[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Notices]
[Pages 47348-47349]
[FR Doc No: 2018-20315]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2018-0023; OMB No. 1660-0070]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; National Fire Department Registry

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before October 19, 2018.

ADDRESSES: Submit written comments on the proposed information
collection

to the Office of Information and Regulatory Affairs, Office of
Management and Budget. Comments should be addressed to the Desk Officer
for the Department of Homeland Security, Federal Emergency Management
Agency, and sent via electronic mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Information Management Division, 500 C Street SW, Washington, DC 20472,
email address [email protected] or
Gayle Kelch, Statistician, FEMA, United States Fire Administration,
National Fire Data Center at<PHONE_NUMBER> or email
[email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on May 22, 2018 at 83 FR
23702 with a 60 day public comment period. No comments were received.
The purpose of this notice is to notify the public that FEMA will
submit the information collection abstracted below to the Office of
Management and Budget for review and clearance.

Collection of Information

    Title: National Fire Department Registry.
    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0070.
    FEMA Forms: FEMA Form 070-0-0-1, National Fire Department Registry.
    Abstract: This collection seeks to identify fire departments in the
United States to compile a database related to their demographics,
capabilities, and activities. The database is used to guide
programmatic decisions and provide information to the public and the
fire service.
    Affected Public: State, local, or Tribal government.
    Estimated Number of Respondents: 8,223.
    Estimated Number of Responses: 8,223.
    Estimated Total Annual Burden Hours: 2,067 hours.
    Estimated Total Annual Respondent Cost: $11,558.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $91,847.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Rachel Frier,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2018-20315 Filed 9-18-18; 8:45 am]
 BILLING CODE 9111-76-P


[Federal Register Volume 76, Number 200 (Monday, October 17, 2011)]
[Rules and Regulations]
[Pages 64009-64010]
[FR Doc No: 2011-26545]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0335]
RIN 1625-AA09

Drawbridge Operation Regulation; Apponagansett River, Dartmouth,
MA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard has changed the drawbridge operation
regulations that govern the operation of the Padanaram Bridge across
the Apponagansett River, mile 1.0, at Dartmouth, Massachusetts. The
owner of the bridge requested relief from crewing the bridge in the
early morning hours when there have been no requests to open the
bridge. It is expected that this change to the regulations would
provide relief to the bridge owner while continuing to meet the
reasonable needs of navigation.

DATES: This rule is effective November 16, 2011.

ADDRESSES: Comments and related materials received from the public, as
well as documents mentioned in this preamble as being available in the
docket, are part of docket USCG-2011-0335 and are available online by
going to http://www.regulations.gov, inserting USCG-2011-0335 in the
``Keyword'' box, and then clicking ``Search.'' This material is 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 rule,
call or e-mail Mr. John McDonald, Project Officer, First Coast Guard
District Bridge Branch,<PHONE_NUMBER><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

    On June 24, 2011, we published a notice of proposed rulemaking
(NPRM) entitled Drawbridge Operation Regulations Apponagansett River,
in the Federal Register (76 FR 37041). We received no comments in
response to the proposed rule. No public meeting was requested, and
none was held.

Basis and Purpose

    The Padanaram Bridge across the Apponagansett River, mile 1.0, at
Dartmouth, Massachusetts, has a vertical clearance in the closed
position of 9 feet at mean high water and 12 feet at mean low water.
The drawbridge operation regulations are listed at 33 CFR 117.587.
    The existing drawbridge operation regulations require the draw to
open on signal 1 May through 31 October from 5 a.m. to 9 p.m., daily.
The following intervals apply to open on signal: The bridge shall open
on signal, twice an hour, on the hour and the half hour between 5 a.m.
and 9 a.m. and between 8 p.m. and 9 p.m or on signal, once an hour, on
the hour between 9 a.m. and 8 p.m. At all other times the bridge shall
open if at least four hours advance notice is given.
    The Coast Guard received a request from the owner of the bridge,
the Town of Dartmouth, to change the drawbridge operation regulations
concerning the daily hours the bridge is crewed from 1 May through 31
October. The bridge owner requested to crew the bridge from 6 a.m.
through 9 p.m. instead of 5 a.m. through 9 p.m., daily.
    A review of the bridge opening logs reveals that the bridge has not
received any requests to open between 5 a.m. and 6 a.m. since 2009.
    As a result of the above information the Coast Guard believes it is
reasonable for the bridge owner to crew the Padanaram Bridge from 6
a.m. through 9 p.m., 1 May through 31 October, since there have been no
requests to open the bridge before 6 a.m.

Discussion of Comments and Changes

    The Coast Guard received no comments in response to the notice of
proposed rulemaking. As a result no changes were made to this final
rule.

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.

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, 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. There will not be a significant impact. This
conclusion is based on the fact that the bridge has not received any
requests to open between 5 a.m. and 6 a.m., daily, between May 1 and
October 31.

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 would affect the following entities, some of which
might be small entities: the owners or operators of vessels needing to
transit through the bridge between 1 May through 31 October from 5 a.m.
to 6 a.m. This rule would not have a significant economic impact on a
substantial number of small entities for the following reason:
    The bridge has not received any requests to open between 5 a.m. and
6 a.m., daily, between 1 May and 31 October, since 2009.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.

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,
eliminates 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 would not create an
environmental risk to health or risk to safety that might
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
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under figure 2-1,
paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.587, revise paragraphs (a) introductory text and (a)(1)
to read as follows:

Sec.  117.587  Apponagansett River.

