the owner/operator changes the web address (i.e., Uniform Resource
Locator (URL)) at any point, they must notify EPA via the ``contact
us'' form on EPA's CCR website and the state director within 14 days of
making the change. The facility's CCR website must also have a
``contact us'' form or a specific email address posted on the website
for the public to use to submit questions and issues relating to the
availability of information on the website.
* * * * *
    (i) * * *
    (14) The notification of intent to comply with the site-specific
alternative to initiation of closure due to development of alternative
capacity infeasible as specified under Sec.  257.105(i)(14).
    (15) The approved or denied demonstration for the site-specific
alternative to initiation of closure due to development of alternative
capacity infeasible as required by as specified under Sec.
257.105(i)(15).
    (16) The notification for requesting additional time to the
alternative cease receipt of waste deadline as required by Sec.
257.105(i)(16).
    (17) The semi-annual progress reports for the site-specific
alternative to initiation of closure due to development of alternative
capacity infeasible as specified under Sec.  257.105(i)(17).
    (18) The notification of intent to comply with the site-specific
alternative to initiation of closure due to permanent cessation of a
coal-fired boiler(s) by a date certain as specified under Sec.
257.105(i)(18).
    (19) The approved or denied demonstration for the site-specific
alternative to initiation of closure due to permanent cessation of a
coal-fired boiler(s) by a date certain as required by Sec.
257.105(i)(19).
    (20) The annual progress report for the site-specific alternative
to initiation of closure due to permanent cessation of a coal-fired
boiler(s) by a date certain as required by Sec.  257.105(i)(20).
* * * * *
[FR Doc. 2020-16872 Filed 8-27-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)]
[Notices]
[Pages 57733-57734]
[FR Doc No: 2017-26392]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER14-696-006.
    Applicants: Entergy Services, Inc.
    Description: Compliance filing: LBA Compliance Errata ER14-696 12-
1-2017 to be effective 12/19/2013.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5251.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER14-697-007.
    Applicants: Entergy Services, Inc.
    Description: Compliance filing: LBA Compliance Errata ER14-697 12-
1-2017 to be effective. 12/19/2013.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5254.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER14-699-007
    Applicants: Entergy Services, Inc.
    Description: Compliance filing: LBA Compliance Errata ER14-699 11-
30-2017 to be effective 12/19/2013.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5258.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER14-702-006.
    Applicants: Entergy Arkansas, Inc.
    Description: Compliance filing: LBA Compliance Errata ER14-702 12-
1-2017 to be effective 12/19/2013.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5054.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER14-703-006.
    Applicants: Entergy Services, Inc.
    Description: Compliance filing: LBA Compliance Errata ER14-701 12-
1-2017 to be effective 12/19/2013.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5156.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER14-703-007.
    Applicants: Entergy Services, Inc.
    Description: Compliance filing: LBA Compliance Errata ER14-703 12-
1-2017 to be effective 12/19/2013.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5165.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER14-704-006.
    Applicants: Entergy Services, Inc.
    Description: Compliance filing: LBA Compliance Errata ER14-704 12-
1-2017 to be effective 12/19/2013.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5182.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER14-2952-005.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Report Filing: 2017-12-01_PIPP SSR Refund Report Plan
to be effective N/A.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5059.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER17-558-001.
    Applicants: Louisville Gas and Electric Company.
    Description: Compliance filing: Compliance Filing OATT Att G NOA to
be effective 2/15/2017.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5114.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-192-001.
    Applicants: Dynegy Oakland, LLC.
    Description: Tariff Amendment: Deferral of Commission Action to
Permit Ongoing Settlement Discussions to be effective 12/31/9998.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5161.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-363-000.
    Applicants: Florida Power & Light Company.
    Description: Sec.  205(d) Rate Filing: FPL-FPUC-Original Service
Agreement No. 337-NITSA and NOA to be effective 1/1/2018.

    Filed Date: 11/30/17.
    Accession Number: 20171130-5214.
    Comments Due: 5 p.m. ET 12/21/17.

    Docket Numbers: ER18-364-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-11-30_Revisions to LRZ
for the States of Louisiana and Texas to be effective 12/1/2017.
    Filed Date: 11/30/17.
    Accession Number: 20171130-5223.
    Comments Due: 5 p.m. ET 12/21/17.

    Docket Numbers: ER18-365-000.
    Applicants: Access Energy Solutions, LLC.
    Description: Baseline eTariff Filing: Market Based Rate Tariff to
be effective 1/29/2018.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5002.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-366-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Sec.  205(d) Rate Filing: 2017-12-1_SA 2022 Ameren-
Kirkwood 1st Rev WDS to be effective 11/1/2017.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5056.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-367-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Sec.  205(d) Rate Filing: 2017-12-1_Ameren-RECC WCA/
UCA/WDS to be effective 1/1/2018.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5067.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-368-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: LGIA Arlington Solar, LLC
Service Agreement No. 205, TOT781 to be effective 1/31/2018.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5137.

    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-369-000.
    Applicants: Southern California Edison Company.
    Description: Tariff Cancellation: Notices of Cancellation GIA and
Distrib Serv Agmt Ellwood Storage Project to be effective 1/23/2018.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5140.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-370-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: TO Tariff Amendment New
Appendix XI to be effective 3/31/2018.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5188.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-371-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Installed Capacity Requirements, Hydro-Quebec
Interconnection Capability Credits and Related Values for 2018/2019,
2019/2020 and 2010/2021 Annual Reconfiguration Auctions of ISO New
England, Inc., et al.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5189.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-372-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Memorandum of Agreement on
the Pacific Direct Current Intertie to be effective 2/1/2018.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5244.
    Comments Due: 5 p.m. ET 12/22/17.

    Docket Numbers: ER18-373-000.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ATSI submits Engineering and
Construction Services Agreement SA No. 4716 to be effective 1/31/2018.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5253.
    Comments Due: 5 p.m. ET 12/22/17.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF18-30-000.
    Applicants: Flambeau Solar Partners, LLC.
    Description: Refund Report of Flambeau Solar Partners, LLC.
    Filed Date: 12/1/17.
    Accession Number: 20171201-5209.
    Comments Due: 5 p.m. ET 12/22/17.

