positive sample and what action the system has taken and/or will take
to correct this problem.
    (3) The State may not waive the requirement to collect three
additional routine samples the next month in which the system provides
water to the public solely on the grounds that all repeat samples are
total coliform-negative. If the State determines that the system has
corrected the contamination problem before the system takes the set of
repeat samples required in Sec.  141.858, and all repeat samples were
total coliform-negative, the State may waive the requirement for
additional routine monitoring the next month.

Sec.  141.856  Routine monitoring requirements for subpart H public
water systems serving 1,000 or fewer people.

    (a) General. (1) The provisions of this section apply to subpart H
public water systems of this part serving 1,000 or fewer people.
    (2) Following any total coliform-positive sample taken under the
provisions of this section, systems must comply with the repeat
monitoring requirements and E. coli analytical requirements in Sec.
141.858.
    (3) Once all monitoring required by this section and Sec.  141.858
for a calendar month has been completed, systems must determine whether
any coliform treatment technique triggers specified in Sec.  141.859
have been exceeded. If any trigger has been exceeded, systems must
complete assessments as required by Sec.  141.859.
    (4) Beginning [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL
RULE], all seasonal systems must demonstrate completion of a State-
approved start-up procedure, which may include a requirement for a
startup sample prior to serving water to the public.
    (b) Routine monitoring frequency for total coliforms. Subpart H
systems of this part (including consecutive systems) must monitor
monthly. Systems may not reduce monitoring.
    (c) Unfiltered subpart H systems. A subpart H system of this part
that does not practice filtration in compliance with subparts H, P, T,
and W must collect at least one total coliform sample near the first
service connection each day the turbidity level of the source water,
measured as specified in Sec.  141.74(b)(2), exceeds 1 NTU. When one or
more turbidity measurements in any day exceed 1 NTU, the system must
collect this coliform sample within 24 hours of the first exceedance,
unless the State determines that the system, for logistical reasons
outside the system's control, cannot have the sample analyzed within 30
hours of collection and identifies an alternative sample collection
schedule. Sample results from this coliform monitoring must be included
in determining whether the coliform treatment technique trigger in
Sec.  141.859 has been exceeded.

Sec.  141.857  Routine monitoring requirements for public water systems
serving more than 1,000 people.

    (a) General. (1) The provisions of this section apply to public
water systems serving more than 1,000 persons.
    (2) Following any total coliform-positive sample taken under the
provisions of this section, systems must comply with the repeat
monitoring requirements and E. coli analytical requirements in Sec.
141.858.
    (3) Once all monitoring required by this section and Sec.  141.858
for a calendar month has been completed, systems must determine whether
any coliform treatment technique triggers specified in Sec.  141.859
have been exceeded. If any trigger has been exceeded, systems must
complete assessments as required by Sec.  141.859.
    (4) Beginning [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL
RULE], all seasonal systems must demonstrate completion of a State-
approved start-up procedure, which may include a requirement for a
startup sample prior to serving water to the public.
    (b) Monitoring frequency for total coliforms. The monitoring
frequency for total coliforms is based on the population served by the
system, as follows:

  Total Coliform Monitoring Frequency for Public Water Systems Serving
                         More Than 1,000 People
------------------------------------------------------------------------
                                                              Minimum
                                                             number of
                    Population served                       samples per
                                                               month
------------------------------------------------------------------------
1,001 to 2,500..........................................               2
2,501 to 3,300..........................................               3
3,301 to 4,100..........................................               4
4,101 to 4,900..........................................               5
4,901 to 5,800..........................................               6
5,801 to 6,700..........................................               7
6,701 to 7,600..........................................               8
7,601 to 8,500..........................................               9
8,501 to 12,900.........................................              10
12,901 to 17,200........................................              15
17,201 to 21,500........................................              20
21,501 to 25,000........................................              25
25,001 to 33,000........................................              30
33,001 to 41,000........................................              40
41,001 to 50,000........................................              50
50,001 to 59,000........................................              60
59,001 to 70,000........................................              70
70,001 to 83,000........................................              80
83,001 to 96,000........................................              90
96,001 to 130,000.......................................             100
130,001 to 220,000......................................             120
220,001 to 320,000......................................             150
320,001 to 450,000......................................             180
450,001 to 600,000......................................             210
600,001 to 780,000......................................             240
780,001 to 970,000......................................             270
970,001 to 1,230,000....................................             300

1,230,001 to 1,520,000..................................             330
1,520,001 to 1,850,000..................................             360
1,850,001 to 2,270,000..................................             390
2,270,001 to 3,020,000..................................             420
3,020,001 to 3,960,000..................................             450
3,960,001 or more.......................................             480
------------------------------------------------------------------------

    (c) Unfiltered subpart H systems. A subpart H system of this part
that does not practice filtration in compliance with subparts H, P, T,
and W must collect at least one total coliform sample near the first
service connection each day the turbidity level of the source water,
measured as specified in Sec.  141.74(b)(2), exceeds 1 NTU. When one or
more turbidity measurements in any day exceed 1 NTU, the system must
collect this coliform sample within 24 hours of the first exceedance,
unless the State determines that the system, for logistical reasons
outside the system's control, cannot have the sample analyzed within 30
hours of collection and identifies an alternative sample collection
schedule. Sample results from this coliform monitoring must be included
in determining whether the coliform treatment technique trigger in
Sec.  141.859 has been exceeded.
    (d) Reduced monitoring. Systems may not reduce monitoring, except
for non-community water systems using only ground water (and not ground
water under the direct influence of surface water) serving 1,000 or
fewer people in some months and more than 1,000 persons in other
months. In months when more than 1,000 persons are served, the systems
must monitor at the frequency specified in paragraph (a) of this
section. In months when 1,000 or fewer people are served, the State may
reduce the monitoring frequency, in writing, to a frequency allowed
under Sec.  141.854 for a similarly situated system that always serves
1,000 or fewer people, taking into account the provisions in Sec.
141.854(e) through (g).

Sec.  141.858  Repeat monitoring and E. coli requirements.

