BURDEN	100	11.4

1	R - Roughage; CC - Carbohydrate concentrate; PC - Protein
concentrates.  2	OPPTS 860.1000 Table 1 Feedstuff (June 2008). 3
Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle

References

Author	DP Barcode/ MRID	Date	Title

Loranger, R	D296904	04/17/2006	S-Metolachlor. Petition for Tolerances on
Various Crops, Crop Groups, and Livestock Commodities. Summary of
Analytical Chemistry and Residue Data.

Kinard, S.	D292881	08/15/2003	PP#s: 7F04897, 9E06055, 7E04916, 2E06374,
4E04420, 8E05029, and 8E05030. Revised Metolachlor and S-Metolachlor
Residue Chemistry Chapter for the Tolerance Reassessment Eligibility
Decision (TRED) and Registration for Use on Asparagus, Carrots, Cotton,
Horseradish, Green Onions, Peppers, Rhubarb, Sugar Beet, Sunflower, and
Swiss Chard; DP Barcode D292881; Rereg. Case 0001. DP Barcodes: D255484,
D258813, D258816, D258825, D258958, D259117, D280858, D288570. Case
Nos.: 285998, 289117, 289218, 290491, 290492, 292279, 294578. PC Codes:
108800 and 108801. Submissions: S560957, S630066, S566987, S566988,
S566992, S566995, S567580. 40 CFR 180. 368. MRID Nos.: 44378401,
44908701, 45544701. (August 15, 2003)

Office of the Federal Register	None	2000 to 2008	40CFR§180.368
(Metolachlor and S-Metolachlor)

HED ChemSAC	None	June 2008	Revisions of Feedstuffs in Table 1 of OPPTS
Test Guideline 860.1000 and Guidance on Constructing Maximum Reasonably
Balanced Diets (MRBD)

McNeilly, D	D350492	10/21/2008	S-Metolachlor.  Amended Use Directions
for Sorghum and Soybeans; Revisions to Rotational Crop Restrictions;
Registrant’s Responses to Deficiencies Noted in the Revised
S-Metolachlor TRED.  Summary of Analytical Chemistry and Residue Data.

Ciba-Geigy Corp.	MRID# 00106041	07/07/1982	 (1982) Metolachlor--Peanuts:
Lay by Applications: Split Applications (Including at Cracking Mixtures
with Naptalam/Dinoseb) at Cracking Applications with Dinoseb.
(Compilation; unpublished study received under 100-597; CDL:070977-A)

Ciba-Geigy Corp.	MRID# 00015413	07/11/1975	Mattson, A.M. (1975)
CGA-24705 Residues in Milk, Meat, Eggs and Chickens (Three Level Feeding
Studies): Report No. GAAC-75059. (Unpublished study received Jan 19,
1977 under 100-583; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:095747-X)

S-Metolachlor	     	DP Barcode: D308245

Page   PAGE  3  of   NUMPAGES  5


[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18309-18311]
[FR Doc No: 2023-06367]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-94-000]

Southern Star Central Gas Pipeline, Inc.; Notice of Request Under
Blanket Authorization and Establishing Intervention and Protest
Deadline

    Take notice that on March 14, 2023, Southern Star Central Gas
Pipeline, Inc. (Southern Star), 4700 State Route 56, Owensboro,
Kentucky 42301, filed a prior notice request for authorization, in
accordance with 18 CFR 157.205, 157.208, and 157.213 of the Federal
Energy Regulatory Commission's (Commission) regulations under the
Natural Gas Act and Southern Star's blanket certificate issued in
Docket No. CP82-479-000, to drill a new horizontal