    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: December 1, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-26392 Filed 12-6-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Rules and Regulations]
[Pages 3014-3015]
[FR Doc No: 2011-1034]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0015]

Security Zone; Protection of Military Cargo, Captain of the Port
Zone Puget Sound, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Blair Waterway security zone
in

Commencement Bay, WA from 12:01 a.m. on January 6, 2011, through 11:59
p.m. on January 29, 2011. This action is necessary for the security of
Department of Defense assets and military cargo during loading and off-
loading operations taking place within the Blair Waterway, Commencement
Bay, WA. During periods of enforcement, no person or vessel operator
may enter the security zone unless authorized by the Captain of the
Port, Puget Sound or Designated Representative.

DATES: The security zone described in 33 CFR 165.1321 (c)(1) will be
enforced from 12:01 a.m. on January 6, 2011, through 11:59 p.m. on
January 29, 2011.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail LTJG Ashley M. Wanzer, Waterways Management Division,
Sector Puget Sound, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Blair
Waterway security zone in Commencement Bay, WA for protection of
military cargo in 33 CFR 165.1321 from 12:01 a.m. on January 6, 2011,
through 11:59 p.m. on January 29, 2011. A discussion of these
regulations can be found in the preamble of a final rule published
December 10, 2004 (69 FR 71709).
    Under the provisions of 33 CFR 165.1321, vessel operators may not
enter the following security zone described in Sec.  165.1321(c)(1):
All waters enclosed by a line connecting the following points:
47[deg]16'57'' N, 122[deg]24'39'' W, which is approximately the
beginning of Pier No. 23 (also known as the Army pier); then
northwesterly to 47[deg]17'05'' N, 122[deg]24'52'' W, which is the end
of the Pier No. 23 (Army pier); then southwesterly to 47[deg]16'42'' N,
122[deg]25'18'' W, which is the approximate location of a private buoy
on the end of the sewage outfall; then southeasterly to 47[deg]16'33''
N, 122[deg]25'04'' W, which is approximately the northwestern end of
Pier No. 5; then northeasterly to the northwestern end of Pier No. 1;
then southeasterly along the shoreline of the Blair Waterway to the
Blair Waterway turning basin; then along the shoreline around the Blair
Waterway turning basin; then northwesterly along the shoreline of the
Blair Waterway to the Commencement Bay Directional Light (light list
number 17159); then northeasterly along the shoreline to the point of
origin. [Datum: NAD 1983].
    All vessel operators must obtain permission from the COTP or
Designated Representative to enter, move within, or exit the security
zone during periods of enforcement. To obtain permission to transit the
zone vessel operators can contact the on-scene patrol craft on VHF
Channel 16/13 or VST Puget Sound on VHF Channel 14. Operators of
vessels 20 meters or greater in length should seek permission from the
COTP or a Designated Representative at least 4 hours in advance.
Operators of vessels less than 20 meters in length should seek
permission at least 1 hour in advance.
    Any Coast Guard commissioned, warrant or petty officer may enforce
the rules of this section. The Coast Guard may be assisted by other
Federal, State, or local law enforcement agencies in enforcing this
regulation. Vessels and persons granted permission to enter the
security zone shall obey all lawful orders or directions of the Captain
of the Port or Designated Representative. All vessels shall be operated
at a minimum speed necessary to maintain a safe course.
    This notice is issued under authority of 33 CFR 165.1321 and 5
U.S.C. 552(a).
    If the COTP determines that the regulated area need not be enforced
for the full duration stated in this notice, he may use a Broadcast
Notice to Mariners to temporarily grant general permission to enter
this zone during breaks between loading and off-loading operations.
    Upon notice of temporary periods of suspension of enforcement by
the Captain of the Port Puget Sound, all persons and vessels are
authorized to enter, transit, and exit this security zone until the
zone is reestablished and subject to enforcement.

    Dated: January 5, 2011.
Scott J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2011-1034 Filed 1-18-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: July 10, 2006 (Volume 71, Number 131)]
[Notices]
[Page 38917-38918]
[DOCID:fr10jy06-92]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54074; File No. SR-ISE-2006-30]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing of Proposed Rule Change, and Amendment No. 1
Thereto, To Increase the Linkage Inbound Principal Order Fee

June 30, 2006.
    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 June 5, 2006, the International Securities Exchange, Inc. (``ISE''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which items have been prepared by the ISE. On June 29,
2006, the Exchange filed Amendment No. 1 to the proposed rule
change.\3\ The Commission is publishing this notice to solicit comments
on the proposed rule change, as amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, the Exchange proposed to delete certain
language in its Schedule of Fees.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend its Schedule of Fees to change the
Linkage Inbound Principal Order (``P Order'') fee. The text of the
proposed rule change is available at the Commission's Public Reference
Room, at the Exchange and at the Exchange's Web site (http://www.iseoptions.com/
 legal/proposed--rule-- changes.asp).

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 as
amended 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 Exchange proposes to amend its Schedule of Fees to increase
from $0.15 to $0.24, per contract, the P Order fee for orders sent to
the Exchange via the Intermarket Options Linkage pursuant to the Plan
for the Purpose of Creating and Operating an Intermarket Option Linkage
(``Plan'').\4\ This proposed rule change will remain in effect as part
of an existing pilot program, which is scheduled to expire on July 31,
2006.\5\ Additionally, in order to implement this proposed rule change,
the Exchange is creating two new line items in its Schedule of Fees:
one for Linkage P Orders and one for Linkage P/A Orders.\6\

Both these fees are currently found in the Schedule of Fees under the
Firm Proprietary line item.
---------------------------------------------------------------------------

    \4\ See Exchange Act Release No. 43086 (July 28, 2000), 65 FR
48023 (August 4, 2000) (order approving the Plan and ISE as a
participant in the Plan).
    \5\ Fees for Linkage P and P/A Orders are currently subject to a
pilot program scheduled to expire on July 31, 2006. See Exchange Act
Release No. 52168 (July 29, 2005), 70 FR 45454 (August 5, 2005) (SR-
ISE-2005-32).
    \6\ The fee for Linkage P/A Orders is not subject to change
pursuant to this filing, and would remain at $0.15 per contract. As
before, (1) both Linkage P and Linkage P/A Orders shall remain
subject to a comparison fee of $0.03 per contract, and (2)
Satisfaction Orders are excluded from these fees.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange states that the basis for this proposed rule change is
the requirement under section 6(b)(4) of the Act,\7\ which requires
that an exchange have an equitable allocation of reasonable dues, fees
and other charges among its members and other persons using its
facilities.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed rule change would not
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change; or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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 e-mail to<EMAIL_ADDRESS>Please include

