[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Proposed Rules]
[Pages 52626-52629]
[FR Doc No: 2012-21483]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket No. EPA-R02-OAR-2012-0504; FRL-9723-2]

Approval and Promulgation of Air Quality Implementation Plans;
New York, New Jersey, and Connecticut; Determination of Attainment of
the 2006 Fine Particle Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
determine that the New York-N. New Jersey-Long Island, NY-NJ-CT fine
particle (PM2.5) nonattainment area has attained the 2006
24-hour fine particle National Ambient Air Quality Standard (NAAQS).
This proposed determination is based upon quality assured, quality
controlled, and certified ambient air monitoring data that shows the
area has monitored attainment of the 2006 24-hour PM2.5
NAAQS for the 2007-2009 and 2008-2010 monitoring periods and continues
to show attainment through 2011. If this proposed determination is made
final, the requirements for this area to submit an attainment
demonstration, reasonably available control measures, reasonable
further progress plan, and contingency measures related to attainment
of the 2006 24-hour PM2.5 NAAQS shall be suspended for so
long as the area continues to attain the 2006 24-hour PM2.5
NAAQS.

DATES: Comments must be received on or before October 1, 2012.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-
R02-OAR-2012-0504, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Raymond Werner, Chief, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866.
     Hand Delivery: Raymond Werner, Chief, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866. Such deliveries are only accepted
during the Regional Office's normal hours of operation. The Regional
Office's official hours of business are Monday through Friday, 8:30
a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R02-OAR-
2012-0504. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Region II Office, Air Programs Branch, 290 Broadway,
25th Floor, New York, New York 10007-1866. EPA requests, if at all
possible, that you contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. You
may view the hard copy of the docket Monday through Friday, 8:30 a.m.
to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning
today's proposed action related to New York or New Jersey, please
contact Gavin Lau, Air Programs Branch, Environmental Protection
Agency, 290 Broadway, 25th Floor, New York, New York 10007-1866,
telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, email
<EMAIL_ADDRESS>    If you have questions concerning today's proposed action related to
Connecticut, please contact Alison C. Simcox, Air Quality Planning
Unit, Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square--Suite 100, Mail Code OEP05-02, Boston, MA 02109-
3912, telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For detailed information regarding this
proposal, EPA prepared a Technical Support Document (TSD). The TSD can
be viewed at http://www.regulations.gov.
    The following table of contents describes the format of this
notice:

I. What action is EPA proposing?
II. What is the effect of this action?
III. What is the background for this action?
IV. What is EPA's analysis of the relevant air quality data?
V. How did EPA address missing data?
VI. Proposed Action
VII. Statutory and Executive Order Reviews

I. What action is EPA proposing?

    EPA is proposing to determine that the New York-N. New Jersey-Long
Island, NY-NJ-CT PM2.5 nonattainment area, referred to from
this point forward as the NY-NJ-CT PM2.5 nonattainment area,
has attained the 2006 24-hour PM2.5 NAAQS. This proposed
determination is based upon quality-assured, quality-controlled, and
certified ambient air monitoring data that show that the area has
monitored attainment of the 2006 24-hour PM2.5 NAAQS for the
2007-2009 and 2008-2010 monitoring periods and continues to attain
through 2011. The New York portion of the NY-NJ-CT PM2.5

nonattainment area contains the counties of Bronx, Kings, Nassau, New
York, Orange, Queens, Richmond, Rockland, Suffolk, and Westchester. The
New Jersey portion of the NY-NJ-CT PM2.5 nonattainment area
contains the counties of Bergen, Essex, Hudson, Mercer, Middlesex,
Monmouth, Morris, Passaic, Somerset, and Union. The Connecticut portion
of the NY-NJ-CT PM2.5 nonattainment area includes the
counties of Fairfield and New Haven.
    EPA received requests from the States of Connecticut, New Jersey,
and New York (States) for the determination of attainment for the 2006
24-hour PM2.5 NY-NJ-CT PM2.5 nonattainment area.
The States submitted air monitoring data, design value trends, and
summaries of PM2.5 emissions control programs. The
information provided by the States supports the proposed determination
being made by EPA that the NY-NJ-CT PM2.5 nonattainment area
has attained and continues to attain the 2006 24-hour PM2.5
NAAQS. Copies of the information submitted by the States are available
in the TSD.

