[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63304-63305]
[FR Doc No: 2011-26296]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0212]

Guidance for Industry on Incorporation of Physical-Chemical
Identifiers Into Solid Oral Dosage Form Drug Products for
Anticounterfeiting; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Incorporation of
Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products
for Anticounterfeiting.'' This guidance provides recommendations on
design considerations for incorporating physical-chemical identifiers
(PCIDs) into solid oral dosage forms (SODFs), supporting documentation
to be submitted in new drug applications (NDAs) or abbreviated new drug
applications (ANDAs) to address the proposed incorporation of PCIDs in
SODFs, supporting documentation to be submitted in postapproval
submissions to report or request approval to incorporate PCIDs into
SODFs, and procedures for reporting or requesting approval to
incorporate PCIDs into SODFs as a postapproval change.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY

INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John L. Smith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 2619, Silver Spring, MD 20993, 301-796-
1757.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Incorporation of Physical-Chemical Identifiers Into Solid
Oral Dosage Form Drug Products for Anticounterfeiting.'' For the
purpose of this guidance, a PCID is a substance or combination of
substances possessing a unique physical or chemical property that
unequivocally identifies a drug product or dosage form as authentic and
distinguishes it from counterfeits. To thwart drug product
counterfeiting, pharmaceutical manufacturers have been investigating
technologies that may make drug products more difficult to duplicate,
including the incorporation of PCIDs into SODFs. One approach that
manufacturers appear to be considering involves adding a trace amount
of one or more inactive ingredients to an existing section of the
dosage form (in the guidance, section is the term used for a discrete,
contained solid or a layer in a solid oral dosage form). Any section
can be described by its composition, the functional characteristics
that distinguish it from other sections in that dosage form, and its
position relative to other sections that may be present (e.g.,
coatings, capsule shells, encapsulated particles, a layer in a bilayer
tablet, and compressed powders). A unique physical-chemical
characteristic of that ingredient makes it possible to detect and
authenticate legitimate dosage forms, and to identify counterfeits.
Examples of substances that may be incorporated into SODFs as PCIDs
include inks, pigments, flavors, and molecular taggants. Such PCIDs may
allow product authentication by their presence alone or may be used to
code the product identity into or onto the SODF.
    This guidance provides recommendations to pharmaceutical
manufacturers on the following topics: (1) Design considerations for
PCIDs into SODFs, (2) supporting documentation to be submitted in NDAs
or ANDAs to address the proposed incorporation of PCIDs in SODFs, (3)
supporting documentation to be submitted in postapproval submissions to
report or request approval to incorporate PCIDs into SODFs, and (4)
procedures for reporting or requesting approval to incorporate PCIDs
into SODFs as a postapproval change. Although not addressed in this
guidance, FDA is considering whether to address the incorporation of a
PCID into a drug's packaging or labeling in a future guidance.
    In the Federal Register of July 14, 2009 (74 FR 34021), FDA
announced the availability of a draft guidance for industry entitled
``Draft Guidance for Industry on Incorporation of Physical-Chemical
Identifiers Into Solid Oral Dosage Form Drug Products for
Anticounterfeiting.'' The notice gave interested persons an opportunity
to comment by October 13, 2009. We have carefully considered the
comments we received and, where appropriate, have made corrections,
added information, or clarified the information in the guidance in
response to the comments.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on the use of PCIDs in SODF drug products to
prevent counterfeiting. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The documentation in premarketing regulatory submissions
recommended for applicants incorporating PCIDs into SODFs would be
covered under 21 CFR 314.50 and 314.94, and the documentation in
postapproval regulatory submissions would be covered under 21 CFR
314.70. This information collection has been approved under OMB control
number 0910-0001. The recommendations for labeling would be covered
under 21 CFR 201.57. This information collection has been approved
under OMB control number 0910-0572.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-26296 Filed 10-11-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Rules and Regulations]
[Pages 14149-14153]
[FR Doc No: 2017-05290]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1983-0002; FRL-9958-96-Region 4]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Perdido Ground Water
Contamination Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency Region 4 is publishing
this direct final Notice of Deletion for the Perdido Ground Water
Contamination Superfund Site (Site), located in Perdido, Baldwin
County, Alabama, 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 an appendix of the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). This direct final deletion is being published
by the EPA with the concurrence of the State of Alabama, through the
Alabama Department of Environmental Management (ADEM), because the EPA
has determined that all appropriate response actions under CERCLA have
been completed. However, this deletion does not preclude future actions
under Superfund.