    (a) Repeat monitoring. (1) If a sample taken under Sec. Sec.
141.854 though 141.857 is total coliform-positive, the system must
collect a set of repeat samples within 24 hours of being notified of
the positive result. The system must collect no fewer than three repeat
samples for each total coliform-positive sample found. The State may
extend the 24-hour limit on a case-by-case basis if the system has a
logistical problem in collecting the repeat samples within 24 hours
that is beyond its control. In the case of an extension, the State must
specify how much time the system has to collect the repeat samples. The
State cannot waive the requirement for a system to collect repeat
samples in paragraphs (a)(1) through (a)(3) of this section.
    (2) The system must collect all repeat samples on the same day,
except that the State may allow a system with a single service
connection to collect the required set of repeat samples over a three-
day period or to collect a larger volume repeat sample(s) in one or
more ample containers of any size, as long as the total volume
collected is at least 300 ml.
    (3) The system must collect an additional set of repeat samples in
the manner specified in paragraphs (a)(1) through (a)(3) of this
section if one or more repeat samples in the current set of repeat
samples is total coliform-positive. The system must collect the
additional set of repeat samples within 24 hours of being notified of
the positive result, unless the State extends the limit as provided in
paragraph (a)(1) of this section. The system must continue to collect
additional sets of repeat samples until either total coliforms are not
detected in one complete set of repeat samples or the system determines
that a coliform treatment technique trigger has been exceeded as a
result of a repeat sample being total coliform-positive and notifies
the State. If a trigger identified in Sec.  141.859 is exceeded as a
result of a routine sample being total coliform-positive, systems are
required to conduct only one round of repeat monitoring for each total
coliform-positive routine sample.
    (4) After a system collects a routine sample and before it learns
the results of the analysis of that sample, if it collects another
routine sample(s) from within five adjacent service connections of the
initial sample, and the initial sample, after analysis, is found to
contain total coliforms, then the system may count the subsequent
sample(s) as a repeat sample instead of as a routine sample.
    (5) Results of all routine and repeat samples taken under
Sec. Sec.  141.854 through 141.858 not invalidated by the State must be
used to determine whether a coliform treatment technique trigger Sec.
141.859 has been exceeded.
    (b) Escherichia coli (E. coli) testing. (1) If any routine or
repeat sample is total coliform-positive, the system must analyze that
total coliform-positive culture medium to determine if E. coli are
present. If E. coli are present, the system must notify the State by
the end of the day when the system is notified of the test result,
unless the system is notified of the result after the State office is
closed, in which case the system must notify the State before the end
of the next business day.
    (2) The State has the discretion to allow a system, on a case-by-
case basis, to forgo E. coli testing on a total coliform-positive
sample if that system assumes that the total coliform-positive sample
is E. coli-positive. Accordingly, the system must notify the State as
specified in paragraph (b)(1) of this section and the provisions of
Sec.  141.63(c) apply.

Sec.  141.859  Coliform treatment technique requirements for protection
against potential fecal contamination.

    (a) Treatment technique triggers. Systems must conduct assessments
in accordance with paragraph (b) of this section after exceeding
treatment technique triggers in paragraphs (a)(1) and (a)(2) of this
section.
    (1) Level 1 treatment technique triggers.
    (i) For systems taking 40 or more samples per month, the system
exceeds 5.0% total coliform-positive samples for the month.
    (ii) For systems taking fewer than 40 samples per month, the system
has two or more total coliform-positive samples in the same month.
    (iii) The system fails to take every required repeat sample after
any single total coliform-positive sample.
    (2) Level 2 treatment technique triggers.
    (i) An E. coli MCL violation, including failure to collect repeat
samples within the required time following an E. coli- positive routine
sample.
    (ii) A second Level 1 trigger as defined in paragraph (a)(1) of
this section, within a rolling 12-month period, unless the State has
determined a likely reason that the initial samples that caused the
Level 1 treatment technique trigger were total coliform-positive and
has established that the system has corrected the problem.
    (iii) For systems with approved annual monitoring, a Level 1
trigger in two consecutive years.
    (b) Requirements for assessments. (1) Systems must ensure that
Level 1 and 2 assessments are conducted in order to identify the
possible presence of sanitary defects and defects in distribution
system coliform monitoring practices. Level 2 assessments must be
conducted by parties approved by the State.

    (2) When conducting assessments, systems must ensure that the
assessor evaluates minimum elements that include review and
identification of inadequacies in sample sites; sampling protocol;
sample processing; atypical events that could affect distributed water
quality or indicate that distributed water quality was impaired;
changes in distribution system maintenance and operation that could
affect distributed water quality (including water storage); source and
treatment considerations that bear on distributed water quality, where
appropriate (e.g., small ground water systems); and existing water
quality monitoring data. The State may tailor specific assessment
elements to the size and type of the system. Systems may tailor their
assessment activities based on the characteristics of the distribution
system (consistent with any State directives).
    (3) Level 1 Assessments. A system must conduct a Level 1 assessment
consistent with State requirements if the system exceeds one of the
treatment technique triggers in paragraph (a)(1) of this section.
    (i) The system must complete a Level 1 assessment as soon as
practical after failure to take a repeat sample or after notification
of monitoring results. In the completed assessment form, the system
must identify sanitary defects detected, corrective actions completed,
and a timetable for any corrective actions not already completed. The
assessment form may also note that no sanitary defects were identified.
The system must submit the completed Level 1 assessment form to the
State within 30 days after determination of exceeding the trigger.
    (ii) If the State reviews the completed Level 1 assessment and
determines that the assessment is not sufficient, the State must
consult with the system. If necessary after consultation, the system
must submit a revised assessment form to the State on an agreed-upon
schedule not to exceed 30 days from the date of the consultation. Upon
completion and submission of the assessment form by the system, the
State must determine if the system has identified a likely cause for
the Level 1 trigger and, if so, establish that the system has corrected
the problem, or has included a schedule acceptable to the State for
correcting the problem.
    (4) Level 2 Assessments. A system must ensure that a Level 2
assessment consistent with State requirements is conducted if the
system exceeds one of the treatment technique triggers in paragraph
(a)(2) of this section. The State may direct expedited actions or
additional actions in the case of an E. coli MCL violation.
    (i) The system must ensure that a Level 2 assessment is completed
by the State or by a party approved by the State as soon as practical
after failure to take a repeat sample or after notification of
monitoring results. The system must submit a completed Level 2
assessment form to the State within 30 days after the determination of
exceeding the trigger. The assessment form must describe sanitary
defects detected, corrective actions completed, and a timetable for any
corrective actions not already completed. The assessment form may also
note that no sanitary defects were identified.
    (ii) The system may conduct Level 2 assessments if the system has
staff or management with the certification or qualifications specified
by the State unless otherwise directed by the State.
    (iii) If the State reviews the completed Level 2 assessment and
determines that the assessment is insufficient, the State must consult
with the system. If necessary after consultation, the system must
submit a revised assessment form to the State on an agreed-upon
schedule not to exceed 30 days. Upon completion and submission of the
assessment form by the system, the State must determine if the system
has identified a likely cause for the Level 2 trigger and determine
whether the system has corrected the problem, or has included a
schedule acceptable to the State for correcting the problem.
    (c) Corrective Action. Systems must correct sanitary defects found
through either Level 1 or 2 assessments conducted under paragraph (b)
of this section. For corrections not completed by the time of
submission of the assessment form, the system must complete the
corrective action(s) in compliance with a schedule determined by the
State in consultation with the system. The system must notify the State
when each scheduled corrective action is completed.
    (d) Consultation. At any time during the assessment or corrective
action phase, either the water system or the State may request a
consultation with the other party to determine the appropriate actions
to be taken. The system may consult with the State on all relevant
information that may impact on its ability to comply with a requirement
of this subpart, including the method of accomplishment, an appropriate
timeframe, and other relevant information.

