[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21341-21343]
[FR Doc No: 2016-08279]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0167; FRL-9944-32]

Chlorpyrifos, Diazinon, and Malathion Registration Review; Draft
Biological Evaluations; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of the draft biological
evaluations for the registration reviews of all uses of chlorpyrifos,
diazinon, and malathion for public review and comment. Registration
review is EPA's periodic review of pesticide registrations to ensure
that each pesticide continues to satisfy the statutory standard for
registration, that is, the pesticide can perform its intended function
without unreasonable adverse effects. Through the registration review
program, EPA is ensuring that each pesticide's registration is based on
the most current scientific methods. Furthermore, EPA is meeting its
obligation under section 7 of the Endangered Species Act by ensuring
that each pesticide's registration is not likely to jeopardize the
continued existence of any listed species or result in the destruction
or adverse modification of designated critical habitat.

DATES: Comments must be received on or before June 10, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2016-0167, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information
contact: The Chemical Review Manager for the pesticide of interest
identified in the following table.

------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.                   ID No.       number, email address
------------------------------------------------------------------------
Chlorpyrifos, 100.............  EPA-HQ-OPP-2008-0  Dana Friedman, 703-
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Diazinon, 238.................  EPA-HQ-OPP-2008-0  Khue Nguyen, 703-347-
                                 351.               0248,
<EMAIL_ADDRESS>Malathion, 248................  EPA-HQ-OPP-2009-0  Steven Snyderman, 703-
<PHONE_NUMBER>,
<EMAIL_ADDRESS>------------------------------------------------------------------------

    For general questions on the registration review program, contact:
Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

 A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, farm
worker, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides and/or the potential impacts of pesticide use on
listed species and designated critical habitat. Since others also may
be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the applicability of this action to a particular
entity, consult the Chemical Review Manager for the pesticide of
interest identified under FOR FURTHER INFORMATION CONTACT.

 B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at

http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Executive Summary

A. What action is the agency taking?

    EPA is providing an opportunity for public review of its draft
biological evaluations for the registration reviews of chlorpyrifos,
diazinon, and malathion. Registration review is EPA's periodic review
of pesticide registrations to ensure that each pesticide continues to
satisfy the statutory standard for registration, that is, the pesticide
can perform its intended function without unreasonable adverse effects.
As part of the registration review process, the Agency has completed
comprehensive draft biological evaluations for all chlorpyrifos,
diazinon, and malathion uses.
    These draft biological evaluations represent the first ever
nationwide assessments of these pesticides to federally endangered and
threatened species (i.e., listed species) and designated critical
habitat. The interim scientific methods used in these draft biological
evaluations were developed collaboratively with the U.S. Fish and
Wildlife Service (USFWS) and the National Marine Fisheries Service
(NMFS), hereafter referred to as the Services, based on recommendations
from the April 2013 National Academy of Sciences (NAS) report
``Assessing Risks to Endangered and Threatened Species from
Pesticides.'' As part of this effort, the U.S. Department of
Agriculture has provided expertise on crop production and pesticide
uses and assistance with the use of the National Agricultural
Statistics Service Cropland Data Layer to help define the footprint of
agricultural use patterns.
    After reviewing comments received during the public comment period,
EPA will issue revised final biological evaluations, explain any
changes, respond to comments, and may request public input on risk
mitigation before completing proposed registration review decisions for
chlorpyrifos, diazinon, and malathion. For those species and designated
critical habitats where registered uses of the pesticides are ``likely
to adversely affect'' species and/or habitat, USFWS and NMFS will
utilize the analyses and data from the biological evaluations in their
final Biological Opinions for each of the three chemicals.

B. What is the agency's authority for taking this action?

    EPA is conducting its registration review of chlorpyrifos,
diazinon, and malathion pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq., and the Procedural Regulations for Registration Review at 40 CFR
part 155, subpart C. Section 3(g) of FIFRA provides, among other
things, that the registrations of pesticides are to be reviewed every
15 years. Under FIFRA, a pesticide product may be registered, or remain
registered, only if it meets the statutory standard for registration
given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in
accordance with widespread and commonly recognized practice, the
pesticide product must perform its intended function without
unreasonable adverse effects on the environment; that is, without any
unreasonable risk to man or the environment.
    EPA develops endangered species biological evaluations and consults
with the Services pursuant to section 7(a)(2) of the Endangered Species
Act (ESA), 16 U.S.C. 1531 et seq., and the implementing regulations at
50 CFR part 402.

III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations for chlorpyrifos, diazinon, and malathion to ensure that
these registrations continue to satisfy the FIFRA standard for
registration--that is, that chlorpyrifos, diazinon, and malathion can
still be used without unreasonable adverse effects.
    EPA has been collaborating with the Services to develop interim
scientific approaches to assess the impact of pesticides on listed
species and designated critical habitat, as required by ESA and as
recommended by the April 2013 NAS report. Chlorpyrifos, diazinon, and
malathion were selected for the development and implementation of these
interim approaches because these pesticides were included in the first
Biological Opinion issued by NMFS in response to litigation brought by
the Washington Toxics Coalition (WTC) with regard to salmonids in the
Pacific Northwest. This Biological Opinion was later remanded to NMFS
by the U.S. Court of Appeals for the 3rd Circuit. The interim
scientific approaches used in the draft biological evaluations for
chlorpyrifos, diazinon, and malathion were developed based on a
collaborative effort among the agencies, and will be refined based on
the public comments received on the draft biological evaluations as
well as input from an ESA stakeholder workshop planned for the summer
of 2016. More information on this process is available at https://www.epa.gov/endangered-species/implementing-nas-report-recommendations-ecological-risk-assessment-endangered-and.
    Chlorpyrifos is an organophosphate (OP) insecticide, acaricide, and
miticide used to control a variety of insects on a variety of food and
feed crops. Currently registered uses include a variety of fruits,
nuts, vegetables, grains, and non-agricultural areas (such golf course
turf, industrial sites, greenhouses and nurseries, sod farms, and wood
products). Public health uses include aerial and ground-based fogger
treatments to control mosquitoes. There are also residential uses of
ant and roach bait products and fire ant mound treatments. EPA has
completed a draft biological evaluation to assess whether all
registered uses of chlorpyrifos may affect listed species and
designated critical habitat. The chlorpyrifos draft biological
evaluation is viewable at: https://www.epa.gov/endangered-species/biological-evaluation-chapters-chlorpyrifos. Comments on the draft
biological evaluation for chlorpyrifos should be submitted to the
chlorpyrifos registration review docket (EPA-HQ-OPP-2008-0850) at
http://www.regulations.gov.
    Diazinon is a restricted use OP insecticide currently registered
for use on a number of fruits, vegetables, nuts, ornamentals, and in
cattle ear tags. All residential uses were phased out as part of risk
mitigation during reregistration, and there are currently no
residential uses. EPA has completed a draft biological evaluation to
assess whether all registered uses of diazinon may affect listed
species and designated critical habitat. The diazinon draft biological
evaluation is viewable at: https://www.epa.gov/endangered-species/biological-evaluation-chapters-diazinon. Comments on the draft
biological evaluation for diazinon should be submitted to the diazinon