    (a) The draw of the Padanaram Bridge, mile 1.0, shall open on
signal from 1 May through 31 October, between 6 a.m. and 9 p.m., daily,
as follows:
    (1) The bridge shall open on signal, twice an hour, on the hour and
half hour between 6 a.m. and 9 a.m. and between 8 p.m. and 9 p.m.
* * * * *

    Dated: September 16, 2011.
Daniel A. Neptun,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2011-26545 Filed 10-14-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33527-33529]
[FR Doc No: 2017-15189]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81144; File No. SR-ISE-2017-69]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Schedule of Fees in Connection With the ISE System Migration

July 14, 2017.
    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 July 3, 2017, Nasdaq ISE, LLC (``ISE'' 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Schedule of Fees to indicate the
treatment of various symbols which are migrating to INET technology in
July 2017.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, 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 amend the Schedule of
Fees to: (1) Exclude certain Select Symbols \3\ which will migrate to
INET from July 3rd through July 30th 2017 from the Market Maker Plus
\4\ Tiers for the month of July 2017; and (2) exclude certain activity
for certain Select Symbols which will migrate to INET on July 31, 2017
from the Market Maker Plus Tiers for the month of July 2017. Each rule
change will be described in greater detail below.
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    \3\ ``Select Symbols'' are options overlying all symbols listed
on ISE that are in the Penny Pilot Program.
    \4\ A Market Maker Plus is a Market Maker who is on the National
Best Bid or National Best Offer a specified percentage of the time
for series trading between $0.03 and $3.00 (for options whose
underlying stock's previous trading day's last sale price was less
than or equal to $100) and between $0.10 and $3.00 (for options
whose underlying stock's previous trading day's last sale price was
greater than $100) in premium in each of the front two expiration
months. The specified percentage is at least 80% but lower than 85%
of the time for Tier 1, at least 85% but lower than 95% of the time
for Tier 2, and at least 95% of the time for Tier 3. A Market
Maker's single best and single worst quoting days each month based
on the front two expiration months, on a per symbol basis, will be
excluded in calculating whether a Market Maker qualifies for this
rebate, if doing so will qualify a Market Maker for the rebate.
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    These rule changes are being made in connection with the migration
of the Exchange's trading system to the Nasdaq INET technology, which
began on June 12, 2017.\5\ On June 9, 2017, the Exchange filed a
proposed rule change that eliminated fees and rebates for trades in FX
Options that began trading on INET with the launch of the re-platformed
trading system.\6\ In addition, on June 27, 2017 the Exchange filed
another proposed rule change that eliminated fees and rebates for
trades in symbol KANG that began trading on INET on that date.\7\ The
Exchange recently filed a proposed rule change that eliminated fees and
rebates for trades executed on June 30, 2017 in the following symbols:
ACN, ACOR, AEO, AFSI, AMJ, AOBC, BKD, BTE, BV, CBI, CCL, CLR, CME, CNQ,
ADM, ADSK, AGNC, ASHR, BBT, BK, BSX, CIEN, and

IBM.\8\ Additionally, that rule change also proposed that activity in
the following Select Symbols will not be counted for purposes of
determining Market Maker Plus tiers: ADM, ADSK, AGNC, ASHR, BBT, BK,
BSX, CIEN, and IBM.\9\
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    \5\ See Securities Exchange Act Release No. 80432 (April 11,
2017), 82 FR 18191 (April 17, 2017) (SR-ISE-2017-03). See also
Options Trader Alert 2017-51.
    \6\ See Securities Exchange Act Release No. 80999 (June 22,
2017) 82 FR 29354 (June 28, 2017) (SR-ISE-2017-59).
    \7\ See SR-ISE-2017-63 (publication pending).
    \8\ See SR-ISE-2017-66 (publication pending).
    \9\ Id.
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Current Proposal--Number 1

    The Exchange proposes that Select Symbols which will migrate to
INET from July 3rd through July 30th 2017, as noticed by the Exchange
in Options Trader Alert #2017-51\10\ (``Migrated Symbols'') will not be
subject to Market Maker Plus Tiers 1-3 for the month of July 2017.
These Migrated Symbols will be subject to Market Maker Plus Tiers 1-3
as of August 1, 2017 and thereafter.
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    \10\ This alert contains a link to the specific symbols that
migrate on each date.
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    During the transition symbols will migrate from the legacy T7
system to the INET system. The two systems utilize different billing
systems. For ease of transition and to ensure that Members are not
impacted by the transition to a new billing system, the Exchange is
proposing to simply not apply the Market Maker Plus Tiers to the
symbols which will be transitioning from July 3rd through July 30th
2017 for the month of July 2017. In August 2017, the Migrated Symbols
will all be subject to the INET billing system and therefore the
Exchange would begin applying the Market Maker Plus Tiers at that time.
Current Proposal--Number 2
    The Exchange proposes to exclude Select Symbols which will migrate
to INET on July 31, 2017, as noticed by the Exchange at Options Trader
Alert #2017-51 (``July 31 Migrated Symbols'') and only include activity
from July 3, 2017 through July 30, 2017 for purposes of qualifying for
the Market Maker Plus Tiers for the month of July 2017.
    As noted above, since the July 31 Migrated Symbols will migrate
from the legacy T7 system to the INET system and utilize two different
billing systems the Exchange proposes this exclusion. The Exchange
believes that the exclusion will provide ease of transition and ensure
that Members are not impacted by the transition to a new billing
system. In August 2017, the July 31 Migrated Symbols will be subject to
the INET billing system and therefore the Exchange would begin applying
the Market Maker Plus Tiers at that time for the entire month of August
2017.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\11\ in general, and
Section 6(b)(4) of the Act,\12\ in particular, in that it is designed
to provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
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    \11\ 15 U.S.C. 78f.
    \12\ 15 U.S.C. 78f(b)(4).
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Current Proposal--Number 1
    The Exchange's proposal that Migrated Symbols will not be subject
to Market Maker Plus Tiers 1-3 for the month of July 2017 is reasonable
because the Exchange will utilize two billing systems with the
migration from legacy T7 to INET. For ease of transition and to ensure
that Members are not impacted by the transition to a new billing
system, the Exchange believes it is reasonable to not apply the Market
Maker Plus Tiers to the symbols which will be transitioning from July
3rd through July 30th 2017 for the month of July 2017. The new INET
system would result in higher performance, scalability, and more robust
architecture for ISE Members.
    The Exchange's proposal that Migrated Symbols will not be subject
to Market Maker Plus Tiers 1-3 for the month of July 2017 is equitable
and not unfairly discriminatory as it will apply to all transactions in
Migrated Symbols on INET.
Current Proposal--Number 2
    The Exchange's proposal that July 31 Migrated Symbols will only
include activity from July 3, 2017 through July 30, 2017 for purposes
of qualifying for the Market Maker Plus Tiers for the month of July
2017 is reasonable because the Exchange will utilize two billing
systems with the migration from legacy T7 to INET. For ease of
transition and to ensure that Members are not impacted by the
transition to a new billing system, the Exchange believes it is
reasonable to exclude the July 31, 2017 trading activity from the
Market Maker Plus Tiers for the July 31 Migrated Symbols and only apply
activity from July 3rd through July 30th 2017 for purposes of
qualifying for the Market Maker Plus Tiers for the month of July 2017.
The new INET system would result in higher performance, scalability,
and more robust architecture for ISE Members.
    The Exchange's proposal to exclude activity for July 31, 2017 for
the July 31 Migrated Symbols qualification for July 2017 and only
include activity from July 3, 2017 through July 30, 2017 for purposes
of qualifying for the Market Maker Plus Tiers for the month of July
2017 is equitable and not unfairly discriminatory as it will apply to
all transactions in July 31 Migrated Symbols on INET.

