[Federal Register: June 23, 2006 (Volume 71, Number 121)]
[Rules and Regulations]
[Page 36015-36019]
[DOCID:fr23jn06-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[FRL-8186-5]

National Oil and Hazardous Substance Pollution Contingency Plan;
National Priorities List Update

AGENCY: Environmental Protection Agency.

ACTION: Direct final notice of deletion of the Brio Refining, Inc.
Superfund Site from the National Priorities List.

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SUMMARY: The United States Environmental Protection Agency (EPA) Region
6 is publishing a direct final notice of deletion of the Brio Refining,
Inc. Superfund Site (Site), located in Friendswood, Texas, from the
National Priorities List (NPL). The NPL, promulgated pursuant to
Section 105 of the Comprehensive Environmental Response, Compensation,
and Liability Act (CERCLA) of 1980, as amended, is appendix B of 40 CFR
Part 300, which is the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). This direct final notice of deletion is being
published by EPA with the concurrence of the State of Texas, through
the Texas Commission on Environmental Quality (TCEQ), because EPA has
determined that all appropriate response actions under CERCLA have been
completed and, therefore, further remedial action pursuant to CERCLA is
not appropriate.

DATES: This direct final notice of deletion will be effective August
22, 2006 unless EPA receives adverse comments by July 24, 2006. If
adverse comments are received, EPA will publish a timely withdrawal of
the

direct final notice of deletion in the Federal Register informing the
public that the deletion will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-1989-0008, by one of the following methods:
    http://www.regulations.gov: Follow the on-line instruction for

submitting comments.
    E-mail: mail to<EMAIL_ADDRESS>    Fax:<PHONE_NUMBER>.
    Mail: Donn Walters, Community Outreach Team, U.S. EPA Region 6
(6SF-PO), 1445 Ross Avenue, Dallas, TX 75202-2733,<PHONE_NUMBER> or 1-
800-533-3508.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
1989-0008. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through or e-mail. The http://www.regulations.gov
 Web site is an ``anonymous access'' system, which

means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through http://www.regulations.gov, your

e-mail address be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the information

repositories.
    Information Repositories: Comprehensive information about the Site
is available for viewing and copying during central standard time at
the Site information repositories located at: U.S. EPA Region 6
Library, 7th Floor, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-
2733,<PHONE_NUMBER>, Monday through Friday 9 a.m. to 12 p.m. and 1
p.m. to 4 p.m.; San Jacinto College, South Campus Library, 13735 Beamer
Road, Houston, Texas, 77089,<PHONE_NUMBER>, Monday through Thursday 8
a.m. to 9 p.m.; Friday 8 a.m. to 3 p.m.; Saturday 10 a.m. to 1 p.m.;
Texas Commission on Environmental Quality (TCEQ), Central File Room
Customer Service Center, Building E, 12100 Park 35 Circle, Austin,
Texas, 78753,<PHONE_NUMBER>, Monday through Friday 8 a.m. to 5 p.m.

FOR FURTHER INFORMATION CONTACT: John C. Meyer, Remedial Project
Manager (RPM), U.S. EPA Region 6 (6SF-LP), 1445 Ross Avenue, Dallas, TX
75202-2733,<PHONE_NUMBER> or 1-800-533-3508 (meyer.john@epa.gov).

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Site Deletion
V. Deletion Action

I. Introduction

    The EPA Region 6 office is publishing this direct final notice of
deletion of the Brio Refining, Inc. Superfund Site from the NPL.
    The EPA identifies sites that appear to present a significant risk
to public health or the environment and maintains the NPL as the list
of those sites. As describes in Sec.  300.425(e)(3) of the NCP, sites
deleted from the NPL remain eligible for remedial actions if conditions
at a deleted site warrant such action.
    Because EPA considers this action to be noncontroversial and
routine, EPA is taking it without prior publication of a notice of
intent to delete. This action will be effective August 22, 2006 unless
EPA receives adverse comments by July 24, 2006 on this document. If
adverse comments are received within the 30-day public comment period
on this document, EPA will publish a timely withdrawal of this direct
final notice of deletion before the effective date of the deletion and
the deletion will not take effect. The EPA will, as appropriate,
prepare a response to comments and continue with the deletion process
on the basis of the notice of intent to delete and the comments already
received. There will be no additional opportunity to comment.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III discusses procedures that EPA is using
for this action. Section IV discusses the Brio Refining, Inc.,
Superfund Site and demonstrates how it meets the deletion criteria.
Section V discusses EPA's action to delete the Site from the NPL unless
adverse comments are received during the public comment period.

II. NPL Deletion Criteria

    Section 300.425(e) of the NCP provides that releases may be deleted
from the NPL where no further response is appropriate. In making a
determination to delete a release from the NPL, EPA shall consider, in
consultation with the State, whether any of the following criteria have
been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed (Hazardous Substance Superfund
Response Trust Fund) responses under CERCLA has been implemented, and
no further response action by responsible parties is appropriate; or,
    iii. The remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measure is not appropriate.
    Even if a site is deleted from the NPL, where hazardous substances,
pollutants, or contaminants remain at the deleted site above levels
that allow for unlimited use and unrestricted exposure, CERCLA Section
121(c), 42 U.S.C. 9621(c) requires that a subsequent review of the site
be conducted at least every five years after the initiation of the
remedial action at the deleted site to ensure that the action remains
protective of public health and the environment. If new information
becomes available which indicates a need for further action, EPA may
initiate remedial actions. Whenever there is a significant release from
a site deleted from the NPL, the deleted site may be restored to the
NPL without application of the hazard ranking system.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    (1) The EPA consulted with TCEQ on the deletion of the Site from
the NPL prior to developing this direct final notice of deletion.
    (2) TCEQ concurred with deletion of the Site from the NPL.

    (3) Concurrently with the publication of this direct final notice
of deletion, a notice of the availability of the parallel notice of
intent to delete published today in the ``Proposed Rules'' section of
the Federal Register is being published in a major local newspaper of
general circulation at or near the Site and is being distributed to
appropriate federal, state, and local government officials and other
interested parties; the newspaper notice announces the 30-day public
comment period concerning the notice of intent to delete the Site from
the NPL.
    (4) The EPA placed copies of documents supporting the deletion in
the Site information repositories identified above.
    (5) If adverse comments are received within the 30-day public
comment period on this document, EPA will publish a timely notice of
withdrawal of this direct final notice of deletion before its effective
date and will prepare a response to comments and continue with the
deletion process on the basis of the notice of intent to delete and the
comments already received.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion of a site from
the NPL does not in any way alter EPA's right to take enforcement
actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist EPA management. Section
300.425(e)(3) of the NCP states that the deletion of a site from the
NPL does not preclude eligibility for future response actions, should
future conditions warrant such actions.