Sec.  141.860  Violations.

    (a) E. coli MCL Violation. A system is in violation of the MCL for
E. coli when any of the conditions identified in paragraphs (a)(1)
through (a)(4) of this section occur.
    (1) The system has an E. coli-positive repeat sample following a
total coliform-positive routine sample.
    (2) The system has a total coliform-positive repeat sample
following an E. coli-positive routine sample.
    (3) The system fails to take all required repeat samples following
an E. coli-positive routine sample.
    (4) The system fails to test for E. coli when any repeat sample
tests positive for total coliform.
    (b) Treatment technique violation. A treatment technique violation
occurs when a system exceeds a treatment technique trigger specified in
Sec.  141.859(a) and then fails to conduct the required assessment or
corrective actions within the timeframe specified in Sec.  141.859(b)
and (c).
    (c) Monitoring violations. Failure to take every required routine
or additional routine sample in a compliance period is a routine
monitoring violation. Failure to analyze for E. coli following a total
coliform routine sample is a monitoring violation.
    (d) Reporting violations. (1) Failure to submit a monitoring report
or completed assessment form after a system properly conducts
monitoring or assessment is a reporting violation.
    (2) Failure to notify the State following an E. coli-positive
sample as required by Sec.  141.858(b)(1) is a reporting violation.

Sec.  141.861  Reporting and recordkeeping.

    (a) Reporting. (1) A system that has violated the E. coli MCL must
report the violation to the State no later than the end of the next
business day after it learns of the violation, and notify the public in
accordance with subpart Q of this part. A system must notify the State
no later than the end of the next business day after it learns of an E.
coli-positive sample.
    (2) A system that has violated the treatment technique for total
coliforms in Sec.  141.859 must report the violation to the State no
later than the end of the next business day after it learns of the
violation, and notify the public in accordance with subpart Q of this
part. The system must notify the State in accordance with Sec.
141.859(c) when each scheduled corrective action is completed for
corrections not completed by the time of submission of the assessment
form.
    (3) A system that has failed to comply with a coliform monitoring
requirement must report the monitoring violation to the State within 10
days after the system discovers the violation, and notify the

public in accordance with subpart Q of this part.
    (b) Recordkeeping. The system must maintain any assessment form,
regardless of who conducts the assessment, and documentation of
corrective actions completed as a result of those assessments, or other
available summary documentation of the sanitary defects and corrective
actions taken under Sec.  141.858 for State review. This record must be
maintained by the system for a period not less than five years after
completion of the assessment or corrective action.

PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS
IMPLEMENTATION

    21. The authority citation for part 142 continues to read as
follows:

    Authority:  42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4,
300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

    22. Section 142.14 is amended by revising paragraph (a)(1)(iii) and
adding a new paragraph (a)(10) to read as follows:

Sec.  142.14  Records kept by States.

    (a) * * *
    (1) * * *
    (iii) The analytical results, set forth in a form that makes
possible comparison with the limits specified in Sec. Sec.  141.63,
141.71, and 141.72 of this chapter and with the limits specified in
subpart Y of this chapter.
* * * * *
    (10) Records of each of the following decisions made pursuant to
the provisions of subpart Y of part 141 must be made in writing and
retained by the State.
    (i) Records of the following decisions or activities must be
retained for five years.
    (A) Sections 141.858(a), 141.853(b)(2), 141.856(c), and 141.857(c)
of this chapter--Any decision to waive the 24-hour time limit for
collecting repeat samples after a total coliform-positive routine
sample, or to extend the 24-hour limit for collection of samples
following invalidation, or for an unfiltered subpart H system of this
part to collect a total coliform sample following a turbidity
measurement exceeding 1 NTU.
    (B) Sections 141.854(j) and 141.855(f) of this chapter--Any
decision to allow a system to waive the requirement for three routine
samples the month following a total coliform-positive sample. The
record of the waiver decision must contain all the items listed in
those sections.
    (C) Section 141.853(c) of this chapter--Any decision to invalidate
a total coliform-positive sample. If the decision to invalidate a total
coliform-positive sample as provided in Sec.  141.853(c)(1) of this
chapter is made, the record of the decision must contain all the items
listed in that section.
    (D) Section 141.859 of this chapter--Completed and approved subpart
Y assessments, including reports from the system that corrective action
has been completed as required by Sec.  141.861(a)(2) of this chapter.
    (ii) Records of each of the following decisions must be retained in
such a manner so that each system's current status may be determined:
    (A) Section 141.855(d) of this chapter--Any decision to reduce the
total coliform monitoring frequency for a community water system
serving 1,000 or fewer people to less than once per month, as provided
in Sec.  141.855(d) of this chapter, including what the reduced
monitoring frequency is. A copy of the reduced monitoring frequency
must be provided to the system.
    (B) Section 141.854(e) of this chapter--Any decision to reduce the
total coliform monitoring frequency for a non-community water system
using only ground water and serving 1,000 or fewer people to less than
once per quarter, as provided in Sec.  141.854(e) of this chapter,
including what the reduced monitoring frequency is. A copy of the
reduced monitoring frequency must be provided to the system.
    (C) Section 141.857(d) of this chapter--Any decision to reduce the
total coliform monitoring frequency for a non-community water system
using only ground water and serving more than 1,000 persons during any
month the system serves 1,000 or fewer people, as provided in Sec.
141.857(d) of this chapter. A copy of the reduced monitoring frequency
must be provided to the system.
    (D) Section 141.858(b)(2) of this chapter--Any decision to allow a
system to forgo E. coli testing of a total coliform-positive sample if
that system assumes that the total coliform-positive sample is E. coli-
positive.
* * * * *
    23. Section 142.15 is amended by adding paragraph (c)(3) to read as
follows:

Sec.  142.15  Reports by States.

* * * * *
    (c) * * *
    (3) Total coliforms under subpart Y. A list of systems that the
State is allowing to monitor less frequently than once per month for
community water systems or less frequently than once per quarter for
non-community water systems as provided in Sec. Sec.  141.855 and
141.854 of this chapter, including the applicable date of the reduced
monitoring requirement for each system.
* * * * *
    24. Section 142.16 is amended by adding a new paragraph (q) to read
as follows:

Sec.  142.16  Special primacy requirements.