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

    In accordance with Section 6(b)(8) of the Act,\13\ the Exchange
does not believe that the proposed rule changes will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
changes are intended to ease members' transition to the re-platformed
INET trading system and is not designed to have any significant
competitive impact. The proposed changes will apply to all transactions
in both the Migrated Symbols and the July 31 Migrated Symbols. The
Exchange operates in a highly competitive market in which market
participants can readily direct their order flow to competing venues.
In such an environment, the Exchange must continually review, and
consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed fee changes reflect this competitive environment.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b)(8).
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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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\14\ and Rule 19b-4(f)(2) \15\ thereunder.
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: (i) Necessary or
appropriate in the public interest; (ii) for the protection of
investors; or (iii) 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.
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    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \15\ 17 CFR 240.19b-4(f)(2).

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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-ISE-2017-69 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-ISE-2017-69. 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 Web site (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 Web site 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2017-69 and should be
submitted on or before August 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Jill M. Peterson,
Assistant Secretary.
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    \16\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2017-15189 Filed 7-19-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]
[Page 19497-19498]
[DOCID:fr10ap08-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13023-000]

Michael D. Mason; Notice of Application Accepted for Filingand
Soliciting Comments, Protests, and Motions to Intervene

April 3, 2008.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 13023-000.
    c. Date filed: September 17, 2007.
    d. Applicant: Michael D. Mason.
    e. Name and Location of Project: The proposed Upper Kiser Creek
Hydroelectric Project would be located on Kiser Creek in Delta County,
Colorado and would be entirely located in the Grand Mesa National
Forest.
    f. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    g. Applicant contact: Mr. Michael D. Mason; 26380 Cedar Mesa Road,
Cedaredge, CO 81413,<PHONE_NUMBER>.
    h. FERC Contact: Tom Papsidero,<PHONE_NUMBER>.
    i. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-13023-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    j. Description of Existing Facilities and Proposed Project: The
proposed project would consist of: (1) A proposed diversion structure;
(2) a proposed 5,755-foot-long, 16-inch-diameter plastic/steel
penstock, (3) a proposed powerhouse containing one generator unit with
a total installed capacity of 644 kilowatts, (4) a proposed 918-foot-
long 12-kV transmission line interconnection, and (5) appurtenant
facilities. The project would have an annual generation of 1.5 GWh
which would be sold to a local utility.
    k. Location of Applications: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site at http://
www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY,

call<PHONE_NUMBER>. A copy is also available for inspection and
reproduction at the address in item g above.
    l. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    m. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    n. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    p. Proposed Scope of Studies under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    q. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    r. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', or ``MOTION TO INTERVENE'', as applicable, and the Project
Number of the particular application to which the filing refers. Any of
the above-named documents must be filed by providing the original and
the number of copies provided by the Commission's regulations to: The
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. An additional copy must be sent to Director,
Division of Hydropower Administration and Compliance, Federal Energy
Regulatory Commission, at the above-mentioned address. A copy of any
notice of intent, competing application or motion to intervene must
also be served upon each representative of the Applicant specified in
the particular application.
    s. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-7602 Filed 4-9-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 30 (Wednesday, February 17, 2021)]
[Notices]
[Pages 9924-9925]
[FR Doc No: 2021-03159]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4451-024]

Green Mountain Power Corporation, City of Somersworth, New
Hampshire; Notice of Application Ready for Environmental Analysis and
Soliciting Comments, Recommendations, Terms and Conditions, and
Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent Minor License.
    b. Project No.: 4451-024.
    c. Date filed: April 30, 2020.
    d. Applicants: Green Mountain Power and the City of Somersworth,
New Hampshire.
    e. Name of Project: Lower Great Falls Hydroelectric Project.
    f. Location: On the Salmon Falls River in Strafford County, New
Hampshire, and York County, Maine. The project does not occupy federal
land.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. John Greenan, Green Mountain Power
Corporation, 1252 Post Road, Rutland, VT 05701; Phone at (802) 770-
2195, or email at<EMAIL_ADDRESS>    i. FERC Contact: Amanda Gill,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
https://ferconline.ferc.gov/QuickComment.aspx. 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, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include docket
number P-4451-024.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted and is ready for
environmental analysis at this time.
    The Council on Environmental Quality (CEQ) issued a final rule on
July 15, 2020, revising the regulations under 40 CFR parts 1500-1518
that federal agencies use to implement the National Environmental
Policy Act (NEPA) (see Update to the Regulations Implementing the
Procedural Provisions of the National Environmental Policy Act, 85 FR
43,304). The Final Rule became effective on and applies to any NEPA