registration review docket (EPA-HQ-OPP-2008-0351) at http://www.regulations.gov.
    Malathion is a non-systemic, wide spectrum OP. It is used in the
agricultural production of a wide variety of food/feed crops to control
insects such as aphids, leafhoppers, and Japanese beetles. Malathion is
also used in USDA's Cotton Boll Weevil Eradication Program, Fruit Fly
(Medfly) Control Program, and for mosquito-borne disease control. It is
also registered for outdoor residential uses which include vegetable
gardens, home orchards, and ornamentals. EPA has completed a draft
biological evaluation to assess whether all registered uses of
malathion may affect listed species and designated critical habitat.
The draft malathion biological evaluation is viewable at: https://www.epa.gov/endangered-species/biological-evaluation-chapters-malathion. Comments on the draft biological evaluation for malathion
should be submitted to the malathion registration review docket (EPA-
HQ-OPP-2009-0317) at http://www.regulations.gov.

IV. Public Review and Comment Opportunity

    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft biological evaluations
for chlorpyrifos, diazinon, and malathion. Such comments and input
could address, among other things, the Agency's risk assessment
methodologies and assumptions, as applied to these draft biological
evaluations. The Agency will consider all comments received during the
public comment period and make changes, as appropriate, to the draft
biological evaluations. EPA will then issue final biological
evaluations, explain any changes to the draft biological evaluations,
and respond to comments. For those species and designated critical
habitats where registered uses of the pesticides are ``likely to
adversely affect'' species and/or habitat, USFWS and NMFS will utilize
the analyses and data from the biological evaluations in their final
Biological Opinions for each of the three chemicals. The final
Biological Opinions for the three chemicals are currently scheduled for
December 2017. In the Federal Register notice announcing the
availability of the final biological evaluations, if the final
biological evaluations indicate risks of concern, the Agency may
provide a comment period for the public to submit suggestions for
mitigating the risk identified in the final biological evaluations
before developing proposed registration review decisions for
chlorpyrifos, diazinon, and malathion.
    1. Other related information. Additional information on endangered
species risk assessment and the NAS report recommendations are
available at https://www.epa.gov/endangered-species/implementing-nas-report-recommendations-ecological-risk-assessment-endangered-and.
Information on the Agency's registration review program and its
implementing regulation is available at https://www.epa.gov/pesticide-reevaluation.
    2. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English, and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

    Authority: 7 U.S.C. 136 et seq.

    Dated: March 28, 2016.
Michael Goodis,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2016-08279 Filed 4-8-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 28 (Friday, February 12, 2021)]
[Notices]
[Pages 9328-9329]
[FR Doc No: 2021-02855]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

    Docket Number: PR21-26-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Tariff filing per 284.123(b),(e)/: Revised Statement
of

Operating Condition Exhibit A to be effective 2/1/2021 under PR21-26.
    Filed Date: 2/4/2021.
    Accession Number:<PHONE_NUMBER>35.
    Comments/Protests Due: 5 p.m. ET 2/25/2021.

    Docket Numbers: RP21-453-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 2.3.21 Negotiated Rates--Mieco
LLC H-7080-89 to be effective 2/3/2021.
    Filed Date: 2/3/21.
    Accession Number: 20210203-5027.
    Comments Due: 5 p.m. ET 2/16/21.

    Docket Numbers: RP21-454-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 2.3.21 Negotiated Rates--
Sequent Energy Management, L.P. H-3075-89 to be effective 2/3/2021.
    Filed Date: 2/3/21.
    Accession Number: 20210203-5028.
    Comments Due: 5 p.m. ET 2/16/21.

    Docket Numbers: RP21-455-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 2.3.21 Negotiated Rates--
Castleton Commodities Merchant Trading L.P. H-4010-89 to be effective
2/3/2021.
    Filed Date: 2/3/21.
    Accession Number: 20210203-5029.
    Comments Due: 5 p.m. ET 2/16/21.

    Docket Numbers: RP21-456-000.
    Applicants: Transwestern Pipeline Company, LLC.
    Description: Compliance filing Alert Day Penalty Report on 2-3-
2021.
    Filed Date: 2/3/21.
    Accession Number: 20210203-5054.
    Comments Due: 5 p.m. ET 2/16/21.

    Docket Numbers: RP21-457-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 2/3/21 Negotiated Rates--
Hartree Partners, LP H-7090-89 to be effective 2/3/2021.
    Filed Date: 2/3/21.
    Accession Number: 20210203-5088.
    Comments Due: 5 p.m. ET 2/16/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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(s). 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: February 5, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-02855 Filed 2-11-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 10, 2008 (Volume 73, Number 238)]
[Notices]
[Page 75169-75171]
[DOCID:fr10de08-114]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration Proposed Agency Information
Collection Activities; Comment Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking renewal of the following currently
approved information collection activities. Before submitting these
information collection requirements for clearance by the Office of
Management and Budget (OMB), FRA is soliciting public comment on
specific aspects of the activities identified below.