well and install a lateral pipeline to connect the new well to existing
facilities at Southern Star's Webb Storage Field in Grant County,
Oklahoma (Webb Storage Field Project or Project).
    Southern Star states that the Webb Storage Field Project is
designed to supplement existing deliverability and improve overall
efficiency, reduce operating costs, and serve as an alternative to the
installation of new dewatering facilities on existing storage gathering
laterals. Southern Star further states that the Project will not
require any changes to working or cushion gas volumes, reservoir
pressure, reservoir and buffer boundaries, or the certificated capacity
of the field. Specifically, Southern Star proposes to drill the new
horizontal well approximately 110 feet from existing line VM-002 and to
construct a 6-inch-diameter lateral (Line VM-066) connecting the well
to Line VM-002. Additional pig launcher/receiver valves and metering,
communications, and power facilities would be constructed at the well
head and enclosed with fencing.
    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 the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
Cindy Thompson, Director, Regulatory, Compliance & Information
Governance, Southern Star Central Gas Pipeline, Inc., 4700 State Route
56, Owensboro, Kentucky 42301, by phone at<PHONE_NUMBER> or by email
to [email protected].
    Pursuant to section 157.9 of the Commission's Rules of Practice and
Procedure,\1\ within 90 days of this Notice the Commission staff will
either: complete its environmental review and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or environmental
assessment (EA) for this proposal. The filing of an EA in the
Commission's public record for this proceeding or the issuance of a
Notice of Schedule for Environmental Review will serve to notify
Federal and State agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all Federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
---------------------------------------------------------------------------

    \1\ 18 CFR (Code of Federal Regulations) 157.9.
---------------------------------------------------------------------------

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on May 20, 2023. How
to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is May 20, 2023. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
---------------------------------------------------------------------------

    \4\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is May 20, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before May 20, 2023. The filing of a comment alone will not serve
to make the filer a party to the proceeding. To become a party, you
must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-94-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \7\
---------------------------------------------------------------------------

    \7\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP23-94-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To mail via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: Cindy
Thompson, Director, Regulatory, Compliance & Information Governance,
Southern Star Central Gas Pipeline, Inc., 4700 State Route 56,
Owensboro, Kentucky 42301, by phone at<PHONE_NUMBER> or by email to
[email protected]. Any subsequent submissions by an
intervenor must be served on the applicant and all other parties to the
proceeding. Contact information for parties can be downloaded from the
service list at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: March 21, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-06367 Filed 3-27-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 8 (Thursday, January 12, 2017)]
[Rules and Regulations]
[Pages 3633-3637]
[FR Doc No: 2017-00160]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 19

[FRL-9958-06-OECA]

Civil Monetary Penalty Inflation Adjustment Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is promulgating this
final rule to adjust the level of statutory civil monetary penalty
amounts under the statutes EPA administers. This action is mandated by
the Federal Civil Penalties Inflation Adjustment Act of 1990, as

amended through the Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015 (``the 2015 Act''). The 2015 Act prescribes a
formula for annually adjusting statutory civil penalties to reflect
inflation, maintain the deterrent effect of statutory civil penalties,
and promote compliance with the law. The rule does not necessarily
revise the penalty amounts that EPA chooses to seek pursuant to its
civil penalty policies in a particular case. EPA's civil penalty
policies, which guide enforcement personnel in how to exercise EPA's
statutory penalty authorities, take into account a number of fact-
specific considerations, e.g., the seriousness of the violation, the
violator's good faith efforts to comply, any economic benefit gained by
the violator as a result of its noncompliance, and a violator's ability
to pay.

DATES: This final rule is effective on January 15, 2017.

FOR FURTHER INFORMATION CONTACT:  David Smith-Watts, Office of Civil
Enforcement, Office of Enforcement and Compliance Assurance, Mail Code
2241A, Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460, telephone number:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Since 1990, Federal agencies have been required to issue
regulations adjusting for inflation the statutory civil penalties \1\
that can be imposed under the laws administered by that agency. The
Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by
the Debt Collection Improvement Act of 1996 (DCIA), required agencies
to review their statutory civil penalties every 4 years, and to adjust
the statutory civil penalty amounts for inflation if the increase met
the DCIA's adjustment methodology. In accordance with the DCIA, EPA
reviewed and, as appropriate, adjusted the civil penalty levels under
each of the statutes the agency implements in 1996 (61 FR 69360), 2004
(69 FR 7121), 2008 (73 FR 75340), and 2013 (78 FR 66643).
---------------------------------------------------------------------------