DATES: This direct final deletion is effective May 16, 2017 unless the
EPA receives adverse comments by April 17, 2017. If adverse comments
are received,

the EPA will publish a timely withdrawal of the direct final 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-1983-0002, by one of the following methods:
     www.regulations.gov. Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>, Attention: Deborah P. Cox, PE.
     Mail: Deborah P. Cox, PE, Remedial Project Manager,
Superfund Restoration and Sustainability Branch, Superfund Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
     Hand Delivery: U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Such
deliveries are only accepted during the Docket'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-SFUND-
1983-0002. The 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 http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means 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 http://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
due to technical difficulties and cannot contact you for clarification,
the 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 the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at:
    U.S. EPA Record Center, attn: Ms. Tina Terrell, Atlanta Federal
Center, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960, Phone:
(404) 562-8835, Hours 8 a.m.-4 p.m., Monday through Friday by
appointment only; or, Atmore Public Library, 700 East Church Street,
Atmore, AL 36502, Phone:<PHONE_NUMBER>, Hours 8 a.m.-5 p.m., Monday thru
Friday, Saturday 9 a.m.-1 p.m.

FOR FURTHER INFORMATION CONTACT: Deborah P. Cox, PE, Remedial Project
Manager, Superfund Restoration and Sustainability Branch, Superfund
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960, phone<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
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 4 is publishing this direct final Notice of Deletion
of the Perdido Ground Water Contamination Superfund Site (Site) from
the National Priorities List (NPL). The NPL constitutes Appendix B of
40 CFR part 300 which is the National Oil and Hazardous Substances
Pollution Contingency Plan (NCP), which the EPA promulgated pursuant to
section 105 of the Comprehensive Environmental Response, Compensation
and Liability Act (CERCLA) of 1980, as amended. The EPA maintains the
NPL as the list of sites that appear to present a significant risk to
public health, welfare or the environment. Sites on the NPL may be the
subject of remedial actions financed by the Hazardous Substance
Superfund (Fund). As described in the Section 300.425(e)(3) of the NCP,
sites deleted from the NPL remain eligible for Fund-financed remedial
actions if future conditions warrant such actions.
    Section II of this document explains the criteria to delete sites
from the NPL. Section III discusses procedures that the EPA is using
for this action. Section IV discusses the Perdido Ground Water
Contamination Superfund Site and demonstrates how it meets the deletion
criteria. Section V discusses the EPA's action to delete the Site from
the NPL unless adverse comments are received during the public comment
period.

II. NPL Deletion Criteria

    The NCP establishes the criteria that the EPA uses to delete sites
from the NPL. In accordance with 40 CFR 300.425(e), sites may be
deleted from the NPL where no further response is appropriate. In
making such a determination pursuant to 40 CFR 300.425(e), the EPA will
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 response 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 measures is not appropriate.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    (1) The EPA consulted with the State of Alabama prior to developing
this direct final Notice of Deletion and the Notice of Intent to Delete
co-published today in the ``Proposed Rules'' section of the Federal
Register.
    (2) The EPA has provided the state 30 working days for review of
this notice and the parallel Notice of Intent to Delete prior to their
publication today, and the state, through ADEM, has concurred on the
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 is being published in a major local newspaper, The
Atmore Advance. 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 proposed
deletion in the deletion docket and made these items available for
public inspection and copying at the Site

information repositories identified above.
    (5) If adverse comments are received within the 30-day public
comment period on this deletion action, the 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 the EPA's right to take enforcement
actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist the 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 the EPA's rationale for deleting
the Site from the NPL:

Site Background and History

    The Perdido Ground Water Contamination Site is located in Perdido,
Baldwin County, Alabama, and is the site of a train derailment, which
occurred on May 17, 1965. The Site originated as a borrow area which
provided sand and fill material to the County for local use. In 1965, a
train derailment by the Louisville and Nashville Railroad (a
predecessor of CSX Transportation, Inc., CSXT) occurred approximately
200 yards east of the intersection of State Highways 47 and 61.
Chemicals from the derailed tank cars spilled into the drainage ditches
along State Highway 61 and caught fire. Later, as a result of the
accident, an unknown quantity of benzene that had not been destroyed by
the fire eventually penetrated the soil and entered the ground water
aquifer.
    In 1982, benzene was identified in several residential domestic
water supply wells within the community of Perdido. An alternate supply
of drinking water was provided by CSXT by constructing a waterline six
miles from the nearby town of Atmore. Approximately 150 Perdido homes
within a one mile radius of the derailment were connected to the
alternate water supply.
    Due to the benzene in the ground water, the EPA proposed listing
the Site on the National Priorities List (EPA ID: ALD980728703) on
December 30, 1982 (47 FR 58476), and finalized the listing on September
8, 1983 (48 FR 40658) under the CERCLA Act of 1980.