IV. Basis for Site Deletion

    The following information provides EPA's rationale for deleting
this Site from the NPL.

Site Location

    The Brio Site is located almost 20 miles south of Houston, Texas,
and occupies approximately 58 acres. The site is divided by Dixie Farm
Road, with Brio North being historically used for storage purposes and
Brio South being primarily used for processing activities. A
neighboring residential subdivision (Southbend, now abandoned) is
located along and north of the northern boundary of Brio North. Mud
Gully, a flood control ditch and local tributary of Clear Creek, runs
along the western boundary of the Site.

Site History

    Processing activities began at the Site in the early 1950's and
consisted of reclamation of petrochemicals from various source
materials, most of which were residues, tank bottoms, and tars of other
processes performed at off-site locations. Most of the feedback
materials for processing at Brio were stored in on-site pits, many of
which were located on Brio North. All of the pits were closed during
site operations, which ceased in December 1982.

Remedial Investigation and Feasibility Study (RI/FS)

    In 1985, EPA entered into an Administrative Order on Consent with
the Brio Site Task Force (BSTF) to perform the RI/FS. The investigation
focused on five predominant media: Soils in and around the closed
impoundments, groundwater, above ground tanks, the waste water
treatment system, and sewage sludge.
    The investigations found that the majority of the contamination at
the site is found within the location of the former storage pit areas.
The pits were constructed within the uppermost geologic units
designated the Upper Clay. This unit occurs across the entire site and
ranges in depth from 14 to 32 feet. The RI/FS estimated the volume of
contaminated soils associated with the former pits at approximately
200,000 cubic yards.
    The three primary affected media at the site include ground water,
surface soils, and subsurface soils. The principal contaminants of
concern at the site are organic compounds and chlorinated solvent
compounds. The contaminants include the following: 1,1,2-
trichloroethane; 1,2-dichloroethane; 1,2-dichloroethene; 1,1-
dichloroethene; 1,1-dichloroethane; vinyl chloride; bis-(2-chloroethyl)
ether; and phenanthrene.
    The risk assessment concluded that the site potentially poses four
major risks to human health and the environment: Ingestion of on-site
soils, direct contact with on-site soils, inhalation of dust from the
site, and ingestion of shallow ground water from the site.

Record of Decision

    Following the site investigations, EPA issued a Record of Decision
(ROD) on March 31, 1988, that selected on-site incineration of pit
residuals, removal of surface contamination, channel improvements to
Mud Gully, demobilization of remaining process equipment and removal of
debris on the site, removal of dense non-aqueous phase liquids (DNAPL)
and pump and treat for groundwater in the numerous sand channel zone
(NSCZ). The ROD addressed all the threats at the site as a single
operable unit, including ground water contamination. A consent decree
was entered in April 1991 between EPA and the BSTF for implementation
of the ROD. A remedial design was performed by the BSTF and approved by
EPA in July 1993. Demolition of the majority of the remaining process
equipment was completed prior to mobilization of the incinerator.
    A rotary kiln incinerator and support equipment were mobilized to
the site following the demolition work. Temporary enclosures were
erected over the pits requiring remediation in order to contain
emissions during excavation. The incinerator began clean burn
operations with imported material, and excavation began at Pit R on
Brio South for shakedown operations and to stockpile material for the
trial burn. Emission problems during excavation led to a ``stop work''
order until appropriate emission control equipment could be installed.
Before additional controls could be installed, the BSTF submitted a
force majeure claim which resulted in the decision by EPA to allow the
dismantling of the incinerator. The incinerator and support equipment
were demobilized by December 1994.
    A focused feasibility study was initiated to evaluate alternatives
to the incineration remedy selected in 1988. The EPA signed an Amended
Record of Decision on July 2, 1997, selecting containment as the
preferred alternative. The elements of the containment remedy included
a vertical barrier wall, site cover, groundwater flow control and
institutional controls.

Response Actions

    In June 1989, an Administrative order on Consent was signed with
the BSTF, to begin dismantlement of the process equipment on the site.
The facility dismantlement was completed in December 1989. Material
present in the process equipment and tanks was consolidated into
remaining tanks. The process equipment and tanks were decontaminated
and sent to an off-site smelter for reclamation.
    A consent decree with a scope of work to implement the remainder of
the ROD was entered by the Federal district court on April 4, 1991. A
remedial design was completed in 1993 that addressed installation and
operation of an incinerator to treat contaminated soils, sludges, and
liquids above the action levels specified in the ROD.
    In May 1993, surface water discharges were found to be occurring in
Mud Gully. Characterization of the water and sediments in Mud Gully and
Clear Creek found that chlorinated volatile organics were discharging
from the Brio site in the area of Pit B in order to

control the discharges of contaminated ground water to Mud Gully.
    In December 1993, site preparation work for the mobilization of the
incinerator began. This work included removal of the majority of the
remaining tanks from the initial dismantling operation. The tanks were
cleaned and sent off-site for smelting. A rotary kiln incinerator and
support equipment were mobilized to the site following the demolition
work. The incinerator was demobilized by December 1994 following EPA's
decision to evaluate other alternatives for the Site.
    During the time between the demobilization of the incinerator and
the implementation of the containment alternative in the Amended ROD,
several elements of construction continued. The elements included:
Initiation and operation of DNAPL recovery; ground water extraction and
treatment to prevent off-site migration to Mud Gully; removal of
storage tanks and drums remaining at the site and off-site disposal of
the contents; and closure of the waste water treatment system.
    Construction of the remedial action pursuant to the Amended ROD
began in July 2000 and was implemented in phases. Approximately 5900
lineal feet of slurry wall was constructed around the perimeter of the
site from September to December 2000. The slurry wall was constructed
by excavating a 30-inch wide trench to a depth that seals the wall into
a low-permeable natural clay layer termed ``Middle Clay Unit''(MCU).
The depth of the slurry wall ranges from approximately 35 to 50 feet.
Once the excavation achieved the proper depth, a backfill material
(consisting of thoroughly mixed native soils and fresh slurry) was
placed in the excavation.
    The sheet pile barrier wall was installed from July 2001 to
December 2001. The wall is approximately 1,781 feet long and varies in
depth from 35 to 50 feet below ground surface. The wall was installed
to designed depths into the low-permeable natural clay layer and in
conjunction with the slurry wall completed the vertical barrier wall
component of the Amended ROD.
    The cover system was divided into two major components: Brio North
and Brio south. The two areas are divided by Dixie Farm Road and
separate borrow pit areas were developed in order to minimize truck
traffic over the road. The Brio South cover was initiated first due to
its smaller size. The Brio South cover system was constructed from May
2001 to February 2002. An additional compacted clay layer was extended
over a segment of the adjacent Dixie Oil Processors (DOP) South site to
provide controlled surface water runoff. The Brio North cover system
was constructed from December 2001 to September 2003.
    The improvements to Mud Gully were done under the jurisdiction of
the Harris County Flood Control District and were completed in June
2003. The improvements included realignment of the gully, lining with
articulated concrete blocks, and a topsoil cover with vegetation.
    A ground water control system was installed that included a water
treatment plant, extraction wells, and extensive piping and utilities.
The system includes 17 extraction wells to control the hydraulic
gradient and 21 monitoring wells to determine compliance with the
performance standards.
    A pre-certification inspection was conducted by EPA on March 11,
2004, to determine if all the elements of the remedial action met the
construction requirements of the Amended ROD and the remedial design.
EPA prepared a preliminary closeout report to document the attainment
of construction completion and issued the report on April 28, 2004. A
final inspection was conducted on April 20, 2006, and EPA found that
all elements fo the remedy had been successfully constructed and were
operating in accordance with approved plans.