* * * * *
    (q) Requirements for States to adopt 40 CFR part 141 subpart Y--
Revised Total Coliform Rule. In addition to the general primacy
requirements elsewhere in this part, including the requirements that
State regulations be at least as stringent as federal requirements, an
application for approval of a State program revision that adopts 40 CFR
part 141, subpart Y, must contain the information specified in this
paragraph (q).
    (1) In their application to EPA for approval to implement the
federal requirements, the primacy application must indicate what
baseline and reduced monitoring provisions of 40 CFR part 141, subpart
Y the State will adopt and must describe how they will implement 40 CFR
part 141, subpart Y in these areas so that EPA can be assured that
implementation plans meet the minimum requirements of the rule.
    (2) The State's application for primacy for subpart Y must include
a written description for each provision included in paragraphs
(q)(2)(i) through (viii) of this section.
    (i) Sample Siting Plans--The frequency and process used to review
and revise sample siting plans in accordance with 40 CFR part 141,
subpart Y to determine adequacy.
    (ii) Reduced Monitoring Criteria--An indication of whether the
State will adopt the reduced monitoring provisions of 40 CFR part 141,
subpart Y. If the State adopts the reduced monitoring provisions, it
must describe the specific types or categories of water systems that
will be covered by reduced monitoring and whether the State will use
all or a reduced set of the optional criteria. For each of the reduced
monitoring criteria, both mandatory and optional, the State must
describe how the criteria will be evaluated to determine when systems
qualify.
    (iii) Assessments and Corrective Actions--The process for
implementing the new assessment and corrective action phase of the
rule, including the elements in paragraphs (q)(2)(iii)(A) through (D)
of this section.
    (A) Elements of Level 1 and Level 2 assessments. This must include
an explanation of how the State will ensure

that Level 2 assessments provide a more detailed examination of the
system (including the system's monitoring and operational practices)
than do Level 1 assessments through the use of more comprehensive
investigation and review of available information, additional internal
and external resources, and other relevant practices.
    (B) Examples of sanitary defects.
    (C) Examples of assessment forms or formats.
    (D) Methods that systems may use to consult with the State on
appropriate corrective actions.
    (iv) Invalidation of routine and repeat samples collected under 40
CFR part 141, subpart Y--The criteria and process for invalidating
total coliform and E. coli-positive samples under 40 CFR part 141,
subpart Y. This description must include criteria to determine if a
sample was improperly processed by the laboratory, reflects a domestic
or other non-distribution system plumbing problem or reflects
circumstances or conditions that do not reflect water quality in the
distribution system.
    (v) Approval of individuals allowed to conduct Level 2 assessments
under 40 CFR part 141, subpart Y--The criteria and process for approval
of individuals allowed to conduct Level 2 assessments under 40 CFR part
141, subpart Y.
    (vi) Special monitoring evaluation--The procedure for performing
special monitoring evaluations during sanitary surveys for ground water
systems serving 1,000 or fewer people to determine whether systems are
on an appropriate monitoring schedule.
    (vii) Seasonal systems--How the State will identify seasonal
systems, how the State will determine when systems on less than monthly
monitoring must monitor, and what start-up provisions seasonal system
must meet under 40 CFR part 141, subpart Y.
    (viii) Additional criteria for reduced monitoring--How the State
will require systems on reduced monitoring to demonstrate:
    (A) Continuous disinfection entering the distribution system and a
residual in the distribution system.
    (B) Cross connection control.
    (C) Other enhancements to water system barriers.
    25. Section 142.63 is amended by revising paragraph (b) to read as
follows:

Sec.  142.63  Variances and exemptions from the maximum contaminant
level for total coliforms.

* * * * *
    (b) EPA has stayed this section as it relates to the total coliform
MCL of Sec.  141.63(a) of this chapter for systems that demonstrate to
the State that the violation of the total coliform MCL is due to a
persistent growth of total coliforms in the distribution system rather
than fecal or pathogenic contamination, a treatment lapse or
deficiency, or a problem in the operation or maintenance of the
distribution system. This stay is applicable until [DATE THREE YEARS
FOLLOWING PUBLICATION OF THE FINAL RULE], at which time the total
coliform MCL is no longer applicable.

[FR Doc. 2010-15205 Filed 7-13-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24807-24808]
[FR Doc No: 2023-08545]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1259]

Advancing the Utilization and Supporting the Implementation of
Innovative Manufacturing Approaches; Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we), in
cosponsorship with the Duke-Margolis Center for Health Policy, is
announcing a public workshop entitled ``Advancing the Utilization and
Supporting the Implementation of Innovative Manufacturing Approaches.''
This workshop will address innovative manufacturing technologies for
drug and biological products and will include a discussion of potential
best practices, case studies from previous submissions, potential
barriers to adoption, corresponding regulatory strategies, and the
Advanced Manufacturing Technologies Designation Program.

DATES: The public workshop will be held on June 8, 2023, from 9 a.m. to
4:30 p.m. Eastern Time. Either electronic or written comments on this
public workshop must be submitted by July 8, 2023. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held at the National Press Club,
529 14th Street NW, Washington, DC 20045.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on July 8, 2023. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-1259 for ``Advancing the Utilization and Supporting the
Implementation of Innovative Manufacturing Approaches.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on

https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Luke Durocher, Duke-Margolis Center
for Health Policy, 1201 Pennsylvania Ave., Suite 500, Washington, DC
20004,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    There is significant interest in the use, implementation, and
advancement of innovative drug manufacturing approaches and
technologies. In accordance with commitments described in the
Prescription Drug User Fee Act (PDUFA) VII commitment letter ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2023
through 2027,'' \1\ FDA agreed to conduct a public workshop by the end
of fiscal year 2023 on the use of innovative manufacturing technologies
for products regulated by the Center for Drug Evaluation and Research
(CDER) or the Center for Biologics Evaluation and Research (CBER).
---------------------------------------------------------------------------

    \1\ See section I.N.5, ``Advancing Utilization and
Implementation of Innovative Manufacturing'' at https://www.fda.gov/media/151712/download.
---------------------------------------------------------------------------

    Additionally, section 506L of the Federal Food, Drug, and Cosmetic
Act (FD&C Act, 21 U.S.C. 356l), as added by section 3213 of the Food
and Drug Omnibus Reform Act of 2022 (FDORA), authorizes the Advanced
Manufacturing Technologies Designation Program and requires FDA to
publish a Federal Register notice announcing a public meeting to
solicit industry and public feedback regarding this program.
    FDA is holding a public workshop entitled ``Advancing the
Utilization and Supporting the Implementation of Innovative
Manufacturing'' to fulfill both the PDUFA VII commitment and the FD&C
Act requirement described above. The purpose of the public workshop is
to discuss potential best practices for drug applications that include
innovative manufacturing technologies, sponsor-presented case studies
from previous submissions involving innovative technology, potential
barriers to the adoption of innovative manufacturing technologies,
corresponding regulatory strategies, ways in which FDA will support the
use of innovative manufacturing technologies and approaches for drug
and biological products, and the Advanced Manufacturing Technologies
Designation Program.