process begun after September 14, 2020. An agency may also apply the
regulations to ongoing activities and environmental documents begun
before September 14, 2020, which includes the proposed Lower Great
Falls Hydroelectric Project relicensing. Commission staff intends to
conduct its NEPA review in accordance with CEQ's new regulations.
    l. Project Description: The existing Lower Great Falls
Hydroelectric Project consists of: (1) A 297-foot-long, 32-foot-high
stone masonry and concrete dam that includes the following sections:
(a) a 176-foot-long spillway section with a crest elevation of 102.37
feet National Geodetic Vertical Datum of 1929 (NGVD) and 4-foot-high
flashboards at an elevation of 106.37 feet NGVD at the top of the
flashboards; (b) a 50-foot-long left abutment section with two 8-foot-
wide, 8-foot-high low-level outlet gates (only one of which is
operational), that control flow into two 7-foot-diameter, 40-foot-long
outlet pipes; and (c) a 71-foot-long right abutment section; (2) a 40-
acre impoundment with a normal elevation of 106.37 feet NGVD; (3) a
40.5-foot-wide, 20-foot-high intake structure with four 5-foot-wide,
10.5-foot-high steel frame gates and a trashrack with 2-inch bar
spacing; (4) an 8.5-foot-diameter, 120-foot-long steel penstock that
bifurcates into a 5.3-foot-diameter, 85-foot-long section and a 7.6-
foot-diameter, 85-foot-long section; (5) an 8.5-foot-diameter, 140-
foot-long steel penstock that bifurcates into a 7-foot-diameter, 85-
foot-long section and a 7.6-foot-diameter, 85-foot-long section; (6) a
46-foot-long, 30-foot-wide concrete and brick powerhouse with two 260-
kilowatt (kW) F-type Francis turbine-generator units and two 380-kW F-
type Francis turbine-generator units, for a total installed capacity of
1.28 megawatts; (7) a 55-foot-long, 30-foot-wide tailrace; (8) a 260-
foot-long underground transmission line that delivers power to a 4.16-
kilovolt distribution line; and (9) appurtenant facilities. The project
creates a 250-foot-long bypassed reach of the Salmon Falls River
between the dam and the downstream end of the tailrace.
    The project operates as a run-of-river (ROR) facility with no
storage or flood control capacity. The project impoundment is
maintained at a flashboard crest elevation of 106.37 feet NGVD. The
current license requires the project to maintain a continuous minimum
flow of 6.05 cubic feet per second (cfs) or inflow, whichever is less,
to the bypassed reach for the purpose of protecting and enhancing
aquatic resources in the Salmon Falls River. The average annual
generation production of the project was 3,916,825 kilowatt-hours from
2005 through 2018.
    The applicant proposes to: (1) Continue operating the project in a
ROR mode; (2) provide a minimum flow of 30 cfs or inflow, whichever is
less, to the bypassed reach; (3) install an eel ramp for upstream eel
passage at the project; (4) implement targeted nighttime turbine
shutdowns to protect eels during downstream passage; and (5) install a
downstream fish passage structure for eels and other fish species.
    m. A copy of the application can be viewed on the Commission's
website at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support.
    All filings must: (1) Bear in all capital letters the title
``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions, or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. The applicant must file no later than 60 days following the date
of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification. Please note
that the certification request must be sent to the certifying authority
and to the Commission concurrently.
    o. Procedural Schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Deadline for filing comments,               April 2021.
 recommendations, preliminary terms and
 conditions, and preliminary fishway
 prescriptions.
Deadline for filing reply comments........  May 2021.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.

    Dated: February 10, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-03159 Filed 2-16-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Notices]
[Page 28655]
[FR Doc No: 2020-10180]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4504-DR; Docket ID FEMA-2020-0001]

Kansas; Amendment No. 1 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Kansas (FEMA-4504-DR), dated March 29, 2020, and
related determinations.

DATES: This amendment was issued April 30, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Kansas is hereby amended to include Individual
Assistance limited to the Crisis Counseling Program for those areas
determined to have been adversely affected by the event declared a
major disaster by the President in his declaration of March 29, 2020.

    Individual Assistance limited to the Crisis Counseling Program
for all areas in the State of Kansas (already designated for
emergency protective measures [Category B] not authorized under
other Federal statutes, including direct Federal assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-10180 Filed 5-12-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Notices]
[Pages 58727-58728]
[FR Doc No: 2015-24735]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EG15-131-000.
    Applicants: Desert Stateline LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Desert Stateline LLC.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5030.
    Comments Due: 5 p.m. ET 10/15/15.

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

    Docket Numbers: ER15-1409-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Report Filing: 2015-09-24_SA 2769 Refund Report for
ATC-City of Reedsburg CFA to be effective N/A.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5058.
    Comments Due: 5 p.m. ET 10/15/15.

    Docket Numbers: ER15-1411-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Report Filing: 2015-09-24_SA 2770 Refund Report of
ATC-City of Sun Prairie CFA to be effective N/A.

    Filed Date: 9/24/15.
    Accession Number: 20150924-5060.
    Comments Due: 5 p.m. ET 10/15/15.

    Docket Numbers: ER15-1494-000.
    Applicants: Convergent Energy and Power Inc.
    Description: Report Filing: Market-Based Rate Tariff Refund Report
to be effective N/A.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5077.
    Comments Due: 5 p.m. ET 10/15/15.

    Docket Numbers: ER15-2695-000.
    Applicants: Crosswind Transmission, LLC.
    Description: Sec.  205(d) Rate Filing: Crosswind and Eagle View
Transmission and Interconnection Agreement to be effective 11/22/2015.
    Filed Date: 9/23/15.
    Accession Number: 20150923-5160.
    Comments Due: 5 p.m. ET 10/14/15.

    Docket Numbers: ER15-2696-000.
    Applicants: Crosswind Transmission, LLC.
    Description: Sec.  205(d) Rate Filing: Crosswind and Elk Lake
Transmission and Interconnection Agreement to be effective 11/22/2015.
    Filed Date: 9/23/15.
    Accession Number: 20150923-5162.
    Comments Due: 5 p.m. ET 10/14/15.

