[Federal Register: November 7, 2005 (Volume 70, Number 214)]
[Notices]
[Page 67474]
[DOCID:fr07no05-77]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12608-000]

Alternatives Unlimited, Inc., Notice of Application Accepted for
Filing and Soliciting Motions To Intervene and Protests

November 1, 2005.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption from Licensing.
    b. Project No.: 12608-000.
    c. Date filed: August 15, 2005.
    d. Applicant: Alternatives Unlimited, Inc.
    e. Name of Project: Alternatives Hydro Power Project.
    f. Location: On the Mumford River, in the Town of Northbridge,
Worcester County, Massachusetts. The project would not use Federal
land.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. sections 2705 and 2708.
    h. Applicant Contact: Kathleen D. Hervol. Beals and Thomas, Inc.
Reservoir Corporate Center, 144 Turnpike Road (Route 9), Southborough,
MA 01772-2104,<PHONE_NUMBER>.
    i. FERC Contact: Stefanie Harris,<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Motions to intervene and protests 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.
    k. This application has been accepted for filing, but is not ready
for environmental analysis at this time.
    l. Description of Project: The Alternatives Hydro Power Project
would consist of: (1) The existing 127-foot-long by 15.5-foot-high Ring
Shop Dam consisting of a concrete 9.5-foot-high spillway topped with
2.5-foot-high flashboards, a waste gate, and two inlet structures
located at the north and south ends of the spillway; (2) an existing
1.3-acre reservoir enlarged to 2 acres with a normal full pond
elevation of 285.1 feet above mean sea level; (3) a restored 8-foot-
wide head gated intake structure; (4) a new 23-foot by 6-foot metal
service platform (to be enclosed for a future powerhouse) located at
the south side of the dam containing three generating units with a
total installed capacity of 45 kilowatts; and (5) appurtenant
facilities. The restored project would have an average annual
generation of 340 megawatt-hours.
    m. A copy of the filing is available for review at the Commission
in the Public Reference Room or may be viewed on the Commission's Web
site at http://www.ferc.gov using the ``eLibrary'' link. Enter the

docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. 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 e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received on or before the specified
deadline date for the particular application.
    All filings must (1) Bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6159 Filed 11-4-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 93 (Wednesday, May 14, 2014)]
[Notices]
[Pages 27623-27626]
[FR Doc No: 2014-11048]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-1107]

Oxiplex[supreg]/SP Gel; FzioMed, Incorporated's Petition for
Review of the Food and Drug Administration's Denial of Premarket
Approval; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The topic to be
discussed is the Center for Device and Radiological Health's (CDRH's)
denial of a premarket approval application (PMA) for Oxiplex[supreg]/SP
Gel (OXIPLEX) submitted by FzioMed, Inc.--the sponsor for OXIPLEX. The
meeting will be open to the public.
    Name of Committee: Medical Devices Dispute Resolution Panel of the
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on scientific disputes between CDRH and
sponsors, applicants, and manufacturers.
    Date and Time: The meeting will be held on June 10, 2014, from 8
a.m. to 6 p.m.
    Location: The meeting will be held at the Hilton Washington DC/
North, salons A, B, C, and D of the Ballroom, 620 Perry Pkwy.,
Gaithersburg, MD. The hotel's telephone number is 1-301-977-8900.
    Contact Person: Pamela D. Scott, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3611, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:
301-847-8510, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that affect a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions from persons other than FzioMed and CDRH may be
made to the docket on or before June 3, 2014. Submit electronic
comments 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. It is only necessary
to send one set of comments. Identify all written and electronic
comments and submissions with the docket number found in brackets in
the heading of this document. All written and electronic comments and
submissions will be considered to be publicly disclosable.
    Oral presentations from persons other than FzioMed and CDRH will be
scheduled between approximately 12:45 and 1:15 p.m. on June 10, 2014.
If you wish to make an oral presentation during the meeting, you should
register on or before May 27, 2014. Send registration information
(including name, title, firm name, address, telephone, email, and FAX
number), and requests to make oral presentations to Pamela D. Scott
(see Contact Person). You should provide the docket number appearing in
the heading of this notice. You also should submit a brief summary of
the presentation, including the discussion topic(s) that will be
addressed and the approximate time requested for your presentation. The
amount of time to be allotted to each presenter may be limited to
provide opportunities to as many persons wishing to present as
possible. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for that session. We encourage individuals and organizations with
common interests to consolidate or coordinate their presentations to
allow adequate time for each request for presentation. Pamela D. Scott
will notify interested persons regarding their request to speak by June
2, 2014. On the day of the meeting scheduled open public speakers
should identify themselves at the registration desk.
    After the scheduled speakers have spoken, the Chair of the advisory
committee may ask them to remain if the advisory committee wishes to
question them further. The Chair may recognize unscheduled speakers
should time allow.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing that, in accordance with section 515(g)(2) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(g)(2)),
a public advisory committee will review CDRH's denial of a PMA for
OXIPLEX submitted by FzioMed--the sponsor for OXIPLEX.
    On August 21, 2007, FzioMed submitted a PMA (PMA P070023) for
OXIPLEX. OXIPLEX is an absorbable, clear, viscoelastic gel designed to
be applied in the lower back during lumbar spine surgery. The device's
proposed indication is for use as a surgical adjuvant in adult patients
with primary leg pain and severe baseline back pain undergoing first
surgical intervention (i.e., open or endoscopic posterior lumbar
laminectomy, laminotomy, or discectomy) for diagnosed unilateral
herniation of lumbar intervertebral disc material associated with
radiculopathy. The proposed intended use is for one-time use, up to 3
milliliters, after hemostasis during wound closure, as an adjunct to
primary surgical intervention to improve patient outcomes by reducing
leg pain, back pain and neurologic symptoms.
    On October 9, 2012, CDRH issued a decision upholding a not
approvable letter in response to the PMA P070023 for OXIPLEX. CDRH
determined that PMA P070023 is not approvable based on its conclusion
that the data and information offered in support of the PMA do not
provide a reasonable assurance that the device is safe and effective
under the conditions of use prescribed, recommended, or suggested in
the proposed labeling, as required by section 515(d)(2) of the FD&C
Act.
    On November 5, 2012, FzioMed requested administrative review of
CDRH's decision to uphold its not approvable letter. Submitted in the
form of a petition for reconsideration under 21 CFR 10.33 (see Sec.
814.44 (21 CFR 814.44(f)(2))), FzioMed's petition for review (petition)
stated that, in accordance with Sec.  814.44(f), FzioMed