Operation and Maintenance (O&M)

    In March 2004, the BSTF submitted a Monitoring, Operation and
Maintenance (MO&M) Plan for the site. EPA approved the plan on May 20,
2004. The purpose of the MO&M Plan is to document procedures to be used
to assess the long-term success of the site remedy while minimizing
adverse natural or man-made impacts on the site. The plan requires (i)
operation of the groundwater recovery and treatment system, (ii)
operation of the gas collection and recovery system, (iii) monitoring
and maintenance of the cover system, and (iv) monitoring of the
environmental media (soil, ground water, and air). The plan includes an
institutional control plan that provides for deed restrictions on all
properties within the site boundary where property owners could be
located, and deed notices on properties where the land owner was
recalcitrant. The requirements of the institutional control plan have
been completed through a Grant of Environmental Deed Restriction and
Right of Access, which was recorded August 30, 2005, in the Harris
County real property records.

Five-Year Review

    Consistent with Section 121(c) of the CERCLA and requirements of
the OSWER Directive 9355.7-03B-P (``Comprehensive Five-Year Review
Guidance'', June 2001), a five-year review is required at this Site.
The Directive requires EPA to conduct statutory five-year reviews at
sites where, upon attainment of ROD cleanup levels, hazardous
substances remaining within restricted areas onsite do not allow
unlimited use of the entire site.
    Since hazardous substances remain onsite, this Site is subject to
five-year reviews to ensure the continued protectiveness of the remedy.
Based on the five-year results, EPA will determine whether human health
and the environment continue to be adequately protected by the
implemented remedy. Five-year reviews were completed on January 8,
1998, and May 13, 2003. The reviews found that the remedy remains
protective of human health and the environment.

Community Involvement

    Public participation activities have been satisfied as required in
CERCLA Section 113(k), 42 U.S.C. 9613(k), and CERCLA Section 117, 42
U.S.C. 9617. Documents in the deletion docket which EPA relied on for
recommendation of the deletion from the NPL are available to the public
in the information repositories.

V. Deletion Action

    The EPA, with concurrence of the State of Texas, has determined
that all appropriate responses under CERCLA have been completed, and
that no further response actions, under CERCLA, other than O&M and
five-year reviews, are necessary. Therefore, EPA is deleting the Site
from the NPL.
    Because EPA considers this action to be noncontroversial and
routine, EPA is taking it without prior publication. This action will
be effective August 22, 2006 unless EPA receives adverse comments by
July 24, 2006. If adverse comments are received within the 30-day
public comment period, EPA will publish a timely withdrawal of this
direct final notice of deletion before the effective date of the
deletion and it will not take effect. The EPA will prepare a response
to comments and continue with the deletion process on the basis of the
notice of intent to delete and the comments already received. There
will be no additional opportunity to comment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous

substances, Hazardous waste, Intergovernmental relations, Penalties,
Reporting and recordkeeping requirements, Superfund, Water pollution
control, Water supply.

    Dated: May 25, 2006.
Richard E. Greene,
Regional Administrator, Region 6.

0
For the reasons set out in this document, 40 CFR part 300 is amended as
follows:

PART 300--[AMENDED]

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1321(c)(2), 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p. 193.

Appendix B--[Amended]

0
2. Table 1 of Appendix B to Part 300 is amended under Texas (``TX'') by
removing the entry for ``Brio Refining, Inc.''.

[FR Doc. 06-5568 Filed 6-22-06; 8:45 am]

BILLING CODE 6560-50-M


[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Proposed Rules]
[Pages 52393-52394]
[FR Doc No: 2016-18520]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 745

[EPA-HQ-OPPT-2016-0126; FRL-9950-27-OA]

Section 610 Review of the 2008 Lead; Renovation, Repair, and
Painting Program (RRP); Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of public comment period.

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SUMMARY: On June 9, 2016 the Environmental Protection Agency (EPA)
published a request for comments on a Regulatory Flexibility Act
section 610 review titled, Section 610 Review of Lead-Based Paint
Activities; Training and Certification for Renovation and Remodeling
Section 402(C)(3) (Section 610 Review). As initially published in the
Federal Register, written comments were to be submitted to the EPA on
or before August 8, 2016 (a 60-day public comment period). Since
publication, the EPA has received a request for additional time to
submit comments. Therefore, the EPA is extending the public comment
period for 30 days until September 7, 2016.

DATES: The public comment period for the review published June 9, 2016
(81 FR 37373) is being extended for 30 days to September 7, 2016 in
order to provide the public additional time to submit comments and
supporting information.

ADDRESSES: Comments: Submit your comments, identified by Docket ID No.

EPA-HQ-OPPT-2016-0126, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-
OPPT-2016-0126.
     Fax:<PHONE_NUMBER>.
     U.S. Mail: Environmental Protection Agency, EPA Docket
Center, Mailcode: 28221T, Attention Docket ID No. EPA-HQ-OPPT-2016-
0126, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, EPA West, Room 3334,
1301 Constitution Avenue NW., Washington, DC, Attention Docket ID No.
EPA-HQ-OPPT-2016-0126. Such deliveries are accepted only during the
Docket Center's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OPPT-
2016-0126. The EPA's policy is that all comments received will be
included in the public docket without change and could be made
available online at www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
www.regulations.gov or email. The www.regulations.gov Web site is an
``anonymous access'' system, which means that the EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an email comment directly to the EPA
without going through www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, the EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. If the EPA cannot read your comment
because of technical difficulties and cannot contact you for
clarification, the EPA might not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses. For additional
information about the EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm. For additional
instructions on submitting comments, go to the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at EPA/DC, EPA West, Room 3334,
1301 Constitution Ave. NW., Washington, DC 20004. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding federal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For additional information contact,

Jonathan Shafer, Environmental Protection Agency, Office of Chemical
Safety and Pollution Prevention, 7404T, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>
Michelle Price, Environmental Protection Agency, Office of Chemical
Safety and Pollution Prevention, 7404T, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

    Section 610 of the Regulatory Flexibility Act requires that an
agency review, within 10 years of promulgation, each rule that has or
will have a significant economic impact on a substantial number of
small entities (SISNOSE). The EPA undertakes section 610 reviews to
decide whether the agency should continue a rule unchanged, amend it,
or withdraw it. We encourage small entities to provide comments on the
need to change these rules, and in particular, how the rules could be
made clearer, more effective, or if there is need to remove conflicting
or overlapping requirements with other Federal or State regulations.
    The EPA has exercised its discretion to include changes made to the
2008 RRP rule as well as solicit comments on lead-test kits in this
review.