File No. SR-ISE-2006-30 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2006-30. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE. 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-2006-30 and should be submitted on or before July
31, 2006.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\8\
Nancy M. Morris,
Secretary.
[FR Doc. E6-10682 Filed 7-7-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Rules and Regulations]
[Pages 10986-10989]
[FR Doc No: 2020-03247]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2019-0493; FRL-10005-65-Region 9]

Air Plan Conditional Approval; Arizona; Maricopa County

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to conditionally approve revisions to the Maricopa County Air
Quality Department (MCAQD or the County) portion of the Arizona State
Implementation Plan (SIP). These revisions concern emissions of
volatile organic compounds (VOCs) from organic liquid and gasoline
storage and transfer operations. We are conditionally approving local
rules that regulate these emission sources under the Clean Air Act (CAA
or the Act). We are also conditionally approving the County's
Reasonably Available Control Technology (RACT) demonstration for the
source categories associated with these rules.

DATES: This rule will be effective on March 27, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2019-0493. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through https://www.regulations.gov, or please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section for
additional availability information.

FOR FURTHER INFORMATION CONTACT: Rebecca Newhouse, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On September 23, 2019 (84 FR 49699), the EPA proposed to
conditionally approve the following rules into the Arizona SIP.

------------------------------------------------------------------------
   Local agency           Document            Revised        Submitted
------------------------------------------------------------------------
MCAQD.............  Rule 350: Storage         11/02/2016      06/22/2017
                     and Transfer of
                     Organic Liquids
                     (Non-Gasoline) at
                     an Organic Liquid
                     Distribution
                     Facility.
MCAQD.............  Rule 351: Storage         11/02/2016      06/22/2017
                     and Loading of
                     Gasoline at Bulk
                     Gasoline Plants and
                     Bulk Gasoline
                     Terminals.
MCAQD.............  Rule 352: Gasoline        11/02/2016      06/22/2017
                     Cargo Tank Testing
                     and Use.
MCAQD.............  Rule 353: Storage         11/02/2016      06/22/2017
                     and Loading of
                     Gasoline at
                     Gasoline Dispensing
                     Facilities.
------------------------------------------------------------------------

    We proposed to conditionally approve these rules pursuant to CAA
section 110(k)(4) because, although rule deficiencies preclude full SIP
approval pursuant to section 110(k)(3), the rules largely comply with
the relevant CAA requirements, and because the MCAQD and the Arizona
Department of Environmental Quality (ADEQ) have committed to provide
the EPA with a SIP submission within one year of this final action that
will include specific rule revisions that would adequately address the
deficiencies.\1\ We also proposed to conditionally approve MCAQD's RACT
demonstrations for the 2008 8-hr ozone National Ambient Air Quality
Standards (NAAQS) with respect to the VOC source categories covered by
Rules 350, 351, 352, and 353. Our proposed action contains more
information on the rules, deficiencies, MCAQD and ADEQ commitments, and
our evaluation.
---------------------------------------------------------------------------

    \1\ Letter dated January 28, 2019, from Philip A. McNeely,
Director, MCAQD, to Misael Cabrera, Director, ADEQ, and letter dated
February 25, 2019, from Timothy S. Franquist, Director, Air Quality
Division, ADEQ, to Michael Stoker, Regional Administrator, EPA,
Region IX.
---------------------------------------------------------------------------

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received two comments. One member of the public
expressed support for our proposed action, stating that ``[t]he EPA
should approve the revisions contingent on Arizona's submission of
further revisions to account for the deficiencies of its SIP.''
    The second commenter stated that Maricopa County struggles to meet
its air quality standards, and described health and welfare impacts of
the area's air quality. The commenter wrote that, ``I believe it is due
time that Maricopa County enforce and meet the regulatory standards
mandated by the EPA,'' and that the County's feet should be ``held to
the fire'' because existing air quality actions have not been
sufficient. Accordingly, the commenter does not support the EPA's
proposal to conditionally approve the SIP revisions. The commenter
acknowledged that the changes detailed in the commitment letters allow
for RACT to be satisfied, but wrote that the proposed action would set
a precedent for changing the regulations without changing the practices
that jeopardize young people's health. The commenter cautioned against
allowing Maricopa County to satisfy RACT without ``demonstrated
action.''
    The EPA understands the commenter's concerns about the impacts of
air quality in Maricopa County. The commenter does not appear to
contest that the rules at issue would meet the RACT standard once the
County's commitments are fulfilled. Instead the EPA understands the
commenter's concern to be with the proposed conditional approval.
Section 110(k)(4) of the Act allows the Administrator to conditionally
approve a plan revision based on a commitment of the State to adopt
specific enforceable measures by a date certain, but not later than one
year after the date of approval of the plan revision. The EPA believes
that Maricopa County and ADEQ have made the necessary commitments to
rectify the deficiencies within the statutory timeframe. The commenter
does not contest this. Therefore, the EPA does not understand the
commenter to have stated that the Administrator is prohibited from
conditionally approving Maricopa County's submission; they have instead
asked the EPA to exercise its discretion

to respond to the submission in a different manner. The EPA believes
that a conditional approval is the most appropriate action for the
County's submittal. By conditionally approving the rules, the EPA is
able to add the rules to the SIP without waiting for additional
revisions. Because the rules as-submitted, despite their deficiencies,
would strengthen the SIP, the EPA believes that it is appropriate to
add the rules to the SIP now so that the air quality in the area can
benefit from the stronger rules while additional revisions are made. If
the County were to fail to meet its commitment to correct the
identified deficiencies, the conditional approval would be treated as a
disapproval, starting a sanctions clock under section 179(b), and a
Federal Implementation Plan clock under section 110(c)(1).
    Because the commenter does not suggest that the County has not met
the statutory requirements for a conditional approval, and a
conditional approval would allow the SIP-strengthening provisions in
the submittal to go into effect quickly, the EPA is finalizing the
conditional approval as proposed.