II. What is the effect of this action?

    The proposed determination, if finalized, under the provisions of
EPA's PM2.5 implementation rule (see 40 CFR 51.1004(c) and
further reaffirmed in the implementation guidance for the 2006 24-hour
PM2.5. NAAQS) \1\ would: (1) Suspend the requirements for
the NY-NJ-CT PM2.5 nonattainment area to submit an
attainment demonstration, reasonably available control measures,
reasonable further progress plan, and contingency measures related to
the attainment of the 2006 24-hour PM2.5 NAAQS; (2) continue
until such time, if any, that EPA subsequently determines that the area
has violated the 2006 24-hour PM2.5 NAAQS; (3) be separate
from the designation determination or requirements for the NY-NJ-CT
PM2.5 nonattainment area based on the 1997 annual
PM2.5 NAAQS; and (4) remain in effect regardless of EPA's
designation of this area as a nonattainment area for purposes of the
1997 annual PM2.5 NAAQS. Furthermore, as described below,
any such final determination would not be equivalent to the
redesignation of the area to attainment based on the 2006 24-hour
NAAQS.
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    \1\ EPA's implementation guidance for the 2006 24-hour
PM2.5 NAAQS was issued on March 2, 2012 and is available
at http://www.epa.gov/ttn/naaqs/pm/pdfs/20120302_implement_guidance_24-hr_pm2.5_naaqs.pdf.
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    If this rulemaking is finalized and EPA subsequently determines,
after notice-and-comment rulemaking in the Federal Register, that the
area has violated the 2006 24-hour PM2.5 NAAQS, the basis
for the suspension of the specific requirements, set forth at 40 CFR
51.1004(c), would no longer exist, and the area would thereafter have
to address the pertinent requirements.
    The determination that EPA proposes with this Federal Register
action, that the air quality data shows attainment of the 2006 24-hour
PM2.5 NAAQS, is not equivalent to the redesignation of the
area to attainment. This proposed action, if finalized, would not
constitute a redesignation to attainment under section 107(d)(3) of the
Clean Air Act (CAA), because we would not yet have approved a
maintenance plan for the area as required under section 175A of the
CAA, nor a determination that the area has met the other requirements
for redesignation. The designation status of the area would remain
nonattainment for the 2006 24-hour PM2.5 NAAQS until such
time as EPA determines that it meets the CAA requirements for
redesignation to attainment.
    This proposed action, if finalized, is limited to a determination
that the NY-NJ-CT PM2.5 nonattainment area has attained the
2006 24-hour PM2.5 NAAQS. The 2006 24-hour PM2.5
NAAQS became effective on December 18, 2006 (71 FR 61144, October 17,
2006) and is set forth at 40 CFR 50.13. Effective December 14, 2009,
EPA made designation determinations, as required by CAA section
107(d)(1), for the 2006 24-hour PM2.5 NAAQS (74 FR 58688,
November 13, 2009). EPA's proposed rulemaking action here addresses
only the 2006 24-hour PM2.5 NAAQS, and has no bearing on any
other NAAQS, including any future revised NAAQS. EPA's proposed
rulemaking action in this notice is restricted to EPA's determination
that the NY-NJ-CT PM2.5 nonattainment area is attaining the
2006 24-hour PM2.5. This proposed action has no effect on
control measures, or air quality, in the area.
    If this proposed determination is made final and the NY-NJ-CT
PM2.5 nonattainment area continues to monitor attainment of
the 2006 24-hour PM2.5 NAAQS, the requirements for the area
to submit attainment demonstrations, reasonably available control
measures, reasonable further progress plans, and contingency measures
related to attainment of the 2006 24-hour PM2.5 NAAQS would
remain suspended.

III. What is the background for this action?

    On September 21, 2006, EPA established a 24-hour PM2.5
NAAQS at 35.0 micrograms per cubic meter ([micro]g/m\3\) based on a 3-
year average of the 98th percentile of 24-hour concentrations and
retained the annual PM2.5 NAAQS at 15.0 [micro]g/m\3\ based
on a 3-year average of the annual mean (71 FR 61144). EPA established
the standards based on significant evidence and numerous health studies
demonstrating that serious health effects are associated with exposures
to particulate matter. The process for designating areas following
promulgation of a new or revised NAAQS is contained in section
107(d)(1) of the CAA. EPA and state air quality agencies initiated the
monitoring process for the PM2.5 NAAQS in 1999, and deployed
all air quality monitors by January 2001. On November 13, 2009, (74 FR
58688), EPA published its air quality designations with respect to the
2006 24-hour PM2.5 NAAQS based upon air quality monitoring
data from those monitors for calendar years 2006-2008. These
designations became effective on December 14, 2009. The NY-NJ-CT
PM2.5 area was designated as nonattainment for the 2006 24-
hour PM2.5 NAAQS. This proposed determination addresses the
2006 24-hour standard only.
    On November 15, 2010 (75 FR 69589), EPA made the determination that
the NY-NJ-CT PM2.5 nonattainment area attained the 1997
annual PM2.5 NAAQS. On April 25, 2007 (72 FR 20586), EPA
promulgated its implementation rule to assist states and tribes with
the development of State Implementation Plans (SIPs) to demonstrate
attainment of the annual and 24-hour 1997 PM2.5 NAAQS,
codified at 40 CFR part 51, subpart Z. This rule, at 40 CFR 51.1004(c),
specifies some of the regulatory consequences of a determination of
attainment of the standard.
    On March 2, 2012, EPA provided implementation guidance for the 2006
24-hour PM2.5 NAAQS. The 2012 guidance reaffirms and
continues to use the framework and policy approaches of the April 25,
2007 rule. The 2006 24-hour PM2.5 NAAQS implementation
guidance includes additional guidance for states in developing their
SIPs.

IV. What is EPA's analysis of the relevant air quality data?

    EPA has reviewed the ambient air monitoring data for
PM2.5, consistent with the requirements contained in 40 CFR
part 50 and recorded in the EPA Air Quality System database for the NY-
NJ-CT PM2.5 nonattainment area from 2006 through the present
time. On the basis of that review, EPA has concluded that this area has
attained the 2006 24-hour PM2.5 NAAQS based on data for the
2007-2009 and 2008-2010

monitoring periods and continues to show attainment through 2011.
    Under EPA regulations at 40 CFR 50.13(c): The 24-hour primary and
secondary PM2.5 standards are met when the 98th percentile
24-hour concentration, as determined in accordance with 40 CFR part 50,
Appendix N, is less than or equal to 35.0 [micro]g/m\3\.
    Table 1 shows the design values by county (i.e., the 3-year average
of 98th percentile 24-hour PM2.5 concentrations) for the
2006 24-hour PM2.5 NAAQS for the NY-NJ-CT PM2.5
nonattainment area monitors for the years 2006 through 2010 based on
complete (except where otherwise noted), quality-assured and certified
air quality monitoring data. As shown in Table 1, none of the design
values for the periods of 2007-2009 and 2008-2010 in the NY-NJ-CT
PM2.5 nonattainment area exceed the 2006 24-hour
PM2.5 NAAQS of 35.0 [micro]g/m\3\. Table 1 also provides
certified, complete, and quality assured 98th percentile 24-hour
concentrations for 2011 which show continued attainment of the 24-hour
PM2.5 NAAQS.