DATES: Comments must be received no later than February 9, 2009.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC
20590, or Ms. Nakia Jackson, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop
35, Washington, DC 20590. Commenters requesting FRA to acknowledge
receipt of their respective comments must include a self-addressed
stamped postcard stating, ``Comments on OMB control number 2130-0548.''
Alternatively, comments may be transmitted via facsimile to (202) 493-
6216 or<PHONE_NUMBER>, or via e-mail to Mr. Brogan at
<EMAIL_ADDRESS>or to Ms. Jackson at<EMAIL_ADDRESS>
Please refer to the assigned OMB control number in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT:
    Mr. Robert Brogan, Office of Planning and Evaluation Division, RRS-
21, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail
Stop 17, Washington, DC 20590 (telephone:<PHONE_NUMBER>) or Ms. Nakia
Jackson, Office of Information Technology, RAD-20, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 35, Washington, DC
20590 (telephone:<PHONE_NUMBER>). (These telephone numbers are not
toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law No. 104-13, Sec.  2, 109 Stat. 163 (1995) (codified as
revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5
CFR Part 1320, require Federal agencies to provide 60-days notice to
the public for comment on information collection activities before
seeking approval for

reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A); 5 CFR
1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA invites
interested respondents to comment on the following summary of proposed
information collection activities regarding (i) whether the information
collection activities are necessary for FRA to properly execute its
functions, including whether the activities will have practical
utility; (ii) the accuracy of FRA's estimates of the burden of the
information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. Sec.  3506(c)(2)(A)(i)-(iv); 5
CFR 1320.8(d)(1)(i)-(iv). FRA believes that soliciting public comment
will promote its efforts to reduce the administrative and paperwork
burdens associated with the collection of information mandated by
Federal regulations. In summary, FRA reasons that comments received
will advance three objectives: (i) Reduce reporting burdens; (ii)
ensure that it organizes information collection requirements in a
``user friendly'' format to improve the use of such information; and
(iii) accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below is a brief summary of the currently approved information
collection activities that FRA will submit for clearance by OMB as
required under the PRA:
    Title: Railroad Rehabilitation and Improvement Financing Program.
    OMB Control Number: 2130-0548.
    Abstract: Prior to the enactment of the Transportation Equity Act
of the 21st Century (``TEA 21''), Title V of the Railroad
Revitalization and Regulatory Reform Act of 1976 (the ``Act''), 45
U.S.C. 821 et seq., authorized FRA to provide railroad financial
assistance through the purchase of preference shares (45 U.S.C. 825),
and the issuance of loan guarantees (45 U.S.C. 831). The FRA
regulations implementing the preference share program were eliminated
on February 9, 1996, due to the fact that the authorization for the
program expired (28 FR 4937). The FRA regulations implementing the loan
guarantee provisions of Title V of the Act are contained in 49 CFR 260.
Section 7203 of TEA 21, Public Law 105-178 (June 9, 1998), replaces the
existing Title V financing programs. The collection of information is
used by FRA staff to determine the eligibility of applicants for a loan
regarding eligible projects for the improvement/rehabilitation of rail
equipment or facilities, the refinancing of outstanding debt for these
purposes, or the development of new intermodal or railroad facilities.
The aggregate unpaid principal amounts of obligations can not exceed
$3.5 billion at any one time and not less than $1 billion is to be
available solely for projects benefitting railroads other than Class I
carriers.
    Affected Public: State and local governments, government sponsored
authorities and corporations, railroads (including Amtrak), and joint
ventures that include at least one railroad.

                                                Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average time
            CFR section              Respondent  universe       Total annual       per response    Total annual
                                                                 responses            (hours)      burden hours
----------------------------------------------------------------------------------------------------------------
260.19--Pre-Application Meeting...  21,956 potential       3 meetings...........               1               3
                                     applicants.
260.23--Form and Content of         21,956 potential       15 applications......              20             300
 Applications Generally.             applicants.
229.25--Additional Information for  555 potential          13 financial document              50             650
 Applicants without a Credit         applicants.            packages.
 Rating.
260.31--Execution and Filing of     21,956 potential       15 executed app......              .6               9
 the Application--Original--         applicants.           15 certificates......              .6               9
 Certificates with Original         21,956 potential       20 letters...........              .6               9
 Application--Transmittal Letters--  applicants.           15 app. pkgs.........             1.5              23
 Original Application and           21,956 potential
 Supporting Documents.               applicants.
                                    21,956 potential
                                     applicants.
260.33--Information Requests--      21,956 potential       15 statements........             *30               8
 Statements by Applicants            applicants.
 Requesting Confidentiality of
 Submitted Information.
260/35--Environmental Assessment--  21,956 potential       2 assessments........           1,000           2,000
 Environmental Impact Statements/    applicants.           5 consultations......               1               5
 Documents--Consultations with FRA  21,956 potential
 Administrator.                      applicants.
260.41--Inspection and Reporting--  21,956 potential       120 financial records              10           1,200
 Submission of Financial and Other   applicants.
 Documents Detailing Maintenance
 and Inspection in Compliance with
 Section 260.39.
260.49--Avoiding Defaults--         21,956 potential       1 request............              10              10
 Deferral Requests.                  applicants.
----------------------------------------------------------------------------------------------------------------
* In minutes.

    Total Responses: 239.
    Estimated Total Annual Burden: 4,226 hours.
    Status: Regular Review.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on December 3, 2008.
Martin J. Eble,
Acting Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. E8-29098 Filed 12-9-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Notices]
[Pages 23032-23035]
[FR Doc No: 2016-08955]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77607; File No. SR-BYX-2016-03]

Self-Regulatory Organizations; BATS-Y Exchange, Inc.; Order
Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto,
To Adopt an Early Trading Session and Three New Time-In-Force
Instructions

April 13, 2016.

I. Introduction

    On February 16, 2016, BATS-Y Exchange, Inc. (n/k/a Bats BYX
Exchange, Inc.) (the ``Exchange'' or ``BYX'') filed with the Securities
and Exchange Commission (the ``Commission''), pursuant to Section
19(b)(1) \1\ of the Securities Exchange Act of 1934 (``Act'') \2\ and
Rule 19b-4 thereunder,\3\ a proposed rule change to amend its rules to:
(i) Create a new trading session to be known as the Early Trading
Session, which will run from 7:00 a.m. to 8:00 a.m. Eastern Time; and
(ii) adopt three new Time-in-Force (``TIF'') instructions. The proposed
rule change was published for comment in the Federal Register on
February 29, 2016.\4\ On April 11, 2016, the Exchange filed Amendment
No. 1 to the proposed rule change.\5\ The Commission received no
comments on the proposed rule change. This order approves the proposed
rule change, as modified by Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ See Securities Exchange Act Release No. 77213 (February 23,
2016), 81 FR 10310 (``Notice'').
    \5\ Amendment No. 1 amended and replaced the proposed rule
change in its entirety. In Amendment No. 1, the Exchange made
technical, non-substantive changes to the proposed rule text to
replace references to ``BATS'' with ``BYX,'' and otherwise revised
Exhibit 5, so that the proposed rule text therein is consistent with
the Exchange's current rule text. See Securities Exchange Act
Release No. 77308 (March 7, 2016) 81 FR 12975 (March 11, 2016) (SR-
BYX-2016-07). In Amendment No. 1, the Exchange also proposes a non-
substantive change to Exchange Rule 14.1 to correct an inaccurate
description of the start time for the Pre-Opening Session. Because
Amendment No. 1 adds clarification and does not materially alter the
substance of the proposed rule change or raise unique or novel
regulatory issues, Amendment No. 1 is not subject to notice and
comment.
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange proposes to amend its rules to: (i) Create a new
trading session, the Early Trading Session, which will run from 7:00
a.m. to 8:00 a.m. Eastern Time; and (ii) adopt three new TIF
instructions.