considered the decision to uphold the not approvable letter to be a
denial of approval of PMA P070023 under Sec.  814.45. Pursuant to
section 515(d)(4) of the FD&C Act, FzioMed requested review of this
denial under section 515(g)(2) of the FD&C Act (petition is available
in Docket No. FDA-2012-P-1107).
    Accordingly, as required by Sec.  814.45(e)(3), CDRH issued an
order denying approval of the PMA for OXIPLEX on October 21, 2013.
Pursuant to section 515(g)(2) of the FD&C Act, on October 25, 2013, FDA
granted FzioMed's petition for review of the order denying PMA P070023.
In accordance with section 515(g)(2) of the FD&C Act, the Office of the
Commissioner is referring PMA P070023 and the basis for the order
denying its approval to the Medical Devices Dispute Resolution Panel
(the panel), an advisory committee of experts established, in part, to
receive referrals of petitions for advisory committee review under
section 515(g)(2)(B) of the FD&C Act. The panel for this review will
consist of nine persons, qualified by training and experience to
evaluate the clinical and scientific basis of CDRH's order denying
approval of the PMA. After independent study of the data and
information furnished to it by the Office of the Commissioner, and
other data and information before it, the panel will, during the
meeting, discuss, evaluate, make recommendations, and vote on the
issues in dispute based on the statement of issues described below. A
transcript of the meeting will serve as a report and recommendation
with respect to CDRH's order denying approval. (See section
515(g)(2)(A) of the FD&C Act.) Together with the underlying data and
information before the panel, the transcript of the meeting will be
submitted to FDA's Chief Scientist, who is an official authorized to
perform all delegable functions of the Commissioner and is the
Commissioner's designee for this matter.
    The Office of the Commissioner will make the transcript of the
meeting public in accordance with section 515(g)(2)(C) of the FD&C Act.
The Office of the Commissioner will also provide a copy of the
transcript to FzioMed and CDRH and will offer FzioMed and CDRH the
opportunity to submit comments on the panel's recommendations before a
final order is rendered. In accordance with section 515(g)(2)(C) of the
FD&C Act, the Chief Scientist will issue an order either affirming or
reversing the order denying PMA P070023 and, if appropriate, approving
or denying approval of the PMA.

II. Meeting Issues and Process

A. Issues

    The scientific questions for the panel relate to whether the
information provided by FzioMed is sufficient to provide a reasonable
assurance of safety and effectiveness for OXIPLEX's proposed
indications. Key to a determination regarding effectiveness is whether
the product will provide clinically significant results to a
significant portion of the target population. (See 21 CFR 860.7(e).)
    Over the course of CDRH's review of OXIPLEX, FzioMed submitted data
from four peer-reviewed, published clinical studies in an effort to
demonstrate safety and effectiveness. The clinical studies included a
pilot study and a pivotal study, both of which were conducted in the
United States, and two studies conducted outside of the United States
in China and Italy (the OUS studies). The pivotal study was a
randomized, controlled, double-blinded multicenter study designed to
evaluate the efficacy of OXIPLEX in the reduction of postoperative pain
and symptoms and to evaluate the safety of applying OXIPLEX during
lumbar disc surgery by comparing a group of patients undergoing lumbar
surgery alone and a group undergoing the same surgery with the use of
OXIPLEX. FzioMed maintains that, although the pivotal study did not
show a statistically significant reduction in leg pain for OXIPLEX in
the study patient population as a whole, the study did demonstrate
OXIPLEX to be effective for the subgroup of patients with leg pain and
severe baseline back pain (SBBP):

    For those subjects with both leg pain and severe baseline back
pain, which comprised 55% of the total study population, . . .
improvement in leg pain from baseline to the 6-month visit was
statistically significantly greater for Oxiplex subjects compared to
control subjects (P=0.0123), with an 18% greater improvement in leg
pain in the Oxiplex group compared to controls. (Petition at 7-8.)