II. Extension of Comment Period for the Section 610 Review of the 2008
RRP Rule

    The EPA is extending the deadline for submitting comments on the
section 610 review of the RRP Rule to September 7, 2016. The original
deadline for comments, based on a 60-day comment period, was August 8,
2016. The EPA's decision responds to a request to extend the comment
deadline. The EPA believes that this 30-day extension will assist in
providing an adequate amount of additional time for the public to
review the action and to provide written comments.

    Dated: July 27, 2016.
William Nickerson,
Acting Director, Office of Regulatory Policy and Management.
[FR Doc. 2016-18520 Filed 8-5-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)]
[Notices]
[Pages 61635-61637]
[FR Doc No: 2017-27996]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82376; File No. SR-C2-2017-032]

Self-Regulatory Organizations; C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Rule
6.4, Minimum Increments for Bids and Offers, To Extend the Penny Pilot
Program

December 21, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 14, 2017, C2 Exchange, Inc. (the ``Exchange'' or
``C2'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 6.4 by extending the Penny
Pilot Program through June 30, 2018.
    (additions are italicized; deletions are [bracketed])
* * * * *

Cboe C2 Exchange, Inc.

Rules

* * * * *

Rule 6.4. Minimum Increments for Bids and Offers

    The Board of Directors may establish minimum quoting increments for
options traded on the Exchange. When the Board of Directors determines
to change the minimum increments, the Exchange will designate such
change as a stated policy, practice, or interpretation with respect to
the administration of this Rule within the meaning of subparagraph
(3)(A) of subsection 19(b) of the Exchange Act and will file a rule
change for effectiveness upon filing with the Commission. Until such
time as the Board of Directors makes a change to the minimum
increments, the following minimum increments shall apply to options
traded on the Exchange:
    (1) No change.
    (2) No change.
    (3) The decimal increments for bids and offers for all series of
the option classes participating in the Penny Pilot Program are: $0.01
for all option series quoted below $3 (including LEAPS), and $0.05 for
all option series $3 and above (including LEAPS). For QQQQs, IWM, and
SPY, the minimum increment is $0.01 for all option series. The Exchange
may replace any option class participating in the Penny Pilot Program
that has been delisted with the next most actively-traded, multiply-
listed option class, based on national average daily volume in the
preceding six calendar months, that is not yet included in the Pilot
Program. Any replacement class would be added on the second trading day
following [July 1, 2017]January 1, 2018. The Penny Pilot shall expire
on [December 31, 2017]June 30, 2018. Also, for so long as SPDR options
(SPY) and options on Diamonds (DIA) participate in the Penny Pilot
Program, the minimum increments for Mini-SPX Index Options (XSP) and
options on the Dow Jones Industrial Average (DJX), respectively, may be
$0.01 for all option series quoting less than $3 (including LEAPS), and
$0.05 for all option series quoting at $3 or higher (including LEAPS).

    (4) No change.
* * * * *
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Penny Pilot Program (the ``Pilot Program'') is scheduled to
expire on December 31, 2017. The Exchange proposes to extend the Pilot
Program until June 30, 2018. The Exchange believes that extending the
Pilot Program will allow for further analysis of the Pilot Program and
a determination of how the Pilot Program should be structured in the
future.
    During this extension of the Pilot Program, the Exchange proposes
that it may replace any option class that is currently included in the
Pilot Program and that has been delisted with the next most actively
traded, multiply listed option class that is not yet participating in
the Pilot Program (``replacement class''). Any replacement class would
be determined based on national average daily volume in the preceding
six months,\5\ and would be added on the second trading day following
January 1, 2018. The Exchange will announce to its Trading Permit
Holders by circular any replacement classes in the Pilot Program. The
Exchange notes that it intends to utilize the same parameters to select
prospective replacement classes as was originally approved.
---------------------------------------------------------------------------

    \5\ The month immediately preceding a replacement class's
addition to the Pilot Program (i.e., December) would not be used for
purposes of the six-month analysis. Thus, a replacement class to be
added on the second trading day following January 1, 2018 would be
identified based on The Option Clearing Corporation's trading volume
data from June 1, 2017 through November 30, 2017.
---------------------------------------------------------------------------

    The Exchange is specifically authorized to act jointly with the
other options exchanges participating in the Pilot Program in
identifying any replacement class.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\6\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \7\ requirements that the rules of an exchange be
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 regulating, clearing,
settling, processing information with respect to, and facilitation
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. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \8\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers. In particular, the proposed rule change allows for
an extension of the Pilot Program for the benefit of market
participants.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
    \8\ Id.
---------------------------------------------------------------------------

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 that is not necessary or appropriate
in furtherance of the purposes of the Act.
    Specifically, the Exchange believes that, by extending the
expiration of the Pilot Program, the proposed rule change will allow
for further analysis of the Pilot Program and a determination of how
the Program should be structured in the future. In doing so, the
proposed rule change will also serve to promote regulatory clarity and
consistency, thereby reducing burdens on the marketplace and
facilitating investor protection. In addition, the Exchange has been
authorized to act jointly in extending the Pilot Program and believes
the other exchanges will be filing similar extensions.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 15 U.S.C. 78s(b)(3)(A).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.\12\
However, pursuant to Rule 19b-4(f)(6)(iii),\13\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because doing so will
allow the Pilot Program to continue without interruption in a manner
that is consistent with the Commission's prior approval of the
extension and expansion of the Pilot Program and will allow the
Exchange and the Commission additional time to analyze the impact of

the Pilot Program.\14\ Accordingly, the Commission designates the
proposed rule change as operative upon filing with the Commission.\15\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this pre-filing requirement.
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ See Securities Exchange Act Release No. 61061 (November 24,
2009), 74 FR 62857 (December 1, 2009) (SR-NYSEArca-2009-44). See
also supra note 5.
    \15\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \16\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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 protected]. Please
include File Number SR-C2-2017-032 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-C2-2017-032. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-C2-2017-032 and should be submitted on
or before January 18, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-27996 Filed 12-27-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5448-5453]
[FR Doc No: 2019-02971]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1939]

Use of Investigational Tobacco Products; Revised Draft Guidance
for Industry and Investigators; Availability; Agency Information
Collection Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry and investigators
entitled ``Use of Investigational Tobacco Products.'' The revised draft
guidance replaces the draft guidance of the same title announced in the
Federal Register of September 24, 2015 (September 2015 draft guidance).
The revised draft guidance, when finalized, will describe FDA's current
thinking regarding the definition of ``investigational tobacco
product'' and will discuss the kind of information FDA intends to
consider in making enforcement decisions regarding the use of
investigational tobacco products until regulations governing the use of
investigational tobacco products become effective or FDA provides
written notice of its intent to change its enforcement policy.