    Docket Numbers: ER15-2697-000.
    Applicants: Crosswind Transmission, LLC.
    Description: Sec.  205(d) Rate Filing: Crosswind and Green Prairie
Transmission and Interconnection Agreement to be effective 11/22/2015.
    Filed Date: 9/23/15.
    Accession Number: 20150923-5163.
    Comments Due: 5 p.m. ET 10/14/15.

    Docket Numbers: ER15-2698-000.
    Applicants: Crosswind Transmission, LLC.
    Description: Sec.  205(d) Rate Filing: Crosswind and Highland
Transmission and Interconnection Agreement to be effective 11/22/2015.
    Filed Date: 9/23/15.
    Accession Number: 20150923-5164.
    Comments Due: 5 p.m. ET 10/14/15.

    Docket Numbers: ER15-2699-000.
    Applicants: Crosswind Transmission, LLC.
    Description: Sec.  205(d) Rate Filing: Crosswind and Palo Alto
Transmission and Interconnection Agreement to be effective 11/22/2015.
    Filed Date: 9/23/15.
    Accession Number: 20150923-5166.
    Comments Due: 5 p.m. ET 10/14/15.

    Docket Numbers: ER15-2700-000.
    Applicants: Crosswind Transmission, LLC.
    Description: Sec.  205(d) Rate Filing: Crosswind and Silver Lake
Transmission and Interconnection Agreement to be effective 11/22/2015.
    Filed Date: 9/23/15.
    Accession Number: 20150923-5167.
    Comments Due: 5 p.m. ET 10/14/15.

    Docket Numbers: ER15-2701-000.
    Applicants: Crosswind Transmission, LLC.
    Description: Sec.  205(d) Rate Filing: Crosswind and Sunrise View
Transmission and Interconnection Agreement to be effective 11/22/2015.
    Filed Date: 9/23/15.
    Accession Number: 20150923-5168.
    Comments Due: 5 p.m. ET 10/14/15.

    Docket Numbers: ER15-2702-000.
    Applicants: Crosswind Transmission, LLC.
    Description: Sec.  205(d) Rate Filing: Crosswind and Virgin Lake
Transmission and Interconnection Agreement to be effective 11/22/2015.
    Filed Date: 9/23/15.
    Accession Number: 20150923-5169.
    Comments Due: 5 p.m. ET 10/14/15.

    Docket Numbers: ER15-2703-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Amended CLGIA and
Distribution Service Agreement Tulare Solar Center 1 Project to be
effective 9/25/2015.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5000.
    Comments Due: 5 p.m. ET 10/15/15.

    Docket Numbers: ER15-2704-000.
    Applicants: National Gas & Electric, LLC.
    Description: Baseline eTariff Filing: Application for MBR to be
effective 9/25/2015.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5065.
    Comments Due: 5 p.m. ET 10/15/15.

    Docket Numbers: ER15-2705-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Revisions To Address Seams
Transmission Projects to be effective 12/1/2015.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5073.
    Comments Due: 5 p.m. ET 10/15/15.

    Docket Numbers: ER15-2706-000.
    Applicants: Hardin Hilltop Wind, LLC.
    Description: Baseline eTariff Filing: Hardin Hilltop and Cy-Hawk
Transmission and Interconnection Agreement to be effective 11/23/2015.
    Filed Date: 9/24/15.
    Accession Number: 20150924-5101.
    Comments Due: 5 p.m. ET 10/15/15.

    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: September 24, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-24735 Filed 9-29-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 9, 2005 (Volume 70, Number 236)]
[Notices]
[Page 73216]
[DOCID:fr09de05-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-27-000]

Colorado Interstate Gas Company; Notice of Application

December 1, 2005.
    Take notice that Colorado Interstate Gas Company (CIG), P.O. Box
1087, Colorado Springs, Colorado 80944, filed in Docket No. CP06-27-000
on November 22, 2005, an application pursuant to section 7(b) of the
Natural Gas Act (NGA), for authorization for CIG to abandon, in place,
the compressor facilities located at the Fourway Compressor Station,
located in Moore County, Texas. The Fourway Compressor Station is
comprised of five 1,320 horsepower (ISO) units, all as more fully set
forth in the application which is on file with the Commission and open
to public inspection. This filing may be also viewed on the Web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, call<PHONE_NUMBER> or TTY, (202)
208-3676.
    Any questions regarding this application should be directed to
Richard Derryberry, Director, Regulatory Affairs, Colorado Interstate
Gas Company, P.O. Box 1087, Colorado Springs, Colorado 80944 at (719)
520-3788 or by fax at<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.

    Comment Date: December 22, 2005.
Magalie R. Salas,
Secretary.
[FR Doc. E5-7090 Filed 12-8-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Rules and Regulations]
[Pages 30747-30749]
[FR Doc No: 2017-13907]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2017-0025; FRL-9964-26-Region 1]

Air Plan Approval; Rhode Island; Reasonably Available Control
Technology for US Watercraft, LLC

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of Rhode
Island. The revision consists of a reasonably available control
technology (RACT) approval for a volatile organic compound (VOC)
emission source in Rhode Island, specifically, US Watercraft, LLC. This
action is being taken in accordance with the Clean Air Act.

DATES: This direct final rule will be effective September 1, 2017,
unless EPA receives adverse comments by August 2, 2017. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2017-0025 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the Web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: David L. Mackintosh, Air Quality
Planning Unit, U.S. Environmental Protection Agency, EPA New England
Regional Office, 5 Post Office Square--Suite 100, (Mail code OEP05-2),
Boston, MA 02109-3912, tel.<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Description and Evaluation of the State's Submittal
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background and Purpose

    Section 184(b) of the CAA requires Rhode Island to implement RACT
for all major sources of VOCs and all sources covered by a Control
Techniques Guideline (CTG). The Rhode Island Department of
Environmental Management (RI DEM) submitted RACT Approval File No. 01-
05-AP as a SIP revision for incorporation into the Rhode Island SIP.
RACT Approval File No. 01-05-AP was originally issued to TPI Composites
Incorporated (currently owned and operated by US Watercraft, LLC) in
Warren, Rhode Island. The RACT Approval was received by EPA on August
8, 2003, and amended shortly thereafter. The amendment was received by
EPA on February 20, 2004.