A. Early Trading Session

    The Exchange trading day is currently divided into three sessions:
(i) The Pre-Opening Session, which starts at 8:00 a.m. and ends at 9:30
a.m. Eastern Time; (ii) Regular Trading Hours, which run from 9:30 a.m.
to 4:00 p.m. Eastern Time; and (iii) the After Hours Session, which
runs from 4:00 p.m. to 5:00 p.m. Eastern Time.\6\ The Exchange proposes
to amend its rules to create the Early Trading Session. Exchange Rule
1.5 would be amended to add a new term, ``Early Trading Session,''
under proposed paragraph (ee). ``Early Trading Session'' would be
defined as ``the time between 7:00 a.m. and 8:00 a.m. Eastern Time.''
---------------------------------------------------------------------------

    \6\ See Notice, supra note 4, at 10310.
---------------------------------------------------------------------------

    The Exchange also proposes to amend Exchange Rule 11.1(a) to state
that orders may be entered or executed on, or routed away from, the
Exchange during the Early Trading Session and to reflect the start time
of the Early Trading Session as 7:00 a.m. Eastern Time. Other than the
proposal to adopt an Early Trading Session, the Exchange does not
propose to amend the substance or operation of Exchange Rule
11.1(a).\7\
---------------------------------------------------------------------------

    \7\ See id.
---------------------------------------------------------------------------

    Users \8\ currently designate when their orders are eligible for
execution by selecting a desired TIF instruction. Orders entered
between 6:00 a.m. and 8:00 a.m. Eastern Time are not eligible for
execution until the start of the Pre-Opening Session or Regular Trading
Hours, depending on the TIF selected by the User. A User may enter
orders in advance of the trading session for which its orders are
eligible. For example, Users may enter orders starting at 6:00 a.m.
Eastern Time with a TIF of Regular Hours Only (``RHO''), which
designates that the order only be eligible for execution during Regular
Trading Hours.\9\ Users may enter orders as early as 6:00 a.m. Eastern
Time, but those orders would not be eligible for execution until the
start of the Pre-Opening Session at 8:00 a.m. According to the
Exchange, some Users have requested the ability for their orders to be
eligible for execution starting at 7:00 a.m. Eastern Time. Therefore,
the Exchange is proposing to adopt the Early Trading Session.\10\
---------------------------------------------------------------------------

    \8\ ``User'' is defined as ``any Member or Sponsored Participant
who is authorized to obtain access to the System pursuant to Rule
11.3.'' See Exchange Rule 1.5(cc).
    \9\ See Exchange Rule 11.9(b)(7).
    \10\ See Notice, supra note 4, at 10310.
---------------------------------------------------------------------------

    As amended, Exchange Rule 11.1(a) would state that orders entered
between 6:00 a.m. and 7:00 a.m. Eastern Time, rather than 6:00 a.m. and
8:00 a.m.

Eastern Time, would not be eligible for execution until the start of
the Early Trading Session, Pre-Opening Session, or Regular Trading
Hours, depending on the TIF selected by the User. Exchange Rule 11.1(a)
would also be amended to state that the Exchange would not accept the
following orders prior to 7:00 a.m. Eastern Time, rather than 8:00
a.m.: (i) BYX Post Only Orders; \11\ (ii) Partial Post Only at Limit
Orders; \12\ (iii) Intermarket Sweep Orders (``ISOs''); \13\ (iv) BYX
Market Orders \14\ with a TIF other than RHO; (v) Minimum Quantity
Orders \15\ that also include a TIF of RHO; (vi) Retail Price
Improvement Orders; \16\ and (vii) all orders with a TIF instruction of
Immediate-or-Cancel (``IOC'') \17\ or Fill-or-Kill (``FOK'').\18\ At
the commencement of the Early Trading Session, orders entered between
6:00 a.m. and 7:00 a.m. Eastern Time, rather than 6:00 a.m. and 8:00
a.m. Eastern Time, would be handled in time sequence, beginning with
the order with the oldest time stamp, and would be placed on the BYX
Book,\19\ routed, cancelled, or executed in accordance with the terms
of the order. As amended, Exchange Rule 11.1(a) would state that orders
may be executed on the Exchange or routed away from the Exchange during
Regular Trading Hours and during the Early Trading, Pre-Opening, and
After Hours Trading Sessions.\20\
---------------------------------------------------------------------------

    \11\ See Exchange Rule 11.9(c)(6).
    \12\ See Exchange Rule 11.9(c)(7).
    \13\ See Exchange Rule 11.9(d).
    \14\ See Exchange Rule 11.9(a)(2).
    \15\ See Exchange Rule 11.9(c)(5).
    \16\ See Exchange Rule 11.24(a)(3).
    \17\ See Exchange Rule 11.9(b)(1).
    \18\ See Exchange Rule 11.9(b)(6).
    \19\ See Exchange Rule 1.5(e).
    \20\ See Notice, supra note 4, at 10310-11. Amendment No. 1
updated Exhibit 5 so that the names of orders, order modifiers, and
the Exchange's book stated therein conform with those used in the
current Exchange Rules. See supra, note 5. The Exchange also
describes how the Early Trading Session will affect its Members'
operations and the Exchange's opening process, order types, routing
services, order processing, data feeds, trade reporting, market
surveillance, and clearly erroneous trade processing. The Exchange
clarifies that these processes would operate in the same manner with
the exception of changes in time to reflect the adoption of the
Early Trading Session. See Notice, supra note 4, at 10311.
---------------------------------------------------------------------------