DATES: Submit either electronic or written comments on the draft
guidance by April 22, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information by April 22, 2019.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-1939 for ``Use of Investigational Tobacco Products; Revised
Draft Guidance for Industry and Investigators; Availability; Agency
Information Collection Activities; Proposed Collection; Comment
Request.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this draft guidance to
the Center for Tobacco Products, Food and Drug Administration, Document
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:
    With regard to the draft guidance: Laura Rich or Samantha
LohCollado,

Center for Tobacco Products, Food and Drug Administration, Document
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 1-877-287-1373, email<EMAIL_ADDRESS>    With regard to the proposed collection of information: Amber
Sanford, Office of Operations, Food and Drug Administration, Three
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Use of Investigational Tobacco Products.'' This
revised draft guidance replaces the September 2015 draft guidance and,
when final, will describe FDA's current thinking regarding the
definition of ``investigational tobacco product'' and discuss the kind
of information FDA intends to consider in making enforcement decisions
regarding the use of investigational tobacco products until regulations
are issued and become effective or FDA provides written notice of its
intent to change its enforcement policy. It is intended to provide
guidance to persons who currently intend to submit study information on
tobacco products to FDA as well as to persons who conduct
investigations using investigational tobacco products.
    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and provided FDA
with the authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors.
    To introduce or deliver for introduction into interstate commerce a
new tobacco product, there must be in effect a marketing authorization
order issued by FDA for the tobacco product under section
910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) unless:
     The manufacturer has submitted a substantial equivalence
report for the tobacco product under section 905(j) of the FD&C Act (21
U.S.C. 387e(j)) and obtained from FDA a substantial equivalence order
under section 910(a)(2)(A)(i) of the FD&C Act;
     The manufacturer has submitted, under 21 CFR 1107.1, a
request for an exemption for the tobacco product from the requirement
to obtain a substantial equivalence order, FDA has granted the
exemption request, and the manufacturer has made the required
submission under section 905(j)(1)(A)(ii) of the FD&C Act and waited 90
days before introducing its product to the market; or
     The manufacturer has submitted a substantial equivalence
report in accordance with section 910(a)(2)(B) of the FD&C Act and
there is no order finding that the tobacco product is not substantially
equivalent.
    To introduce or deliver for introduction into interstate commerce a
modified risk tobacco product, there must be in effect an order under
section 911(g) of the FD&C Act (21 U.S.C. 387k(g)) and the applicant
must satisfy any applicable premarket review requirements under section
910 of the FD&C Act.
    Furthermore, a tobacco product must conform in all respects with
applicable tobacco product standards established under section 907 of
the FD&C Act (21 U.S.C. 387g). Any tobacco product, including a tobacco
product intended for investigational use, is deemed adulterated if it
is subject to a tobacco product standard established under section 907
of the FD&C Act and does not in all respects conform with such
standard.
    Section 910(g) of the FD&C Act gives FDA the authority to issue
regulations to exempt tobacco products intended for investigational use
from the provisions of chapter IX of the FD&C Act, including premarket
submission requirements. FDA intends to propose regulations
establishing conditions for exempting investigational tobacco products
from certain FD&C Act requirements. Until then, investigational tobacco
products are not exempt from applicable FD&C Act requirements,
including premarket submission requirements and tobacco product
standards.
    FDA recognizes that researchers may seek to study tobacco products
that do not have marketing authorization or that do not comply with an
applicable tobacco product standard. Until regulations governing the
use of investigational tobacco products are issued and finalized, FDA
intends to evaluate specific uses of investigational tobacco products
according to potential human subject protection concerns or other
impacts on public health. This revised draft guidance discusses the
factors FDA intends to consider in making enforcement decisions
regarding the use of investigational tobacco products.
    FDA issued the September 2015 draft guidance in the Federal
Register of September 24, 2015 (80 FR 57623). Interested parties were
given an opportunity to submit comments by November 23, 2015. FDA
received numerous comments on the September 2015 draft guidance. Based
on careful review of these comments, FDA is issuing this revised draft
guidance to clarify the Agency's thinking.

II. Significance of Draft Guidance

    FDA is issuing this revised draft guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance replaces the September 2015 draft guidance. The draft
guidance, when finalized, will represent the current thinking of FDA
regarding the definition of ``investigational tobacco product'' and
discuss the factors FDA intends to consider in making enforcement
decisions regarding the use of investigational tobacco products until
regulations are issued or FDA provides written notice of its intent to
change its enforcement policy. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This draft guidance is not subject to
Executive Order 12866.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 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.