  Table 1--Design Values \2\ by County for the 2006 24-Hour PM2.5 NAAQS for the NY-NJ-CT Monitors in Micrograms
                                         per Cubic Meter ([micro]g/m\3\)
                      [The standard for the 2006 24-hour PM2.5 NAAQS is 35.0 [micro]g/m\3\]
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                     County                          06-08  DV       07-09  DV       08-10 DV        2011 \3\
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NY:
    Bronx.......................................              36              33              29              27
    Kings.......................................              34              30              27              24
    Nassau \4\..................................             INC             INC              25              23
    New York \5\................................              37          \6\ 33          \6\ 31              27
    Orange......................................              28              26              24              21
    Queens......................................              32              30              28              25
    Richmond....................................              30              29              26              24
    Rockland....................................              NM              NM              NM              NM
    Suffolk.....................................              29              26              25              22
    Westchester.................................              32              29              28              23
NJ:
    Bergen......................................              35              31              28              24
    Essex \7\...................................             INC          \6\ 30          \6\ 26              24
    Hudson......................................              38              32              29              26
    Mercer......................................              33              29              27              28
    Middlesex...................................              31              27              23              21
    Monmouth....................................              NM              NM              NM              NM
    Morris......................................              29              26              23              24
    Passaic.....................................              33              30             INC              25
    Somerset....................................              NM              NM              NM              NM
    Union.......................................              36          \6\ 32              30              33
CT:
    Fairfield...................................              33              31              28              29
    New Haven...................................              34              31              29              28
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NM--No monitor located in county.
INC--All counties listed as INC did not meet 75 percent data completeness requirement for the relevant time
  period.

    EPA's review of monitoring data indicates that, for the periods of
2007-2009 and 2008-2010 and 2011, the NY-NJ-CT PM2.5
nonattainment area has met, and continues to meet, the 2006 24-hour
PM2.5 NAAQS. EPA is soliciting public comments on the issues
discussed in this document. These comments will be considered before
taking final action.
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    \2\ PM2.5 Design Values can be found at: http://www.epa.gov/airtrends/values.html.
    \3\ Data reported is the 98th percentile concentration from
certified, complete, and quality assured data for the highest
reading monitor in the county for 2011.
    \4\ The monitor located in Nassau County had incomplete data for
2007 which lead to the inability to calculate design values for the
periods of 2005-2007, 2006-2008, and 2007-2009. The monitor did not
show previous violations and therefore it was deemed that
determining the design values though alternative procedures was not
necessary. The 2008-2010 design value was 25 [micro]g/m\3\.
    \5\ The monitor in New York County located at Public School 59
was the highest reading monitor in the County at the time EPA made
designations for the 2006 PM2.5 NAAQS. Midway through
2008, the monitor at PS 59 was shut down due to the demolition of
the building site. Missing 2008 data had an effect on calculating
the design value for the 24-hour standard. EPA used an alternative
procedure to determine the design value for the 24-hour standard. A
description of the alternate procedure can be found in Section V.
Detailed information on this alternative procedure can be found in
the Technical Support Document.
    \6\ Design Value was calculated using the alternative procedure
described in Section V. Detailed information on this alternative
procedure can be found in the Technical Support Document.
    \7\ The air monitor at the Newark Willis Center station in Essex
County was discontinued on July 24, 2008 due to an unexpected loss
of access, and replaced with a new monitor at the Newark Firehouse.
PM2.5 monitoring was established at the firehouse on May
13, 2009. EPA used an alternative procedure to determine the design
value for the 24-hour standard. A description of the alternate
procedure can be found in Section V. Detailed information on this
alternative procedure can be found in the Technical Support
Document.
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V. How did EPA address missing data?

    Data handling conventions and computations necessary for
determining whether areas have met the PM2.5 NAAQS,
including requirements for data completeness, are listed in Appendix N
of 40 CFR part 50. A year meets data completeness requirements when at
least 75 percent of the scheduled sampling days for each quarter have
valid data. The use of less than complete data is subject to the
approval of EPA, which may consider factors such as monitoring site
closures/relocation, monitoring diligence, and nearby concentrations in
determining whether to use such data as set forth at 40 CFR part 50,
Appendix N, section 4.1(c). Five monitors in the NY-NJ-CT
PM2.5 nonattainment area with less than complete data were
examined to determine if the monitors would have attained the 24-hour
PM2.5 NAAQS had

they collected complete data. EPA had previously addressed less than
complete data in the determination of attainment for the NY-NJ-CT
PM2.5 nonattainment area for the 1997 annual standard NAAQS
(see 75 FR 45076, 45079 (August 2, 2010), 75 FR 69589 (November 15,
2010)). The same statistical based method used to examine less than
complete data for the 1997 annual PM2.5 NAAQS was used for
this action regarding the 2006 24-hour PM2.5 NAAQS.
    The statistical method used addressed less than complete data by
determining if a monitor would have been in attainment of the NAAQS had
it operated to completeness from 2007-2009 and 2008-2010. The approach
summarized in this section, and further described in the TSD, may or
may not be appropriate for other areas with less than complete data.
EPA will determine the appropriateness of this analytical approach for
each area with less than complete data on a case-by-case basis. In this
case, EPA has determined that it is appropriate to use this statistical
method for the NY-NJ-CT PM2.5 nonattainment area due to the
adequateness of the monitoring network in the nonattainment area,
historical air quality trends, and valid explanations for completeness
issues.
    EPA determined the adequacy of the monitoring network by examining
the number and placement of monitors located in the nonattainment area
through annual monitoring reviews and approval of network plans. The
NY-NJ-CT PM2.5 nonattainment area is required to have 3
monitors and the nonattainment area had 42 in 2009. The States of New
York, New Jersey, and Connecticut meet annually with EPA to discuss
issues or concerns with air monitoring, data, and network. The three
states also have approved network plans. Copies of the approved annual
network review letters are available in the TSD.