    The Exchange also proposes to make the changes described below to
Exchange Rules 3.21, 11.9, 11.13, 11.17, and 14.1 to reflect the
adoption of the Early Trading Session:
     Exchange Rule 3.21, Customer Disclosures. Exchange Rule
3.21 prohibits Members from accepting an order from a customer for
execution in the Pre-Opening or After Hours Trading Session without
disclosing to their customer that extended hours trading involves
material trading risks, including the possibility of lower liquidity,
high volatility, changing prices, unlinked markets, an exaggerated
effect from news announcements, wider spreads and any other relevant
risk. The Exchange proposes to amend Exchange Rule 3.21 to also require
such disclosures for customer orders that are to be executed during the
Early Trading Session.\21\
---------------------------------------------------------------------------

    \21\ See id.
---------------------------------------------------------------------------

     Exchange Rule 11.9, Orders and Modifiers. The Exchange
proposes to amend the description of BYX Market Orders under Exchange
Rule 11.9(a)(2), Market Maker Peg Orders under Rule 11.9(c)(16), and
Supplementary Peg Orders under Rule 11.9(c)(19) to account for the
Early Trading Session. Every order type that is currently available
beginning at 8:00 a.m. would be available beginning at 7:00 a.m. for
inclusion in the Early Trading Session. All other order types, and all
order type behaviors, would otherwise remain unchanged. Therefore, each
of the above rules for BYX Market Orders, Market Maker Peg Orders, and
Supplemental Peg Orders would be amended to account for the Early
Trading Session.\22\
---------------------------------------------------------------------------

    \22\ See id. at 10311-12. Amendment No. 1 updated Exhibit 5 so
that the names of orders and order modifiers stated therein conform
with those used in the current Exchange Rules. See supra, note 5.
---------------------------------------------------------------------------

     Exchange Rule 11.13, Order Execution and Routing. Exchange
Rule 11.13(a)(2)(B) discusses compliance with Regulation NMS and Trade
Through Protections and states that the price of any execution
occurring during the Pre-Opening Session or the After Hours Trading
Session must be equal to or better than the highest Protected Bid or
lowest Protected Offer, unless the order is marked ISO or a Protected
Bid is crossing a Protected Offer. The Exchange proposes to amend
Exchange Rule 11.13(a)(2)(B) to expand the Exchange Rule's requirements
to the Early Trading Session.\23\
---------------------------------------------------------------------------

    \23\ See Notice, supra note 4, at 10312.
---------------------------------------------------------------------------

     Exchange Rule 11.17, Clearly Erroneous Executions.
Exchange Rule 11.17 outlines under which conditions the Exchange may
determine that an execution is clearly erroneous. The Exchange proposes
to amend Exchange Rule 11.17 to include executions that occur during
the Early Trading Session. Exchange Rule 11.17(c)(1) sets forth the
numerical guidelines the Exchange is to follow when determining whether
an execution was clearly erroneous during Regular Trading Hours or the
Pre-Opening or After Hours Trading Session. Exchange Rule 11.17(c)(3)
sets forth additional factors the Exchange may consider in determining
whether a transaction is clearly erroneous. These factors include
whether the transaction was executed during the Pre-Opening or After
Hours Trading Sessions. The Exchange proposes to amend Exchange Rule
11.17(c)(1) and (3) to include executions occurring during the Early
Trading Session.\24\
---------------------------------------------------------------------------

    \24\ See id. The Exchange also proposes technical amendments to
Exchange Rules 11.17(c)(1) and (3) to delete the letter ``s'' from
the word ``Trading Sessions'' and the letter ``s'' from the word
``tapes,'' respectively.
---------------------------------------------------------------------------

     Rule 14.1, Unlisted Trading Privileges. The Exchange
proposes to amend Rules 14.1(c)(2), and Interpretation and Policies
.01(a) and (b) to account for the proposed Early Trading Session.
Specifically, the Exchange proposes to amend paragraph (c)(2) to state
that an information circular distributed by the Exchange prior to the
commencement of trading of a UTP Derivative Security will include the
risk of trading during the Early Trading Session, in addition to the
Pre-Opening Session and After Hours Trading Session.\25\ In addition,
the Exchange proposes to amend Interpretation and Policies .01(a) to
add Early Trading Session to the paragraph's title and to state that if
a UTP Derivative Security begins trading on the Exchange in the Early
Trading Session or Pre-Opening Session and subsequently a temporary
interruption occurs in the calculation or wide dissemination of the
Intraday Indicative Value (``IIV'') or the value of the underlying
index, as applicable, to such UTP Derivative Security, by a major
market data vendor, the Exchange may continue to trade the UTP
Derivative Security for the remainder of the Early Trading Session and
Pre-Opening Session. Lastly, the Exchange proposes to amend
Interpretation and Policies .01(b) to add Early Trading Session to the
paragraph's title and to amend subparagraph (ii) of that section to
state that if the IIV or the value of the underlying index continues
not to be calculated or widely available as of the commencement of the
Early Trading Session or Pre-Opening Session on the next business day,
the Exchange shall not commence trading of the UTP Derivative Security
in the Early Trading Session or Pre-Opening Session that day.\26\
---------------------------------------------------------------------------

    \25\ In Amendment No. 1, the Exchange also proposes to amend
Rule 14.1(c)(2) to correct an inaccurate description of the Pre-
Opening Session, which currently reads as 9:00 a.m. to 9:30 a.m.
rather than 8:00 a.m. to 9:30 a.m. as is set forth throughout
Exchange Rules.
    \26\ See Notice, supra note 4, at 10312.

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

B. TIF Instructions

    The Exchange proposes to adopt three new TIF instructions under
Exchange Rule 11.9(b). As discussed above, a User may designate when
its order is eligible for execution by selecting the desired TIF
instruction under Exchange Rule 11.9(b).\27\
---------------------------------------------------------------------------

    \27\ See Exchange Rule 11.1(a).
---------------------------------------------------------------------------

    Although the Exchange states that the proposal to adopt an Early
Trading Session is in response to User requests for their orders to be
eligible for execution starting at 7:00 a.m. Eastern Time, the Exchange
states that some Users have requested that their orders continue to not
be eligible for execution until the start of the Pre-Opening Session at
8:00 a.m. Therefore, the Exchange proposes to adopt the following three
new TIF instructions under Exchange Rule 11.9(b): \28\
---------------------------------------------------------------------------

    \28\ See Notice, supra note 4, at 10312.
---------------------------------------------------------------------------

     Pre-Opening Session Plus (``PRE''). A limit order that is
designated for execution during the Pre-Opening Session and Regular
Trading Hours. Like the current Good `til Cancel TIF instruction,\29\
any portion not executed would expire at the end of Regular Trading
Hours.
---------------------------------------------------------------------------