    \1\ The Federal Civil Penalties Inflation Adjustment Act of
1990, Public Law 101-410, 28 U.S.C. 2461 note, defines ``civil
monetary penalty'' as ``any penalty, fine, or other sanction that--
(A)(i) is for a specific monetary amount as provided by Federal law;
or (ii) has a maximum amount provided for by Federal law; and (B) is
assessed or enforced by an agency pursuant to Federal law; and (C)
is assessed or enforced pursuant to an administrative proceeding or
a civil action in the Federal courts.''
---------------------------------------------------------------------------

    The 2015 Act \2\ requires agencies to: (1) Adjust the level of
statutory civil penalties with an initial ``catch-up'' adjustment
through an interim final rulemaking; and (2) beginning January 15,
2017, make subsequent annual adjustments for inflation. The purpose of
the 2015 Act is to maintain the deterrent effect of civil penalties by
translating originally enacted statutory civil penalty amounts to
today's dollars and rounding statutory civil penalties to the nearest
dollar.
---------------------------------------------------------------------------

    \2\ The Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015 (Section 701 of Pub. L. 114-74) was signed
into law on Nov. 2, 2015, and further amended the Federal Civil
Penalties Inflation Adjustment Act of 1990.
---------------------------------------------------------------------------

    As required by the 2015 Act, EPA issued a catch up rule on July 1,
2016, which was effective August 1, 2016 (81 FR 43091). This rule
implements the annual penalty inflation adjustments mandated by the
2015 Act. Beginning in 2017, Section 4 of the 2015 Act requires each
federal agency to publish annual adjustments to all civil penalties
under the laws implemented by that agency. These annual adjustments are
required to be published by January 15 of each year. The 2015 Act
describes the method for calculating the adjustments. Each statutory
maximum civil monetary penalty is multiplied by the cost-of-living
adjustment, which is the percentage by which the Consumer Price Index
for all Urban Consumers (CPI-U) for the month of October 2016 exceeds
the CPI-U for the month of October 2015.
    With this rule, the new statutory maximum (or minimum \3\) penalty
levels listed in Table 2 to 40 CFR 19.4 will apply to all statutory
civil penalties assessed on or after January 15, 2017, for violations
that occurred after November 2, 2015, when the 2015 Act was enacted.
The statutory civil penalty levels, as codified at Table 1 to 40 CFR
19.4, will continue to apply to: (1) Violations that occurred on or
before November 2, 2015, and (2) violations that occurred after
November 2, 2015, where the penalty assessment was made prior to August
1, 2016.
---------------------------------------------------------------------------

    \3\ Under Section 3(2)(A) of the 2015 Act, ``civil monetary
penalty'' means ``a specific monetary amount as provided by Federal
law''; or ``has a maximum amount provided for by Federal law.'' EPA-
administered statutes generally refer to statutory maximum
penalties, with the following exceptions: Section 311(b)(7)(D) of
the Clean Water Act, 33 U.S.C. 1321(b)(7)(D), refers to a minimum
penalty of ``not less than $100,000 . . .''; Section 104B(d)(1) of
the Marine Protection, Research, and Sanctuaries Act, 33 U.S.C.
1414b(d)(1), refers to an exact penalty of $600 ``[f]or each dry ton
(or equivalent) of sewage sludge or industrial waste dumped or
transported by the person in violation of this subsection in
calendar year 1992. . .''; and Section 325(d)(1) of the Emergency
Planning and Community Right-to-Know Act, 42 U.S.C. 11045(d)(1),
refers to an exact civil penalty of $25,000 for each frivolous trade
secret claim.
---------------------------------------------------------------------------

    The formula for determining the cost-of-living or inflation
adjustment to statutory civil penalties consists of the following
steps:
    Step 1: The cost-of-living adjustment multiplier for 2017, based on
the CPI-U of October 2016, is 1.01636.\4\ Multiply 1.01636 by the
current penalty amount. This is the raw adjusted penalty value.
---------------------------------------------------------------------------

    \4\ Office of Management and Budget Memorandum, Implementation
of the 2017 annual adjustment pursuant to the Federal Civil
Penalties Inflation Adjustment Act Improvements Act of 2015 (OMB
Memorandum M-17-11) at p. 1 (December 16, 2016).
---------------------------------------------------------------------------

    Step 2: Round the raw adjusted penalty value. Section 5 of the 2015
Act states that any adjustment shall be rounded to the nearest multiple
of $1. The result is the final penalty value for the year.