III. EPA Action

    No comments were submitted that change our assessment of the rules
as described in our proposed action. Therefore, as authorized in
section 110(k)(4) of the Act, the EPA is conditionally approving into
the Arizona SIP, Rules 350, 351, 352, and 353, and MCAQD's RACT
demonstrations for the 2008 8-hr ozone NAAQS with respect to the
following six Control Techniques Guidelines (CTGs), as described in our
proposal: Control of Volatile Organic Emissions from Storage of
Petroleum Liquids in Fixed-Roof Tanks (EPA-450/2-77-036); Control of
Volatile Organic Emissions from Petroleum Liquid Storage in External
Floating Roof Tanks (EPA-450/2-78-047); Control of Hydrocarbons from
Tank Truck Gasoline Loading Terminals (EPA-450/2-77-026); Control of
Volatile Organic Emissions from Bulk Gasoline Plants (EPA-450/2-77-
035); Control of Volatile Organic Compound Leaks from Gasoline Tank
Trucks and Vapor Collection Systems (EPA-450/2-78-051); and Design
Criteria for Stage I Vapor Control Systems--Gasoline Service Stations
(EPA-450/R-75-102). If the MCAQD and the ADEQ submit the required rule
revisions by the specified deadline, and the EPA approves the
submission, then the identified deficiencies will be cured. However, if
MCAQD, through the ADEQ, fails to submit these revisions within the
required timeframe, the conditional approval will be treated as a
disapproval for those rules for which the revisions are not submitted
(and the associated RACT SIP CTG source categories).

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 MCAQD
rules described in the amendments to 40 CFR part 52 set forth below.
Therefore, these materials have been approved by the EPA for inclusion
in the SIP, have been incorporated by reference by the EPA into that
plan, are fully federally enforceable under sections 110 and 113 of the
CAA as of the effective date of the final rulemaking of the EPA's
approval, and will be incorporated by reference in the next update to
the SIP compilation.\2\ The EPA has made, and will continue to make,
these documents available through www.regulations.gov and at the EPA
Region IX Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).
---------------------------------------------------------------------------

    \2\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www.epa.gov/laws-regulations/laws-and-executive-orders.

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

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action
because SIP approvals, including conditional approvals, are exempted
under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because the conditional approvals will not in-and-of themselves
create any new information collection burdens, but will simply
conditionally approve certain State requirements for inclusion in the
SIP.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, will
result from this action.

F. Executive Order 13132: Federalism

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

G. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction, and will not
impose substantial direct costs on tribal governments or preempt tribal
law. Thus, Executive Order 13175 does not apply to this action.

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

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive order. This action is not subject to
Executive Order 13045 because the conditional approvals will not in-
and-of themselves create any new regulations, but will simply
conditionally approve certain State requirements for inclusion in the
SIP.

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

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

J. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

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

    The EPA lacks the discretionary authority to address environmental
justice in this rulemaking.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

M. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 27, 2020. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action 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: January 24, 2020.
Deborah Jordan,
Acting Regional Administrator, Region IX.
    Part 52, 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 D--Arizona

0
2. Section 52.119 is amended by adding paragraph (c) to read as
follows:

Sec.  52.119   Identification of plan--conditional approvals.

* * * * *
    (c) A plan revision for the Maricopa County Air Quality Department
(MCAQD) submitted June 22, 2017, by the Arizona Department of
Environmental Quality (ADEQ), the Governor's designee, providing
MCAQD's Reasonably Available Control Technology (RACT) demonstration
for the 2008 8-hour ozone National Ambient Air Quality Standards, and
rule submissions in satisfaction thereof.
    (1) The conditional approval is based upon the February 25, 2019
commitment from the State to submit a SIP revision consisting of rule
revisions that will cure the identified deficiencies. MCAQD commits to
submit these rules to the ADEQ within eleven (11) months after the
EPA's conditional approval, and ADEQ commits to make the final
submission to the EPA not later than twelve (12) months after the EPA's
approval. If the State fails to meet its commitment, the conditional
approval will be treated as a disapproval with respect to the rules and
CTG categories for which the corrections are not made. The following
MCAQD rules and additional materials are conditionally approved:
    (i) Rule 350, Storage and Transfer of Organic Liquids (Non-
Gasoline) at an Organic Liquid Distribution Facility;
    (ii) Rule 351, Storage and Loading of Gasoline at Bulk Gasoline
Plants and Bulk Gasoline Terminals;
    (iii) Rule 352, Gasoline Cargo Tank Testing and Use;
    (iv) Rule 353, Storage and Loading of Gasoline at Gasoline
Dispensing Facilities; and
    (v) The RACT demonstration titled ``Analysis of Reasonably
Available Control Technology for the 2008 8-Hour Ozone National Ambient
Air Quality Standard (NAAQS) State Implementation Plan (RACT SIP),''
Only those portions of the document beginning with ``Gasoline Bulk
Plants, Fixed Roof Petroleum Tanks, External Floating Roof Petroleum
Tanks, And Gasoline Loading Terminals'' on page 33 through the first
full paragraph on page 35, and Appendix C: CTG RACT Spreadsheet, the
rows beginning with ``Gasoline Bulk Plants'' on page 60, through
``Service Stations--Stage I'' on pages 67-69. This demonstration
represents the RACT requirement for the following source categories:
Control of Volatile Organic Emissions from Storage of Petroleum Liquids
in Fixed-Roof Tanks (EPA-450/2-77-036), Control of Volatile Organic
Emissions from Petroleum Liquid Storage in External Floating Roof Tanks
(EPA-450/2-78-047); Control of Hydrocarbons from Tank Truck Gasoline
Loading Terminals (EPA-450/2-77-026); Control of Volatile Organic
Emissions from Bulk Gasoline Plants (EPA-450/2-77-035); Control of
Volatile Organic Compound Leaks from Gasoline Tank Trucks and Vapor
Collection Systems (EPA-450/2-78-051); and Design Criteria for Stage I
Vapor Control Systems--Gasoline Service Stations (EPA-450/R-75-102).
    (2) [Reserved]

0
3. Amend Sec.  52.120 as follows:
0
a. In paragraph (c), Table 4, under the table headings ``Post-July 1988
Rule Codification'' and ``Regulation III--Control of Air
Contaminants,'' by revising the entries for ``Rule 350,'' ``Rule 351,''
``Rule 352,'' and ``Rule 353.''
0
b. In paragraph (e), Table 1, under the subheading ``Part D Elements
and Plans for the Metropolitan Phoenix and Tucson Areas,'' by adding an
entry for ``Analysis of Reasonably Available Control Technology for the
2008 8-Hour Ozone National Ambient Air Quality Standard (NAAQS) State
Implementation Plan (RACT SIP)'' after the entry for ``Maricopa
Association of Governments (MAG) 1987 Carbon Monoxide (CO) Plan for the
Maricopa County Area, MAG CO Plan Commitments for Implementation, and
Appendix A through E, Exhibit 4, Exhibit D.''
    The revisions and addition read as follows:

Sec.  52.120   Identification of plan.