II. Description and Evaluation of the State's Submittal

    US Watercraft, LLC is located at 373 Market Street, Warren, Rhode
Island,

and operates two fiberglass process areas that emit VOCs: Fiberglass
production; and Research and Development (R&D). The RI DEM RACT
Approval replaced the requirements in the original 1990 RACT Consent
Agreement, File No. 90-1-AP, which EPA approved on August 31, 1990 (55
FR 35623). RI DEM issued the updated RACT Approval for this facility to
reflect technological advances in the fiberglass manufacturing industry
as well as to correct and clarify requirements contained in the consent
agreement. The RACT Approval control strategy was revised to include
the Seemann Composite Resin Infusion Molding Process (SCRIMP), a closed
molding process, and VOC limitations on gel coats and resins used to
limit VOC emissions from the operations performed at the facility. In
addition, the updated Approval provides for enhanced recordkeeping to
track VOC emissions from the facility. Specifically, the submitted
amendment to the RACT Approval restricts US Watercraft when applying
vinyl ester resin to using the closed molding process or using a
roller, except that US Watercraft may apply vinyl ester resin by spray
layup for corrosion proof laminate, as is the case with the consent
agreement currently in the SIP. Additionally, the updated RACT Approval
prohibits the use of VOC solvents for cleanup, whereas the consent
agreement currently in Rhode Island's SIP allows solvents containing
VOCs to be used on a limited basis for cleaning activities. Since the
RACT Approval and its amendment are no less stringent than the
previously-approved consent agreement, and in some instances are more
stringent, the anti-back sliding requirements of section 110(l) of the
CAA are met. Therefore, EPA is approving the new RACT Approval and
amendment for US Watercraft, LLC.
    It should be noted that subsequent to RI DEM's submittal of its SIP
revision and amendment for US Watercraft in 2003 and 2004,
respectively, EPA later issued a Control Techniques Guidelines (CTG)
for Fiberglass Boat Manufacturing Materials on October 7, 2008 (73 FR
58481). RI DEM has not yet addressed this CTG. On February 3, 2017 (82
FR 9158), EPA issued a Findings of Failure to Submit State
Implementation Plan Submittals for the 2008 Ozone National Ambient Air
Quality Standards for Rhode Island's failure to submit a SIP revision
to satisfy the 2008 CTG for Fiberglass Boat Manufacturing Materials.
    At this time, EPA is taking no action with regard to Rhode Island's
obligation to address the 2008 CTG for Fiberglass Boat Manufacturing
Materials since Rhode Island has not yet taken formal action to address
this CTG. In this action, we are approving the revised RACT Approval
for US Watercraft as meeting the section 110(l) anti-back sliding
requirement of the CAA and incorporating it into the SIP as SIP-
strengthening. Rhode Island is still obligated to submit a formal SIP
revision to EPA detailing how the state is addressing the Fiberglass
Boat Manufacturing Materials CTG for any and all sources in the state
covered by that CTG.

III. Final Action

    EPA is approving, and incorporating into the Rhode Island SIP, a
RACT Approval effective July 16, 2003, and a RACT Approval amendment
effective February 11, 2004, for US Watercraft, LLC (formerly known as
TPI Composites or Tillotson-Pearson). EPA is also removing the
previously approved consent agreement for this facility from the Rhode
Island SIP.
    The EPA is publishing this action without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision should
relevant adverse comments be filed. This rule will be effective
September 1, 2017 without further notice unless the Agency receives
relevant adverse comments by August 2, 2017.
    If the EPA receives such comments, then EPA will publish a notice
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on the proposed rule. All parties
interested in commenting on the proposed rule should do so at this
time. If no such comments are received, the public is advised that this
rule will be effective on September 1, 2017 and no further action will
be taken on the proposed rule. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the RACT
Approval for US Watercraft, LLC described in the amendments to 40 CFR
part 52 set forth below. The EPA has made, and will continue to make,
these materials generally available through https://www.regulations.gov, and/or at the EPA Region 1 Office (please contact
the person identified in the For Further Information Contact section of
this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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 Clean Air Act; 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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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. Section 804, however, exempts from section 801 the
following types of rules: Rules of particular applicability; rules
relating to agency management or personnel; and rules of agency
organization, procedure, or practice that do not substantially affect
the rights or obligations of non-agency parties. 5 U.S.C. 804(3).
Because this is a rule of particular applicability, EPA is not required
to submit a rule report regarding this action under section 801.
    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 September 1, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action 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. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the proposed
rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action 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, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: June 7, 2017.
Deborah A. Szaro,
Acting Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart OO--Rhode Island

0
2. In Sec.  52.2070 in the table in paragraph (d), remove the entry
``Tillotson-Pearson in Warren, Rhode Island''; and add the entry for
``US Watercraft, LLC in Warren, Rhode Island'' to the end of the table
to read as follows:

Sec.  52.2070   Identification of plan.

* * * * *
    (d) EPA-approved State Source specific requirements.

                             EPA-Approved Rhode Island Source Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                                        State effective
         Name of source               Permit No.             date          EPA approval date     Explanations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
US Watercraft, LLC in Warren,     File No. 01-05-AP.  7/16/2003 and 2/11/ 7/3/2017, [Insert   VOC RACT Approval
 Rhode Island.                                         2004.               Federal Register    and Amendment.
                                                                           citation].
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-13907 Filed 6-30-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Notices]
[Pages 83973-83975]
[FR Doc No: 2020-28346]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2272]

Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 27 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.

DATES: Approval is withdrawn as of January 22, 2021.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec.  314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application
under Sec.  314.150(c) is without prejudice to refiling.