Draft Guidance for Industry: Use of Investigational Tobacco Products

OMB Control Number 0910-NEW

    FDA is announcing the availability of the revised draft guidance
entitled ``Use of Investigational Tobacco Products.'' This revised
draft guidance supersedes the September 2015 draft guidance and, when
final, will describe FDA's current thinking regarding the definition of
``investigational tobacco product'' and discuss the kind of information
FDA intends to consider in making enforcement decisions regarding the
use of investigational tobacco products until regulations are issued
and become effective or FDA provides written notice of its intent to
change its enforcement policy. The revised draft guidance is intended
to provide guidance to persons who currently intend to submit study
information on tobacco products to FDA and to persons who conduct
investigations using investigational tobacco products. Such persons may
include sponsors, investigators, sponsor-investigators, and contract
research organizations (CROs). This revised draft guidance is also
intended to provide recommendations to committees or groups formally
designated to oversee human subject research (e.g., institutional
review boards) involving investigational tobacco products.
    FDA recognizes that researchers may seek to study tobacco products
that do not have marketing authorization or that do not comply with an
applicable tobacco product standard. Until regulations governing the
use of investigational tobacco products are issued and finalized, as
discussed in the guidance, FDA intends to evaluate specific uses of
investigational tobacco products according to potential human subject
protection concerns or other impacts on public health.
    FDA has identified the following recommendations in the revised
draft guidance as collections of information.
    In the revised draft guidance, FDA provides examples of information
that may help FDA to evaluate specific proposed uses of investigational
tobacco products and encourages persons who intend to study
investigational tobacco products to meet with FDA to discuss certain
topics in connection with investigations. FDA does not recommend that
investigators engaging in nonclinical laboratory investigations
correspond with FDA about use of investigational tobacco products in
nonclinical studies in all situations. However, sponsors of nonclinical
studies may elect to meet with FDA early in the development process to
discuss what, if any, animal testing is appropriate and the suitability
and acceptability of non-animal tests for a particular tobacco product.
    For clinical investigations, FDA encourages sponsors to submit
information regarding a proposed use of an investigational tobacco
product to FDA for review prior to enrolling subjects in the planned
investigation. FDA has created a form entitled ``Proposed Use of an
Investigational Tobacco Product'' to assist sponsors in submitting
information. Although use of this form is voluntary, its use will
likely reduce the burden hours and will help ensure that sponsors
provide complete information for FDA's consideration, processing, and
review. The amount of information the revised draft guidance recommends
that a sponsor submit depends on the scope of the investigation. For
example, the revised draft guidance encourages persons conducting
studies with investigational tobacco products that involve minor
modifications to legally marketed products to meet with FDA before
making a submission. This is because in such cases, it may be
appropriate to submit less information. Although the submission of
information is voluntary, FDA encourages it, so that sponsors can
ensure their investigations account for the factors FDA considers in
making enforcement decisions.
    Regardless of whether a sponsor intends to consult with FDA in
conducting research with an investigational tobacco product, the
revised draft guidance contains recommendations for information to
include within the study protocol. This information may be considered
should FDA assess the enforcement priority of a particular
investigation.
    Furthermore, to help ensure that studies are conducted in a manner
that protects human subjects, the revised draft guidance contains
recommendations for procedures sponsors can implement to keep FDA and
the committee or group formally designated to oversee research
involving human subjects informed about any changes relating to the
conduct of, and issues that arise during, the study. In the revised
draft guidance, FDA further recommends that the sponsor ensure that
clinical investigators maintain complete and accurate records to
account for receipt, use, and disposition of investigational tobacco
products. FDA also recommends that the sponsor keep clinical
investigators and any committee or group formally designated to oversee
research involving human subjects informed of new information on the
product, particularly adverse experience information.
    In addition, FDA recommends that if there are changes to the
current investigational use, sponsors consult with the Office of
Science, Center for Tobacco Products (CTP), and any committee or group
formally designated to oversee research involving human subjects to
ensure that the sponsor's use of an investigational tobacco product
continues to appropriately account for the factors FDA intends to
consider in determining enforcement priorities. FDA recommends that
sponsors also notify FDA if they choose to terminate a study, withdraw
or inactivate a protocol, or want to withdraw studies of a product
before completion. This information is relevant for FDA to consider in
making decisions relating to future investigations involving the
tobacco product that was the subject of the terminated study. Moreover,
in the revised draft guidance, FDA recommends that under certain
circumstances, sponsors also inform any clinical investigators who
participated in the discontinued investigation of the reason(s) for
discontinuing the clinical investigation.
    FDA also makes recommendations related to clinical investigations
using investigational tobacco products conducted outside of the United
States, but intended for submission to FDA, and refers to section
801(e) of the FD&C Act (21 U.S.C. 381(e)) with respect to exported
tobacco products intended for investigational use. The revised draft
guidance also recommends that sponsors prepare and maintain certain
records and reports for studies conducted outside of the United States
but intended for submission to FDA to permit FDA to evaluate the
conduct of a clinical investigation, including assessing the quality
and integrity of the study data and protection of human subjects.
    Finally, in the revised draft guidance, FDA recommends that
sponsors, CROs, sponsor-investigators, and clinical investigators
maintain documentation to permit evaluation of the conduct of a
clinical investigation, including assessing the quality and integrity
of the study data and protection of human subjects. The revised draft
guidance recommends that records be maintained and available for
inspection upon request for a period of at least 4 years after the date
on which the investigation

is terminated or completed, or the date that the records are no longer
considered necessary for supporting marketing of a product, or the
later of the two dates if both apply.
    FDA estimates the burden of this collection of information as
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Capital and
Activity/FDA form for proposed use of     Number of       Number of     Total annual                                                       operating and
  an investigational tobacco product     respondents    responses per     responses       Average burden per response       Total hours     maintenance
                                                         respondent                                                                            costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial Submission...................              20               1              20  35...............................             700  ..............
Protocol Amendments..................              30               1              30  4................................             120  ..............
Information Amendments...............              20               1              20  15...............................             300  ..............
Administrative Amendments............               1             1.5             1.5  0.5 (30 minutes).................            0.75  ..............
Other Information....................               3               1               3  0.5 (30 minutes).................             1.5  ..............
Serious or Unexpected Adverse                      75               3              75  2................................             150  ..............
 Experience Reports.
First year, electronic setup safety                15               1              15  0.5 (30 minutes).................             7.5  ..............
 reporting portal.
First year, Electronic Gateway setup                2               1               2  42 \1\...........................              84          37,800
 and verification certificate (one-
 time burden).
First year, CTP Portal setup.........              18  ..............              18  3................................              54  ..............
Electronic Gateway Submission                       2               1               2  3................................               6           2,700
 (recurring).
                                      ------------------------------------------------------------------------------------------------------------------
    Total Reporting Burden Hours.....  ..............  ..............  ..............  .................................           1,424          40,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Respondent may already have a valid WebTrader account established for other FDA electronic submissions.

    Table 1 describes the annual reporting burden as a result of
respondents submitting information regarding the use of investigational
tobacco products in certain clinical investigations. FDA estimates that
20 respondents will submit study information to FDA annually. FDA
estimates that it will take each respondent approximately 35 hours to
prepare the study information necessary for FDA to issue a response to
the proposed use of an investigational tobacco product in these
clinical investigations. FDA's estimate includes the anticipated burden
for completing the form for the initial submission, which will include
the initial protocol, time for intracompany edits and approvals, as
well as the burden for assembling additional information, as described
in the revised draft guidance.
    Since the initial publication of the September 2015 draft guidance,
FDA has updated the estimated burden hours using current information.
In addition, FDA has revised table 1 to clarify the types of
submissions we anticipate receiving and to clarify what type of
information may be included in the initial submission. Specifically, we
now estimate that protocol submissions would be included with the
initial submission. As such, the approximate burden on respondents is
less than discussed in the original Notice of Availability (NOA) for
the September 2015 draft guidance.
    In response to the original NOA, FDA received one PRA-related
comment.
    (Comment) The comment stated that FDA has vastly underestimated the
time and burden of preparing an initial submission. The comment
contended that our estimate is not in line with the Agency's experience
with respect to investigational new drug applications, which the
comment also contends is an analogous context.
    (Response) FDA does not agree with this comment. The Agency based
its estimates on its understanding of the submissions it has received
to date. The revised draft guidance announced in this notice also
attempts to clarify the Agency's proposed recommendations regarding
submissions.
    Following the initial submission, sponsors may wish to provide
protocol amendments to reflect certain changes to a protocol. FDA
estimates that 30 respondents will submit a protocol amendment. The
estimated time for submitting a protocol amendment is 4 hours per
response. In addition, FDA estimates that 20 respondents will submit
information amendments. Since this may take a little less than half the
time of an initial submission, FDA estimates information amendments
taking around 15 hours.
    FDA estimates that respondents will infrequently need to report
administrative amendments. The total number of respondents of this type
of information is estimated to be one. FDA estimates administrative
amendments taking around 30 minutes per response.
    FDA estimates that approximately three respondents will report
other types of submissions. These submissions are estimated to take 30
minutes per response.
    FDA estimates that it will receive 75 reports of serious or
unexpected adverse experiences. This submission will take an average of
2 hours per report. FDA further estimates that approximately 15
respondents will set up an account in the safety reporting portal for
purposes of submitting serious or unexpected adverse experiences. The
first year setup of the safety reporting portal for this purpose will
take 30 minutes per respondent.
    As referenced in the September 2015 draft guidance, FDA allows for
three ways of submission. However, FDA strongly encourages the use of
electronic format for submission because of its overall efficiency in
transmitting information. To submit information through the Electronic
Submissions Gateway (ESG), the submitter should first set up an account
with WebTrader. FDA estimates from past experience with WebTrader that
the first year to set up the account and to receive the verification
certificate takes approximately 40 hours. This burden may be minimized
if the respondent already has an established account in WebTrader for
other electronic submissions to FDA, but FDA is assuming that all
respondents for these products will be setting up a WebTrader account
for the first time in the first year. In subsequent years, the burden
hours are estimated at 1 hour to renew the yearly required Verification