In addition, FzioMed submitted data from the two OUS studies that,
according to FzioMed, provide confirmatory evidence of the safety and
efficacy of OXIPLEX in the severe back pain subgroup.

    In denying PMA P070023, CDRH concluded that the effect observed in
the SBBP subgroup in the pivotal study was not adequate to support
approval because it stemmed from what CDRH characterized as FzioMed's
``exploratory subgroup analysis.'' CDRH further determined that the OUS
studies do not confirm the results of improvement shown in
postoperative leg pain in the SBBP subgroup from the pivotal study
because: (1) Differences in subject population and study endpoints
among the three studies preclude pooling the data; (2) the Chinese
clinical study was not initially designed to assess the treatment
effect in the SBBP subgroup, and review of the quartile of patients
with the most severe baseline back pain in the study did not
demonstrate a treatment effect for OXIPLEX at either the 30- or 60-day
endpoint; and (3) the Italian clinical study was not truly randomized,
resulting in important baseline differences between the control and
treatment groups that preclude meaningful comparison between the two
groups, and few study subjects had baseline back pain of the severity
considered in the SBBP subgroup of the pivotal study.
    FzioMed contests the scientific bases for CDRH's determination that
the evidence from the pivotal study and the two OUS studies does not
provide a reasonable assurance of the device's safety and effectiveness
for the device's proposed indications. First, FzioMed contends that the
agency should place greater weight on the treatment results for the
SBBP subgroup in the pivotal study. While acknowledging that ``severe''
was not prospectively defined in identifying the SBBP subgroup, the
company notes that the statistical analysis plan did prospectively
identify baseline back pain as a covariate for analysis. FzioMed
maintains that analysis of this subgroup was justified and executed in
a manner consistent with the approved statistical analysis plan.
Second, FzioMed maintains that differences in study population among
the clinical studies submitted to FDA actually strengthen support for
the effectiveness of OXIPLEX:

    The fact that consistent results were observed using the LSOQ
[Lumbar Spine Outcomes Questionnaire] and the Visual Analogue Scale
(VAS), and that these results were demonstrated at short (60 days),
intermediate (6 months) and long-term (3 years) follow-up intervals
supports the robustness of the data and confirms that the results
observed in the U.S. pivotal study did not occur by chance.
(Petition at 13.)

    Third, FzioMed argues that CDRH improperly rejected the submitted
OUS studies as confirmatory evidence of safety and effectiveness, based
on, among other things, inappropriate subgroup analyses and improper
restrictions on study design.
    CDRH and FzioMed have agreed that, in order to demonstrate
clinically significant results for a significant portion of the target
population from the adjunctive use of OXIPLEX for the proposed SBBP
indications, the

submitted information must demonstrate, based on patients' self-
assessment under validated pain scales, at least a 10 percent
difference in the mean leg pain reduction from baseline pain to 6-month
postoperative residual pain in favor of Oxiplex, when the mean
difference between the treatment and control groups is divided by the
mean reduction in leg pain in the control group. This assumes at least
a 50 percent reduction in baseline to 6-month residual pain in the
control group.
    Questions for the panel to consider relative to safety and
effectiveness are:
    1. With respect to the pivotal study:
    a. Is it scientifically and statistically valid to rely on analysis
of the SBBP subgroup of the pivotal study to support, in part, a
determination of reasonable assurance of effectiveness for the proposed
SBBP indications?
    b. Did CDRH give the effect observed in the SBBP subgroup of the
pivotal study sufficient weight in evaluating OXIPLEX's effectiveness
for the proposed SBBP indications?
    2. With respect to the Chinese clinical study (Confirmatory Study
1):
    a. Is it scientifically and statistically valid to rely on analysis
of the SBBP subgroup as confirmatory evidence of effectiveness for the
proposed SBBP indications?
    b. In evaluating whether OXIPLEX provides clinically significant
results for the proposed SBBP indications, is it scientifically and
statistically valid to look at the treatment effect for OXIPLEX
observed for the quartile of patients (N=17) with the most severe
baseline back pain (VAS score >=6.2) at the 30- and 60-day endpoints?
    3. With respect to the Italian case series (Confirmatory Study
2): Does the study design enable a scientifically and
statistically valid comparison between the treatment and control groups
for the proposed SBBP indications?
    4. Do the differences in study design for the pivotal study and the
OUS studies prevent considering all three studies in the aggregate to
evaluate whether OXIPLEX provides statistically and clinically
significant results for the proposed SBBP indications?
    5. When reviewed in total, do the data and other information
submitted for OXIPLEX provide a reasonable assurance of effectiveness
for the proposed SBBP indications (i.e., do the data and information
demonstrate, based on patients' self-assessment under validated pain
scales, at least a 10 percent difference in the mean leg pain reduction
from baseline pain to 6-month post-operative residual leg pain in favor
of OXIPLEX, when the mean difference between the treatment and control
groups is divided by the mean reduction in pain in the control group,
assuming at least a 50 percent reduction in baseline to 6-month
residual pain in the control group)?
    6. When reviewed in total, do the data and other information
submitted for OXIPLEX provide a reasonable assurance of safety for the
proposed SBBP indications? For there to be ``reasonable assurance of
safety,'' valid scientific evidence must enable a determination that
the probable benefits to health from use of OXIPLEX for the proposed
SBBP indications outweigh any probable risks.