* * * * *
    (c) * * *

                     Table 4--EPA-Approved Maricopa County Air Pollution Control Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State
      County citation             Title/subject       effective      EPA approval date    Additional explanation
                                                         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                        Post-July 1988 Rule Codification
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   Regulation III--Control of Air Contaminants
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Rule 350...................  Storage and Transfer     11/02/2016  2/26/2020, [INSERT      Submitted on June 22,
                              of Organic Liquids                   Federal Register        2017.
                              (Non-Gasoline) at an                 CITATION].
                              Organic Liquid
                              Distribution Facility.
Rule 351...................  Storage and Loading of   11/02/2016  2/26/2020, [INSERT      Submitted on June 22,
                              Gasoline at Bulk                     Federal Register        2017.
                              Gasoline Plants and                  CITATION].
                              Bulk Gasoline
                              Terminals.
Rule 352...................  Gasoline Cargo Tank      11/02/2016  2/26/2020, [INSERT      Submitted on June 22,
                              Testing and Use.                     Federal Register        2017.
                                                                   CITATION].
Rule 353...................  Storage and Loading of   11/02/2016  2/26/2020, [INSERT      Submitted on June 22,
                              Gasoline at Gasoline                 Federal Register        2017.
                              Dispensing Facilities.               CITATION].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                       Table 1--EPA-Approved Non-Regulatory and Quasi-Regulatory Measures
       [Excluding certain resolutions and statutes, which are listed in tables 2 and 3, respectively] \1\
----------------------------------------------------------------------------------------------------------------
                                     Applicable
                                    geographic or         State
     Name of SIP provision       nonattainment area  submittal date   EPA approval date        Explanation
                                  or title/subject
----------------------------------------------------------------------------------------------------------------
                         The State of Arizona Air Pollution Control Implementation Plan
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                     Part D Elements and Plans for the Metropolitan Phoenix and Tucson Areas
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Analysis of Reasonably           Maricopa County      June 22, 2017  2/26/2020, [INSERT  Only those portions of
 Available Control Technology     portion of                          Federal Register    the document beginning
 for the 2008 8-Hour Ozone        Phoenix-Mesa                        CITATION].          with ``Gasoline Bulk
 National Ambient Air Quality     nonattainment                                           Plants, Fixed Roof
 Standard (NAAQS) State           area for 2008 8-                                        Petroleum Tanks,
 Implementation Plan (RACT SIP).  hour ozone NAAQS.                                       External Floating Roof
                                                                                Petroleum Tanks, And
                                                                                Gasoline Loading
                                                                                Terminals'' on page 33
                                                                                through the first full
                                                                                paragraph on page 35,
                                                                                and Appendix C: CTG
                                                                                RACT Spreadsheet, the
                                                                                rows beginning with
                                                                                ``Gasoline Bulk
                                                                                Plants'' on page 60,
                                                                                through ``Service
                                                                                Stations--Stage I'' on
                                                                                pages 67-69.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Table 1 is divided into three parts: Clean Air Act Section 110(a)(2) State Implementation Plan Elements
  (excluding Part D Elements and Plans), Part D Elements and Plans (other than for the Metropolitan Phoenix or
  Tucson Areas), and Part D Elements and Plans for the Metropolitan Phoenix and Tucson Areas.

* * * * *
[FR Doc. 2020-03247 Filed 2-25-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Notices]
[Page 11926-11928]
[DOCID:fr05mr08-80]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0144]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Certification to Accompany Drug, Biological Product,
and Device Applications or Submissions (Form FDA 3674)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the certification to accompany
human drug, biological product, and device applications or submissions
(Form FDA 3674).

DATES:  Submit written or electronic comments on the collection of
information by May 5, 2008.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

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

Certification to Accompany Drug, Biological Product, and Device
Applications or Submissions (Form FDA 3674)--(OMB Control Number 0910-
0616)--Extension

    The information required under section 402(j)(5)(B) of the Public
Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) will be submitted
in the form of a certification with applications and submissions
currently submitted to FDA under part 312 (21 CFR part 312) and 21 CFR
part 314 (human drugs) and approved under OMB control numbers 0910-0014
(expires May 31, 2009) and 0910-0001 (expires May 31, 2008),
respectively; submitted to FDA under part 312 and 21 CFR part 601
(biological products) and approved under OMB control numbers 0910-0014
and 0910-0338 (expires June 30, 2010); and submitted to FDA under 21
CFR parts 807 and 814 (devices) and approved under OMB control numbers
0910-0120 (expires August 31, 2010) and 0910-0231 (expires November 30,
2010), respectively.
    Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Public Law 110-85) amended the PHS Act by adding section
402(j) (42 U.S.C. 282(j)). The new provisions require additional
information to be submitted to the clinical trials data bank
(ClinicalTrials.gov)\1\ previously established by the National
Institutes of Health/National Library of Medicine, including expanded
information on clinical trials and information on the results of
clinical trials. The provisions include new responsibilities for FDA as
well as several amendments to the Federal Food, Drug, and Cosmetic Act
(FD&C Act).
---------------------------------------------------------------------------

    \1\ (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
---------------------------------------------------------------------------

    One new provision, section 402(j)(5)(B) of the PHS Act, requires
that a certification accompany human drug, biological, and device
product submissions made to FDA. Specifically, at the time of
submission of an application under sections 505, 515, or 520(m) of the
FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the
PHS Act (42 U.S.C. 262), or submission of a report under section 510(k)
of the FD&C Act (21 U.S.C. 360(k)), such application or submission must
be accompanied by a certification that all applicable requirements of
section 402(j) of the PHS Act have been met. Where available, such
certification must include the appropriate National Clinical Trial
(NCT) numbers.
    The proposed collection of information is necessary to satisfy the
previously mentioned statutory requirement.
    The importance of obtaining these data relates to adherence to the
legal requirements for submissions to the clinical trials registry and
results data bank and ensuring that individuals and

organizations submitting applications or reports to FDA under the
listed provisions of the FD&C Act or the PHS Act adhere to the
appropriate legal and regulatory requirements for certifying to having
complied with those requirements. The failure to submit the
certification required by section 402(j)(5)(B) of the PHS Act, and the
knowing submission of a false certification are both prohibited acts
under section 301 of the FD&C Act (21 U.S.C. 331). Violations are
subject to civil money penalties.

