[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Notices]
[Pages 15363-15366]
[FR Doc No: 2016-06408]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77388; File No. SR-NYSE-2016-21]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Adopting a Decommission Extension Fee for Receipt of the NYSE BBO and
NYSE Trades Market Data Products

March 17, 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 March 8, 2016, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') 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.
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    \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 Substance
of the Proposed Rule Change

    The Exchange proposes to adopt a Decommission Extension Fee for
receipt of the NYSE BBO and NYSE Trades market data products. 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to adopt a Decommission Extension Fee for
receipt of the NYSE BBO and NYSE Trades market data products,\4\ as set
forth on the NYSE Proprietary Market Data Fee Schedule (``Fee
Schedule''). Recipients of NYSE BBO and NYSE Trades would continue to
be subject to the already existing subscription fees currently set
forth in the Fee Schedule. The proposed Decommission Extension Fee
would apply only to those subscribers who decide to continue to receive
the NYSE BBO and NYSE Trades feeds in their legacy format for up to two
months after those feeds otherwise will be distributed exclusively in
the new format explained below.
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    \4\ See Securities Exchange Act Release Nos. 61914 (Apr. 14,
2010), 74 FR 21077 (Apr. 22, 2010) (SR-NYSE-2010-30) (notice--NYSE
BBO); 62181 (May 26, 2010), 75 FR 31488 (June 3, 2010) (SR-NYSE-
2010-30) (approval order--NYSE BBO); 59309 (Jan. 28, 2009), 74 FR
6073 (Feb. 4, 2009) (SR-NYSE-2009-04) (notice--NYSE Trades); and
59309 (Mar. 19, 2009), 74 FR 13293 (Mar. 26, 2009) (approval order--
NYSE Trades) (SR-NYSE-2009-04) and 62038 (May 5, 2010), 75 FR 26825
(May 12, 2010) (SR-NYSE-2010-22).
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    NYSE Trades is an NYSE-only last sale market data feed. NYSE Trades
currently allows vendors, broker-dealers and others to make available
on a real-time basis the same last sale information that the Exchange
reports under the Consolidated Tape Association (``CTA'') Plan for
inclusion in the CTA Plan's consolidated data streams. Specifically,
the NYSE Trades feed includes, for each security traded on the
Exchange, the real-time last sale price, time and size information and
bid/ask quotations at the time of each sale and a stock summary
message. The stock summary message updates every minute and includes
NYSE's opening price, high price, low price, closing price, and
cumulative volume for the security.\5\
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    \5\ Id.
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    NYSE BBO is an NYSE-only market data feed that allows a vendor to
redistribute on a real-time basis the same best-bid-and-offer
information that the Exchange reports under the Consolidated Quotation
(``CQ'') Plan for inclusion in the CQ Plan's consolidated quotation
information data stream. The data feed includes the best bids and
offers for all securities that are traded on the Exchange and for which
NYSE reports quotes under the CQ Plan.
    As part of the Exchange's efforts to regularly upgrade systems to
support more modern data distribution formats and protocols as
technology evolves, beginning March 1, 2016, NYSE BBO and NYSE Trades
will both be transmitted in a new format, Exchange Data Protocol (XDP).
Beginning March 1, 2016, the Exchange will transmit NYSE BBO and NYSE
Trades in both the legacy format and in XDP without any additional fee
being charged for providing these data feeds in both formats. The dual
dissemination will remain in place until July 1, 2016, the planned
decommission date of the legacy format. Beginning July 1, 2016,
recipients of NYSE BBO and NYSE Trades who wish to continue to receive
NYSE BBO and NYSE Trades in the legacy format will each be subject to
the proposed Decommission Extension Fee of $5,000 per month. During the
extension period, recipients of NYSE BBO and NYSE Trades would continue
to be subject to the subscription fees currently noted in the Fee
Schedule. The extension period for receiving these data feeds in the
legacy format will expire on September 1, 2016, on which date
distribution of NYSE BBO and NYSE Trades in the legacy format will be
permanently discontinued.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\6\ in general, and
Sections 6(b)(4) and 6(b)(5) of the Act,\7\ in particular, in that it
provides an equitable allocation of reasonable fees among users and
recipients of the data and is not designed to permit unfair
discrimination among customers, issuers, and brokers.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4), (5).
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    The Exchange believes that adopting an extension fee for
subscribers of NYSE BBO and NYSE Trades who wish to receive these data
feeds in the legacy format for a period of time beyond the built-in
overlap period is reasonable, equitable and not unfairly discriminatory
because the proposed fee would apply equally to all data recipients
that currently subscribe to NYSE BBO and NYSE Trades. The Exchange
believes that it is reasonable to require data recipients to pay an
additional fee for taking the data feeds in the legacy format beyond
the period of time specifically allotted by the Exchange for data feed
customers to adapt to the new XDP format at no extra cost. To that end,
the extension fee is designed to encourage data recipients to migrate
to the XDP format in order to continue to receive NYSE BBO and NYSE
Trades in XDP as the legacy format would no longer be available after
that date. The Exchange does not intend to support the legacy format at
all after September 1, 2016.
    The Exchange notes that NYSE BBO and NYSE Trades are entirely
optional. The Exchange is not required to make NYSE BBO and NYSE Trades
available or to offer any specific pricing alternatives to any
customers, nor is any firm required to purchase NYSE BBO and NYSE
Trades, nor is the Exchange required to offer any feed (NYSE BBO, NYSE
Trades, or otherwise) in a particular format, and it is a benefit to
the markets generally that NYSE update its distribution technology to
make it more efficient (and at the same time eliminate less efficient
forms of dissemination). Firms that do purchase NYSE BBO and NYSE
Trades do so for the primary goals of using them to increase revenues,
reduce expenses, and in some instances compete directly with the
Exchange (including for order flow); those firms are able to determine
for themselves whether NYSE BBO and NYSE Trades or any other similar
products are attractively priced or not.\8\
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    \8\ See, e.g., Proposing Release on Regulation of NMS Stock
Alternative Trading Systems, Securities Exchange Act Release No.
76474 (Nov. 18, 2015) (File No. S7-23-15). See also, ``Brokers
Warned Not to Steer Clients' Stock Trades Into Slow Lane,''
Bloomberg Business, December 14, 2015 (Sigma X dark pool to use
direct exchange feeds as the primary source of price data).
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    The decision of the United States Court of Appeals for the District
of Columbia Circuit in NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir.
2010), upheld reliance by the Securities and Exchange Commission
(``Commission'') upon the existence of competitive market mechanisms to
set reasonable and equitably allocated fees for proprietary market
data:

    In fact, the legislative history indicates that the Congress
intended that the market system

`evolve through the interplay of competitive forces as unnecessary
regulatory restrictions are removed' and that the SEC wield its
regulatory power `in those situations where competition may not be
sufficient,' such as in the creation of a `consolidated
transactional reporting system.'

Id. at 535 (quoting H.R. Rep. No. 94-229 at 92 (1975), as reprinted in
1975 U.S.C.C.A.N. 323). The court agreed with the Commission's
conclusion that ``Congress intended that `competitive forces should
dictate the services and practices that constitute the U.S. national
market system for trading equity securities.' '' \9\
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    \9\ NetCoalition, 615 F.3d at 535.

    As explained below in the Exchange's Statement on Burden on
Competition, the Exchange believes that there is substantial evidence
of competition in the marketplace for proprietary market data and that
the Commission can rely upon such evidence in concluding that the fees
established in this filing are the product of competition and therefore
satisfy the relevant statutory standards. In addition, the existence of
alternatives to the legacy format, such as converting to XDP as soon as
possible, further ensures that the Exchange cannot set unreasonable
fees, or fees that are unreasonably discriminatory, when vendors and
subscribers can select such alternatives.
    As the NetCoalition decision noted, the Commission is not required
to undertake a cost-of-service or ratemaking approach. The Exchange
believes that, even if it were possible as a matter of economic theory,
cost-based pricing for proprietary market data would be so complicated
that it could not be done practically or offer any significant
benefits.\10\
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    \10\ The Exchange believes that cost-based pricing would be
impractical because it would create enormous administrative burdens
for all parties and the Commission to cost-regulate a large number
of participants and standardize and analyze extraordinary amounts of
information, accounts, and reports. In addition, and as described
below, it is impossible to regulate market data prices in isolation
from prices charged by markets for other services that are joint
products. Cost-based rate regulation would also lead to litigation
and may distort incentives, including those to minimize costs and to
innovate, leading to further waste. Under cost-based pricing, the
Commission would be burdened with determining a fair rate of return,
and the industry could experience frequent rate increases based on
escalating expense levels. Even in industries historically subject
to utility regulation, cost-based ratemaking has been discredited.
As such, the Exchange believes that cost-based ratemaking would be
inappropriate for proprietary market data and inconsistent with
Congress's direction that the Commission use its authority to foster
the development of the national market system, and that market
forces will continue to provide appropriate pricing discipline. See
Appendix C to NYSE's comments to the Commission's 2000 Concept
Release on the Regulation of Market Information Fees and Revenues,
which can be found on the Commission's Web site at http://www.sec.gov/rules/concept/s72899/buck1.htm. Finally, the prices set
herein are prices for continuing to support distribution formats the
Exchange has elected to retire in favor of new and more efficient
distribution formats, making cost-based analyses even less relevant.
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    For these reasons, the Exchange believes that the proposed fees are
reasonable, equitable, and not unfairly discriminatory.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. An exchange's ability to
price its proprietary market data feed products is constrained by
actual competition for the sale of proprietary market data products,
the joint product nature of exchange platforms, and the existence of
alternatives to the Exchange's proprietary data (and in this instance,
the ability of any firm to switch to the new distribution format in a
time frame that eliminates the need to pay these fees entirely).
The Existence of Actual Competition
    The market for proprietary data products is currently competitive
and inherently contestable because there is fierce competition for the