B. Process

    Although no statute or regulation requires that separation of
functions be applied to this review proceeding under section 515(g)(2)
of the FD&C Act, FDA is adopting the following measures to ensure
impartiality and promote efficiency. First, the Office of the
Commissioner has formed two teams. The first, the Substantive Team,
handles all decisions on any issues or matters that either relate
directly to the merits of the review proceeding or are the subject of a
dispute between CDRH and FzioMed, which are both parties to this
proceeding. The second team, the Administrative Team, handles all
undisputed procedural matters related to the administration of the
panel meeting. The Administrative Team ensures that it keeps the
parties apprised of all significant procedural decisions. Moreover, the
Administrative Team refers the parties to the Substantive Team if
either or both of the parties have concerns about the manner in which
the Administrative Team has resolved a procedural issue.
    To promote efficiency and facilitate the flow of information
between the Office of the Commissioner and the parties, the agency is
not requiring that all communications between the parties and the
Office of the Commissioner be made part of the public record. However,
until the Office of the Commissioner issues an order either affirming
or reversing the order denying approval of PMA P070023, the Office of
the Commissioner will not engage, and has not engaged, in any
communication concerning the merits of the review proceeding with
anyone participating as a party to the hearing or any person outside
the agency unless the communication is made part of the public record.
Communications between the parties and the Administrative Team that are
not part of the public record will be limited to discussion of
procedural issues and questions.
    For the purposes of this proceeding, members of CDRH are considered
to represent CDRH unless specifically designated to advise the Office
of the Commissioner as a member of the Substantive Team or
Administrative Team. All other members of FDA are available to advise
and participate with the Office of the Commissioner on matters related
to this proceeding.
    At the meeting, each party will be provided 1 hour and 45 minutes
during the first portion of the meeting to present relevant information
or views orally. The parties may use the allotted time as desired,
consistent with an orderly meeting, and may be accompanied by
additional persons, who may present relevant information or views. The
parties will subsequently be allowed 15 minutes for rebuttal. During
the panel's open discussion, the panel members may pose questions to,
or seek requests for clarification from, FzioMed and/or CDRH.
Thereafter, each party will be allocated 15 minutes for summation,
after which panel deliberation and voting will occur.
    FDA welcomes the public's attendance at this advisory committee
meeting and will make every effort to accommodate persons with physical
disabilities or special needs. If you need special accommodations due
to a disability, please contact AnnMarie Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3611, Silver Spring, MD 20993, 301-796-
5966, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>in
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Because this is a public meeting before an advisory committee, it
is subject to our regulations concerning the policy and procedures for
electronic media coverage of public agency administrative proceedings
(21 CFR 10.200 through 10.206). These procedures are primarily intended
to expedite media access to our public proceedings. Representatives of
the electronic media may be permitted, subject to certain limitations,
to videotape, film, or otherwise record our public administrative
proceedings, including the testimony of witnesses in the proceedings.
Accordingly, the parties and nonparty participants, and all other
interested persons, are directed to Sec.  10.200 through 10.206, for a
more

complete explanation of those regulations' effect on this meeting.
    Documents filed in this matter are available for public review
under Docket No. FDA-2012-P-1107 in the Division of Dockets Management
(see Procedure) between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain documents at http://www.regulations.gov. FDA intends to make background material, including
briefing materials for the panel provided by CDRH and FzioMed,
available to the public no later than 2 business days before the
meeting. If FDA is unable to provide the background material prior to
the meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be available in the Division of Dockets Management (see
Procedure) and at http://www.regulations.gov after the meeting.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

III. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD.

    Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11048 Filed 5-13-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Notices]
[Pages 81182-81184]
[FR Doc No: 2016-27602]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79291; File No. SR-NYSEArca-2016-144]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE
Arca Options Fee Schedule Effective November 3, 2016