II. Topics for Discussion at the Public Workshop

    The public workshop will include the following topics for
discussion:
     Best practices and lessons learned from the CDER Emerging
Technology Team and the CBER Advanced Technology Team programs from
both industry and regulatory perspectives.
     Case studies from previous innovative technology
submissions presented by industry sponsors.
     Potential barriers (e.g., technical, regulatory) to the
adoption of innovative manufacturing technologies.
     Regulatory strategies for the adoption of innovative
manufacturing technologies, including submission strategies for the
implementation of certain innovative technologies across multiple
commercial products or multiple manufacturing sites.
     Science- and risk-based approaches for developing and
accessing innovative technologies across platform products and sites to
streamline adoption.
     Input and recommendations from stakeholders regarding
initiation and implementation of the Advanced Manufacturing
Technologies Designation Program, including the process and information
needed to request a designation, the evaluation of designation
requests, and the review of applications that involve use of designated
advanced manufacturing technologies.\2\
---------------------------------------------------------------------------

    \2\ In the context of this program, application refers to an
application submitted under section 505 of the FD&C Act (21 U.S.C.
355), or section 351 of the Public Health Service Act (42 U.S.C.
262).
---------------------------------------------------------------------------

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop
must register online at https://duke.is/8zckq by 9 a.m. Eastern Time,
June 8, 2023. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by 9 a.m. Eastern Time, June 8, 2023. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted.
    If you need special accommodations due to a disability, please
contact Luke Durocher, Duke-Margolis Center for Health Policy, 202-621-
2800, [email protected], no later than 5 p.m. Eastern Time, May
25, 2023.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Refer to registration information online at https://duke.is/8zckq.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff.

    Dated: April 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08545 Filed 4-21-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Notices]
[Page 46978]
[DOCID:fr22au07-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-571-000]

Centerpoint Energy Gas Transmission Company; Notice of Proposed
Changes in FERC Gas Tariff

August 15, 2007.
    Take notice that on August 13, 2007, CenterPoint Energy Gas
Transmission Company (CEGT) tendered for filing as part of its FERC Gas
Tariff, Sixth Revised Volume No. 1, First Revised Sheet No. 572,
effective September 12, 2007.
    CEGT states that the purpose of this filing is to amend and clarify
the operational controls provisions of its Tariff.
    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 and 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 in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than 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 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>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-16518 Filed 8-21-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 23, 2007 (Volume 72, Number 225)]
[Notices]
[Page 65732-65733]
[DOCID:fr23no07-69]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-1080; FRL-8341-3]

Endocrine Disruptor Screening Program; Workshop to Discuss Draft
Policies and Procedures

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is convening a 1-day public workshop to discuss the
Agency's draft administrative policies and procedures for completing
the initial screening and testing under EPA's Endocrine Disruptor
Screening Program (EDSP) and the burden and cost estimates for the
related information collection activities. In two forthcoming notices
in the Federal Register, EPA will announce the availability for public
review and comment of: (1) The draft policies and procedures EPA is
considering adopting for conducting the initial screening and testing
under the EDSP and (2) the draft Information Collection Request (ICR)
for the initial screening and testing. The purpose of the public
workshop is to allow the public to ask questions and for EPA to provide
further explanation about these aspects of the EDSP, which in turn may
facilitate the preparation of comments.

DATES: The meeting is on Monday, December 17, 2007, from 9 a.m. to 5
p.m.
    Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the person listed under FOR FURTHER
INFORMATION CONTACT at least 10 days prior to the meeting to give EPA
as much time as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center--Lobby Level, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: William Wooge, Office of Science
Coordination and Policy (OSCP), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 546-8476; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Who Should Attend?

    You may be interested in attending this workshop if you produce,
manufacture, use, or import pesticide/agricultural chemicals and other
chemical substances; or if you are or may otherwise be involved in the
testing of chemical substances for potential endocrine effects. To
determine whether you or your business may have an interest in this
workshop you should carefully examine section 408(p) of the Federal,
Food, Drug, and Cosmetic Act (FFDCA). [21 U.S.C. 346a(p)]

II. What is the EDSP?

    The EDSP was established in 1998 to carry out the mandate in
section 408(p) of FFDCA [21 U.S.C. 346a et. seq.],

which directed EPA ``to develop a screening program . . . to determine
whether certain substances may have an effect in humans that is similar
to an effect produced by a naturally occurring estrogen, or such other
endocrine effect as the Administrator may designate.'' If a substance
is found to have an effect, FFDCA section 408(p)(6) directs the
administrator to take action under available statutory authority to
ensure protection of public health. That is, the ultimate purpose of
the EDSP is to provide information to the Agency that will allow the
Agency to evaluate the risks associated with the use of a chemical and
take appropriate steps to mitigate any risks. The necessary information
includes identifying any adverse effects that might result from the
interaction of a substance with the endocrine system and establishing a
dose-response curve. Section 1457 of the Safe Drinking Water Act (SDWA)
also authorizes EPA to screen substances that may be found in sources
of drinking water, and to which a substantial population may be
exposed, for endocrine disruption potential. [42 U.S.C. 300j-17]
    EPA currently is implementing its EDSP in three major parts that
are being developed in parallel and with substantial work on each well
underway. This document announces a public workshop related
specifically to the third component of the EDSP (i.e., policies and
procedures). The three parts are briefly summarized as follows:
    1. Assay validation. Under FFDCA section 408(p), EPA is required to
use ``appropriate validated test systems and other scientifically
relevant information'' to determine whether substances may have
estrogenic effects in humans. EPA is validating assays that are
candidates for inclusion in the Tier 1 screening battery and Tier 2
tests, and will select the appropriate screening assays for the Tier 1
battery based on the validation data. Validation is defined as the
process by which the reliability and relevance of test methods are
evaluated for the purpose of supporting a specific use. The status of
each assay can be viewed on the EDSP website in the Assay Status
table:http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/status.htm.
 In addition, on July 13, 2007, EPA published a Federal

Register document that outlined the approach EPA intends to take for
conducting the peer reviews of the Tier 1 screening assays and Tier 2
testing assays and EPA's approach for conducting the peer review of the
Tier 1 battery (72 FR 38577) (FRL-8138-4). EPA also announced the
availability of a ``list server'' (Listserv) that will allow interested
parties to sign up to receive e-mail notifications of EDSP peer review
updates, including information on the availability of peer review
materials to be posted on the EDSP website.
    2. Priority setting. EPA described its priority setting approach to
select pesticide chemicals for initial screening on September 27, 2005
(70 FR 567449) (FRL-7716-9), and announced the draft list of initial
pesticide active ingredients and pesticide inerts to be considered for
screening under FFDCA on June 18, 2007 (72 FR 33486) (FRL-8129-3). The
Agency expects to finalize this initial list of chemicals before
screening is initiated in 2008. More information on EPA's priority
setting approach and the draft list of chemicals is available at http://www.epa.gov/scipoly/oscpendo/prioritysetting.
 The first 73 pesticide

chemicals to undergo screening is also referred to as ``initial
screening'' in this document.
    3. Policies and procedures. A forthcoming Federal Register document
will describe EPA's draft policies relating to:
     The procedures that EPA is considering using to issue
orders.
     How joint data development, cost sharing, data
compensation, and data protection would be addressed.
     Procedures that order recipients would use to respond to
an order.
     Other related procedures and/or policies.
    In addition, EPA has developed an ICR to obtain the necessary
approval under the Paperwork Reduction Act (PRA) for the related
paperwork activities. The ICR document, which describes the information
collection activities and related estimated paperwork burden and costs,
will also be announced for public review and comment in a forthcoming
Federal Register document.