inputs necessary for the creation of proprietary data and strict
pricing discipline for the proprietary products themselves. Numerous
exchanges compete with one another for listings and order flow and
sales of market data itself, providing ample opportunities for
entrepreneurs who wish to compete in any or all of those areas,
including producing and distributing their own market data. Proprietary
data products are produced and distributed by each individual exchange,
as well as other entities, in a vigorously competitive market. Indeed,
the U.S. Department of Justice (``DOJ'') (the primary antitrust
regulator) has expressly acknowledged the aggressive actual competition
among exchanges, including for the sale of proprietary market data. In
2011, the DOJ stated that exchanges ``compete head to head to offer
real-time equity data products. These data products include the best
bid and offer of every exchange and information on each equity trade,
including the last sale.'' \11\
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    \11\ Press Release, U.S. Department of Justice, Assistant
Attorney General Christine Varney Holds Conference Call Regarding
NASDAQ OMX Group Inc. and IntercontinentalExchange Inc. Abandoning
Their Bid for NYSE Euronext (May 16, 2011), available at http://www.justice.gov/iso/opa/atr/speeches/2011/at-speech-110516.html; see
also Complaint in U.S. v. Deutsche Borse AG and NYSE Euronext, Case
No. 11-cv-2280 (D.C. Dist.) ] 24 (``NYSE and Direct Edge compete
head-to-head . . . in the provision of real-time proprietary equity
data products.'').
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    Moreover, competitive markets for listings, order flow, executions,
and transaction reports provide pricing discipline for the inputs of
proprietary data products and therefore constrain markets from
overpricing proprietary market data. Broker-dealers send their order
flow and transaction reports to multiple venues, rather than providing
them all to a single venue, which in turn reinforces this competitive
constraint. As a 2010 Commission Concept Release noted, the ``current
market structure can be described as dispersed and complex'' with
``trading volume . . . dispersed among many highly automated trading
centers that compete for order flow in the same stocks'' and ``trading
centers offer[ing] a wide range of services that are designed to
attract different types of market participants with varying trading
needs.'' \12\ More recently, SEC Chair Mary Jo White has noted that
competition for order flow in exchange-listed equities is ``intense''
and divided among many trading venues, including exchanges, more than
40 alternative trading systems, and more than 250 broker-dealers.\13\
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    \12\ Concept Release on Equity Market Structure, Securities
Exchange Act Release No. 61358 (Jan. 14, 2010), 75 FR 3594 (Jan. 21,
2010) (File No. S7-02-10). This Concept Release included data from
the third quarter of 2009 showing that no market center traded more
than 20% of the volume of listed stocks, further evidencing the
dispersal of and competition for trading activity. Id. at 3598. Data
available on ArcaVision show that from June 30, 2013 to June 30,
2014, no exchange traded more than 12% of the volume of listed
stocks by either trade or dollar volume, further evidencing the
continued dispersal of and fierce competition for trading activity.
See https://www.arcavision.com/Arcavision/arcalogin.jsp.
    \13\ Mary Jo White, Enhancing Our Equity Market Structure,
Sandler O'Neill & Partners, L.P. Global Exchange and Brokerage
Conference (June 5, 2014) (available on the Commission Web site),
citing Tuttle, Laura, 2014, ``OTC Trading: Description of Non-ATS
OTC Trading in National Market System Stocks,'' at 7-8.
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    If an exchange succeeds in competing for quotations, order flow,
and trade executions, then it earns trading revenues and increases the
value of its proprietary market data products because they will contain
greater quote and trade information. Conversely, if an exchange is less
successful in attracting quotes, order flow, and trade executions, then
its market data products may be less desirable to customers in light of
the diminished content and data products offered by competing venues
may become more attractive. Thus, competition for quotations, order
flow, and trade