November 10, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on November 3, 2016, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Options Fee Schedule
(``Fee Schedule''). The Exchange proposes to implement the fee change
effective November 3, 2016. The proposed rule change is available on
the Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to amend the Fee Schedule effective
November 3, 2016. Specifically, the Exchange proposes to (i) modify the
qualification for Tier 6 of Customer and Professional Customer Monthly
Posting Credit Tiers and Qualifications in Penny Pilot Issues (the
``Posting Tiers''); and (ii) modify one aspect of the Customer and
Professional Customer Incentive Program.
    Currently, to qualify for Tier 6 of the Posting Tiers, OTP Holders
and OTP Firms (``OTPs'') must execute at least 0.50% of Total Industry
Customer equity and ETF option ADV (``TCADV'') from Customer and
Professional Customer posted orders in all issues (``the options
component''), plus executed ADV of 0.70% of U.S. equity market share
posted and executed on NYSE Arca Equity Market (``the equity
component''). OTPs that achieve Tier 6 are eligible to receive a $0.48
credit applied to posted electronic Customer and Professional Customer
executions in Penny Pilot Issues.
    In addition, the Customer and Professional Customer Incentive
Program (``the Incentive Program''), which provides OTPs six
alternatives to earn additional posting credits ranging from $0.01 to
$0.05, currently affords OTPs the ability to earn an additional $0.03
credit on Customer and Professional Customer Posting Credits by meeting
the same 0.70% minimum qualification of the equity component as set
forth in Tier 6.
    The Exchange is proposing to modify Tier 6 of the Posting Tiers by
reducing the options component from 0.50% TCADV to 0.35% TCADV, while
increasing the threshold of the equity component from 0.70% to 0.80% of
U.S.

equity market share posted and executed on NYSE Arca Equity Market.
    In addition, to maintain parity with the Incentive Program that
likewise offers a credit when an OTP meets the same 0.70% minimum
qualification of the equity component as set forth in current Tier 6,
the Exchange similarly proposes to increase this qualification basis.
Specifically, the Exchange proposes to increase the equity threshold
alternative from 0.70% to 0.80% of U.S. equity market share posted and
executed on NYSE Arca Equity Market qualification in order for OTPs to
qualify to earn an additional $0.03 credit.
    The Exchange believes that the proposal to modify Tier 6 of the
Posting Tiers by reducing the option component, while increasing the
equity component would encourage greater participation on both the
options and equity exchanges. The Exchange likewise believes that the
proposed change to the Incentive Program would operate to maintain
parity with the similar, alternative incentives offered by the Exchange
and would also encourage participation in the NYSE Arca Equity Market.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\4\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\5\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed to modifications to the
qualifications for Tier 6 of the Posting Tiers, and the similar
adjustment to the Incentive Program, are reasonable, equitable, and not
unfairly discriminatory because the changes are designed to attract
additional Customer and Professional Customer electronic equity and ETF
option volume to the Exchange, which would benefit all participants by
offering greater price discovery, increased transparency, and an
increased opportunity to trade on the Exchange. The Exchange believes
that adjusting the methods for achieving the credits available on the
Exchange (i.e., by reducing the qualification basis for the options
component, while increasing the qualification basis for the equity
component) is reasonable, equitable and not unfairly discriminatory
because it would encourage more OTPs to direct both options and equity
volume to the Exchange in an effort to qualify for the credits.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\6\ 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. Instead, the Exchange believes that the proposed
changes would continue to encourage competition, including by
attracting additional liquidity to the Exchange, which would continue
to make the Exchange a more competitive venue for, among other things,
order execution and price discovery. The Exchange does not believe that
the proposed change would impair the ability of any market participants
or competing order execution venues to maintain their competitive
standing in the financial markets.
---------------------------------------------------------------------------

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

    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues. In
such an environment, the Exchange must continually review, and consider
adjusting, its fees and credits to remain competitive with other
exchanges. Because competitors are free to modify their own fees and
credits in response, and because market participants may readily adjust
their order routing practices, the degree to which fee changes in this
market may impose any burden on competition is extremely limited. For
the reasons described above, the Exchange believes that the proposed
rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \7\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \8\ thereunder, because it establishes a due, fee, or other charge
imposed by the Exchange.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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) \9\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \9\ 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_ADDRESS>Please include
File Number SR-NYSEArca-2016-144 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-NYSEArca-2016-144. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public

Reference Room, 100 F Street NE., Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2016-144, and should be submitted on or before
December 8, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-27602 Filed 11-16-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Pages 55672-55673]
[FR Doc No: 2015-23216]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75887; File No. SR-ICC-2015-009]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing of Amendments No. 1 and 2 and Order Granting Accelerated
Approval of Proposed Rule Change, as Modified by Amendments No. 1 and
2, To Revise the ICC Risk Management Framework

September 10, 2015.

I. Introduction

    On May 28, 2015, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to make revisions
to the ICC Risk Management Framework (SR-ICC-2015-009). The proposed
rule change was published for comment in the Federal Register on June
12, 2015.\3\ The Commission did not receive comments on the proposed
rule change. On July 27, 2015, the Commission extended the time period
in which to either approve, disapprove, or institute proceedings to
determine whether to disapprove the proposed rule change to September
10, 2015.\4\ On September 1, 2015, ICC filed Amendment No. 1 to the
proposed rule change. On September 8, 2015, ICC filed Amendment No. 2
to the proposed rule change. As discussed below, Amendments No. 1 and 2
are intended to provide further clarification to the Initial Rule
Filing. The Commission is publishing this notice to solicit comments on
Amendments No. 1 and 2 from interested persons and is approving the
proposed rule change, as modified by Amendments No. 1 and 2, on an
accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-75119 (Jun. 8, 2015),
80 FR 33573 (Jun. 12, 2015) (SR-ICC-2015-009) (hereinafter referred
to as the ``Initial Rule Filing'').
    \4\ Securities Exchange Act Release No. 34-75529 (Jul. 27,
2015), 80 FR 45688 (Jul. 31, 2015) (SR-ICC-2015-009).
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