II. The 2015 Act Requires Federal Agencies To Publish Annual Penalty
Inflation Adjustments Notwithstanding Section 553 of the Administrative
Procedures Act

    Section 4 of the 2015 Act directs federal agencies to publish
annual adjustments no later than January 15, 2017. In accordance with
section 553 of the Administrative Procedures Act (APA), most rules are
subject to notice and comment and are effective no earlier than 30 days
after publication in the Federal Register. However, Section 4(b)(2) of
the 2015 Act provides that each agency shall make the annual inflation
adjustments ``notwithstanding section 553'' of the APA. According to
OMB guidance issued to Federal agencies on the implementation of the
2017 annual adjustment,\5\ the phrase ``notwithstanding section 553''
means that ``the public procedure the APA generally provides--notice,
an opportunity for comment, and a delay in effective date--is not
required for agencies to issue regulations implementing the annual
adjustment.'' Consistent with the language of the 2015 Act and OMB's
implementation guidance, this rule is not subject to notice and an
opportunity for public comment and will be effective immediately upon
publication.
---------------------------------------------------------------------------

    \5\ See OMB Memorandum M-17-11 at p. 3.
---------------------------------------------------------------------------

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866, OMB determined this final rule to be a
``non-significant'' regulatory action and, therefore, it did not
undergo interagency review.\6\
---------------------------------------------------------------------------

    \6\ See OMB Memorandum M-17-11 at p. 3.

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

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA. This rule merely increases the level of statutory civil
penalties that could be imposed in the context of a Federal civil
administrative enforcement action or civil judicial case for violations
of EPA-administered statutes and their implementing regulations.

C. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to
rules subject to notice and comment rulemaking requirements under the
APA, 5 U.S.C. 553, or any other statute. Because the 2015 Act directs
Federal agencies to publish this rule notwithstanding section 553 of
the APA, this rule is not subject to notice and comment requirements or
the RFA.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action is required by the 2015 Act, without the
exercise of any policy discretion by EPA. This action also imposes no
enforceable duty on any state, local or tribal governments or the
private sector. Because the calculation of any increase is formula-
driven pursuant to the 2015 Act, EPA has no policy discretion to vary
the amount of the adjustment.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
a substantial direct effect on the states, or on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This rule merely reconciles the real value of
current statutory civil penalty levels to reflect and keep pace with
the levels originally set by Congress when the statutes were enacted.
The calculation of the increases is formula-driven and prescribed by
statute, and EPA has no discretion to vary the amount of the adjustment
to reflect any views or suggestions provided by commenters.
Accordingly, this rule will not have a substantial direct effect on
tribal governments, on the relationship between the Federal government
and Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive Order. This action is not subject to Executive Order
13045 because it does not concern an environmental health risk or
safety risk.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    The rule does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard. Rather, this action is
mandated by the 2015 Act, which prescribes a formula for adjusting
statutory civil penalties on an annual basis to reflect inflation.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. The CRA allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency finds
that notice and comment rulemaking procedures are impracticable,
unnecessary or contrary to the public interest (5 U.S.C. 808(2)). The
2015 Act directs Federal agencies to publish their annual penalty
inflation adjustments ``notwithstanding section 553 [of the APA].''
Because OMB has instructed Federal agencies that this provision means
that ``notice, an opportunity for comment, and a delay in the effective
date'' are not required for agencies to issue regulations implementing
the annual adjustment,\7\ EPA finds that the APA's notice and comment
rulemaking procedures are impracticable, unnecessary or contrary to the
public interest.
---------------------------------------------------------------------------

    \7\ See OMB Memorandum M-17-11 at p. 3.
---------------------------------------------------------------------------

List of Subjects in 40 CFR Part 19

    Environmental protection, Administrative practice and procedure,
Penalties.