Remedial Investigation/Feasibility Study (RI/FS)

    On October 11, 1985, CSXT executed an Administrative Order of
Consent with the EPA to conduct a Remedial Investigation/Feasibility
Study (RI/FS) at the Site. The RI was then initiated and submitted in
August 1986. In March 1987, the EPA's Ground Water Technology Unit
constructed a solute transport ground water model and predicted the
extent of the ground water plume in the Perdido area. In April 1987 the
Environmental Response Team (ERT) performed a soil vapor study. The
revised RI was submitted in November 1987. Based on review of the data,
the EPA requested the installation of additional monitoring wells
further down gradient of the derailment area. CSXT's contractor
completed a supplement to the revised RI report in May 1988. The
supplement to the revised RI confirmed the presence of benzene in the
ground water and led to the conclusion that by approximately 1985, all
of the benzene in the soils had leached to the ground water,
volatilized to the atmosphere, or biodegraded. As a result of these
actions, the ``source'' of contamination at the Site had been
``remediated'' by natural processes.
    A risk assessment of current and potential routes of exposure at
the Site identified several exposure pathways. The potential exposure
pathway for humans was determined to be ingestion of contaminated
ground water. Additional pathways investigated included ingestion of
and dermal contact with surface water for humans and ingestion of
surface water by cattle. These additional pathways were removed from
further consideration because the benzene spill occurred over 20 years
ago, benzene is a highly volatile substance and benzene had been
detected only in ground water. The EPA ultimately determined that
continued migration of contaminated ground water was a threat to public
health and the environment in the area surrounding and down gradient of
the contaminant plume.
    In May, 1988, CXST submitted the FS report, which evaluated three
remedial alternatives to address contaminated ground water. These three
alternatives were as follows:
     Ground water withdrawal with off-site benzene removal.
     Ground water withdrawal with on-site benzene removal.
     No action, with natural attenuation/degradation of benzene
in ground water.

Selected Remedy

    The EPA's Record of Decision (ROD) was signed on September 30,
1988, and ADEM concurred with the selected remedy of ground water
extraction with on-site treatment. The selected remedy for the ground
water contamination included the following:
     Recovery of the contaminated ground water by means of a
recovery well field;
     Treatment of the recovered contaminated ground water by
air stripping to achieve the 5 parts per billion (ppb) maximum
concentration limit (MCL) cleanup level established for benzene;
     Re-injection of the treated ground water back into the
aquifer and into the surface water.
    Operation and maintenance activities required to ensure the
continued effectiveness of the remedy included:
     Periodic monitoring of the pump and treat system to ensure
continued effectiveness in attaining cleanup standards;
     Periodic ground water monitoring to ensure that long term
performance goals have been achieved.
    The ROD also specified that once the ground water cleanup level was
attained, ground water monitoring would be required for an additional
five years to ensure cleanup levels were maintained.
    The remedial action objectives for the Site were to eliminate
potential health hazards due to the impact of benzene in ground water
that resulted from the May 1965, train derailment in Perdido, Alabama,
and restoration of the contaminated ground water to levels protective
of human health and the environment. The EPA's MCL of 5 [mu]g/L benzene
in ground water was to be used as the criteria for measuring whether
the remedial action objective had been met. During start-up of the
treatment system in December 1992, the reinjection system was unable to
accept the design flows. In May 1993, the EPA approved an Explanation
of Significant Differences (ESD) for a surface water discharge system
to discharge excess treated water to the Perdido Creek.

Response Actions

    The remedial design (RD) Report for the Site was submitted in
December 1991, and construction of the ground water treatment system
was completed between May and November 1992, with a Pre-Final Remedial
Action (RA) Inspection completed on July 7, 1993. On September 3, 1993
the Revised RA

Report, documenting that all construction requirements were met and
installation of the treatment system was complete, was submitted to the
EPA, and subsequently approved on September 13, 1993. The initial
treatment system included twelve ground water withdrawal wells, which
delivered contaminated ground water to the treatment plant. The
treatment plant consisted of nine air strippers that transferred
benzene from the contaminated water into the air stream, which in turn
passed through the carbon adsorption unit prior to release to the
atmosphere. The treated water passed through bag filters for removal of
solids prior to being pumped to the reinjection system. The ten
reinjection wells were each equipped with controllers to regulate the
flow of injection water back into the aquifer. Twenty-four observation
wells were also installed between 1986 and 1991, primarily for water
level or benzene concentration monitoring. An additional observation
well was installed in 1999.
    During start-up of the treatment system in December 1992, the
reinjection system was unable to accept the design flows. The excess
water flooded the injection system and activated a high-level cut-off
switch that shut down the entire system. To alleviate this problem and
allow the ground water remediation to start, a surface water discharge
system was proposed to handle the excess water. The EPA subsequently
approved the proposal for a surface water discharge system to the
Perdido Creek in the Site's May 1993 ESD. In June 1993, the surface
water discharge line and the originally designed Hazleton Maxi-
Strippers\TM\ were installed. Modifications were made to divert treated
water to the surface water discharge system once capacity of the
reinjection system was reached. Ground water recovery withdrawal and
treatment began in 1992 after start-up of the treatment system.
    CSXT conducted more frequent inspections during January through
March 1997 that revealed significant improvements could be made to
optimize treatment system performance. Originally, the extraction wells
were installed with pneumatic pumps, which tended to vibrate the wells
and to cause an influx of sand into the system. In fall 1997, these
pumps were replaced with electric submersible pumps, increasing system
reliability and performance. Additionally, because of the high levels
of iron and sand content in the influent ground water, the small
orifices in the original Hazleton Maxi-Stripper\TM\ system would become
plugged. Considerable maintenance efforts were required to clean each
of the orifices of the stripper by hand using a small drill. In April
1998, the Hazleton Maxi-Strippers\TM\ system was replaced with a New
England Environmental Products low profile, four tray air stripper.
Maintenance efforts and costs were significantly reduced after these
changes were implemented.
    In 1999 CSXT further optimized treatment by installing three
biosparge wells (BS-1, -2, and -3). These wells were intended to
provide dissolved oxygen to areas of the benzene plume that were
exhibiting decreased levels of dissolved oxygen, subsequently
increasing the natural degradation of the benzene plume. In February
and April 2000, nine additional biosparge wells were added on Site
north of Highway 47 (BS-4 through BS-12). Twelve new biosparge wells
(BS-13 thru BS-24) were installed in September 2003 on Site south of
Highway 47.