Certification. In addition, to submit information through the ESG (or
any other means of electronic submission), the submitter must package
the information using the eSubmitter formatting software. FDA estimates
that the gathering and scanning of information and related
correspondence would take approximately 2 hours using the eSubmitter
system.
    Therefore, the first year will include 40 hours for the WebTrader
system plus 2 hours for the eSubmitter process, resulting in 42 hours
per response for the first year. For subsequent years, it is estimated
that only 1 hour will be necessary for the WebTrader system plus the 2
hours for the eSubmitter process, resulting in 3 hours per response
each year thereafter.
    In addition to the ESG system, an alternative electronic method for
respondents to submit electronic information is through the CTP Portal.
Respondents with access to an Industry Account Manager (IAM) may
contact the IAM directly for establishment of an account and access to
the CTP Portal. Respondents without access to an IAM will be required
to identify and establish an IAM. To establish an IAM with the CTP
Portal, respondents should contact the CTP Portal Helpdesk and submit
required administrative information. FDA estimates that the first-year
setup for the CTP Portal is approximately 1 hour per respondent. After
receiving access to the CTP Portal, respondents will submit information
through the CTP Portal using the eSubmitter system. FDA estimates the
gathering, scanning, and submission of information and related
correspondence would take approximately 2 hours using the ESG system.
    Additionally, there are capital and operating or maintenance costs
associated with the ESG platform for the purpose of information
collection. The costs are $30 per year to establish and maintain the
ESG verification certificate. The total cost may be lower if the
respondents already have a verification certificate for that year for
other electronic submissions to FDA. However, for purposes of this
estimate, FDA is assuming that all respondents for these products will
be incurring this cost. The total costs are estimated to be $40,500.
    The total reporting burden for this collection of information is
estimated to be 1,424 hours. These burden estimates were computed using
FDA staff expertise and by reviewing comments received from recent FDA
information collections for other tobacco-related initiatives.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
 Activity records maintained     Number of      records per    Total annual     Average  burden     Total hours
                               recordkeepers   recordkeeper       records     per  recordkeeping
----------------------------------------------------------------------------------------------------------------
Records by Sponsors.........              20               1              20                  10             200
Records by Sponsor-                       10               1              10                  20             200
 Investigators..............
Records by Investigators and              15               1              15                  15             225
 CROs.......................
                             -----------------------------------------------------------------------------------
    Total Recordkeeping       ..............  ..............  ..............  ..................             625
     Burden Hours...........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 2 describes the annual recordkeeping burden of maintaining
records relating to the investigational use of tobacco products. FDA
has updated these numbers based on submissions received since the
publication of the September 2015 draft guidance. Compared to FDA's
original estimates, the recordkeeping burden has been decreased by
1,025 hours. In addition, FDA has revised table 2 to reflect that we
have clarified which records we are recommending should be maintained.
Consequently, FDA now anticipates that 20 sponsors, 10 sponsor-
investigators, and 15 investigators and CROs (for a total of 45
respondents) will maintain records relating to the use of
investigational tobacco products in clinical investigations. FDA
estimates that it will take each sponsor approximately 10 hours per
study annually to maintain these records. FDA further estimates that it
will take each sponsor-investigator approximately 20 hours per study
annually to maintain these records. Finally, FDA estimates that it will
take investigators and CROs approximately 15 hours per study annually
to maintain these records. The total reporting burden for recordkeeping
is estimated to be 625 hours [200 hours for sponsors (20 x 10) + 200
hours for sponsor-investigators (10 x 20) + 225 for investigators and
CROs (15 x 15)].

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                                                  Number of      disclosures    Total annual
                   Activity                      respondents         per         disclosures        Average  burden per  disclosure         Total hours
                                                                 respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosures to Investigators.................              50               1              50  1........................................              50
Disclosures to any Committee or Group........              50               1              50  0.17 (10 minutes)........................               9
Disclosure to Study Subjects.................              50               2             100  0.5 (30 minutes).........................              50
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................             109
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 3 describes the annual third-party disclosure burden.
    FDA increased the number of anticipated disclosures based on
submissions received since publication of the September 2015 draft
guidance. Additionally, FDA recognizes that sponsors will need to make
third-party disclosures to multiple individuals and groups including
investigators, study subjects, as well as any committee or group
designated to oversee research. FDA estimates that disclosing

information to investigators will take 1 hour per disclosure. FDA
estimates that disclosing information to any committee or group
formally designated to oversee research involving human subjects will
average 10 minutes per disclosure.
    The revised draft guidance also references examples of disclosing
information to study subjects such as informed consent. On average, two
disclosures per respondent will be provided to study subjects. FDA
estimates this will take 30 minutes per disclosure.
    The total burden for the collection of information under this
revised draft guidance is estimated to be approximately 2,158 hours.
    The revised draft guidance also refers to previously approved
collections of information. The revised draft guidance includes a
recommendation that persons who intend to study tobacco products meet
with FDA to discuss research plans. Additional information about how to
request meetings with FDA's CTP can be found in FDA's guidance
``Meetings with Industry and Investigators on the Research and
Development of Tobacco Products'' (https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM305282.pdf).
    The collections of information in the guidance referenced have been
approved under OMB control number 0910-0731. The collections of
information in section 801(e) of the FD&C Act and 21 CFR 1.101(b) have
been approved under OMB control number 0910-0482; the collections of
information for the Safety Reporting Portal have been approved under
OMB control number 0910-0645; the collections of information in section
905(j) of the FD&C Act have been approved under OMB control number
0910-0673.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the revised draft guidance at either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: February 15, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02971 Filed 2-20-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 55 (Friday, March 21, 2014)]
[Notices]
[Page 15787]
[FR Doc No: 2014-06161]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending March 1, 2014