    Dated: January 3, 2017.
Gina McCarthy,
Administrator.

    For the reasons set out in the preamble, EPA amends title 40,
chapter I, part 19 of the Code of Federal Regulations as follows:

PART 19--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

0
1. The authority citation for part 19 continues to read as follows:

    Authority:  Pub. L. 101-410, Oct. 5, 1990, 104 Stat. 890, as
amended by Pub. L. 104-134, title III, sec. 31001(s)(1), Apr. 26,
1996, 110 Stat. 1321-373; Pub. L. 105-362, title XIII, sec. 1301(a),
Nov. 10, 1998, 112 Stat. 3293; Pub. L. 114-74, title VII, sec.
701(b), Nov. 2, 2015, 129 Stat. 599.

0
2. Revise Sec.  19.2 to read as follows:

Sec.  19.2   Effective date.

    The penalty levels in the last column of Table 1 to Sec.  19.4
apply to all violations which occurred after December 6, 2013 through
November 2, 2015, and to violations occurring after November 2, 2015,
where penalties are assessed before August 1, 2016. The statutory civil
penalty levels set forth in the fourth column of Table 2 to Sec.  19.4
apply to all violations which occur after November 2, 2015, where the
penalties are assessed on or after August 1, 2016 and before January
15, 2017. The statutory civil penalty levels set forth in the last
column of Table 2 to Sec.  19.4 apply to all violations which occur
after November 2, 2015, where the penalties are assessed on or after
January 15, 2017.

0
3. Amend Sec.  19.4 by revising the introductory text and Table 2 to
read as follows:

Sec.  19.4   Statutory civil penalties, as adjusted for inflation, and
tables.

    Table 1 to Sec.  19.4 sets out the statutory civil penalty
provisions of statutes administered by EPA, with the original statutory
civil penalty levels, as enacted, and the operative statutory civil
penalty levels, as adjusted for inflation, for violations occurring on
or before

November 2, 2015, and for violations occurring after November 2, 2015,
where penalties are assessed before August 1, 2016. Table 2 sets out
the statutory civil penalty provisions of statutes administered by EPA,
with the third column displaying the original statutory civil penalty
levels, as enacted. The fourth column of Table 2 displays the operative
statutory civil penalty levels where penalties are assessed on or after
August 1, 2016 but before January 15, 2017, for violations that
occurred after November 2, 2015; the last column displays the operative
statutory civil penalty levels where penalties are assessed on or after
January 15, 2017, for violations that occurred after November 2, 2015.
* * * * *