Clean-Up Levels

    Based on the success of remedial activities in reducing the benzene
plume, the EPA, ADEM, CSXT and CSXT consultant, AMEC Earth &
Environmental, Inc. (AMEC), met on August 2, 2005 to discuss an Interim
Evaluation Work Plan (IEWP) that would involve shutting down the ground
water treatment system and monitoring ground water conditions for a
period of one year in order to determine future remedial actions. A
primary goal of the plan was to determine whether ground water benzene
concentrations would remain below the 5 [mu]g/L MCL cleanup goal or
``rebound'' after the pump-and-treat and biosparge systems were turned
off. The EPA and ADEM approved the plan on July 25, 2006. On September
24, 2006, the ground water treatment system was turned off.
    Results of the first-quarter and second-quarter ground water
sampling under the IEWP were submitted in January 2007 and April 2007,
respectively. The results indicated that benzene concentrations in
ground water remained consistent with historical data and did not
rebound. Based on the data, implementation of the IEWP continued. On
May 21, 2007, all parties agreed that the fourth-quarter sampling event
would be replaced with a closure strategy if the third-quarter
monitoring results continued to follow the positive trend. ADEM also
requested the use of a low-flow micro-purging method to collect samples
at different depths in two wells (Observation Well 41 (OW-41) and
Withdrawal Well 14 (WW-14)). After approval from ADEM, this sampling
approach was followed during the third-quarter sampling under the IEWP
in June 2007. Based on the sampling results, a Closure Monitoring Plan
(CMP) was drafted to make changes to the current ground water
monitoring program, remedial actions and site closure procedures in a
series of phases to bring the Site to closure in accordance with the
1990 Consent Decree (CD) with CSXT.
    Addendum I to the CMP dated January 16, 2008 was submitted after a
team conference call. ADEM and the EPA approved the CMP with Addendum I
in January and February 2008, respectively. Recommendations in the
approved CMP included: Continued monitoring the 10 out of 42 total site
observation and withdrawal wells that had not yet achieved sample
results below the benzene clean-up goal of 5 [mu]g/L for five
consecutive years; Monitoring of these 10 wells on a semi-annual basis
and reporting the data on a semi-annual basis; Discontinuation of the
monitoring of observation and withdrawal wells located south of Highway
47 once a well has remained below the benzene cleanup goal of 5 [mu]g/L
for five consecutive years and properly plugging and abandoning all the
wells (including observation, withdrawal, biosparge and injection
wells) located south of Highway 47 once ground water benzene
concentrations have remained below the benzene cleanup goal of 5 [mu]g/
L for five consecutive years; Discontinuation of the monitoring of
observation and withdrawal wells located north of Highway 47 once a
well has remained below the benzene cleanup goal of 5 [mu]g/L for five
consecutive years and properly plugging and abandoning all wells
located north of Highway 47 once ground water benzene concentrations
within all observation and withdrawal wells have remained below the
benzene cleanup goal of 5 [mu]g/L for five consecutive years.
    Addendum II to the CMP dated October 9, 2008 presented the minor
revisions discussed during the September 3, 2008 team conference call.
Clarification was provided to identify the type of public notification
to be implemented prior to conducting closure type of events. ADEM
approved the actions proposed in Addendum II on December 2008.