Investigational New Drug Applications

    FDA's Center for Drug Evaluation and Research (CDER) received 1,837
investigational new drug applications (INDs) and 24,581 new IND
amendments in fiscal year (FY) 2004. CDER anticipates that IND and
amendment submission rates will remain at or near this level in the
near future.
    FDA's Center for Biologics Evaluation and Research (CBER) received
227 new INDs and 6,689 new IND amendments in FY 2004. CBER anticipates
that IND and amendment submission rates will remain at or near this
level in the near future.
    The estimated total number of submissions (new INDs and new
submissions) subject to mandatory certification requirements under
section 402(j)(5)(B) of the PHS Act is 26,418 for CDER plus 6,916 for
CBER, or 33,334 submissions per year. The minutes per response is the
estimated number of minutes that a respondent would spend preparing the
information to be submitted to FDA under section 402(j)(5)(B) of the
PHS Act, including the time it takes to type the necessary information.
    Based on its experience reviewing INDs and consideration of the
previously mentioned information, FDA estimated that approximately 15.0
minutes on average would be needed per response for certifications
which accompany IND applications and submissions. It is assumed that
most submissions to investigational applications will reference only a
few protocols for which the sponsor/applicant/submitter has obtained an
NCT number from ClinicalTrials.gov prior to making the submission to
FDA. It is also assumed that the sponsor/applicant/submitter has
electronic capabilities allowing them to retrieve the information
necessary to complete the form in an efficient manner.

Marketing Applications/Submissions

    CDER and CBER received 214 new drug applications (NDA)/biologics
license applications (BLA)/resubmissions and 8,535 NDA/BLA amendments
in FY 2004. CDER and CBER received 259 efficacy supplements/
resubmissions to previously approved NDAs/BLAs; 2,500 manufacturing
submissions; and 1,273 labeling submissions in FY 2004. CDER and CBER
anticipate that new drug/biologic and efficacy supplement submission
rates will remain at or near this level in the near future.
    FDA's Center for Devices and Radiological Health (CDRH) received 51
new applications for premarket approvals (PMA); 3,635 premarket
notification submissions under section 510(k) of the FD&C Act; and 9
applications for humanitarian device exemptions (HDE), for a total of
3,695 new applications/submissions in FY 2004. CDRH received 2,267 PMA/
510(k)/HDE amendments in FY 2004. CDRH received 2,705 PMA/510(k)/HDE
supplements in FY 2004. CDRH anticipates that application, amendment,
and supplement rates will remain at or near this level in the near
future.
    The estimated total number of new submissions (new marketing
applications/submissions, amendments, and supplements) subject to the
mandatory certification requirements under section 402(j)(5)(B) of the
PHS Act is 12,781 for CDER and CBER plus 8,667 for CDRH, or 21,448 new
submissions per year. The hours per response is the estimated number of
hours that a respondent would spend preparing the information to be
submitted to FDA under section 402(j)(5)(B) of the PHS Act, including
the time it takes to type the necessary information and compile a list
of relevant NCT numbers.
    Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, and
510(k)s, and consideration of the previously mentioned information, FDA
estimated that approximately 45.0 minutes on average would be needed
per response for certifications which accompany NDA, BLA, PMA, HDE, and
510(k) applications and submissions. It is assumed that the sponsor/
applicant/submitter has electronic capabilities allowing them to
retrieve the information necessary to complete the form in an efficient
manner.
    Table 1 of this document provides an estimate of the annual
reporting burden for the submission of information to satisfy the
requirements of section 402(j)(5)(B) of the PHS Act.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                             Investigational          Marketing
                              Applications          Applications       Hours per  Response       Total Hours
----------------------------------------------------------------------------------------------------------------
CDER (new application)                   1,837                  ----                   .25                   459
----------------------------------------------------------------------------------------------------------------
CBER (new application)                     227                  ----                   .25                    57
----------------------------------------------------------------------------------------------------------------
CDER (amendment)                        24,581                  ----                   .25                 6,145
----------------------------------------------------------------------------------------------------------------
CBER (amendment)                         6,689                  ----                   .25                 1,672
----------------------------------------------------------------------------------------------------------------
CDER/CBER (new                            ----                   214                   .75                   161
 application/
 resubmission)
----------------------------------------------------------------------------------------------------------------
CDRH (new application)                    ----                 3,695                   .75                 2,771
----------------------------------------------------------------------------------------------------------------
CDER/CBER (amendment)                     ----                 8,535                   .75                 6,401
----------------------------------------------------------------------------------------------------------------
CDRH (amendment)                          ----                 2,267                   .75                 1,700
----------------------------------------------------------------------------------------------------------------
CDER/CBER (efficacy                       ----                   259                   .75                   194
 supplement/
 resubmission)
----------------------------------------------------------------------------------------------------------------

CDER/CBER (manufacturing                  ----                 2,500                   .75                 1,875
 supplement)
----------------------------------------------------------------------------------------------------------------
CDER/CBER (labeling                       ----                 1,273                   .75                   955
 supplement)
----------------------------------------------------------------------------------------------------------------
CDRH (supplement)                         ----                 2,705                   .75                 2,029
----------------------------------------------------------------------------------------------------------------
Total                                                                                24,419
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We believe the estimate of 24,419 hours per year accurately
reflects the burden. We recognize that individuals or entities less
familiar with FDA forms and the clinical trials data bank
(ClinicalTrials.gov) may require greater than 15 and 45 minutes
(depending on the type of application/submission) per response.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

    Dated: February 28, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4158 Filed 3-4-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Notices]
[Pages 38727-38728]
[FR Doc No: 2013-15356]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4119-DR; Docket ID FEMA-2013-0001]

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

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-4119-DR), dated May 31, 2013, and related
determinations.

DATES: Effective Date: June 20, 2013.