executions puts significant pressure on an exchange to maintain both
execution and data fees at reasonable levels.
    In addition, in the case of products that are also redistributed
through market data vendors, such as Bloomberg and Thompson Reuters,
the vendors themselves provide additional price discipline for
proprietary data products because they control the primary means of
access to certain end users. These vendors impose price discipline
based upon their business models. For example, vendors that assess a
surcharge on data they sell are able to refuse to offer proprietary
products that their end users do not or will not purchase in sufficient
numbers. Vendors will not elect to make available NYSE BBO or NYSE
Trades in the legacy format unless their customers request it, and
customers will not elect to pay the proposed fees unless NYSE BBO and
NYSE Trades can provide value in the legacy formats by sufficiently
increasing revenues or reducing costs in the customer's business in a
manner that will offset the fees. The Exchange has provided customers
with adequate notice that it intends to discontinue dissemination of
the data feeds in the legacy format. Therefore, the proposed
Decommission Extension Fee would only be applicable to those customers
who have a need or desire to continue to take the data feeds in the
legacy format beyond the period provided for migration to the XDP
format. Customers who timely migrate to the XDP format to receive the
data feeds would not need to receive the data feeds in the legacy
format and therefore would not be subject to the Decommission Extension
Fee at all. All of these factors operate as constraints on pricing
proprietary data products.

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) \14\ of the Act and subparagraph (f)(2) of Rule
19b-4 \15\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(2).
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    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) \16\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \16\ 15 U.S.C. 78s(b)(2)(B).
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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-NYSE-2016-21 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2016-22. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2016-21 and should be
submitted on or before April 12, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-06408 Filed 3-21-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57179-57180]
[FR Doc No: 2021-22386]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4609-DR; Docket ID FEMA-2021-0001]

Tennessee; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Tennessee (FEMA-4609-DR), dated August 23,
2021, and related determinations.

DATES: The declaration was issued August 23, 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: Notice is hereby given that, in a letter
dated August 23, 2021, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Tennessee

resulting from a severe storm and flooding on August 21, 2021, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Tennessee.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and
assistance for emergency protective measures (Category B), including
direct Federal assistance, under the Public Assistance program in
the designated areas, Hazard Mitigation throughout the State, and
any other forms of assistance under the Stafford Act that you deem
appropriate subject to completion of Preliminary Damage Assessments
(PDAs).
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance, Hazard Mitigation, and Other Needs Assistance
under section 408 will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

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

    Humphreys County for Individual Assistance.
    Humphreys County for emergency protective measures (Category B),
including direct federal assistance, under the Public Assistance
program.
    All areas within the State of Tennessee are eligible for
assistance under the Hazard Mitigation Grant Program.