Community Involvement

    Throughout the removal and remedial process, the EPA has kept the
public informed of the activities being conducted at the Site by way of
public meetings, progress fact sheets, and the announcement through
local newspaper advertisement on the availability of

documents such as the RI/FS, Risk Assessment, ROD, Proposed Plan, ESD
and Five-Year Reviews.
    On July 25, 2006 representatives from the EPA, ADEM CSXT, and AMEC
held a public availability session, regarding the upcoming IEWP for the
Site. The purpose of the availability session was to inform the general
public and local residents living near the Site, of the success of the
long term cleanup activities at the Site. At the time of the meeting,
benzene was detected in only three of the monitoring wells, with two of
those exceeding the 5 [mu]g/L cleanup level.
    On September 16, 2009 representatives from the EPA, ADEM, CSXT, and
AMEC held a public availability session to discuss the closure of a
portion of the monitoring network, located south of Highway 47. These
wells had completed five years of sampling with laboratory results
below the 5 [mu]g/L cleanup goal. In accordance with the approved CMP,
this milestone achievement allowed the southern portion of the former
plume to be eligible for closure.
    On March 19, 2014 representatives held a public availability
session to discuss the attainment of cleanup goals for five consecutive
years in each of the remaining monitoring wells. With the attainment of
all cleanup goals set forth for the Site, this public availability
session served to inform the local community that all monitoring and
site related activities would cease.
    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 the EPA relied on
for recommendation of the deletion from the NPL, are available to the
public in the information repositories identified above.

Determination That the Site Meets the Criteria for Deletion From the
NCP

    Region 4 has followed the procedures required by 40 CFR 300.425(e)
as mentioned above and the implemented remedy achieves the degree of
cleanup specified in the ROD for all pathways of exposure.
Specifically, ground water sampling results have been below the benzene
clean-up goal of 5 [mu]g/L for five consecutive years. These results
verify that the Site has achieved the ROD cleanup standards, and that
all cleanup actions specified in the ROD and ESD have been implemented.
All selected remedial and removal action objectives and associated
cleanup levels are consistent with agency policy and guidance. This
Site meets all the site completion requirements as specified in Office
of Solid Waste and Emergency Response (OSWER) Directive 9320.22, Close-
Out Procedures for National Priorities List Sites. No further Superfund
response is needed to protect human health and the environment.

V. Deletion Action

    The EPA, with concurrence of the State of Alabama through ADEM, has
determined that all appropriate response actions under CERCLA have been
completed. Therefore, the EPA is deleting the Site from the NPL.
    Because the EPA considers this action to be noncontroversial and
routine, the EPA is taking it without prior publication. This action
will be effective May 16, 2017 unless the EPA receives adverse comments
by April 17, 2017. If adverse comments are received within the 30-day
public comment period, the 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 waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: September 6, 2016.
V. Anne Heard,
Acting Regional Administrator, Region 4.

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

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 is revised 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 to Part 300--[Amended]

0
2. Table 1 of Appendix B to part 300 is amended by removing ``AL'',
``Perdido Ground Water Contamination'', ``Perdido''.

[FR Doc. 2017-05290 Filed 3-16-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: August 1, 2008 (Volume 73, Number 149)]
[Notices]
[Page 44980-44982]
[DOCID:fr01au08-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12965-001]

Wickiup Hydro, LLC; Notice of Intent To File License Application,
Filing Of Pre-Application Document, Commencement of Licensing
Proceeding, and Scoping; Request for Comments on the Pad and Scoping
Document, and Identification of Issues and Associated Study Requests

July 25, 2008.
    a. Type of Filing: Notice of Intent to File License Application for
a New License and Commencing Licensing Proceeding.
    b. Project No.: 12965-001.
    c. Dated Filed: January 22, 2008.
    d. Submitted by: Wickiup Hydro, LLC.
    e. Name of Project: Wickiup Dam Hydroelectric Project.
    f. Location: On the Deschutes River, in Deschutes County, Oregon.
The project would use the U.S. Bureau of Reclamation's Wickiup Dam. The