    \29\ See Exchange Rule 11.9(b)(3).
---------------------------------------------------------------------------

     Pre-Opening Session `til Extended Day (``PTX''). A limit
order that is designated for execution during the Pre-Opening Session,
Regular Trading Hours, and the After Hours Session. Like the current
Good `til Extended Day TIF instruction,\30\ any portion not executed
would expire at the end of the After Hours Session.
---------------------------------------------------------------------------

    \30\ See Exchange Rule 11.9(b)(5).
---------------------------------------------------------------------------

     Pre-Opening Session `til Day (``PTD''). A limit order that
is designated for execution during the Pre-Opening Session, Regular
Trading Hours, and the After Hours Session. Like the current Good `til
Day TIF instruction,\31\ any portion not executed would be cancelled at
the expiration time assigned to the order, which can be no later than
the close of the After Hours Trading Session.
---------------------------------------------------------------------------

    \31\ See Exchange Rule 11.9(b)(4).
---------------------------------------------------------------------------

    Under each proposed TIF instruction, Users may designate that their
orders only be eligible for execution starting with the Pre-Opening
Session. Users may continue to enter orders as early as 6:00 a.m., but
orders with the proposed TIF instructions would not be eligible for
execution until 8:00 a.m. Eastern Time, which is the start of the Pre-
Opening Session. At the commencement of the Pre-Opening Session, orders
entered between 6:00 a.m. and 8:00 a.m. Eastern Time with one of the
proposed TIF instructions would be handled in time sequence, beginning
with the order with the oldest time stamp, and would be placed on the
BYX Book, routed, cancelled, or executed in accordance with the terms
of the order.\32\
---------------------------------------------------------------------------

    \32\ See Notice, supra note 4, at 10312. Amendment No. 1 updated
Exhibit 5 so that the name of the Exchange's book stated therein
conforms with the name used in the current Exchange Rules. See
supra, note 5. Orders utilizing one of the proposed TIF instructions
would not be eligible for execution during the Early Trading
Session. See Notice, supra note 4, at 10312, n.32.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful consideration, the Commission finds that the proposed
rule change, as modified by Amendment No. 1, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities exchange.\33\ The Commission
believes that the proposed rule change is consistent with Section
6(b)(5) \34\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, 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.
---------------------------------------------------------------------------

    \33\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \34\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange proposes to adopt an Early Trading Session and three
new TIF instructions and to make related changes to its rules as
discussed above.\35\ The Commission believes that the proposed rules
would provide Users with additional options for trading on the
Exchange. The Commission notes that the proposed Early Trading Session
hours are similar to those of other exchanges,\36\ and that the
proposed TIF instructions would offer functionality similar to existing
functionality available on the Exchange and other exchanges that allows
Members to select when their orders become eligible for execution.\37\
---------------------------------------------------------------------------

    \35\ See supra section II.
    \36\ For example, NYSE Arca, Inc. operates an Opening Session
that starts at 4:00 a.m. Eastern Time and ends at 9:30 a.m. Eastern
Time, and Nasdaq Stock Market LLC operates a pre-market session that
also opens at 4:00 a.m. and ends at 9:30 a.m. Eastern Time. See NYSE
Arca Rule 7.34(a)(1); Nasdaq Rule 4701(g). See also Securities
Exchange Act Release No. 60605 (September 1, 2009), 74 FR 46277
(September 8, 2009) (SR-CHX-2009-13) (adopting bifurcated post-
trading session on the Chicago Stock Exchange, Inc.).
    \37\ Specifically, on the Exchange, Users may enter an order
starting at 6:00 a.m. Eastern Time with a TIF of Regular Hours Only,
which designates that the order only be eligible for execution
during Regular Trading Hours, which begin at 9:30 a.m. Eastern Time.
See Exchange Rule 11.9(b)(7); see also NASDAQ Rule 4703(a)(7).
---------------------------------------------------------------------------

    The Commission notes that the Exchange has represented that it
would subject orders that are eligible for execution as of the start of
the Pre-Opening Session to all of the Exchange's standard regulatory
checks, as it currently does with all orders upon entry.\38\
Specifically, the Exchange would subject such orders to checks for
compliance with, including but not limited to, Regulation NMS,\39\
Regulation SHO,\40\ and relevant Exchange rules.\41\ Moreover, the
Exchange reminds its Members of their regulatory obligations when
submitting an order with one of the proposed TIF instructions.\42\ In
particular, the Exchange states that Members must comply with the
Market Access Rule,\43\ which requires, among other things, pre-trade
controls and procedures that are reasonably designed to assure
compliance with Exchange trading rules and Commission rules pursuant to
Regulation SHO and Regulation NMS. The Exchange also notes that a
Member's procedures must be reasonably designed to ensure compliance
with the applicable regulatory requirements, not just at the time the
order is routed to the Exchange, but also at the time the order becomes
eligible for execution.\44\
---------------------------------------------------------------------------

    \38\ See Notice, supra note 4, at 10314.
    \39\ See 17 CFR 242.600-613.
    \40\ See 17 CFR 242.200-204.
    \41\ See Notice, supra note 4, at 10314.
    \42\ See id.
    \43\ See 17 CFR 240.15c3-5.
    \44\ See Notice, supra note 4, at 10314.
---------------------------------------------------------------------------

    The Commission further notes the Exchange's discussion of the best
execution obligations of Members utilizing the proposed TIF
instructions.\45\ Specifically, the Exchange states that a Member's
best execution obligations may include cancelling an order when market
conditions deteriorate and could result in an inferior execution or
informing customers when the execution of their order may be delayed
intentionally while the Member utilizes reasonable diligence to
ascertain the best market for the security.\46\ The Exchange further
notes that Members will maintain the ability to cancel or modify the
terms of an order utilizing any of the proposed TIF instructions at any
time, including during the time from when the order is routed to the
Exchange until the start of the Pre-Opening Session.\47\ As a result,

the Exchange states that a Member who utilizes the proposed TIF
instructions, but later determines that market conditions favor
execution during Early Trading Session, can cancel the order residing
at the Exchange and enter a separate order to execute during the Early
Trading Session.\48\
---------------------------------------------------------------------------

    \45\ See id. at 10314.
    \46\ See id. at n.41.
    \47\ See id. at 10313.
    \48\ See id. at 10313-14.
---------------------------------------------------------------------------

    Furthermore, the Exchange proposes technical amendments to its
Rules to correct erroneous plural words and an inaccurate description
of the Pre-Opening Session times in Exchange Rules 11.17 and 14.1,
respectively. The Commission believes these proposed amendments would
help alleviate potential confusion among Users and Members regarding
the operation of the Exchange's rules and are, therefore, consistent
with the Act.