A. Description of the Initial Rule Filing

    In the Initial Rule Filing, ICC proposed changes to the ICC Risk
Management Framework to incorporate risk model enhancements related to
the General Wrong Way Risk (``GWWR'') methodology. More specifically,
ICC proposed changing the ICC Risk Management Framework to extend the
GWWR framework to the portfolio level. Currently, there exists no
Clearing Participant-level cumulative GWWR requirement incorporated in
the Jump-to-Default calculations. The uncollateralized WWR exposure of
a Risk Factor needs to exceed its corresponding WWR threshold in order
to trigger WWR collateralization. According to ICC, the proposed
enhancement is introduced to account for the potential accumulation of
portfolio WWR through Risk Factor specific WWR exposures. ICC asserts
that under the proposed approach, if the cumulative uncollateralized
exposure exceeds a pre-determined portfolio GWWR threshold, the amount
above the threshold is collateralized.

B. Description of Amendment No. 1

    On September 1, 2015, ICC filed Amendment No. 1 to the proposed
rule change. ICC stated that the purpose of the amendment was to
provide further clarity regarding the risk enhancements described in
the Initial Rule Filing. ICC proposed to revise its Risk Management
Framework to include specific language regarding the pre-determined
portfolio GWWR threshold. Specifically, ICC added clarifying language
setting the minimum and maximum value of the parameter. According to
ICC, the value of the parameter must be greater than, or equal to, the
value of the greatest Risk Factor specific WWR threshold level. ICC
stated that the parameter is further constrained not to exceed the sum
of the minimum value and the value of the average of all Risk Factor-
specific WWR thresholds (excluding the greatest Risk Factor specific
WWR threshold). ICC proposes to set the initial GWWR global parameter
equal to the minimum value, the greatest Risk Factor specific WWR
threshold, and will not increase the parameter value prior to March 31,
2016.
    Additionally, in Amendment No. 1, ICC added clarifying language
regarding how the Risk Factor specific WWR loss thresholds are
determined. The proposed revisions clarify that the risk enhancements
described in the Initial Rule Filing will apply to all products cleared
by ICC within the Sovereign and Banking \5\ sectors. ICC represented
that, should it decide to expand its product offering to include credit
default swap contracts on its Clearing Participant names, it will
specifically file a separate proposed rule change with the Commission
regarding the applicability of the GWWR framework to such contracts.
ICC has also updated its stress testing methodology to include
additional analysis related to Clearing Participant WWR exposures.
---------------------------------------------------------------------------

    \5\ ICC stated that the Banking sector attribution follows the
Bloomberg Industry Classification system (BICS).
---------------------------------------------------------------------------

C. Description of Amendment No. 2

    On September 8, 2015, ICC filed Amendment No. 2 to the proposed
rule change. ICC stated that the purpose of the amendment was to
provide further clarity regarding the risk enhancements described in
the Initial Rule Filing. In Amendment No. 2, ICC revised its Risk
Management Framework to include specific language regarding the jump-
to-default requirement related to the exposure to single name (``SN'')
risk factors (``RFs''), which reflect outright and index-derived single
name positions. Additionally, ICC added language clarifying that the
GWWR analysis is applied to all cleared SN RFs within the Sovereign and
Banking sectors, is applicable to post index-decomposition positions
and reflects the combined exposure resulting from outright and index-
derived SN positions. ICC also added language regarding the
determination of correlation parameters needed for GWWR computations,
specifically the quantification of loss-given-default resulting from
correlated defaults. Finally, ICC updated its Stress Testing Framework
to include additional analysis related to GWWR exposures for Clearing
Participants' portfolios. As further described in the Stress Testing
Framework, a portfolio of highly correlated RFs is created and is
further subjected to additional stress testing analyses to uncover
pockets of increased risk due to adverse market realizations for the
highly correlated factors. ICC has also represented that it intends to
submit a separate filing regarding its Stress Testing Framework, which
contains the aforementioned enhanced stress testing analyses.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \6\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if the
Commission finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such self-regulatory organization. Section 17A(b)(3)(F)
of the Act \7\ requires, among other things, that the rules of a
clearing agency are designed to promote the prompt and accurate
clearance and settlement of securities transactions and, to the extent
applicable, derivative agreements, contracts, and transactions and, in
general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2)(C).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission finds that ICC's proposed revisions to its Risk
Management Framework are consistent with the requirements of Section
17A of the Act \8\ and regulations thereunder applicable to it,
including the standards under Rule 17Ad-22.\9\ The proposed revisions
are intended to enhance ICC's risk policies and are expected to impose
more conservative initial margin requirements to account for the
potential accumulation of portfolio WWR through Risk Factor specific
WWR exposures, which ICC represents will enhance its available
financial resources. The Commission therefore believes that the
proposal is designed to promote the prompt and accurate clearance and
settlement of securities transactions and derivative agreements,
contracts and transactions cleared by ICC and, in general, to protect
investors and the public interest, consist with Section 17A(b)(3)(F) of
the Act.\10\ Further, the Commission believes that the proposal is
reasonably designed to meet the financial resource requirements of Rule
17Ad-22(b)(3).\11\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78q-1.
    \9\ 17 CFR 240.17Ad-22.
    \10\ 15 U.S.C. 78q-1(b)(3)(F).
    \11\ 17 CFR 240.17Ad-22(b)(3).
---------------------------------------------------------------------------