----------------------------------------------------------------------------------------------------------------
          Application No.                                  Drug                                Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008809.........................  M.V.I.-12 Adult (ascorbic acid, biotin,
                                      cyanocobalamin, dexpanthenol, ergocalciferol,
                                      folic acid, niacinamide, pyridoxine
                                      hydrochloride (HCl), riboflavin 5'-phosphate
                                      sodium, thiamine HCl, vitamin A, and vitamin
                                      E) Injection, 10 milligrams (mg)/milliliters
                                      (mL), 0.006 mg/mL, 0.5 micrograms (mcg)/mL,
                                      1.5 mg/mL, 20 International Units (IU)/mL,
                                      0.04 mg/mL, 4 mg/mL, 0.4 mg/mL, 0.36 mg/mL,
                                      0.3 mg/mL, 330 Units/mL, and 1 IU/mL; and 20
                                      mg/mL, 0.006 mg/mL, 0.05 mcg/mL, 1.5 mg/mL,
                                      0.0005 mg/mL, 0.06 mg/mL, 4 mg/mL, 0.6 mg/mL,
                                      0.36 mg/mL, 0.6 mg/mL, 0.1 mg/mL, and 1 mg/mL.
                                     M.V.I.-12 Adult (ascorbic acid, biotin,          Hospira, Inc., 275 North
                                      cyanocobalamin, dexpanthenol, ergocalciferol,    Field Dr., Lake Forest,
                                      folic acid, niacinamide, pyridoxine HCl,         IL 60045.
                                      riboflavin, thiamine HCl, vitamin A, and
                                      vitamin E) Injection, 20 mg/mL, 0.006 mg/mL,
                                      0.5 mcg/mL, 1.5 mg/mL, 20 IU/mL, 0.6 mg/mL, 4
                                      mg/mL, 0.4 mg/mL, 0.36 mg/mL, 0.6 mg/mL, 330
                                      Units/mL, and 1 IU/mL..
NDA 017673.........................  Aminosyn (amino acids) Injection, 5% (5 grams
                                      (g)/100 mL), 7% (7 g/100 mL), 7% (pH6) (7 g/
                                      100 mL), 8.5% (8.5 g/100 mL), 8.5% (pH6) (8.5
                                      g/100 mL), 10% (10 g/100 mL), and 10% (pH6)
                                      (10 g/100 mL).
                                     Aminosyn 8.5% With Electrolytes (amino acids,
                                      magnesium chloride, potassium chloride, sodium
                                      chloride, and sodium phosphate dibasic)
                                      Injection, 8.5% (8.5 g/100mL), 102 mg/100 mL,
                                      487 mg/100 mL, 28 mg/100 mL, and 425 mg/100
                                      mL..
                                     Aminosyn 8.5% With Electrolytes (amino acids,    ICU Medical, Inc., 600
                                      magnesium chloride, potassium phosphate          North Field Dr., Lake
                                      dibasic, and sodium chloride) Injection, 8.5%    Forest, IL 60045.
                                      (8.5 g/100 mL), 102 mg/100 mL, 522 mg/100 mL,
                                      and 410 mg/100 mL..
NDA 017735.........................  Modicon 28 (ethinyl estradiol and                Janssen Pharmaceuticals,
                                      norethindrone) Tablets, 0.035 mg/0.5 mg.         Inc., 1125 Trenton-
                                                                                Harbourton Rd.,
                                                                                Titusville, NJ 08560.
NDA 017743.........................  Brevicon 28-Day (ethinyl estradiol and           Allergan Sales, LLC, 5
                                      norethindrone) Tablets, 0.035 mg/0.5 mg.         Giralda Farms, Madison,
                                                                                NJ 07940.
NDA 017789.........................  Aminosyn 3.5% (amino acids) Injection, 3.5%
                                      (3.5 g/100 mL).
                                     Aminosyn 3.5% M (amino acids, magnesium
                                      acetate, phosphoric acid, potassium acetate,
                                      and sodium chloride) Injection, 3.5% (3.5 g/
                                      100 mL), 21 mg/100 mL, 40 mg/100 mL, 128 mg/
                                      100 mL, and 234 mg/100 mL..
                                     Aminosyn 3.5% M (amino acids, magnesium
                                      acetate, potassium acetate, and sodium
                                      chloride) Injection, 3.5% (3.5 g/100 mL), 21
                                      mg/100 mL, 128 mg/100 mL, and 234 mg/100 mL..