IV. Conclusion

    IT IS THEREFORE ORDERED, pursuant to Section 19(b)(2) of the Act
\49\ that the proposed rule change (SR-BYX-2016-03), as modified by
Amendment No.1, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \49\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\50\
---------------------------------------------------------------------------

    \50\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-08955 Filed 4-18-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Notices]
[Pages 17717-17718]
[FR Doc No: 2016-07094]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4263-DR; Docket ID FEMA-2016-0001]

Louisiana; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Louisiana (FEMA-4263-DR), dated March 13,
2016, and related determinations.

DATES: Effective Date: March 13, 2016.

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: Notice is hereby given that, in a letter
dated March 13, 2016, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Louisiana resulting from severe storms and flooding beginning on
March 8, 2016, and continuing, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Louisiana.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and
assistance for debris removal and emergency protective measures
(Categories A and B) under the Public Assistance program in the
designated areas, Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act that you deem
appropriate subject to completion of Preliminary Damage Assessments
(PDAs). Direct Federal assistance is authorized.

    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation and Other Needs Assistance will be limited to 75
percent of the total eligible costs. Federal funds provided under
the Stafford Act for Public Assistance also will be limited to 75
percent of the total eligible costs, with the exception of projects
that meet the eligibility criteria for a higher Federal cost-sharing
percentage under the Public Assistance Alternative Procedures Pilot
Program for Debris Removal implemented pursuant to section 428 of
the Stafford Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Gerard M. Stolar, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Louisiana have been designated
as adversely affected by this major disaster:

    The parishes of Bossier, Claiborne, Grant, Morehouse, Ouachita,
Richland, and Webster for Individual Assistance.
    The parishes of Bossier, Claiborne, Grant, Morehouse, Ouachita,
Richland, and Webster for debris removal and emergency protective
measures (Categories A and B), including direct federal assistance,
under the Public Assistance program.
    All areas within the State of Louisiana are eligible for
assistance under the Hazard Mitigation Grant Program.

    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. 2016-07094 Filed 3-29-16; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 69 (Friday, April 10, 2015)]
[Rules and Regulations]
[Pages 19203-19206]
[FR Doc No: 2015-08345]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR PART 165

[Docket No. USCG-2015-0213]
RIN 1625-AA00

Safety Zone; Barge-Based Fireworks, Sturgeon Bay, Wisconsin

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of Sturgeon Bay in Sturgeon Bay, Wisconsin. This safety zone is
intended to restrict vessels from a portion of Sturgeon Bay due to a
fireworks display. This temporary safety zone is necessary to protect
the

surrounding public and vessels from the hazards associated with the
fireworks display.

DATES: This rule is effective from 8:30 p.m. on May 15, 2015, until
9:30 p.m. on May 16, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2015-0213. To view documents mentioned in this
preamble as being available in the docket, go to http://www.regulations.gov, type the docket number in the “SEARCH”
box and click “SEARCH.” Click on Open Docket Folder on the
line associated with this rulemaking. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, contact or email MST1 Joseph McCollum, U.S. Coast Guard
Sector Lake Michigan, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone 1-800-647-5527.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are “impracticable, unnecessary, or contrary to the
public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds
that good cause exists for not publishing an NPRM with respect to this
rule because doing so would be impracticable and contrary to the public
interest. The final details for this event were not known to the Coast
Guard until there was insufficient time remaining before the event to
publish an NPRM. Specifically, the Coast Guard did not receive the
final details for this event until March 4, 2015. Thus, delaying the
effective date of this rule to wait for a comment period to run would
be both impracticable and contrary to the public interest because it
would inhibit the Coast Guard's ability to protect the public and
vessels from the hazards associated with the barge-based fireworks
display on May 15, 2015, which are discussed further below.

B. Basis and Purpose

    The legal basis for this rule is the Coast Guard's authority to
establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05-1, 160.5;
Department of Homeland Security Delegation No. 0170.1.
    On May 15, 2015, the Coast Guard anticipates that a tug and barge
will be anchored in the vicinity of the Sturgeon Bay Yacht Harbor on
the waters of Sturgeon Bay in Sturgeon Bay, Wisconsin for the purpose
of launching a fireworks display. The Captain of the Port Lake Michigan
has determined that this fireworks display will pose a significant risk
to public safety and property. Such hazards include falling and/or
flaming debris, and collisions among spectator vessels.

C. Discussion of the Final Rule

    With the aforementioned hazards in mind, the Captain of the Port
Lake Michigan has determined that this temporary safety zone is
necessary to ensure the safety of persons and vessels during the barge-
based fireworks display from the waters of Sturgeon Bay. This zone is
effective from 8:30 p.m. on May 15, 2015, until 9:30 p.m. on May 16,
2015. This zone will be enforced from 8:30 p.m. until 9:30 p.m. on May
15, 2015. In the case that inclement weather forces a postponement of
the fireworks display on May 15, 2015, this rule will be enforced from
8:30 p.m. until 9:30 p.m. on May 16, 2015. The safety zone will
encompass all waters of Sturgeon Bay, in the vicinity of Sturgeon Bay
Yacht Harbor, within the arc of a circle with a 420-foot radius from
the fireworks launch site, located on a barge in approximate position
44°49.579′ N., 087°22.384′ W. (NAD 83).
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Lake Michigan
or her designated on-scene representative. The Captain of the Port or
her designated on-scene representative may be contacted via VHF Channel
16.