Methodology

    The method used to determine the design value for monitors with
incomplete data involves establishing a linear relationship between
incomplete monitors and another site in the NY-NJ-CT PM2.5
nonattainment area that has more complete data for the missing period
and has a substantial number of samples in common over the period of
interest. The same method was used for each incomplete monitor that had
previously violated the NAAQS. The monitor in the nonattainment area
that had complete data and had the highest correlation with an
incomplete monitor was used to develop a regression equation. The
regression equation was used to estimate values for the missing
quarters of data for an incomplete monitor. The design value for each
incomplete monitor was then calculated using the estimated values to
fill in for the missing quarters. The estimated design value was then
analyzed using a bootstrapping statistical method. Bootstrapping
involves the use of regression residuals and repeating the regression
analysis 1000 times. There were no exceedances of the NAAQS as a result
of the bootstrapping analysis.
    The result of the analysis determined that the design value for 5
monitoring sites that: (1) Had incomplete monitoring data during 2006-
2008, 2007-2009, and/or 2008-2010, (2) had previously violated the 2006
annual PM2.5 NAAQS, and (3) did not have clean data
subsequent to their latest violation, would be below the 2006 24-hour
PM2.5 NAAQS of 35.0 [micro]g/m\3\ if they had operated the
entire monitoring time period. The 5 previously incomplete sites in the
NY-NJ-CT PM2.5 nonattainment area were: Newark-Willis Center
in Essex County, NJ; Elizabeth Lab in Union County, NJ (only incomplete
for 2007-2009); and PS 59, Canal Street, and PS 19, in New York County,
NY. The detailed statistical analysis performed to obtain the completed
design values for these monitors can be found in the TSD.

VI. Proposed Action

    EPA is proposing to determine that the NY-NJ-CT PM2.5
nonattainment area for the 2006 24-hour PM2.5 NAAQS has
attained the 2006 24-hour PM2.5 NAAQS for the 2007-2009 and
2008-2010 monitoring periods and continues to attain the standard based
on data through 2011. As provided in 40 CFR 51.1004(c), if EPA
finalizes this determination, it would suspend the requirements for
this area to submit attainment demonstrations, reasonably available
control measures, reasonable further progress plans, and contingency
measures related to attainment of the 2006 24-hour PM2.5
NAAQS so long as the area continues to attain the 2006 24-hour
PM2.5 NAAQS.

VIII. Statutory and Executive Order Reviews

    This action proposes to make a determination based on air quality
data, and would, if finalized, result in the suspension of certain
Federal requirements. For that reason, this proposed action:
    Is not a significant regulatory action subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);
    Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
    Is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);
    Does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4);
    Does not have Federalism implications as specified in Executive
Order 13132 (64 FR 43255, August 10, 1999);
    Is not an economically significant regulatory action based on
health or safety risks subject to Executive Order 13045 (62 FR 19885,
April 23, 1997);
    Is not a significant regulatory action subject to Executive Order
13211 (66 FR 28355, May 22, 2001);
    Is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with
the CAA; and
    Does not provide EPA with the discretionary authority to address,
as appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have Tribal implications, as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on Tribal governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Particulate
matter, Reporting and recordkeeping requirements.

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

    Dated: July 31, 2012.
Judith A. Enck,
Regional Administrator, Region 2.
    Dated: August 7, 2012.
H. Curtis Spalding,
Regional Administrator, Region 1.
[FR Doc. 2012-21483 Filed 8-29-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60707-60708]
[FR Doc No: 2016-21177]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Generic Drug User Fee Act Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements of the Animal Generic Drug User Fee Act (AGDUFA) cover
sheet.

DATES: Submit either electronic or written comments on the collection
of information by November 1, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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 submission):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0655 for ``Animal Generic Drug User Fee Act Cover Sheet.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the

claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,]
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Form FDA 3728, Animal Generic User Fee Act Cover Sheet--21 U.S.C. 379j-
21 OMB Control Number 0910-0632--Extension

    Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 379j-21) establishes three different kinds of user
fees: (1) Fees for certain types of abbreviated applications for
generic new animal drugs; (2) annual fees for certain generic new
animal drug products; and (3) annual fees for certain sponsors of
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). Because concurrent submission of user fees with
applications is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3728 is the AGDUFA Cover Sheet,
which is designed to provide the minimum necessary information to
determine whether a fee is required for review of an application, to
determine the amount of the fee required, and to account for and track
user fees.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                            Form FDA No.                                Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
3728...............................................................              20                2               40     .08 (5 min.)              3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information

    Respondents to this collection of information are generic animal
drug applicants. Based on FDA's data base system, there are an
estimated 20 sponsors of new animal drugs potentially subject to
AGDUFA.

    Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21177 Filed 9-1-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19717-19718]
[FR Doc No: 2013-07568]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Clinical Chemistry and Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee: Notice of Change of Meeting
Schedule

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of Wednesday, February 27, 2013
(78 FR 13347). The meeting was shortened to one day, as it was later
determined that in order to be more financially prudent all three
topics could fit into one day.

FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>301-796-7047, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). Please call the Information Line for up-to-date information on
this meeting.

SUPPLEMENTARY INFORMATION: In FR doc. 2013-04543, appearing on page
13347 in the Federal Register of Wednesday, February 27, 2013, the
following correction is made:
    1. On page 13347, in the first column, under the section entitled
``Date and Time'', the date is corrected to be April 25, 2013.
    2. On page 13347, in the second column, the section entitled
``Agenda'' is corrected to read as follows:
    Agenda: On April 25, 2013, the committee will discuss and make
recommendations on the appropriate regulatory classification for
diagnostic devices known as methotrexate enzyme immunoassays.
Methotrexate enzyme immunoassays are considered pre-Amendment devices
since they were in commercial distribution prior to May 28, 1976, when
the Medical Device Amendments became effective. Methotrexate enzyme
immunoassays are currently regulated under the heading of ``Enzyme
Immunoassay, Methotrexate,'' Product Code LAO, as unclassified under
the 510(k) premarket notification authority. Methotrexate enzyme
immunoassays are for the quantitative determination of methotrexate.
The measurements obtained are used in monitoring levels of methotrexate
to ensure appropriate drug therapy. FDA is seeking panel input on the
safety and effectiveness of methotrexate enzyme immunoassays.
    The committee will also discuss and make recommendations on the
appropriate regulatory classification for diagnostic devices known as
phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP
enzyme immunoassays and PCP radioimmunoassays are considered pre-
Amendment devices since they were in commercial distribution prior to
May 28, 1976 when the Medical Device Amendments became effective. PCP
enzyme immunoassays are currently regulated under the heading of
``Enzyme Immunoassay, Phencyclidine,'' Product Code LCM, and
``Radioimmunoassay, Phencyclidine,'' Product Code LCL, as unclassified
under the 510(k) premarket notification authority. FDA is seeking panel
input on the safety and effectiveness of PCP enzyme immunoassays and
PCP radioimmunoassays.
    The committee will also discuss and make recommendations on the
appropriate regulatory classification for diagnostic devices known as
isoniazid test strips. Isoniazid test strips are considered pre-
Amendment devices since they were in commercial distribution prior to
May 28, 1976 when the Medical Device Amendments became effective.
Isoniazid test strips are currently regulated under the heading of
``Strip, Test Isoniazid,'' Product Code MIG, as unclassified under the
510(k) premarket notification authority. Isoniazid test strips are a
qualitative assay used for detecting isonicotinic acid and its
metabolites in

urine to determine compliance of isoniazid (INH) medication. FDA is
seeking panel input on the safety and effectiveness of isoniazid test
strips.
    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.
    3. On page 13347, in the third column, the section entitled
``Procedure'' is corrected to read as follows:
    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 April 16,
2013. On April 25, 2013, oral presentations from the public regarding
Methotrexate Test Systems will be scheduled between approximately 9:15
a.m. and 9:45 a.m.; regarding phencyclidine (PCP) Test Systems between
approximately 1:55 p.m. and 2:25 p.m.; and regarding Isoniazid Test
Systems between approximately 4:15 p.m. and 4:45 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 April 8, 2013. 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 April 9, 2013.

    Dated: March 27, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-07568 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Notices]
[Pages 57468-57469]
[FR Doc No: 2018-24881]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP19-238-001.
    Applicants: Southwest Gas Transmission Company, A Limited
Partnership.
    Description: Tariff Amendment: Stipulation in Lieu of Filing Form
501-G to be effective 1/1/2019.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5125.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-245-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement-
CapacityRelease Macquarie 11072018 to be effective 11/7/2018.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5069.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-246-000.
    Applicants: Saltville Gas Storage Company L.L.C.
    Description: Sec.  4(d) Rate Filing: SGSC RCC In-service Filing to
be effective 12/1/2018.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5070.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-247-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Yankee
release to Direct Energy 798171 to be effective 11/8/2018.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5076.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-248-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt
(Newfield 18) to be effective 11/7/2018.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5078.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-249-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2018-11-07 Encana to
be effective 11/7/2018.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5110.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-250-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Aethon/1849 Energy Negotiated
Rate to be effective 11/2/2018.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5116.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-251-000.
    Applicants: Gulf Shore Energy Partners, LP.
    Description: eTariff filing per 1430: Form 501G Filing.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5117.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-252-000.
    Applicants: Gulf Shore Energy Partners, LP.
    Description: Sec.  4(d) Rate Filing: Limited Section 4 Rate Filing
to be effective 11/7/2018.
    Filed Date: 11/7/18.
    Accession Number: 20181107-5118.
    Comments Due: 5 p.m. ET 11/19/18.

    Docket Numbers: RP19-253-000.
    Applicants: Dominion Energy Questar Pipeline, LLC.
    Description: eTariff filing per 1430: Form 501-G of Dominion Energy
Questar Pipeline, LLC.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5000.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-254-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: eTariff filing per 1430: Filing in Compliance with
Order No. 849--Form No. 501-G.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5001.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-255-000.
    Applicants: Lucid Energy Delaware, LLC, EOG Resources, Inc.
    Description: Joint Petition for Temporary Waiver of Capacity
Release Regulations and Policies, et al. of Lucid Energy Delaware, LLC,
et al. under RP19-255.

    Filed Date: 11/7/18.
    Accession Number: 20181107-5139.
    Comments Due: 5 p.m. ET 11/14/18.