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et. seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2014-0026
    Date Filed: February 24, 2014
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: March 17, 2014
    Description: Application of Blue Jet SP. z o.o. (``Blue Jet'')
requesting a foreign air carrier permit to the full extent authorized
by the Air Transport Agreement Between the United States and the
European Community and the Member States of the European Community to
enable it to engage in: (i) foreign charter air transportation of
persons and property from any point or points behind any Member State
of the European Union via any point or points in any Member State and
via intermediate points to any point or points in the United States and
beyond; (ii) foreign charter air transportation of persons and property
between any point or points in the United States and any point or
points in any member of the European Common Aviation Area; (iii) other
charters pursuant to the prior approval requirements; and (iv)
transportation authorized by any additional route rights made available
to European Community carriers in the future. Blue Jet further requests
exemption authority to the extent necessary to enable it to provide the
services described above pending issuance of a foreign air carrier
permit and such additional or other relief as the Department may deem
necessary or appropriate.

Barbara J. Hairston,
Supervisory Dockets Officer, Docket Operations, Federal Register
Liaison.
[FR Doc. 2014-06161 Filed 3-20-14; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Pages 33251-33252]
[FR Doc No: 2019-14837]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2997-031]

South Sutter Water District; Notice of Application Tendered for
Filing With the Commission and Soliciting Additional Study Requests and
Establishing Procedural Schedule for Relicensing and a Deadline for
Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Major, new license.
    b. Project No.: P-2997-031.
    c. Date Filed: July 1, 2019.
    d. Applicant: South Sutter Water District (SSWD).
    e. Name of Project: Camp Far West Hydroelectric Project.
    f. Location: The existing hydroelectric project is located on the
Bear River in Yuba, Nevada, and Placer Counties, California. The
project, with the proposed project boundary modifications, would occupy
a total of 2,674 acres. No federal or tribal lands occur within or
adjacent to the project boundary or along the Bear River downstream of
the project.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Brad Arnold, General Manager, South Sutter
Water District, 2464 Pacific Avenue, Trowbridge, California 95659.
    i. FERC Contact: Quinn Emmering,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Cooperating Agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: August 30, 2019.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202)
502-8659 (TTY). In lieu of electronic filing, please send a paper copy
to: Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Washington, DC 20426. The first page of any filing should include
docket number P-2997-031.
    m. The application is not ready for environmental analysis at this
time.
    n. The existing Camp Far West Hydroelectric Project operates to
primarily provide water during the irrigation season, generate power,
and meet streamflow requirements for the Bear River. The existing
project includes: (1) A 185-foot-high, 40-foot-wide, 2,070-foot-long,
zoned, earth-filled main dam; (2) a 45-foot-high, 20-foot-wide, 1,060-
foot-long, earth-filled south wing dam; (3) a 25-foot-high, 20-foot-
wide, 1,460-foot-long, earth-filled north wing dam; (4) a 15-foot-high,
20-foot-wide, 1,450-foot-long, earth-filled dike; (5) a 1,886-acre
reservoir with a gross storage capacity of about 93,737 acre-feet at
the normal maximum water surface elevation (NMWSE) of 300 feet; (6) an
overflow spillway with a 15-foot-wide concrete approach apron, 300-
foot-long ungated, ogee-type concrete structure, and a 77-foot-long
downstream concrete chute with concrete sidewalls; (7) a 1,200-foot-
long, unlined, rock channel that carries spill downstream to the Bear
River; (8) a 22-foot-high, concrete, power intake tower with openings
on three sides protected by steel trashracks; (9) a 760-foot-long, 8-
foot-diameter concrete tunnel through the left abutment of the main dam
that conveys water from the power intake to the powerhouse; (10) a
steel-reinforced, concrete powerhouse with a 6.8-MW, vertical-shaft,
Francis-type turbine, which discharges to the Bear River at the base of
the main dam; (11) a 25-foot-4-inch-high, concrete, vertical intake
tower with openings on three sides protected by steel trashracks that
receives water for the outlet works; (12) a 350-foot-long, 48-inch-
diameter steel pipe that conveys water from the intake structure to a
valve chamber for the outlet works; (13) a 400-foot-long, 7.5-foot-
diameter concrete-lined horseshoe tunnel that connects to the valve
chamber; (14) a 48-inch-diameter, outlet valve with a 500-cubic-feet-
per-second release capacity at NMWSE on the downstream face of the main
dam that discharges directly into the Bear River; (15) a switchyard
adjacent to the powerhouse; (16) two recreation areas with campgrounds,
day-use areas, boat ramps, restrooms, and sewage holding ponds; (17) a
recreational water system that includes two pumps in the reservoir that
deliver water to a treatment facility that is piped to a 60,000-gallon
storage tank to supply water to recreation facilities. The estimated
average annual generation (2010 to 2017) is 22,637 megawatt-hours.
    SSWD proposes to: (1) Raise the NMWSE of the project reservoir by 5
feet from an elevation of 300 feet to an elevation of 305 feet; (2)
replace and restore several recreation facilities; (3) add an existing
0.25-mile road as a primary project road to access the powerhouse and
switchyard; and (4) modify the project boundary to account for the
removal of the 1.9-mile-long transmission line from the license in
1991, corrections based on current project operation and maintenance,
and changes under the category of a contour 20 feet above the 300-ft
NMWSE or proximity of 200-horizontal-feet from the 300-foot NMWSE.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects.

For assistance, contact FERC Online Support.
    p. Procedural schedule and final amendments: The application will
be processed according to the following preliminary Hydro Licensing
Schedule. Revisions to the schedule will be made as appropriate.

Issue Notice of Acceptance--September 2019
Request Additional Information (if necessary)--September 2019
Issue Acceptance Letter--December 2019
Issue Scoping Document 1 for comments--January 2020
Hold Scoping Meeting--February 2020
Request Additional Information (if necessary)--April 2020
Issue Scoping Document 2--April 2020
Issue notice of ready for environmental analysis--April 2020
Commission issues EA, draft EA, or draft EIS--October 2020
Comments on EA or draft EA or draft EIS--November 2020
Initiate 10(j) process (if necessary)--December 2020
Commission issues final EA of final EIS--April 2021

    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: July 8, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-14837 Filed 7-11-19; 8:45 am]
 BILLING CODE 6717-01-P