D. Regulatory Analyses

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

 1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
“significant” under the regulatory policies and procedures
of the Department of Homeland Security (DHS). We conclude that this
rule is not a significant regulatory action because we anticipate that
it will have minimal impact on the economy, will not interfere with
other agencies, will not adversely alter the budget of any grant or
loan recipients, and will not raise any novel legal or policy issues.
The safety zone created by this rule will be relatively small and
enforced for only one day. Under certain conditions, moreover, vessels
may still transit through the safety zone when permitted by the Captain
of the Port.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we
have considered the impact of this temporary rule on small entities.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not
have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to transit or anchor in the affected portion of Sturgeon Bay on May 15
or May 16, 2015.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the reasons cited in the
Regulatory Planning and Review section. Additionally, before the
enforcement of this zone, we would issue local Broadcast Notice to
Mariners so vessel owners and operators can plan accordingly.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person

listed in the FOR FURTHER INFORMATION CONTACT section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call
1-888-REG-FAIR (1-888-734-3247).
The Coast Guard will not retaliate against small entities that question
or complain about this rule or any policy or action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a “significant energy action” under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD,
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f),
and have determined that this action is one of a category of actions
that do not individually or cumulatively have a significant effect on
the human environment. This rule involves the establishment of a safety
zone and, therefore it is categorically excluded from further review
under paragraph 34(g) of Figure 2-1 of the Commandant
Instruction. An environmental analysis checklist supporting this
determination and a Categorical Exclusion Determination are available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165-REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add §&thnsp;165.T09-0213 to read as follows:

§&thnsp;165.T09-0213  Safety Zone; Barge-based Fireworks,
Sturgeon Bay, Wisconsin.

    (a) Location. All waters of Sturgeon Bay, in the vicinity of
Sturgeon Bay Yacht Harbor, within the arc of a circle with a 420-foot
radius from the fireworks launch site located on a barge in approximate
position 44°49.579′ N., 087°22.384′ W. (NAD 83).
    (b) Effective and enforcement period. This zone is effective from
8:30 p.m. on May 15, 2015, until 9:30 p.m. on May 16, 2015. This zone
will be enforced from 8:30 p.m. until 9:30 p.m. on May 15, 2015. If the
scheduled event is postponed due to inclement weather on May 15, 2015,
this rule will be enforced from 8:30 p.m. until 9:30 p.m. on May 16,
2015.
    (c) Regulations. (1) In accordance with the general regulations in
§&thnsp;165.23 of this part, entry into, transiting, or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port Lake Michigan or her designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Lake Michigan or her designated
on-scene representative.
    (3) The “on-scene representative” of the Captain of the
Port Lake Michigan is any Coast Guard commissioned, warrant or petty
officer who has been designated by the Captain of the Port Lake
Michigan to act on her behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the Captain of the Port Lake

Michigan or her on-scene representative to obtain permission to do so.
The Captain of the Port Lake Michigan or her on-scene representative
may be contacted via VHF Channel 16. Vessel operators given permission
to enter or operate in the safety zone must comply with all directions
given to them by the Captain of the Port Lake Michigan or her on-scene
representative.

    Dated: March 30, 2015.
A.B. Cocanour,
Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
[FR Doc. 2015-08345 Filed 4-9-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38303-38305]
[FR Doc No: 2012-15708]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0253]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Adverse
Drug Experience Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
27, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0230.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT:  Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Postmarketing Adverse Drug Experience Reporting--21 CFR 310.305 and
314.80--(OMB Control Number 0910-0230)--(Extension)

    Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) require that marketed
drugs be safe and effective. In order to know whether drugs that are
not safe and effective are on the market, FDA must be promptly informed
of adverse experiences occasioned by the use of marketed drugs. In
order to help ensure this, FDA issued regulations at Sec. Sec.  310.305
and 314.80 (21 CFR 310.305 and 314.80) to impose reporting and
recordkeeping requirements on the drug industry that would enable FDA
to take the action necessary to protect the public health from adverse
drug experiences.
    All applicants who have received marketing approval of drug
products are required to report to FDA serious, unexpected adverse drug
experiences, as well as follow up reports when needed (Sec.
314.80(c)(1)). This includes reports of all foreign or domestic adverse
experiences as well as those based on information from applicable
scientific literature and certain reports from postmarketing studies.
    Section 314.80(c)(1)(iii) pertains to such reports submitted by
nonapplicants. Under Sec.  314.80(c)(2) applicants must provide
periodic reports of adverse drug experiences. A periodic report
includes, for the reporting interval, reports of serious, expected
adverse drug experiences and all nonserious adverse drug experiences
and an index of these reports, a narrative summary and analysis of
adverse drug experiences, and a history of actions taken because of
adverse drug experiences. Under Sec.  314.80(i), applicants must keep
for 10 years records of all adverse drug experience reports known to
the applicant.
    For marketed prescription drug products without approved new drug
applications or abbreviated new drug applications, manufacturers,
packers, and distributors are required to report to FDA serious,
unexpected adverse drug experiences as well as follow-up reports when
needed (Sec.  310.305(c)). Section 310.305(c)(5) pertains to the
submission of follow-up reports to reports forwarded by FDA. Under
Sec.  310.305(f), each manufacturer, packer, and distributor shall
maintain for 10 years records of all adverse drug experiences required
to be reported.
    The primary purpose of FDA's adverse drug experience reporting
system is to provide a signal for potentially serious safety problems
with marketed drugs. Although premarket testing discloses a general
safety profile of a new drug's comparatively common adverse effects,
the larger and more diverse patient populations exposed to the marketed
drug provide the opportunity to collect information on rare, latent,
and long-term effects. Signals are obtained from a variety of sources,
including reports from patients, treating physicians, foreign
regulatory agencies, and clinical investigators. Information derived
from the adverse drug experience reporting system contributes directly
to increased public health protection because the information enables
FDA to make important changes to the product's labeling (such as adding
a new warning), decisions about risk evaluation and mitigation
strategies or the need for postmarket studies or clinical trials, and
when necessary, to initiate removal of a drug from the market.
    Respondents to this collection of information are manufacturers,
packers, distributors, and applicants.
    In the Federal Register of March 20, 2012 (77 FR 16232), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received several comments, but they did
not pertain to the information collection in 21 CFR 310.305(c)(5) and
(f), and 314.80(c)(1)(iii), (c)(2), and (i).
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        21 CFR Section                              Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(c)(5).................................................                 3                 1                 3                 1                 3
314.80(c)(1)(iii).............................................                 5                 1                 5                 1                 5
314.80(c)(2)..................................................               665             22.85            15,195                60           911,700
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................           911,708
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec.  Sec.   310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) is reported under OMB No. 0910-0291. The
  capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                        Average burden
                        21 CFR Section                              Number of        records per      Total annual           per           Total hours
                                                                  recordkeepers     recordkeeper         records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(f)....................................................                25                 1                25                16               400

314.80(i).....................................................               665             601.5           399,998                16         6,399,968
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................         6,400,368
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually.

    These estimates are based on FDA's knowledge of adverse drug
experience reporting, including the time needed to prepare the reports,
and the number of reports submitted to the Agency.

    Dated: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15708 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P