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 Iowa is hereby amended to include the following area
among those areas determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
May 31, 2013.

    Jefferson County for Public Assistance, 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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-15356 Filed 6-26-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Notices]
[Pages 47491-47492]
[FR Doc No: 2012-19449]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Flight
Simulation Device Initial and Continuing Qualification and Use

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on May 18, 2012, 77 FR 29748. The collection of this
information is necessary to ensure safety of flight by ensuring
complete and adequate training, testing, checking, and experience is
obtained and maintained by those who conduct flight simulation
training.

DATES: Written comments should be submitted by September 7, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0680.
    Title: Flight Simulation Device Initial and Continuing
Qualification and Use.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: This request reflects requirements necessary under
Title 14 CFR parts 61, 63, 91, 121, 135, 141, and 142, to ensure
safety-of-flight by ensuring that complete and adequate training,
testing, checking, and experience is obtained and maintained by those
who operate under these parts of the regulation and use flight
simulation in lieu of aircraft for these functions. The FAA uses the
information it collects and reviews to ensure compliance and adherence
to regulations and, where necessary, to take enforcement action on
violators of the regulations.
    Respondents: 46 flight simulation device operators.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 88 hours.
    Estimated Total Annual Burden: 66,840 hours.

ADDRESSES: Interested persons are invited to 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 attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC
20503.
    Public Comments Invited: You are asked to comment on any aspect of
this

information collection, including (a) whether the proposed collection
of information is necessary for FAA's performance; (b) the accuracy of
the estimated burden; (c) ways for FAA to enhance the quality, utility
and clarity of the information collection; and (d) ways that the burden
could be minimized without reducing the quality of the collected
information. The agency will summarize and/or include your comments in
the request for OMB's clearance of this information collection.

    Issued in Washington, DC on August 1, 2012.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2012-19449 Filed 8-7-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23560-23561]
[FR Doc No: 2013-09292]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9803-7]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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

SUMMARY: In accordance with the Clean Air Act, as amended (``CAA''),
notice is hereby given of a proposed consent decree to resolve a
lawsuit filed by the Center for Biological Diversity and the Center for
Environmental Health (``Plaintiffs'') in the United States District
Court for the Northern District of California: Center for Biological
Diversity, et al. v. Jackson, No. C-12-04968 JWT (N.D. CA.). On
September 24, 2012, Plaintiffs filed a complaint alleging that EPA
failed to make a finding of failure to submit infrastructure state
implementation plans (SIPs) for Colorado, Hawaii, Illinois, Maryland,
Massachusetts, New Jersey, Oklahoma, Oregon, Pennsylvania, South
Dakota, Vermont, and Washington with regard to the 2008 lead National
Ambient Air Quality Standard (2008 lead NAAQS) by the statutory
deadline established by CAA. Plaintiffs' complaint also alleged that
EPA failed to take final action on the infrastructure SIP submitted by
Tennessee with regard to the 2008 Lead NAAQs by the statutory deadline
established by CAA. In addition, the complaint alleges that EPA failed
to determine whether the Herculaneum nonattainment area, in Jefferson
County, Missouri attained the 1978 lead National Ambient Air Quality
Standard (1978 lead NAAQS) by its attainment date as mandated by CAA.
The proposed consent decree establishes a deadline of August 15, 2013
for EPA to take action with respect to the Tennessee infrastructure SIP
and the Herculaneum nonattainment area.

DATES: Written comments on the proposed consent decree must be received
by May 20, 2013.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2013-0236, online at www.regulations.gov (EPA's preferred method);
by email to<EMAIL_ADDRESS>mailed to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: David Orlin, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    The proposed consent decree would resolve a lawsuit filed by
Plaintiffs seeking to compel the Agency to satisfy certain mandatory
duties under the Clean Air Act. The proposed consent decree provides
that no later than August 15, 2013, EPA shall sign for publication in
the Federal Register a notice of EPA's action approving, disapproving,
or approving in part and disapproving in part the infrastructure SIP
for the 2008 lead NAAQS submitted by Tennessee. In addition, the
proposed consent decree provides that no later than August 15, 2013,
EPA shall sign for publication in the Federal Register a notice of
EPA's determination whether the Herculaneum nonattainment area, in
Jefferson County, Missouri attained the 1978 lead NAAQS by its
attainment date, unless as of that date, EPA issues a determination
that it has received from Missouri a nonattainment area SIP for the
2008 lead NAAQS for the Herculaneum nonattainment area which meets the
requirements of 40 CFR 51.103(a) or EPA signs for publication in the
Federal Register a notice finding that Missouri has failed to submit a
complete nonattainment area SIP for the 2008 lead NAAQS for the
Herculaneum nonattainment area. The proposed consent decree also notes
that on February 15, 2013, EPA signed a notice making certain findings
that the States of Hawaii, Illinois, Massachusetts, New Jersey, Oregon,
Vermont and Washington had failed to submit complete infrastructure
SIPs for the 2008 lead NAAQS, and noted that as of February 14, 2013,
Colorado, Maryland, Oklahoma, Pennsylvania, and South Dakota had
submitted complete infrastructure SIPs for the 2008 lead NAAQS.
    Following signature of each final action described in the proposed
consent decree, EPA shall promptly deliver notice of such action to the
Office of the Federal Register for review and publication in the
Federal Register. After EPA fulfills its obligations under the consent
decree, the consent decree provides that this case shall be dismissed
with prejudice.
    The proposed consent decree also states that that the consent
decree can be modified by the parties, or by the court following a
motion by a party and a response thereto. In addition, the parties
agree to seek to resolve informally Plaintiffs' claim for litigation
costs pursuant to 42 U.S.C. 7604(d), but the court would retain
jurisdiction to resolve that claim.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines that consent to this consent decree should be
withdrawn, the terms of the decree will be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC- 2013-0236) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
www.regulations.gov. You may use the www.regulations.gov to submit or
view public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, key in
the appropriate docket identification number then select ``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or other information
whose disclosure is restricted by statute. Information claimed as CBI
and other information whose disclosure is restricted by statute is not
included in the official public docket or in the electronic public
docket. EPA's policy is that copyrighted material, including
copyrighted material contained in a public comment, will not be placed
in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or CD
ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(email) system is not an ``anonymous access'' system. If you send an
email comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: April 8, 2013.
Lorie J. Schmidt,
Associate General Counsel.
[FR Doc. 2013-09292 Filed 4-18-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71548-71549]
[FR Doc No: 2016-24979]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79081; File No. SR-NASDAQ-2016-135]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Amend the Continued Listing
Requirements for Exchange-Traded Products