project would occupy lands in the Deschutes National Forest managed by
the U.S. Forest Service.
    g. Filed Pursuant to: 18 CFR part 5 of the Commission's
Regulations.
    h. Potential Applicant Contact: Mr. Brent Smith, COO, Symbiotics,
LLC, P.O. Box 535, Rigby, Idaho 83442,<PHONE_NUMBER>.
    i. FERC Contact: Jim Puglisi at<PHONE_NUMBER> or e-mail at
<EMAIL_ADDRESS>    j. We are asking federal, state, local, and tribal agencies with
jurisdiction and/or special expertise with respect to environmental
issues to cooperate with us in the preparation of the environmental
document. Agencies who would like to request cooperating status should
follow the instructions for filing comments described in paragraph o
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. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, part 402, and (b) the State Historic
Preservation Officer, as required by section 106, National Historical
Preservation Act, and the implementing regulations of the Advisory
Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Wickiup Hydro, LLC as the
Commission's non-federal representative for carrying out informal
consultation, pursuant to Section 7 of the Endangered Species Act and
Section 106 of the National Historic Preservation Act.
    m. Wickiup Hydro, LLC filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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 at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    Register online at http://ferc.gov/esubscribenow.htm to be notified
via e-mail of new filings and issuances related to this or other
pending projects. For assistance, contact FERC Online Support.
    o. With this notice, we are soliciting comments on the PAD and
Scoping Document 1 (SD1), as well as study requests. All comments on
the PAD and SD1, and study requests, should be sent to the address
above in paragraph h. In addition, all comments on the PAD and SD1,
study requests, requests for cooperating agency status, and all
communications to and from Commission staff related to the merits of
the potential application (original and eight copies) must be filed
with the Commission at the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. All filings with the Commission must include on
the first page the project name (Wickiup Dam Hydroelectric Project) and
number (P-12965-001) and bear the heading ``Comments on Pre-Application
Document,'' ``Study Requests,'' ``Comments on Scoping Document 1,''
``Request for Cooperating Agency Status,'' or ``Communications to and
from Commission Staff.'' Any individual or entity interested in
submitting study requests, commenting on the PAD or SD1, and any agency
requesting cooperating status must do so by September 23, 2008.
    Comments on the PAD and SD1, study requests, requests for
cooperating agency status, and other permissible forms of
communications with the Commission may be filed electronically via the
Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the ``e-
filing'' link.
    p. Although our current intent is to prepare an environmental
assessment (EA), there is the possibility that an Environmental Impact
Statement (EIS) will be required. Nevertheless, this meeting will
satisfy the NEPA scoping requirements, irrespective of whether an EA or
EIS is issued by the Commission.

Scoping Meetings

    Commission staff will hold two scoping meetings in the vicinity of
the project at the time and place noted below. The daytime meeting will
focus on resource agency, Indian tribes, and non-governmental
organization concerns, while the evening meeting is primarily for
receiving input from the public. We invite all interested individuals,
organizations, and agencies to attend one or both of the meetings, and
to assist staff in identifying particular study needs, as well as the
scope of environmental issues to be addressed in the environmental
document. The times and locations of these meetings are as follows:
    Daytime Scoping Meeting
    Date: Wednesday, August 20, 2008.
    Time: 9 a.m.-2p.m. (PST).
    Location: Deschutes National Forest Supervisors Office, 1001 SW.,
Emkay Drive, Bend, OR 97702.
    Phone:<PHONE_NUMBER>.
    Evening Scoping Meeting
    Date: Tuesday, August 19, 2008.
    Time: 7 p.m.-10 p.m.(PST).
    Location: La Pine Senior Center, 16450 Victory Way, La Pine, OR
97739.
    Phone:<PHONE_NUMBER>.
    Scoping Document 1 (SD1), which outlines the subject areas to be
addressed in the environmental document, was mailed to the individuals
and entities on the Commission's mailing list. Copies of SD1 will be
available at the scoping meetings, or may be viewed on the web at
http://www.ferc.gov, using the ``eLibrary'' link. Follow the directions
for accessing information in paragraph n. Based on all oral and written
comments, a Scoping Document 2 (SD2) may be issued. SD2 may include a
revised process plan and schedule, as well as a list of issues,
identified through the scoping process.

Site Visit

    The potential applicant and Commission staff will conduct a site
visit of the project on Tuesday, August 19, 2008, starting at 10 a.m.
at Wickiup dam. From Bend, head south on Highway 97 approximately 23
miles to Burgess Road. Turn right (west) on Burgess Road. Proceed west
on Burgess Road for about 10 miles. Turn left (south) on Wickiup Road.
Proceed south on Wickiup Road to Wickiup dam. Turn left (east) at the
base of the dam and go to the parking area located on the stability
berm. All participants are responsible for their own transportation.
Anyone with questions about the site visit should contact Eric Steimle
of Wickiup Hydro, LLC at<PHONE_NUMBER>.

Meeting Objectives

    At the scoping meetings, staff will: (1) Initiate scoping of the
issues; (2) review and discuss existing conditions and resource
management objectives; (3) review and discuss existing information and
identify preliminary information and study needs; (4) review and
discuss the process plan and schedule for pre-filing activity that
incorporates the time frames provided for in Part 5 of the

Commission's regulations and, to the extent possible, maximizes
coordination of federal, state, and tribal permitting and certification
processes; and (5) discuss the appropriateness of any federal or state
agency or Indian tribe acting as a cooperating agency for development
of an environmental document.
    Meeting participants should come prepared to discuss their issues
and/or concerns. Please review the PAD in preparation for the scoping
meetings. Directions on how to obtain a copy of the PAD and SD1 are
included in item n. of this document.