III. Why Hold a Workshop?

    EPA is holding this workshop to facilitate the public's comments on
the draft policies and procedures that EPA is considering for
conducting the initial screening and testing under the EDSP, as well as
the Agency's estimated burden and costs for the related paperwork
activities. The workshop is an opportunity for the public, stakeholders
and the regulated community to discuss the draft EDSP policies and
procedures and the draft ICR documents that are expected to be released
for public comment shortly. Although the workshop is not intended to
collect oral comments, the Agency intends to consider the discussion
and will be documenting the discussion for the public docket.
    In addition to attending this workshop, EPA invites you to provide
comments on the draft policies and procedures and the draft ICR for
initial EDSP screening and testing. The Federal Register documents
announcing their availability will include a specific list of questions
on which the Agency is specifically seeking comment, along with
instructions for how to submit comments on those documents. This list,
along with an agenda for the workshop, will be posted on the Agency's
website and provided at the workshop. EPA will consider all comments
received and EPA will announce the availability of the final versions
of the policies and procedures and the ICR for the initial EDSP
screening and testing in the Federal Register.

List of Subjects

    Environmental protection, Chemicals, Endocrine disruptors,
Pesticides and pests, Reporting and recordkeeping.

    Dated: November 16, 2007.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.

[FR Doc. E7-22895 Filed 11-21-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: May 6, 2010 (Volume 75, Number 87)]
[Rules and Regulations]
[Page 24799-24801]
[DOCID:fr06my10-8]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0277]
RIN 1625-AA00

Safety Zone; Tri-City Water Follies Hydroplane Races Practice
Sessions, Columbia River, Kennewick, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
Columbia River in Kennewick, Washington for hydroplane race practice
sessions being held in preparation for the Tri-City Water Follies
Hydroplane Races. The safety zone is necessary to help ensure the
safety of the practice session participants as well as the maritime
public and will do so by prohibiting all persons and vessels from
entering or remaining in the safety zone unless authorized by the
Captain of the Port or his designated representative.

DATES: This rule is effective from 7 a.m. May 7, 2010 through 5:30 p.m.
May 8, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0277 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0277 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground

Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail MST1 Jaime Sayers, Waterways Management
Division, U.S. Coast Guard Sector Portland; telephone<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because to do otherwise would be contrary to
the public interest because immediate action is necessary to provide
for the safety of life and property on navigable waters.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be contrary to public interest because hazards associated with the
hydroplane practice sessions could lead to severe injury, fatalities,
and/or destruction of public property. Therefore, immediate action is
needed to ensure the public's safety.

Basis and Purpose

    The Tri-City Water Follies Association hosts annual hydroplane
races on the Columbia River in Kennewick, Washington. The Association
is planning to hold practice sessions prior to the event for race
participants. The practice sessions will be conducted daily on May 7
and May 8, 2010 from 7 a.m. through 5:30 p.m. Due to the safety hazards
inherent with such events, a safety zone is necessary to help ensure
the safety of the practice session participants as well as the maritime
public.

Discussion of Rule

    The safety zone created by this rule encompasses all waters bounded
by two lines drawn from shore to shore on the Columbia River, and is
approximately 2 miles in length beginning at the Pioneer Memorial
Bridge at the point where U.S. Route 395 crosses the Columbia River;
the first line running between position 46[deg]14'07'' N,
119[deg]10'42'' W and position 46[deg]13'42'' N, 119[deg]10'51'' W and
the second line running between position 46[deg]13'35'' N,
119[deg]07'34'' W and position 46[deg]13'10'' N, 119[deg]07'47'' W.
    The safety zone will be in effect daily from 7 a.m. until 5:30 p.m.
on May 7, 2010 and May 8, 2010. All persons and vessels will be
prohibited from entering or remaining in the safety zone unless
authorized by the Captain of the Port or his designated representative.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. Although this regulation will restrict
access to the area, the effect of this rule will not be significant
because: The safety zone will only be in effect for a limited time and
maritime traffic will be able to transit the safety zone at designated
intervals throughout that time period and as otherwise authorized by
the Captain of the Port or his designated representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities some of which may
be small entities: The owners and operators of vessels intending to
operate in the area covered by the safety zone. The rule will not have
a significant economic impact on a substantial number of small
entities, however, because the safety zone will only be in effect for a
limited time and maritime traffic will be able to transit the safety
zone at designated intervals throughout that time period and as
otherwise authorized by the Captain of the Port or his designated
representative.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or

more in any one year. Though this rule will not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, 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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a safety zone.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T13-139 to read as follows:

Sec.  165.T13-139  Safety Zone; Tri-City Water Follies Hydroplane Races
Practice Sessions, Columbia River, Kennewick, WA

    (a) Location. The following area is a safety zone: All waters
encompassed within the area approximately two miles in length bounded
by two lines drawn from shore to shore on the Columbia River; the first
line running between position 46[deg] 14'07'' N, 119[deg]10'42'' W and
position 46[deg]13'42'' N, 119[deg]10'51'' W and the second line
running between position 46[deg]13'35'' N, 119[deg]07'34'' W and
position 46[deg]13'10'' N, 119[deg]07'47'' W.
    (b) Regulations. In accordance with the general regulations in 33
CFR Part 165, Subpart C, no person may enter or remain in the safety
zone detailed in paragraph (a) of this section or bring, cause to be
brought, or allow to remain in the safety zone detailed in paragraph
(a) of this section any vehicle, vessel, or object unless authorized by
the Captain of the Port or his designated representative. See 33 CFR
Part 165, Subpart C, for additional information and requirements.
    (c) Enforcement Period. The safety zone detailed in paragraph (a)
of this section will be in effect daily from 7 a.m. through 5:30 p.m.
on May 7, 2010 and May 8, 2010.

    Dated: April 22, 2010.
F.G. Myer,
Captain, U.S. Coast Guard, Captain of the Port, Portland.
[FR Doc. 2010-10613 Filed 5-5-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 14, 2006 (Volume 71, Number 114)]
[Rules and Regulations]
[Page 34257-34259]
[DOCID:fr14jn06-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2005-MD-0012; FRL-8183-1]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Ambient Air Quality Standard for Ozone and Fine Particulate
Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the State of Maryland. The revision consists of
modifications to the ambient air quality standards for ozone and fine
particulate matter and the replacement of the abbreviation ``ppm'' with
parts per million in existing standards. This action is being taken
under section 110 of the Clean Air Act (CAA).

DATES: Effective Date: This final rule is effective on July 14, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2005-MD-0012. All documents in the docket are listed
in the http://www.regulations.gov Web site. Although listed in the electronic

docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or

in hard copy for public inspection during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
State submittal are available at the Maryland Department of the
Environment, 1800 Washington Boulevard, Suite 705, Baltimore, Maryland
21230.