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

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22386 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76082-76083]
[FR Doc No: 2020-26229]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1898]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Vaccines and
Related Biological Products Advisory Committee. The general function of
the committee is to provide advice and recommendations to the Agency on
FDA's regulatory issues. The meeting will be open to the public. FDA is
establishing a docket for public comment on this document. Consistent
with FDA's regulations, this notice is being published with less than
15 days prior to the date of the meeting based on a determination that
convening a meeting of the Vaccines and Related Biological Products
Advisory Committee as soon as possible is warranted. This Federal
Register notice could not be published 15 days prior to the date of the
meeting due to a recent submission of a request for Emergency Use
Authorization (EUA) for an investigational vaccine to prevent
Coronavirus Disease 2019 (COVID-19) and the need for prompt discussion
of such submission, given the COVID-19 pandemic.

DATES: The meeting will be held on December 10, 2020, from 9 a.m.
Eastern Time to 6 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions including information regarding special
accommodations due to a disability may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. The online
web conference meeting will be available at the following link on the
day of the meeting: https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2020-N-1898. The docket will close on December
9, 2020. Submit either electronic or written comments on this public
meeting by December 9, 2020. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before December 9, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of December 9, 2020. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before December 4, 2020 will be provided to
the committee. Comments received after December 4, 2020, and by
December 9, 2020, will be taken into consideration by FDA. In the event
that the meeting is cancelled, FDA will continue to evaluate any
relevant applications, submissions, or information, and consider any
comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1898 for ``Vaccines and Related Biological Products; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.

     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya or Kathleen Hayes,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver
Spring, MD 20993-0002,<PHONE_NUMBER> or<PHONE_NUMBER>, respectively;
<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/advisory-committees and scroll down to the appropriate advisory
committee meeting link, or call the advisory committee information line
to learn about possible modifications before joining the meeting.

SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be
heard, viewed, captioned, and recorded through an online
teleconferencing platform. The Committee will meet in open session to
discuss EUA of the Pfizer-BioNTech COVID-19 Vaccine for the prevention
of COVID-19 in individuals 16 years of age and older. EUA authority
allows FDA to help strengthen the nation's public health protections
against chemical, biological, radiological, nuclear (CBRN) threats by
facilitating the availability and use of Medical Countermeasures (MCMs)
needed during public health emergencies. Under section 564 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), FDA may
allow unapproved medical products or unapproved uses of approved
medical products to be used in an emergency to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
CBRN threat agents when certain statutory criteria have been met,
including that there are no adequate, approved, and available
alternatives. Additional information about EUAs can be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, background
material will be made publicly available on FDA's website at the time
of the advisory committee meeting. Background material and the link to
the online teleconference meeting room will be available at https://www.fda.gov/advisory-committees/advisory-committee-calendar. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before December 4, 2020, will be provided to the
committee. Comments received after December 4, 2020, and by December 9,
2020, will be taken into consideration by FDA. Oral presentations from
the public will be scheduled between approximately 12 p.m. Eastern Time
and 1 p.m. Eastern Time. Those individuals interested in making formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before December 2, 2020. Time allotted for each presentation may
be limited. 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 the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by December
3, 2020.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Prabhakara Atreya or Kathleen Hayes
<EMAIL_ADDRESS>at least 7 days in advance of the
meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at: https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during
advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26229 Filed 11-25-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 10, 2010 (Volume 75, Number 46)]
[Notices]
[Page 11414-11418]
[DOCID:fr10mr10-154]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2010-0171; FRL-8814-8]

Certain New Chemicals; Receipt and Status Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires
any person who intends to manufacture (defined by statute to include
import) a new chemical (i.e., a chemical not on the TSCA Inventory) to
notify EPA and comply with the statutory provisions pertaining to the
manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of
TSCA, EPA is required to publish a notice of receipt of a
premanufacture notice (PMN) or an application for a test marketing
exemption (TME), and to publish periodic status reports on the
chemicals under review and the receipt of notices of commencement to
manufacture those chemicals. This status report, which covers the
period from January 25, 2010 through February 12, 2010, consists of the
PMNs pending or expired, and the notices of commencement tomanufacture
a new chemical that the Agency has received under TSCA section 5 during
this time period.