Meeting Procedures

    The meetings will be recorded by a stenographer and will become
part of the formal record of the Commission's proceeding on the
project.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-17636 Filed 7-31-08; 8:45 am]

BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, as you can see from my open letter I published here (https://docs.google.com/document/d/1wrkzg9Hxn_HeGikuyyVVzGhegbfWmaGgNCaQhxWBTOE/edit?usp=sharing)    but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

These devices have to potential to eradicate tobacco related disease if, and only if, the government can get past their agenda and allow them to do what they were designed to do… save lives… Everyone deserves a voice at the table and no voice is more important than the end user, who’s health you are trying to harm.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Notices]
[Page 30933]
[FR Doc No: 2017-13894]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-424, OMB Control No. 3235-0473]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736

Extension:
    Rule 17Ad-3(b)

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 17Ad-3(b) (17 CFR
240.17Ad-3(b)), under the Securities Exchange Act of 1934 (15 U.S.C.
78a et seq.). The Commission plans to submit this existing collection
of information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 17Ad-3(b) requires registered transfer agents to send a copy
of the written notice required under Rule 17Ad-2(c), (d), and (h) to
the chief executive officer of each issuer for which the transfer agent
acts when it has failed to turnaround at least 75% of all routine items
in accordance with the requirements of Rule 17Ad-2(a), or to process at
least 75% of all items in accordance with the requirements of Rule
17Ad-2(b), for two consecutive months. The issuer may use the
information contained in the notices: (1) As an early warning of the
transfer agent's non-compliance with the Commission's minimum
performance standards regarding registered transfer agents; and (2) to
become aware of certain problems and poor performances with respect to
the transfer agents that are servicing the issuer's issues. If the
issuer does not receive notice of a registered transfer agent's failure
to comply with the Commission's minimum performance standards then the
issuer will be unable to take remedial action to correct the problem or
to find another registered transfer agent. Pursuant to Rule 17Ad-3(b),
a transfer agent that has already filed a Notice of Non-Compliance with
the Commission pursuant to Rule 17Ad-2 will only be required to send a
copy of that notice to issuers for which it acts when that transfer
agent fails to turnaround 75% of all routine items or to process 75% of
all items.
    The Commission estimates that only one transfer agent will meet the
requirements of Rule 17Ad-3(b) each year. If a transfer agent fails to
meet those turnaround and processing requirements under 17Ad-3(b), it
would simply send a copy of the notice to its issuer-clients that had
already been produced for the Commission pursuant to Rule 17Ad-2(c) or
(d). The Commission estimates the requirement will take each respondent
approximately four hours to complete. The Commission staff estimates
that compliance staff work at registered transfer agents to comply with
the third party disclosure requirement will result in an internal cost
of compliance, at an estimated hourly wage of $283, of $1,128 per year
per transfer agent (4 hours x $283 per hour = $1,128 per year).
Therefore, the aggregate annual internal cost of compliance for the
approximately one registered transfer agent each year to comply with
Rule 17Ad-3(b) is also $1,128. There are no external labor costs
associated with sending the notice to issuers.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: June 27, 2017.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2017-13894 Filed 6-30-17; 8:45 am]
 BILLING CODE P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57196]
[FR Doc No: 2021-22408]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4563-DR; Docket ID FEMA-2021-0001]

Alabama; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of Alabama (FEMA-4563-DR), dated September 20, 2020, and
related determinations.

DATES: This change occurred on August 17, 2021.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, James R.
Stephenson, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Allan Jarvis as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22408 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: January 19, 2006 (Volume 71, Number 12)]
[Notices]
[Page 3073]
[DOCID:fr19ja06-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-170-000]

Transcontinental Gas Pipe Line Corporation; Notice of Proposed
Changes in FERC Gas Tariff

January 10, 2006.
    Take notice that on January 4, 2006, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, Third Revised Sheet No. 33B, to
become effective December 31, 2005.
    Transco states that the purpose of the instant filing is to remove
South Marsh Island Block 130 C from the list of gathering points
included in its currently effective tariff.
    Transco states that copies of the filing are being mailed to its
customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-492 Filed 1-18-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46771-46772]
[FR Doc No: 2020-16805]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89417; File No. S7-24-89]

Joint Industry Plan; Notice of Filing and Immediate Effectiveness
of the Forty-Eighth Amendment to the Joint Self-Regulatory Organization
Plan Governing the Collection, Consolidation and Dissemination of
Quotation and Transaction Information for Nasdaq-Listed Securities
Traded on Exchanges on an Unlisted Trading Privileges Basis

July 29, 2020.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 608 thereunder,\2\ notice is hereby given that
on June 29, 2020,\3\ the Participants \4\ in the Joint Self-Regulatory
Organization Plan Governing the Collection, Consolidation and
Dissemination of Quotation and Transaction Information for Nasdaq-
Listed Securities Traded on Exchanges on an Unlisted Trading Privileges
Basis (``UTP Plan'' or ``Plan'') filed with the Securities and Exchange
Commission (``Commission'') a proposal to amend the UTP Plan. The
amendment represents the Forty-Eighth Amendment to the Plan
(``Amendment''). Under the Amendment, the Participants propose to add
MEMX LLC (``MEMX'') as a Participant to the Plan and make a technical
correction to the Conflicts of Interest Policy pursuant to Rule
608(b)(3)(ii) under Regulation NMS.
---------------------------------------------------------------------------