FOR FURTHER INFORMATION CONTACT: Linda Miller,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On October 13, 2005 (70 FR 59688), EPA published a notice of
proposed rulemaking (NPR) for the State of Maryland. The NPR proposed
approval of modifications to the ambient air quality standards for
ozone and fine particulate matter (PM2.5) and the replacement of the
abbreviation ``ppm'' with parts per million in existing standards. The
official SIP revision (05-01) was submitted by the State of
Maryland on March 15, 2005.

II. Summary of SIP Revision

    Maryland's revision incorporates the 1997 Federal 8-hour ozone and
PM2.5 standards into Title 26, Subtitle 11, Chapter 4 of the Code of
Maryland Administrative Regulations (COMAR 26.11.04). The new ozone
standard incorporated in this SIP revision is the average of the
fourth-highest daily maximum 8-hour average ozone concentration that is
less than or equal to 0.08 ppm, averaged over three consecutive years.
The standards for PM2.5 incorporated in this SIP revision are 65
micrograms per cubic meter based on a 24-hour concentration and 15.0
micrograms per cubic meter annual arithmetic mean concentration. The
revision also includes a clarification of the unit of measure for
ambient air quality standards for sulfur oxides and nitrogen dioxide.
The abbreviation ``ppm'' has been replaced by the written form ``parts
per million''. No public comments were received on the NPR.

III. Final Action

    EPA is approving the amendments to COMAR 26.11.04, consisting of
the addition of new 8-hour ozone ambient air quality standards and fine
particulate matter ambient air quality standards, as well as
clarification of the

unit of measure, as a revision to the Maryland SIP.

IV. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not
have tribal implications because it will not have a substantial direct
effect on one or more Indian tribes, 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,
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action also does not have federalism implications because it does
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This action merely approves a state rule implementing a Federal
requirement, and does not alter the relationship or the distribution of
power and responsibilities established in the Clean Air Act. This rule
also is not subject to Executive Order 13045 ``Protection of Children
from Environmental Health Risks and Safety Risks'' (62 FR 19885, April
23, 1997), because it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 14, 2006. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.
    This action to approve modifications to the ambient air quality
standards for ozone and fine particulate matter may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: June 1, 2006.
Donald S. Welsh,
Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart V--Maryland

0
2. In Sec.  52.1070, the table in paragraph (c) is amended by revising
the entries for <IP_ADDRESS>, <IP_ADDRESS>, <IP_ADDRESS>, <IP_ADDRESS>, and
<IP_ADDRESS> to read as follows:

Sec.  52.1070  Identification of plan.

* * * * *
    (c)* * *

                                                      EPA-Approved Regulations in the Maryland SIP
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                State
 Code of Maryland administrative                 Title/subject                  effective        EPA  approval  date          Additional  explanation/
  regulations (COMAR) citation                                                     date                                     citation  at 40 CFR 52.1100
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           26.11.04 State Adopted Ambient Air Quality Standards and Guidelines
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>.....................  Definitions, Reference Conditions, and           2/28/05  6/14/06 [Insert page number    .............................
                                   Methods of Measurement.                                   where the document begins]
<IP_ADDRESS>.....................  Particulate Matter.........................      2/28/05  6/14/2006 [Insert page number  Addition of ambient air
                                                                                where the document begins]     quality standard for PM2.5.
<IP_ADDRESS>.....................  Sulfur Oxides..............................      2/28/05  6/14/06 [Insert page number    .............................
                                                                                where the document begins]

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>.....................  Ozone......................................      2/28/05  6/14/06 [Insert page number    Addition of 8-hour ambient
                                                                                quality where the document     air quality standard for
                                                                                begins]                        ozone
<IP_ADDRESS>.....................  Nitrogen Dioxide...........................      2/28/05  6/14/06 [Insert page number    .............................
                                                                                where the document begins]
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 06-5298 Filed 6-13-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: June 22, 2006 (Volume 71, Number 120)]
[Notices]
[Page 35888]
[DOCID:fr22jn06-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2513-066]

Green Mountain Power Corporation; Notice of Availability of
Environment Assessment

June 15, 2006.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, the Office
of Energy Projects has reviewed the application by the licensee to
install a fifth turbine in the project powerhouse, rated at 850 kW,
with a maximum hydraulic capacity of 210 cfs. The project is located on
the Winooski River in the townships of Essex Junction and Williston,
Vermont. An environmental assessment (EA) has been prepared.
    In the EA, the Commission's staff concludes that approval of the
licensee's application would not produce any significant adverse
environmental impacts, consequently the proposal would not constitute a
major Federal action significantly affecting the quality of the human
environment.
    A copy of the EA is attached to a Commission order titled ``Order
Amending License and Revising Annual Charges,'' issued June 15, 2006,
and is available at the Commission's Public Reference Room. A copy of
the EA may also be viewed on the Commission's Web site at http://www.ferc.gov
 using the ``elibrary'' link. Enter the docket numbers (P-

2513) in the docket field to access the document. For assistance, call
(202) 502-8222 or<PHONE_NUMBER> (for TTY).

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9807 Filed 6-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76505-76506]
[FR Doc No: 2015-30970]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Psychopharmacologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 12, 2016, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Jennifer Shepherd, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533<EMAIL_ADDRESS>or FDA Advisory Committee Information Line, 1-
800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss new drug application (NDA)
204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl
acetate) subdermal implant, submitted by Braeburn Pharmaceuticals,
Inc., on behalf of Titan Pharmaceuticals for the proposed indication of
maintenance treatment of opioid dependence.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
December 28, 2015. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before December 17, 2015. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by December 18, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the

Agency is not responsible for providing access to electrical outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Jennifer Shepherd at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 3, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-30970 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 47 (Wednesday, March 11, 2015)]
[Notices]
[Pages 12814-12816]
[FR Doc No: 2015-05546]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-82-000.
    Applicants: Spokane Energy, LLC, Avista Corporation.
    Description: Joint Application of Spokane Energy, LLC and Avista
Corporation for Approval of Assignment of Capacity Sales Agreement,
Waivers, and Request for Expedited Consideration.
    Filed Date: 3/3/15.
    Accession Number: 20150303-5247.
    Comments Due: 5 p.m. ET 3/24/15.

    Docket Numbers: EC15-83-000.
    Applicants: Fowler Ridge Wind Farm LLC, Fowler Ridge II Wind Farm
LLC, Fowler Ridge III Wind Farm LLC, Fowler Ridge IV Wind Farm LLC.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Requests for Waivers, and Expedited
Consideration of Fowler Ridge Wind Farm LLC, et al.
    Filed Date: 3/3/15.
    Accession Number: 20150303-5248.
    Comments Due: 5 p.m. ET 3/24/15.