                                     Aminosyn 7% With Electrolytes (amino acids,      ICU Medical, Inc.
                                      magnesium chloride, potassium phosphate
                                      dibasic, and sodium chloride) Injection, 7% (7
                                      g/100 mL), 102 mg/100 mL, 410 mg/100 mL, and
                                      522 mg/100 mL..
NDA 018069.........................  Vansil (oxamniquine) Capsules, 250 mg..........  Pfizer, Inc., 235 East
                                                                                42nd St., New York, NY
                                                                                10017.
NDA 018081.........................  Depakene (valproic acid) Capsules, 250 mg......  AbbVie, Inc., 1 North
                                                                                Waukegan Rd., North
                                                                                Chicago, IL 60064.
NDA 018281.........................  Tegretol (carbamazepine) Chewable Tablets, 100   Novartis Pharmaceuticals
                                      mg.                                              Corp., 1 Health Plaza,
                                                                                East Hanover, NJ 07936.
NDA 018429.........................  Aminosyn-RF 5.2% (amino acids) Injection, 5.2%   ICU Medical, Inc.
                                      (5.2 g/100 mL)..
NDA 018704.........................  Lopressor (metoprolol tartrate) Injection, 1 mg/ Novartis Pharmaceuticals
                                      mL.                                              Corp.
NDA 018876.........................  Potassium Chloride 5 milliequivalent (mEq) in
                                      Dextrose 5% and Sodium Chloride 0.3% in
                                      Plastic Container (dextrose, potassium
                                      chloride, and sodium chloride) Injection, 5 g/
                                      100 mL, 74.5 mg/100 mL, and 300 mg/100 mL.
                                     Potassium Chloride 5 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 149 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 10 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 74.5 mg/100
                                      mL, and 300 mg/mL..
                                     Potassium Chloride 10 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 149 mg/100
                                      mL, and 300 mg/mL..
                                     Potassium Chloride 15 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 224 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 20 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 298 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 20 mEq in Dextrose 5% in
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 149 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 30 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 224 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 40 mEq in Dextrose 5% and     Do.
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 298 mg/100
                                      mL, and 300 mg/100 mL..
NDA 018985.........................  Ortho Novum 7/7/7 (ethinyl estradiol and         Janssen Pharmaceuticals,
                                      norethindrone) (White) Tablets, 0.035 mg         Inc.
                                      ethinyl estradiol and 0.5 mg norethindrone,
                                      (Light Peach) Tablets, 0.035 mg ethinyl
                                      estradiol and 0.75 mg norethindrone, (Peach)
                                      Tablets, 0.035 mg ethinyl estradiol and 1 mg
                                      norethindrone.
NDA 019029.........................  Metronidazole Tablets, 250 mg..................  LNK International, Inc.,
                                                                                145 Ricefield Lane,
                                                                                Hauppauge, NY 11788.
NDA 019374.........................  Aminosyn-HBC 7% (amino acids) Injection, 7% (7   ICU Medical, Inc.
                                      g/100 mL)..
NDA 019435.........................  Nix (permethrin) Topical Lotion, 1%............  GlaxoSmithKline Consumer
                                                                                Healthcare Holdings (US)
                                                                                LLC, 184 Liberty Corner
                                                                                Rd., suite 2000, Warren,
                                                                                NJ 07059.
NDA 019437.........................  Aminosyn II M (amino acids, magnesium chloride,
                                      potassium chloride, sodium chloride, and
                                      sodium phosphate dibasic heptahydrate)
                                      Injection, 3.5% (3.5 g/100 mL), 30 mg/100 mL,
                                      97 mg/100 mL, 120 mg/100 mL, and 49 mg/100 mL.
                                     Aminosyn II With Electrolytes (amino acids,
                                      magnesium chloride, potassium chloride,
                                      potassium phosphate dibasic, and sodium
                                      chloride) Injection, 7% (7 g/100 mL), 102 mg/
                                      100 mL, 45 mg/100 mL, 522 mg/100 mL, and 410
                                      mg/100 mL; 8.5% (8.5 g/100 mL), 102 mg/100 mL,
                                      45 mg/100 mL, 522 mg/100 mL, and 410 mg/100
                                      mL; and 10% (10 g/100 mL), 102 mg/100 mL, 45
                                      mg/100 mL, 522 mg/100 mL, and 410 mg/100 mL..
                                     Aminosyn II With Electrolytes (amino acids,      Do.
                                      magnesium chloride, potassium chloride, sodium
                                      chloride, and sodium phosphate dibasic)
                                      Injection, 8.5% (8.5 g/100 mL), 102 mg/100 mL,
                                      492 mg/100 mL, 60 mg/100 mL, and 425 mg/100
                                      mL..
NDA 019438.........................  Aminosyn II 3.5% (amino acids) Injection, 3.5%
                                      (3.5 g/100 mL).
                                     Aminosyn II 5% (amino acids) Injection, 5% (5 g/
                                      100 mL).
                                     Aminosyn II 7% (amino acids) Injection, 7% (7 g/
                                      100 mL)..
                                     Aminosyn II 8.5% (amino acids) Injection, 8.5%
                                      (8.5 g/100 mL)..
                                     Aminosyn II 10% (amino acids) Injection, 10%     Do.
                                      (10 g/100 mL)..
NDA 019653.........................  Ortho-Cyclen-21 (ethinyl estradiol and
                                      norgestimate) Oral-21 Tablets, 0.035 mg/0.250
                                      mg.
                                     Ortho Cyclen-28 (ethinyl estradiol and           Janssen Pharmaceuticals,
                                      norgestimate) Oral-28 Tablets, 0.035 mg/0.25     Inc.
                                      mg..
NDA 019894.........................  Dextrose 50% in Plastic Container (dextrose)     ICU Medical, Inc.
                                      Injection, 50 g/100 mL.

NDA 019916.........................  Morphine Sulfate Injection, 1 mg/mL and 5 mg/mL  Do.
NDA 020593.........................  Depacon (valproate sodium) Injection,            AbbVie, Inc.
                                      Equivalent to (EQ) 100 mg base/mL.
NDA 020634.........................  Levaquin (levofloxacin) Tablets, 250 mg, 500     Janssen Pharmaceuticals,
                                      mg, and 750 mg.                                  Inc.
NDA 021241.........................  Ortho Tri-Cyclen Lo (ethinyl estradiol and       Do.
                                      norgestimate) Oral-28 (White) Tablets, 0.025
                                      mg ethinyl estradiol and 0.18 mg norgestimate;
                                      (Light Blue) Tablets, 0.025 mg ethinyl
                                      estradiol and 0.215 mg norgestimate; (Dark
                                      Blue) Tablets, 0.025 mg ethinyl estradiol and
                                      0.250 mg norgestimate.
NDA 206544.........................  MorphaBond ER (morphine sulfate) Extended-       Daiichi Sankyo, Inc., 211
                                      Release Tablets, 15 mg, 30 mg, 60 mg, and 100    Mount Airy Rd., Basking
                                      mg.                                              Ridge, NJ 07920.
NDA 208399.........................  Varubi (rolapitant HCl) Injectable Emulsion, EQ  TerSera Therapeutics LLC,
                                      166.5 mg base/92.5 mL (EQ 1.8 mg base/mL).       520 Lake Cook Rd., suite
                                                                                500, Deerfield, IL 60015.
NDA 209203.........................  Duzallo (allopurinol and lesinurad) Tablets,     Ironwood Pharmaceuticals,
                                      200 mg/200 mg and 300 mg/200 mg.                 Inc., 100 Summer St.,
                                                                                suite 2300, Boston, MA
                                                                                02110.
NDA 210895.........................  Welchol (colesevelam HCl) Chewable Bars, 3.75 g  Daiichi Sankyo, Inc.
----------------------------------------------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 22, 2021. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on January 22, 2021 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28346 Filed 12-22-20; 8:45 am]
BILLING CODE 4164-01-P