October 11, 2016
    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 September 30, 2016, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend the continued listing requirements
for exchange-traded products (``ETPs'') in the Nasdaq Rule 5700 Series,
as well as a related amendment to Nasdaq Rule 5810 (Notification of
Deficiency by the Listing Qualifications Department). The Exchange is
also making housekeeping changes throughout the Nasdaq Rule 5700 Series
and in Nasdaq Rule 5810 for improved clarity.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.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 Exchange proposes to amend the listing rules for ETPs in the
Nasdaq Rule 5700 Series (Other Securities) to add additional continued
listing standards as well as a related amendment to Nasdaq Rule 5810
(Notification of Deficiency by the Listing Qualifications Department).
The Exchange is also making housekeeping changes throughout the Nasdaq
Rule 5700 Series and in Nasdaq Rule 5810 (e.g., punctuation,
formatting, capitalization and renumbering) for improved clarity.
    The proposed rule changes are being made in concert with
discussions with the SEC. Citing their concern for potential
manipulation of ETPs, staff (``Staff'') of the SEC's Office of Trading
and Markets (``T&M'') requested that the Exchange adopt certain
additional continued listing standards for ETPs.
    As a result, the proposed amended rules reflect the guidance
provided by T&M Staff to clarify that most initial listing standards,
as well as certain representations included in Exchange rule filings
under SEC Rule 19b-4 \3\ to list an ETP (``Exchange Rule Filings''),
are also considered continued listing standards. The Exchange Rule
Filing representations that will also be required to be maintained on a
continuous basis include: (a) The description of the fund; (b) the
fund's investment restrictions; and (c) the applicability of Nasdaq
rules and surveillance procedures.
---------------------------------------------------------------------------

    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The proposed rule changes require that ETPs listed by the Exchange
without an Exchange Rule Filing must maintain the initial index or
reference asset criteria on a continued basis. For example, in the case
of a domestic equity index, these criteria generally include: (a)
Stocks with 90% of the weight of the index must have a minimum market
value of at least $75 million; (b) stocks with 70% of the weight of the
index must have a minimum monthly trading volume of at least 250,000
shares; (c) the most heavily weighted component cannot exceed 30% of
the weight of the index, and the five most heavily weighted stocks
cannot exceed 65%; (d) there must be at least 13 stocks in the index;
and (e) all securities in the index must be listed in the U.S. There
are similar criteria for international indexes, fixed-income indexes
and indexes with a combination of components.
    If an Exchange Rule Filing is made to list a specific ETP, the
proposed rule change requires that the issuer of the security comply on
a continuing basis with any statements or representations contained in
the applicable rule proposal, including: (a) The description of the
portfolio; (b) limitations on portfolio holdings or reference assets;
and (c) the applicability of Nasdaq rules and surveillance procedures.
    The Nasdaq listing rules will also be modified to require that
issuers of securities listed under the Nasdaq Rule 5700 Series must
notify the Exchange regarding instances of non-compliance. In addition,
while listed ETPs are currently subject to the delisting process in the
Rule 5800 Series, the rules will be clarified to make this explicit.\4\
The Rule 5800 Series will also be clarified to make explicit that in
cases where Listing Qualifications staff has notified an ETP that it is
deficient under one or more listing standards, the ETP may submit a
plan to regain compliance as set forth under the Listing Rules. In this
regard, consistent with deficiencies from most other rules that allow
issuers to submit a plan to regain compliance,\5\ Nasdaq proposes to
allow issuers of ETPs 45 calendar days to submit such a plan. Nasdaq
staff will review the plan and may grant a limited period of time for
the ETP to regain compliance as permitted under the Listing Rules. If
Nasdaq staff does not accept the plan, Nasdaq staff would issue a
Delisting Determination, which the company could appeal to a Hearings
Panel pursuant to Rule 5815.
---------------------------------------------------------------------------

    \4\ ETPs are also subject to Nasdaq Rule 4120, which governs
trading halts.
    \5\ Pursuant to Rule 5810(c)(2)(A), a company is provided 45
days to submit a plan to regain compliance with Rules 5620(c)
(Quorum), 5630 (Review of Related Party Transactions), 5635
(Shareholder Approval), 5250(c)(3) (Auditor Registration), 5255(a)
(Direct Registration Program), 5610 (Code of Conduct), 5615(a)(4)(E)
(Quorum of Limited Partnerships), 5615(a)(4)(G) (Related Party
Transactions of Limited Partnerships), and 5640 (Voting Rights). A
company is generally provided 60 days to submit a plan to regain
compliance with the requirement to timely file periodic reports
contained in Rule 5250(c)(1).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b)

of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposed rule changes accomplish these objectives by enhancing
the current continued listing standards by clarifying that most initial
listing standards, as well as certain representations included in
Exchange Rule Filings to list an ETP, are considered continued listing
standards. Additionally, the Nasdaq listing rules will be modified to
require that issuers of securities listed under the Nasdaq Rule 5700
Series must notify the Exchange regarding instances of non-compliance
and to clarify that deficiencies will be subject to potential trade
halts and the delisting process in the Rule 5800 Series. The Exchange
believes that these amendments will enhance the Nasdaq listing rules,
thereby serving to improve the national market system and protect
investors and the public interest.
    The Exchange does not believe that the housekeeping changes have
any impact on the reasonable and equitable and not unfairly
discriminatory nature of the proposal.
    For these reasons, Nasdaq believes the proposed rule change is
consistent with the requirements of Section 6(b)(5) of the Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act, as amended. The Exchange
believes that the proposed rule change to amend the listing rules for
ETPs in the Nasdaq Rule 5700 Series and the notification requirement in
Rule 5810 will have no impact on competition. Furthermore, since T&M
Staff has provided the same guidance regarding ETP continued listing
requirements to all exchanges, the Exchange believes that there will be
no effect on competition.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please
include File Number SR-NASDAQ-2016-135 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2016-135. 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-NASDAQ-2016-135 and should
be submitted on or before November 7, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-24979 Filed 10-14-16; 8:45 am]
 BILLING CODE 8011-01-P