    Docket Numbers: EC15-84-000.
    Applicants: Fowler Ridge IV Wind Farm LLC.
    Description: Application for Authorization for Disposition of

Jurisdictional Facilities and Requests for Waivers, Confidential
Treatment, and Expedited Consideration of Fowler Ridge IV Wind Farm
LLC.
    Filed Date: 3/3/15.
    Accession Number: 20150303-5249.
    Comments Due: 5 p.m. ET 3/24/15.

    Docket Numbers: EC15-85-000.
    Applicants: Longview Power, LLC.
    Description: Section 203 Application of Longview Power, LLC.
    Filed Date: 3/3/15.
    Accession Number: 20150303-5251.
    Comments Due: 5 p.m. ET 3/24/15.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG15-61-000.
    Applicants: Bear Mountain Limited.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Bear Mountain Limited.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5074.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: EG15-62-000.
    Applicants: Chalk Cliff Limited.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Chalk Cliff Limited.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5075.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: EG15-63-000.
    Applicants: McKittrick Limited.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of McKittrick Limited.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5076.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: EG15-64-000.
    Applicants: Live Oak Limited.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Live Oak Limited.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5078.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: EG15-65-000.
    Applicants: NTE Energy, LLC.
    Description: EWG Self-Certification of NTE Carolinas.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5165.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: EG15-66-000.
    Applicants: NTE Energy, LLC.
    Description: EWG Self Certification of NTE Ohio.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5167.
    Comments Due: 5 p.m. ET 3/25/15.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1484-011.
    Applicants: Shell Energy North America (U.S.), L.P.
    Description: Notice of Non-Material Change in Status of Shell
Energy North America (U.S.), L.P.
    Filed Date: 3/3/15.
    Accession Number: 20150303-5256.
    Comments Due: 5 p.m. ET 3/24/15.

    Docket Numbers: ER10-1782-006.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits Annual Compliance
Report Regarding Operational Penalties for 2014.
    Filed Date: 3/3/15.
    Accession Number: 20150303-5255.
    Comments Due: 5 p.m. ET 3/24/15.

    Docket Numbers: ER12-1308-005.
    Applicants: Palouse Wind, LLC.
    Description: Notice of Non-Material Change in Status of Palouse
Wind, LLC.
    Filed Date: 3/2/15.
    Accession Number: 20150302-5404.
    Comments Due: 5 p.m. ET 3/23/15.

    Docket Numbers: ER12-2068-007: ER14-2630-003; ER13-17-005; ER13-
1585-004; ER13-1139-010; ER12-682-008; ER12-1311-007; ER11-4029-007;
ER11-2657-004; ER11-2201-011; ER10-2466-008; ER10-2465-003; ER10-2464-
004; ER10-2463-007; ER10-2461-007; ER10-2460-007.
    Applicants: Blue Sky East, LLC, Canandaigua Power Partners, LLC,
Canandaigua Power Partners II, LLC, Erie Wind, LLC, Evergreen Wind
Power, LLC, Evergreen Wind Power III, LLC, First Wind Energy Marketing,
LLC, Imperial Valley Solar 1, LLC, Longfellow Wind, LLC, Milford Wind
Corridor Phase I, LLC, Milford Wind Corridor Phase II, LLC, Regulus
Solar, LLC, Stetson Holdings, LLC, Stetson Wind II, LLC, Vermont Wind,
LLC, Niagara Wind Power, LLC.
    Description: Notice of Change in Status of Blue Sky East, LLC, et.
al.
    Filed Date: 3/2/15.
    Accession Number: 20150302-5406.
    Comments Due: 5 p.m. ET 3/23/15.

    Docket Numbers: ER14-1656-003.
    Applicants: CSOLAR IV West, LLC.
    Description: Notification of Change in Status of CSOLAR IV West,
LLC.
    Filed Date: 3/2/15.
    Accession Number: 20150302-5405.
    Comments Due: 5 p.m. ET 3/23/15.

    Docket Numbers: ER15-1086-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
American Transmission Systems, Incorporation.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): 2015-
02-24_SA 765 Bill of Sale for ATC-Wisconsin Power and Light D-TIA to be
effective 4/26/2015.
    Filed Date: 2/24/15.
    Accession Number: 20150224-5269.
    Comments Due: 5 p.m. ET 3/17/15.

    Docket Numbers: ER15-1162-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Amendment to NCMPA NITSA SA 212 to be effective 2/1/2015.
    Filed Date: 3/3/15.
    Accession Number: 20150303-5211.
    Comments Due: 5 p.m. ET 3/24/15.

    Docket Numbers: ER15-1163-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Revisions to Bylaws Section 6.6 to be effective 5/3/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5050.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1164-000.
    Applicants: Southwestern Electric Power Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
SWEPCO-NTEC PSA Amendment to be effective 1/1/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5053.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1165-000.
    Applicants: Southwestern Electric Power Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
SWEPCO-ETEC PSA Amendment to be effective 1/1/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5054.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1166-000.
    Applicants: Southwestern Electric Power Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
SWEPCO-ETEC NTEC PSA Amendment to be effective 1/1/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5055.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1167-000.
    Applicants: Southwestern Electric Power Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
SWEPCO-TexLa PSA Amendment to be effective 1/1/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5056.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1168-000.
    Applicants: Southwestern Electric Power Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
SWEPCO-Tex-La EC-Entergy TX Facilities Development Agreement to be
effective 2/5/2015.

    Filed Date: 3/4/15.
    Accession Number: 20150304-5066.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1169-000.
    Applicants: AEP Texas Central Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): TCC-
South Texas EC (Red Gate) Interconnection Agreement to be effective 2/
9/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5068.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1170-000.
    Applicants: Bear Mountain Limited.
    Description: Initial rate filing per 35.12 Market-Based Rate
Application to be effective 4/30/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5070.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1171-000.
    Applicants: Chalk Cliff Limited.
    Description: Initial rate filing per 35.12 MBR Application to be
effective 4/30/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5071.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1172-000.
    Applicants: Live Oak Limited.
    Description: Initial rate filing per 35.12 MBR Application to be
effective 4/30/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5072.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1173-000.
    Applicants: McKittrick Limited.
    Description: Initial rate filing per 35.12 MBR Application to be
effective 4/30/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5073.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1174-000.
    Applicants: Covanta Power, LLC.
    Description: Tariff Withdrawal per 35.15: Notice of Cancellation of
Market-Based Rate Tariff to be effective 5/3/2015.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5097.
    Comments Due: 5 p.m. ET 3/25/15.

    Docket Numbers: ER15-1175-000.
    Applicants: Consumers Energy Company.
    Description: Notice of Cancellation of Consumers Energy Company
Service Agreement No. 4 Under FERC Electric Tariff, Volume No. 7.
    Filed Date: 3/4/15.
    Accession Number: 20150304-5149.
    Comments Due: 5 p.m. ET 3/25/15.

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

    Dated: March 4, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-05546 Filed 3-10-15; 8:45 am]
 BILLING CODE 6717-01-P