    Docket Numbers: RP19-256-000.
    Applicants: Fayetteville Express Pipeline LLC.
    Description: eTariff filing per 1430: FERC Form No. 501-G Report.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5002.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-257-000.
    Applicants: Southwest Gas Storage Company.
    Description: eTariff filing per 1430: FERC Form No. 501-G Report.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5003.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-258-000.
    Applicants: Lake Charles LNG Company, LLC.
    Description: eTariff filing per 1430: FERC Form No. 501-G Report.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5004.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-259-000.
    Applicants: Gulf States Transmission LLC.
    Description: eTariff filing per 1430: FERC Form No. 501-G Report.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5005.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-260-000.
    Applicants: Bison Pipeline LLC.
    Description: eTariff filing per 1430: Bison Form No. 501-G Filing.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5027.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-261-000.
    Applicants: Blue Lake Gas Storage Company.
    Description: Compliance filing Blue Lake 501-G Settlement.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5028.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-262-000.
    Applicants: Hardy Storage Company, LLC.
    Description: Compliance filing Hardy Storage 501-G Settlement.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5029.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-263-000.
    Applicants: Black Hills Shoshone Pipeline, LLC.
    Description: eTariff filing per 1430: BHS FERC 501-G Filing.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5030.
    Comments Due: 5 p.m. ET 11/20/18.

    Docket Numbers: RP19-264-000.
    Applicants: PGPipeline LLC.
    Description: eTariff filing per 1430: PGPipeline LLC FERC Form 501-
G Filing.
    Filed Date: 11/8/18.
    Accession Number: 20181108-5031.
    Comments Due: 5 p.m. ET 11/20/18.

    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: November 8, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-24881 Filed 11-14-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34347-34348]
[FR Doc No: 2016-12655]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-0403]

Determination That LEVOTHROID (Levothyroxine Sodium) Tablets,
0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram,
0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram,
0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were
Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that LEVOTHROID

(levothyroxine sodium) tablets, 0.025 milligram (mg), 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125
mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Reena Raman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002, 301-
796-7577.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg, are the subject of NDA 021116, held by Lloyd Inc.,
and initially approved on October 24, 2002. LEVOTHROID is used for the
following indications:
     Hypothyroidism--As replacement or supplemental therapy in
congenital or acquired hypothyroidism of any etiology, except transient
hypothyroidism during the recovery phase of subacute thyroiditis.
Specific indications include: Primary (thyroidal), secondary
(pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical
hypothyroidism. Primary hypothyroidism may result from functional
deficiency, primary atrophy, partial or total congenital absence of the
thyroid gland, or from the effects of surgery, radiation, or drugs,
with or without the presence of goiter.
     Pituitary Thyrotropine-Stimulating Hormone Suppression--In
the treatment or prevention of various types of euthyroid goiters,
including thyroid nodules, subacute or chronic lymphocytic thyroiditis
(Hashimoto's thyroiditis), multinodular goiter, and as an adjunct to
surgery and radioiodine therapy in the management of thyrotropin-
dependent well-differentiated thyroid cancer.
    LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition
dated February 4, 2015 (Docket No. FDA-2015-P-0403), under 21 CFR
10.30, requesting that the Agency determine whether LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, were withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that LEVOTHROID (levothyroxine sodium) tablets,
0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that this drug product was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
found no information that would indicate that this drug product was
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, in the ``Discontinued Drug Product List'' section of the Orange
Book. The ``Discontinued Drug Product List'' delineates, among other
items, drug products that have been discontinued from marketing for
reasons other than safety or effectiveness. ANDAs that refer to this
drug product may be approved by the Agency as long as they meet all
other legal and regulatory requirements for the approval of ANDAs. If
FDA determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12655 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 67030-67032]
[FR Doc No: 2020-23259]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90202; File No. SR-NASDAQ-2020-070]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rule 11890 (Clearly Erroneous Transactions)

October 15, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 13, 2020, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the current pilot program related
to Nasdaq Rule 11890 (Clearly Erroneous Transactions) to the close of
business on April 20, 2021.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to extend the current
pilot program related to Rule 11890, Clearly Erroneous Transactions, to
the close of business on April 20, 2021. The pilot program is currently
due to expire on October 20, 2020.
    On September 10, 2010, the Commission approved, on a pilot basis,
changes to Rule 11890 that, among other things: (i) Provided for
uniform treatment of clearly erroneous execution reviews in multi-stock
events involving twenty or more securities; and (ii) reduced the
ability of the Exchange to deviate from the objective standards set
forth in the rule.\3\ In 2013, the Exchange adopted a provision
designed to address the operation of the Plan.\4\ Finally, in 2014, the
Exchange adopted two additional provisions providing that: (i) A series
of transactions in a particular security on one or more trading days
may be viewed as one event if all such transactions were effected based
on the same fundamentally incorrect or grossly misinterpreted issuance
information resulting in a severe valuation error for all such
transactions; and (ii) in the event of any disruption or malfunction in
the operation of the electronic communications and trading facilities
of an Exchange, another SRO, or responsible single plan processor in
connection with the transmittal or receipt of a trading halt, an
Officer, acting on his or her own motion, shall nullify any transaction
that occurs after a trading halt has been declared by the primary
listing market for a security and before such trading halt has
officially ended according to the primary listing market.\5\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 62886 (September 10,
2010), 75 FR 56613 (September 16, 2010) (SR-NASDAQ-2010-076).
    \4\ See Securities Exchange Act Release No. 68819 (February 1,
2013), 78 FR 9438 (February 8, 2013) (SR-NASDAQ-2013-022).
    \5\ See Securities Exchange Act Release No. 72434 (June 19,
2014), 79 FR 36110 (June 25, 2014) (SR-NASDAQ-2014-044).
---------------------------------------------------------------------------