                      Table 2 of Section 19.4--Civil Monetary Penalty Inflation Adjustments
----------------------------------------------------------------------------------------------------------------
                                                                         Statutory civil
                                                                          penalties for        Statutory civil
                                                                         violations that        penalties for
                                                   Statutory civil       occurred after        violations that
      U.S. Code citation        Environmental       penalties, as     November 2, 2015 and     occurred after
                                   statute             enacted        assessed on or after  November 2, 2015 and
                                                                       August 1, 2016 but   assessed on or after
                                                                       before January 15,     January 15, 2017
                                                                              2017
----------------------------------------------------------------------------------------------------------------
7 U.S.C. 136l.(a)(1).........  Federal                        $5,000               $18,750               $19,057
                                Insecticide,
                                Fungicide, and
                                Rodenticide
                                Act (FIFRA).
7 U.S.C. 136l.(a)(2) \1\.....  FIFRA..........    $1,000/$500/$1,000  $2,750/$1,772/$2,750  $2,795/$1,801/$2,795
15 U.S.C. 2615(a)(1).........  Toxic                         $25,000               $37,500               $38,114
                                Substances
                                Control Act
                                (TSCA).
15 U.S.C. 2647(a)............  TSCA...........                $5,000               $10,781               $10,957
15 U.S.C. 2647(g)............  TSCA...........                $5,000                $8,908                $9,054
31 U.S.C. 3802(a)(1).........  Program Fraud                  $5,000               $10,781               $10,957
                                Civil Remedies
                                Act (PFCRA).
31 U.S.C. 3802(a)(2).........  PFCRA..........                $5,000               $10,781               $10,957
33 U.S.C. 1319(d)............  Clean Water Act               $25,000               $51,570               $52,414
                                (CWA).
33 U.S.C. 1319(g)(2)(A)......  CWA............       $10,000/$25,000       $20,628/$51,570       $20,965/$52,414
33 U.S.C. 1319(g)(2)(B)......  CWA............      $10,000/$125,000      $20,628/$257,848      $20,965/$262,066
33 U.S.C. 1321(b)(6)(B)(i)...  CWA............       $10,000/$25,000       $17,816/$44,539       $18,107/$45,268
33 U.S.C. 1321(b)(6)(B)(ii)..  CWA............      $10,000/$125,000      $17,816/$222,695      $18,107/$226,338
33 U.S.C. 1321(b)(7)(A)......  CWA............        $25,000/$1,000        $44,539/$1,782        $45,268/$1,811
33 U.S.C. 1321(b)(7)(B)......  CWA............               $25,000               $44,539               $45,268
33 U.S.C. 1321(b)(7)(C)......  CWA............               $25,000               $44,539               $45,268
33 U.S.C. 1321(b)(7)(D)......  CWA............       $100,000/$3,000       $178,156/$5,345       $181,071/$5,432
33 U.S.C. 1414b(d)(1)........  Marine                           $600                $1,187                $1,206
                                Protection,
                                Research, and
                                Sanctuaries
                                Act (MPRSA).
33 U.S.C. 1415(a)............  MPRSA..........      $50,000/$125,000     $187,500/$247,336     $190,568/$251,382
33 U.S.C. 1901 note (see       Certain Alaskan       $10,000/$25,000       $13,669/$34,172       $13,893/$34,731
 1409(a)(2)(A)).                Cruise Ship
                                Operations
                                (CACSO).
33 U.S.C. 1901 note (see       CACSO..........      $10,000/$125,000      $13,669/$170,861      $13,893/$173,656
 1409(a)(2)(B)).
33 U.S.C. 1901 note (see       CACSO..........               $25,000               $34,172               $34,731
 1409(b)(1)).
33 U.S.C. 1908(b)(1).........  Act To Prevent                $25,000               $70,117               $71,264
                                Pollution From
                                Ships (APPS).
33 U.S.C. 1908(b)(2).........  APPS...........                $5,000               $14,023               $14,252
42 U.S.C. 300g-3(b)..........  Safe Drinking                 $25,000               $53,907               $54,789
                                Water Act
                                (SDWA).
42 U.S.C. 300g-3(g)(3)(A)....  SDWA...........               $25,000               $53,907               $54,789
42 U.S.C. 300g-3(g)(3)(B)....  SDWA...........        $5,000/$25,000       $10,781/$37,561       $10,957/$38,175
42 U.S.C. 300g-3(g)(3)(C)....  SDWA...........               $25,000               $37,561               $38,175
42 U.S.C. 300h-2(b)(1).......  SDWA...........               $25,000               $53,907               $54,789
42 U.S.C. 300h-2(c)(1).......  SDWA...........      $10,000/$125,000      $21,563/$269,535      $21,916/$273,945
42 U.S.C. 300h-2(c)(2).......  SDWA...........       $5,000/$125,000      $10,781/$269,535      $10,957/$273,945
42 U.S.C. 300h-3(c)..........  SDWA...........        $5,000/$10,000       $18,750/$40,000       $19,057/$40,654
42 U.S.C. 300i(b)............  SDWA...........               $15,000               $22,537               $22,906
42 U.S.C. 300i-1(c)..........  SDWA...........   $100,000/$1,000,000   $131,185/$1,311,850   $133,331/$1,333,312
42 U.S.C. 300j(e)(2).........  SDWA...........                $2,500                $9,375                $9,528
42 U.S.C. 300j-4(c)..........  SDWA...........               $25,000               $53,907               $54,789
42 U.S.C. 300j-6(b)(2).......  SDWA...........               $25,000               $37,561               $38,175
42 U.S.C. 300j-23(d).........  SDWA...........        $5,000/$50,000        $9,893/$98,935      $10,055/$100,554
42 U.S.C. 4852d(b)(5)........  Residential                   $10,000               $16,773               $17,047
                                Lead-Based
                                Paint Hazard
                                Reduction Act
                                of 1992.
42 U.S.C. 4910(a)(2).........  Noise Control                 $10,000               $35,445               $36,025
                                Act of 1972.
42 U.S.C. 6928(a)(3).........  Resource                      $25,000               $93,750               $95,284
                                Conservation
                                and Recovery
                                Act (RCRA).
42 U.S.C. 6928(c)............  RCRA...........               $25,000               $56,467               $57,391
42 U.S.C. 6928(g)............  RCRA...........               $25,000               $70,117               $71,264
42 U.S.C. 6928(h)(2).........  RCRA...........               $25,000               $56,467               $57,391
42 U.S.C. 6934(e)............  RCRA...........                $5,000               $14,023               $14,252
42 U.S.C. 6973(b)............  RCRA...........                $5,000               $14,023               $14,252
42 U.S.C. 6991e(a)(3)........  RCRA...........               $25,000               $56,467               $57,391
42 U.S.C. 6991e(d)(1)........  RCRA...........               $10,000               $22,587               $22,957
42 U.S.C. 6991e(d)(2)........  RCRA...........               $10,000               $22,587               $22,957
42 U.S.C. 7413(b)............  Clean Air Act                 $25,000               $93,750               $95,284
                                (CAA).
42 U.S.C. 7413(d)(1).........  CAA............      $25,000/$200,000      $44,539/$356,312      $45,268/$362,141
42 U.S.C. 7413(d)(3).........  CAA............                $5,000                $8,908                $9,054
42 U.S.C. 7524(a)............  CAA............        $25,000/$2,500        $44,539/$4,454        $45,268/$4,527
42 U.S.C. 7524(c)(1).........  CAA............              $200,000              $356,312              $362,141
42 U.S.C. 7545(d)(1).........  CAA............               $25,000               $44,539               $45,268
42 U.S.C. 9604(e)(5)(B)......  Comprehensive                 $25,000               $53,907               $54,789
                                Environmental
                                Response,
                                Compensation,
                                and Liability
                                Act (CERCLA).
42 U.S.C. 9606(b)(1).........  CERCLA.........               $25,000               $53,907               $54,789
42 U.S.C. 9609(a)(1).........  CERCLA.........               $25,000               $53,907               $54,789