IV. Accelerated Approval of Proposed Rule Change as Modified by
Amendments No. 1 and 2

    As discussed above, Amendments No. 1 and 2 are intended to provide
further clarity and specificity regarding the proposed rule change.
Specifically, the amendments provide further details regarding how ICC
determines certain relevant parameters in its GWWR framework and
describe enhancements to ICC's stress testing to monitor GWWR
exposures. The Commission therefore believes that the modifications by
Amendments No. 1 and 2 to the Initial Rule Filing are designed to
promote the prompt and accurate clearance and settlement of securities
transactions and derivative agreements, contracts and transactions
cleared by ICC and, in general, to protect investors and the public
interest, consist with Section 17A(b)(3)(F) of the Act.\12\ Further,
the Commission believes that the modifications are reasonably designed
to meet the financial resource requirements of Rule 17Ad-22(b)(3).\13\
As interested persons received an opportunity to submit written data,
views and arguments concerning the Initial Rule Filing for a period of
21 days after its publication in the Federal Register, and Amendments
No. 1 and 2 include detail that serves to clarify the Initial Rule
Filing, the Commission finds good cause, pursuant to Section
19(b)(2)(C)(iii) of the Act,\14\ to approve the proposed rule change,
as modified by Amendments No. 1 and 2, prior to the thirtieth day after
the date of publication of notice of Amendments No. 1 and 2 in the
Federal Register.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78q-1(b)(3)(F).
    \13\ 17 CFR 240.17Ad-22(b)(3).
    \14\ 15 U.S.C. 78s(b)(2)(C)(iii).
---------------------------------------------------------------------------

V. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICC-2015-009 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-ICC-2015-009. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filings will also be available
for inspection and copying at the principal office of ICE Clear Credit
and on ICE Clear Credit's Web site at https://www.theice.com/clear-credit/regulation.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICC-2015-009
and should be submitted on or before October 7, 2015.

VI. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular with the requirements of Section 17A of the Act \15\ and
the rules and regulations thereunder.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-ICC-2015-009), as modified
by Amendments No. 1 and 2, be, and hereby is, approved on an
accelerated basis.\17\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2).
    \17\ In approving the proposed rule change, the Commission
considered the proposed rule change's impact on efficiency,
competition and capital formation. 15 U.S.C. 78c(f).

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-23216 Filed 9-15-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Notices]
[Page 38479-38480]
[DOCID:fr03au09-108]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Canadian National Railway Company

(Waiver Petition Docket Number FRA-2009-0074)

    The Canadian National Railway Company (CN), the United
Transportation Union (UTU), and the Brotherhood of Locomotive Engineers
and Trainmen (BLET) jointly seek a waiver from compliance of the
provisions of U.S.C. 21103(a)(4), which mandates 48 and 72 hour off
duty periods following qualifying number of days in which an on duty
period was initiated. The parties state that their current collective
bargaining agreements offer an enhanced level of safety and rest beyond
the provisions of Sec.  21103(a)(4). The entire joint CN, UTU and BLE
petition may be viewed at http://www.regulations.gov under the docket
number listed above.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0074) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 20 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written

communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC on July 28, 2009.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E9-18442 Filed 7-31-09; 8:45 am]

BILLING CODE 4910-06-P


MEMORANDUM

To:		Docket EPA - HQ - OAR - 2016 - 0490

From: 	Karen Marsh, U.S. EPA, OAQPS, Sector Policies and Programs Division

-------------------------------------------------------------------------------- Subject:	Discussion of Proposed POTW NESHAP with American Bottoms Regional Wastewater Treatment Facility --------------------------------------------------------------------------------

-------------------------------------------------------------------------------- Date: 	December 2016  -  March 2017  --------------------------------------------------------------------------------

Multiple telephone conversations were conducted with Kay Anderson of the American Bottoms Regional Wastewater Treatment Facility to discuss ABRTF's comments on the proposed revisions to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Publicly Owned Treatment Works (POTW). ABRTF is considered a Group 2 POTW and is subject to the 1999 POTW NESHAP. Below is a summary of the topics discussed during each telephone conversation.