    These changes were originally scheduled to operate for a pilot
period to coincide with the pilot period for the Plan to Address
Extraordinary Market Volatility (the ``Limit Up-Limit Down Plan'' or
``LULD Plan'').\6\ In April 2019, the Commission approved an amendment
to the LULD Plan for it to operate on a permanent, rather than pilot,
basis.\7\ In light of that change, the Exchange amended Rule 11890 to
untie the pilot program's effectiveness from that of the LULD Plan and
to extend the pilot's effectiveness to the close of business on October
18, 2019.\8\ The Exchange later amended Rule 11890 to extend the
pilot's effectiveness to the close of business on April 20, 2020,\9\
and subsequently, to the close of business on October 20, 2020.\10\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
    \7\ See Securities Exchange Act Release No. 85623 (April 11,
2019), 84 FR 16086 (April 17, 2019) (approving Eighteenth Amendment
to LULD Plan).
    \8\ See Securities Exchange Act Release No. 85603 (April 11,
2019), 84 FR 16064 (April 17, 2019) (SR-NASDAQ-2019-028).
    \9\ See Securities Exchange Act Release No. 87358 (October 18,
2019), 84 FR 57129 (October 24, 2019) (SR-NASDAQ-2019-085).
    \10\ See Securities Exchange Act Release No. 88504 (March 27,
2020), 85 FR 18598 (April 2, 2020) (SR-NASDAQ-2020-013).
---------------------------------------------------------------------------

    The Exchange now proposes to amend Rule 11890 to extend the pilot's
effectiveness for a further six months until the close of business on
April 20, 2021. If the pilot period is not either

extended, replaced or approved as permanent, the prior versions of
paragraphs (a)(2)(C), (c)(1), (b)(i), and (b)(ii) shall be in effect,
and the provisions of paragraphs (g) through (i) shall be null and
void.\11\ In such an event, the remaining sections of Rule 11890 would
continue to apply to all transactions executed on the Exchange. The
Exchange understands that the other national securities exchanges and
Financial Industry Regulatory Authority (``FINRA'') will also file
similar proposals to extend their respective clearly erroneous
execution pilot programs, the substance of which are identical to Rule
11890.
---------------------------------------------------------------------------

    \11\ See notes 3-5, supra. The prior versions of paragraphs
(a)(2)(C), (c)(1), (b)(i), and (b)(ii) generally provided greater
discretion to the Exchange with respect to breaking erroneous
trades.
---------------------------------------------------------------------------

    The Exchange does not propose any additional changes to Rule 11890.
Extending the effectiveness of Rule 11890 for an additional six months
will provide the Exchange and other self-regulatory organizations
additional time to consider whether further amendments to the clearly
erroneous execution rules are appropriate.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\12\ in general, and
Section 6(b)(5) of the Act,\13\ in particular, in that it is designed
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest and not to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change promotes just
and equitable principles of trade in that it promotes transparency and
uniformity across markets concerning review of transactions as clearly
erroneous. The Exchange believes that extending the clearly erroneous
execution pilot under Rule 11890 for an additional six months would
help assure that the determination of whether a clearly erroneous trade
has occurred will be based on clear and objective criteria, and that
the resolution of the incident will occur promptly through a
transparent process. The proposed rule change would also help assure
consistent results in handling erroneous trades across the U.S.
equities markets, thus furthering fair and orderly markets, the
protection of investors and the public interest. Based on the
foregoing, the Exchange believes the amended clearly erroneous
executions rule should continue to be in effect on a pilot basis while
the Exchange and other self-regulatory organizations consider whether
further amendments to these rules are appropriate.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposal would ensure
the continued, uninterrupted operation of harmonized clearly erroneous
execution rules across the U.S. equities markets while the Exchange and
other self-regulatory organizations consider whether further amendments
to these rules are appropriate. The Exchange understands that the other
national securities exchanges and FINRA will also file similar
proposals to extend their respective clearly erroneous execution pilot
programs. Thus, the proposed rule change will help to ensure
consistency across market centers without implicating any competitive
issues.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \14\ and Rule 19b-
4(f)(6) thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \17\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become effective and operative immediately upon filing.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the current clearly erroneous execution pilot program to
continue uninterrupted, without any changes, while the Exchange and the
other national securities exchanges consider a permanent proposal for
clearly erroneous execution reviews. For this reason, the Commission
hereby waives the 30-day operative delay and designates the proposed
rule change as operative upon filing.\18\
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2020-070 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2020-070. This
file number should be included on the

subject line if email is used. To help the Commission process and
review your comments more efficiently, please use only one method. The
Commission will post all comments on the Commission's internet website
(http://www.sec.gov/rules/sro.shtml). Copies of the submission, all
subsequent amendments, all written statements with respect to the
proposed rule change that are filed with the Commission, and all
written communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NASDAQ-2020-070 and should be submitted on or before November 12, 2020.
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-23259 Filed 10-20-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 17, 2007 (Volume 72, Number 136)]
[Notices]
[Page 39094-39095]
[DOCID:fr17jy07-76]

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

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 19h-1; SEC File No. 270-247; OMB Control No. 3235-0259.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget a
request for extension of the previously approved collection of
information discussed below.
     Rule 19h-1 (17 CFR 240.19h-1): SRO notification of
admission and/or continuance despite statutory disqualification.
    Rule 19h-1 (``Rule'') under the Securities Exchange Act of 1934 (15