42 U.S.C. 9609(b)............  CERCLA.........       $25,000/$75,000      $53,907/$161,721      $54,789/$164,367
42 U.S.C. 9609(c)............  CERCLA.........       $25,000/$75,000      $53,907/$161,721      $54,789/$164,367
42 U.S.C. 11045(a)...........  Emergency                     $25,000               $53,907               $54,789
                                Planning and
                                Community
                                Right-To-Know
                                Act (EPCRA).
42 U.S.C. 11045(b)(1)(A).....  EPCRA..........               $25,000               $53,907               $54,789
42 U.S.C. 11045(b)(2)........  EPCRA..........       $25,000/$75,000      $53,907/$161,721      $54,789/$164,367
42 U.S.C. 11045(b)(3)........  EPCRA..........       $25,000/$75,000      $53,907/$161,721      $54,789/$164,367
42 U.S.C. 11045(c)(1)........  EPCRA..........               $25,000               $53,907               $54,789
42 U.S.C. 11045(c)(2)........  EPCRA..........               $10,000               $21,563               $21,916
42 U.S.C. 11045(d)(1)........  EPCRA..........               $25,000               $53,907               $54,789
42 U.S.C. 14304(a)(1)........  Mercury-                      $10,000               $15,025               $15,271
                                Containing and
                                Rechargeable
                                Battery
                                Management Act
                                (Battery Act).
42 U.S.C. 14304(g)...........  Battery Act....               $10,000               $15,025               $15,271
----------------------------------------------------------------------------------------------------------------
\1\ Note that 7 U.S.C. 136l.(a)(2) contains three separate statutory maximum civil penalty provisions. The first
  mention of $1,000 and the $500 statutory maximum civil penalty amount were originally enacted in 1978 (Pub. L.
  95-396), and the second mention of $1,000 was enacted in 1972 (Pub. L. 92-516).