December 23, 2016: Ms. Anderson stated that ABRTF is a major source of hazardous air pollutants (HAP) because of the potential methanol emissions from their facility. She indicated that ABRTF prohibits the use of the POTW by industrial facilities to comply with another NESHAP, therefore preventing them from becoming a Group 1 POTW. ABRTF does not utilize covers on any of the primary treatment units and by initial estimates would have difficulty complying with the proposed 0.08 HAP fraction emission limit for existing Group 2 POTW. Ms. Anderson further stated that since pretreatment reduces the influent loading at the POTW treatment plant, that pretreatment would not help a POTW comply with the HAP fraction emission limit. Given the difficulties with the HAP fraction limit, Ms. Anderson suggested that a separate standard could be appropriate for methanol. Finally, Ms. Anderson indicated that modeling or estimating emissions from collection systems would be a substantial requirement. EPA encouraged Ms. Anderson to include these topics in her formal submission of comments to the docket.

March 6, 2017: Ms. Anderson again stated that methanol is the main pollutant from ABRTF and that it is received in large quantities from one specific industrial user. ABRTF had evaluated whether they could impose a limit on the industrial user but determined that would not be beneficial to either the POTW or the industrial user.

During this discussion, Ms. Anderson asked whether any other POTW had identified themselves as subject to the rule and further stated that if any did, she would expect them to be Group 2 POTW. Ms. Anderson asked why additional standards were being proposed if there was no risk associated with the 1999 regulation. She stated that using a "safety factor" to set the HAP fraction was appreciated because it accounts for variability in flow and influent loadings. However, Ms. Anderson did suggest that a HAP fraction for the entire facility, and not just the primary treatment units, could be beneficial and allow ABRTF to comply with the regulation. She indicated that we provided data in the docket with HAP fraction calculations for both the primary units alone and the whole facility and she suggested that we reconsider the HAP fraction limit based on the data we have for the whole treatment plant.

As discussed in the December call, Ms. Anderson again raised the concern that pretreatment would not be a tool that a POTW could use to help with compliance with the HAP fraction. She further indicated that too much pretreatment would actually cause additional compliance issues because emissions resulting from a lower HAP load would actually raise the fraction emitted. Ms. Anderson suggested that the HAP fraction limit only be required when HAP loadings are above a specific threshold.

The proposed revisions indicated that all HAP listed in Table 1 of 40 CFR part 63, subpart DD would need to be evaluated when demonstrating compliance with the HAP fraction limit. Ms. Anderson stated that she had not been able to locate a lab that could actually test for the entire list of HAP in Table 1.

Finally, Ms. Anderson indicated that the 12-month compliance date would not be sufficient for ABRTF to have systems in place to demonstrate compliance with any of the proposed revisions should they be finalized. EPA again requested that Ms. Anderson include all of this information in her formal comment submission to the docket.


[Federal Register: June 23, 2010 (Volume 75, Number 120)]
[Notices]
[Page 35778-35779]
[DOCID:fr23jn10-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12745-002]

Modesto Irrigation District and Turlock Irrigation District;
Notice of Preliminary Permit Application Accepted for Filing and
Soliciting Comments, Motions to Intervene, and Competing Applications

June 16, 2010.
    On February 1, 2010, Modesto Irrigation District and Turlock
Irrigation District filed an application for a preliminary permit,
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Red Mountain Bar Pumped Storage Project located
on the Tuolomne River, Don Pedro reservoir, in Tuolomne County,
California. The sole purpose of a preliminary permit, if issued, is to
grant the permit holder priority to file a license application during
the permit term. A preliminary permit does not authorize the permit
holder to perform any land-disturbing activities or otherwise enter
upon lands or waters owned by others without the owners' express
permission.
    The proposed pumped storage project would consist of the following
new and existing facilities:
    Alternative A (Single Speed Unit)--(1) An upper reservoir with a
total active storage capacity of 34,000 acre-feet and a surface area of
244 acres at maximum normal water surface elevation of 1,570 feet above
mean sea level (msl); (2) a one-half-mile-long, 34-foot-diameter tunnel
to connect the upper reservoir with the existing Don Pedro reservoir;
(3) a powerhouse with pump/turbines having an installed capacity of
approximately 900 megawatts (MW); (4) an intake on the existing Don
Pedro reservoir, which would be used as the lower reservoir; and (5) a
47-mile-long, 230-kilovolt transmission line. Alternative A of the
proposed project would have an annual generation of 1,573,000 megawatt-
hours (MWh).
    Alternative B (Variable Speed Unit)--(1) An upper reservoir with a
total active storage capacity of 34,000 acre-feet and a surface area of
244 acres at maximum normal water surface elevation of 1,570 feet msl;
(2) a 1.1-mile-long, 37-foot-diameter tunnel to connect the upper
reservoir with the existing Don Pedro reservoir; (3) a powerhouse with
pump/turbines having an installed capacity of approximately 1,000 MW;
(4) an intake on the existing Don Pedro reservoir, which would be used
as the lower reservoir; and (5) a 47-mile-long, 230-kilovolt
transmission line. Alternative B of the proposed project would have an
annual generation of 1,747,000 MWh.
    Applicant Contact: Donald H. Clarke, Law Offices of GKRSE, 1500 K
Street, NW., Washington, DC 20005; phone:<PHONE_NUMBER>.
    FERC Contact: Jim Hastreiter,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text-only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the

Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and eight copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-12745) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-15139 Filed 6-22-10; 8:45 am]
BILLING CODE 6717-01-P