    \1\ 15 U.S.C 78k-1(a)(3).
    \2\ 17 CFR 242.608.
    \3\ See Letter from Robert Books, Chairman, Operating Committee,
UTP Plan, to Vanessa A. Countryman, Secretary, Commission, dated
June 26, 2020.
    \4\ The Participants are: Cboe BYX Exchange, Inc., Cboe BZX
Exchange, Inc., Cboe EDGA Exchange, Inc., Cboe EDGX Exchange, Inc.,
Cboe Exchange, Inc., Financial Industry Regulatory Authority, Inc.,
The Investors' Exchange LLC, Long-Term Stock Exchange, Inc., MEMX
LLC, Nasdaq BX, Inc., Nasdaq ISE, LLC, Nasdaq PHLX, Inc., The Nasdaq
Stock Market LLC, New York Stock Exchange LLC, NYSE American LLC,
NYSE Arca, Inc., NYSE Chicago, Inc., and NYSE National, Inc.
(collectively, the ``Participants'').
---------------------------------------------------------------------------

    The proposed Amendment has been filed by the Participants pursuant
to Rule 608(b)(3)(ii) under Regulation NMS \5\ as concerned solely with
the administration of the Plan and as a ``Ministerial Amendment'' under
Section XVI of the Plan. As a result, the Amendment becomes effective
upon filing and was submitted by the Chair of the Plan's Operating
Committee. The Commission is publishing this notice to solicit comments
on the Amendment from interested persons. Set forth in Sections I and
II is the statement of the purpose and summary of the Amendment, along
with the information required by Rules 608(a) and 601(a) under the Act,
prepared and submitted by the Participants to the Commission.
---------------------------------------------------------------------------

    \5\ 17 CFR 242.608(b)(2).
---------------------------------------------------------------------------

I. Rule 608(a)

A. Purpose of the Amendment

    The above-captioned Amendment adds MEMX as a Participant to the UTP
Plan and makes a technical correction to the Conflicts of Interest
Policy to update a cross-reference.

B. Governing or Constituent Documents

    Not applicable.

C. Implementation of Amendment

    Because the Amendment constitutes a ``Ministerial Amendment'' under
Section XVI of the UTP Plan, the Chair of the UTP Plan's Operating
Committee may submit the Amendment to the Commission on behalf of the
Participants in the UTP Plan. Because the Participants designate the
Amendment as concerned solely with the administration of the UTP Plan,
the Amendment becomes effective upon filing with the Commission.

D. Development and Implementation Phases

    Not applicable.

E. Analysis of Impact on Competition

    The Amendment does not impose any burden on competition because it
simply adds MEMX as a Participant to the UTP Plan and makes a minor
correction to the Conflicts of Interest Policy. MEMX has completed the
required steps to be added to the UTP Plan.

F. Written Understanding or Agreements Relating to Interpretation of,
or Participation in, Plan

    Not applicable.

G. Approval by Sponsors in Accordance With Plan

    See Item I.C. above.

H. Description of Operation of Facility Contemplated by the Proposed
Amendment

    Not applicable.

I. Terms and Conditions of Access

    Not applicable.

J. Method of Determination and Imposition, and Amount of, Fees and
Charges

    Not applicable.

K. Method and Frequency of Processor Evaluation

    Not applicable.

L. Dispute Resolution

    Not applicable.

II. Regulation NMS Rule 601(a)

A. Equity Securities for Which Transaction Reports Shall Be Required by
the Plan

    Not applicable.

B. Reporting Requirements

    Not applicable.

C. Manner of Collecting, Processing, Sequencing, Making Available and
Disseminating Last Sale Information

    Not applicable.

D. Manner of Consolidation

    Not applicable.

E. Standards and Methods Ensuring Promptness, Accuracy and Completeness
of Transaction Reports

    Not applicable.

F. Rules and Procedures Addressed to Fraudulent or Manipulative
Dissemination

    Not applicable.

G. Terms of Access to Transaction Reports

    Not applicable.

H. Identification of Marketplace of Execution

    Not applicable.

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number S7-24-89 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 S7-24-89. 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 website (http://www.sec.gov/rules/sro.shtml). Copies of
the submission, all written statements with respect to the proposed
Amendment that are filed with the Commission, and all written
communications relating to the proposed Amendment 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 website viewing and printing at
the principal office of the Plan. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number S7-24-89 and should be submitted on or before August 24,
2020.

    By the Commission.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-16805 Filed 7-31-20; 8:45 am]
BILLING CODE 8011-01-P