[FR Doc. 2017-00160 Filed 1-11-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 32 (Thursday, February 16, 2012)]
[Notices]
[Page 9222]
[FR Doc No: 2012-3662]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13739-001]

Lock+ Hydro Friends Fund XLII, LLC; Notice of Intent To File
License Application, Filing of Pre-Application Document, and Approving
Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 13739-001.
    c. Date Filed: December 23, 2011.
    d. Submitted By: Lock+ Hydro Friends Fund XLII, LLC.
    e. Name of Project: Braddock Locks and Dam Hydroelectric Project.
    f. Location: At the existing Braddock Locks and Dam on the
Monongahela River, in Allegheny County, Pennsylvania. The project would
occupy United States lands administered by the U.S. Army Corps of
Engineers.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Mr. Mark R. Stover, Lock+\TM\ Hydro
Friends Fund XLII, c/o Hydro Green Energy, LLC, 900 Oakmont Lane, Suite
310, Westmont, IL 60559;<PHONE_NUMBER> ext. 711; email_
<EMAIL_ADDRESS>    i. FERC Contact: John Mudre at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Lock+ Hydro Friends Fund XLII, LLC filed its request to use the
Traditional Licensing Process on December 23, 2011. Lock+ Hydro Friends
Fund XLII, LLC provided public notice of its request on December 22,
2011. In a letter dated January 30, 2012, the Director of the Division
of Hydropower Licensing approved Lock+ Hydro Friends Fund XLII, LLC's
request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service under section 7 of the
Endangered Species Act and the joint agency regulations thereunder at
50 CFR, Part 402; and (b) the Pennsylvania State Historic Preservation
Officer, as required by section 106, National Historic Preservation
Act, and the implementing regulations of the Advisory Council on
Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Lock+ Hydro Friends Fund
XLII, LLC as the Commission's non-federal representative for carrying
out informal consultation, pursuant to section 7 of the Endangered
Species Act, and section 106 of the National Historic Preservation Act.
    m. Lock+ Hydro Friends Fund XLII, LLC filed a Pre-Application
Document (PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: February 10, 2012.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-3662 Filed 2-15-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 2, 2007 (Volume 72, Number 41)]
[Notices]
[Page 9599]
[DOCID:fr02mr07-102]

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

SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-8782, 34-55350; File No. 4-532]

Roundtable on International Financial Reporting Standards
``Roadmap''

AGENCY: Securities and Exchange Commission.

ACTION: Notice of roundtable meeting.

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

SUMMARY: On Tuesday, March 6, 2007 the Securities and Exchange
Commission will hold a roundtable discussion on the ``roadmap''
regarding International Financial Reporting Standards (IFRS). The
roadmap describes the path toward eliminating the need for non-U.S.
companies to reconcile to U.S. GAAP financial statements they prepare
pursuant to IFRS issued by the International Accounting Standards Board
in filings with the Commission. The subject matter of the roundtable
will be the effect on the capital raising process in the U.S. capital
markets with respect to the roadmap, the effect on investors in the
U.S. capital markets with respect to the roadmap, and the effect on
issuers in the U.S capital markets with respect to the roadmap.
Representative(s) of the following have been invited to participate:
Issuers, investors, securities counsel, underwriters, credit rating
agencies, stock exchanges, academia, and audit firms.
    The roundtable will take place at the Commission's headquarters at
100 F Street, NE., Auditorium, Room L-002, Washington, DC at 10 a.m.
The public is invited to observe the roundtable discussions. Seating is
available on a first-come, first-serve basis.

FOR FURTHER INFORMATION CONTACT: Katrina Kimpel at<PHONE_NUMBER>.

    Dated: February 26, 2007.

    By the Commission.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-3645 Filed 3-1-07; 8:45 am]

BILLING CODE 8010-01-P