U.S.C. 78a et seq.) prescribes the form and content of notices and
applications by self-regulatory organizations (``SROs'') regarding
proposed admissions to, or continuances in, membership, participation
or association with a member of any person subject to a statutory
disqualification.
    The Commission uses the information provided in the submissions
filed pursuant to Rule 19h-1 to review decisions by SROs to permit the
entry into or continuance in the securities business of persons who
have committed serious misconduct. The filings submitted pursuant to
the Rule also permit inclusion of an application to the Commission for
consent to associate with a member of an SRO notwithstanding a
Commission order barring such association.
    The Commission reviews filings made pursuant to the Rule to
ascertain whether it is in the public interest to permit the employment
in the securities business of persons subject to statutory
disqualification. The filings contain information that is essential to
the staff's review and ultimate determination on whether an association
or employment is in the public interest and consistent with investor
protection.
    It is estimated that approximately 5 respondents will make
submissions pursuant to this rule annually and that they each will make
5 responses, for a total burden of 200 hours, based upon past
submissions (25 x 8 = 200). The staff estimates that the average number
of hours necessary to complete a submission pursuant to Rule 19h-1 is 8
hours. The average cost per hour for completion of a submission is
approximately $101. Therefore, the total cost of compliance for the
respondents is $20,200. (25 responses x 8 hours per response x $101 per
hour).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    General comments regarding the estimated burden hours should be
directed to the following persons: (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or send an e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief Information

Officer, Securities and Exchange Commission, C/O Shirley Martinson,
6432 General Green Way, Alexandria, VA 22312 or send an e-mail to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days

of this notice.

    Dated: July 9, 2007.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-13746 Filed 7-16-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Page 73645]
[FR Doc No: 2012-29850]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meeting related to the transmission planning activities of the Southern
Company Services, Inc.:

Southeastern Regional Transmission Planning Process (SERTP) Interim
Stakeholders' Meeting on Order No. 1000

December 12, 2012, 9:00 a.m.-3:00 p.m., Local Time

    The above-referenced meeting will be held at:
Georgia Transmission Corporation (GTC) Headquarters--Tucker, Georgia
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: www.southeasternrtp.com.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:
Docket No. ER12-337, Mississippi Power Company
    For more information, contact Valerie Martin, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (202) 502-
6139 or<EMAIL_ADDRESS>
    Dated: December 5, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-29850 Filed 12-10-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Page 70106]
[FR Doc No: 2016-24472]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD16-23-000]

California American Water, Southern Division; Notice of
Preliminary Determination of a Qualifying Conduit Hydropower Facility
and Soliciting Comments and Motions To Intervene

    On September 28, 2016, the California American Water, Southern
Division filed a notice of intent to construct a qualifying conduit
hydropower facility, pursuant to section 30 of the Federal Power Act
(FPA), as amended by section 4 of the Hydropower Regulatory Efficiency
Act of 2013 (HREA). The proposed Highland Tank Pressure Reducing Valve
Modernization Project would have an installed capacity of 177 kilowatts
(kW) and would be located in the Highland Tank Pressure Reducing
Station on an existing 24-inch-diameter water supply pipe. The project
would be located near the City of San Diego in San Diego County,
California.
    Applicant Contact: Mark Reifer, California American Water, Southern
Division, 8657 Grand Avenue, Rosemead, CA 91770, Phone No. (626) 614-
2517.
    FERC Contact: Robert Bell, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) A proposed 10-foot long, 14-inch-diameter
intake pipe off the 24-inch main pipeline, (2) a proposed powerhouse
bypassing the existing pressure reducing valve station, containing two
generating units with a total installed capacity of 177-kW, (3) a
proposed 350-foot-long 14-inch diameter outlet pipe returning to the
24-inch main pipeline, and (4) appurtenant facilities. The proposed
project would have an estimated annual generating capacity of 916.650
megawatt-hours.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

                          Table 1--Criteria for Qualifying Conduit Hydropower Facility
----------------------------------------------------------------------------------------------------------------
              Statutory provision                                 Description                    Satisfies (Y/N)
----------------------------------------------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended by HREA...........  The conduit is a tunnel, canal, pipeline,                     Y
                                                 aqueduct, flume, ditch, or similar manmade
                                                 water conveyance that is operated for the
                                                 distribution of water for agricultural,
                                                 municipal, or industrial consumption and not
                                                 primarily for the generation of electricity.
FPA 30(a)(3)(C)(i), as amended by HREA........  The facility is constructed, operated, or                     Y
                                                 maintained for the generation of electric
                                                 power and uses for such generation only the
                                                 hydroelectric potential of a non-federally
                                                 owned conduit.
FPA 30(a)(3)(C)(ii), as amended by HREA.......  The facility has an installed capacity that                   Y
                                                 does not exceed 5 megawatts.
FPA 30(a)(3)(C)(iii), as amended by HREA......  On or before August 9, 2013, the facility is                  Y
                                                 not licensed, or exempted from the licensing
                                                 requirements of Part I of the FPA.
----------------------------------------------------------------------------------------------------------------

    Preliminary Determination: Based upon the above criteria,
Commission staff has preliminarily determined that the proposal
satisfies the requirements for a qualifying conduit hydropower facility
under 16 U.S.C. 823a, and is exempted from the licensing requirements
of the FPA.
    Comments and Motions To Intervene: The deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    The deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All comments contesting
Commission staff's preliminary determination that the facility meets
the qualifying criteria must set forth their evidentiary basis.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.2001-2005 (2015).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (e.g., CD16-23-000) in
the docket number field to access the document. For assistance, call
toll-free 1-866-208-3676 or email<EMAIL_ADDRESS>For TTY,
call<PHONE_NUMBER>.

    Dated: October 4, 2016.
Kimberly Bose,
Secretary.
[FR Doc. 2016-24472 Filed 10-7-16; 8:45 am]
BILLING CODE 6717-01-P