DATES: Comments identified by the specific PMN number or TME number,
must be received on or before April 9, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2010-0171, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2010-0171. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-0171. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. The telephone number of the EPA/DC Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics (7408M), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitter of the premanufacture notices
addressed in the action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and
then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
     i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information
and/or data that you used.
     v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
     vii. Explain your views as clearly as possible, avoiding the use
of profanity or personal threats.
     viii. Make sure to submit your comments by the comment period
deadline identified.

II. Why is EPA Taking this Action?

    Section 5 of TSCA requires any person who intends to manufacture
(defined by statute to include import) a new chemical (i.e., a chemical
not on the TSCA Inventory to notify EPA and comply with the statutory
provisions pertaining to the manufacture of new chemicals. Under
sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a
notice of receipt of a PMN or an application for a TME and to publish
periodic status reports on the chemicals under review and the receipt
of notices of commencement to manufacture those chemicals. This status
report, which covers the period from January 25, 2010 through February
12, 2010, consists of the PMNs pending or expired, and the notices of
commencement to manufacture a new chemical that the

Agency has received under TSCA section 5 during this time period.

III. Receipt and Status Report for PMNs

    This status report identifies the PMNs, pending or expired, and the
notices of commencement to manufacture a new chemical that the Agency
has received under TSCA section 5 during this time period. If you are
interested in information that is not included in the following tables,
you may contact EPA as described in Unit I. to access additional non-
CBI information that may be available.
    In Table I of this unit, EPA provides the following information (to
the extent that such information is not claimed as CBI) on the PMNs
received by EPA during this period: the EPA case number assigned to the
PMN; the date the PMN was received by EPA; the projected end date for
EPA's review of the PMN; the submitting manufacturer; the potential
uses identified by the manufacturer in the PMN; and the chemical
identity.

                                             I. 34 Premanufacture Notices Received From: 1/25/10 to 2/12/10
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-10-0189                            01/25/10                04/24/10                CBI                    (G) Lubricant          (G) Molybdenum
                                                                                additive               alkoxyalkyl-
                                                                                alkyldithiocarbamate
P-10-0190                            01/25/10                04/24/10                CBI                    (S) Tackifier in the   (G) Rosin, polymer
                                                                                rubber / tires         with phenols and
                                                                                industry               formaldehyde
P-10-0191                            01/25/10                04/24/10                CBI                    (S) Tackifier in the   (G) Rosin, polymer
                                                                                rubber / tires         with phenols and
                                                                                industry               formaldehyde
P-10-0192                            01/25/10                04/24/10                CBI                    (S) Tackifier in the   (G) Rosin, polymer
                                                                                rubber / tires         with phenols and
                                                                                industry               formaldehyde
P-10-0193                            01/25/10                04/24/10                CBI                    (S) Tackifier in the   (G) Rosin, polymer
                                                                                rubber / tires         with phenols and
                                                                                industry               formaldehyde
P-10-0194                            01/25/10                04/24/10                CBI                    (S) Tackifier in the   (G) Rosin, polymer
                                                                                rubber / tires         with phenols and
                                                                                industry               formaldehyde
P-10-0195                            01/25/10                04/24/10                CBI                    (S) Tackifier in the   (G) Rosin, polymer
                                                                                rubber / tires         with phenols and
                                                                                industry               formaldehyde
P-10-0196                            01/25/10                04/24/10                Kemira Chemicals,      (S) Scale inhibition   (G) Polycarboxylic
                                                                                Inc.                   for crude oil and      acid derivative
                                                                                gas production
P-10-0197                            01/28/10                04/27/10                CBI                    (G) Adhesives          (G) MDI modified
                                                                                polyester resin
P-10-0198                            01/26/10                04/25/10                CBI                    (G) Component of foam  (G) Fatty acid
                                                                                polymer with
                                                                                aliphatic diol and
                                                                                aromatic diacid
P-10-0199                            01/26/10                04/25/10                Cognis corporation     (S) Leather cleaner    (S) Isononanoic acid,
                                                                                formulation            C16	18 alkyl esters
P-10-0200                            01/26/10                04/25/10                CBI                    (G) Oilfield polymer   (G) Hydroxypropyl
                                                                                methacrylate,
                                                                                reaction products
                                                                                with propylene oxide
                                                                                and ethylene oxide,
                                                                                copolymer with N-
                                                                                vinyl caprolactam
P-10-0201                            01/27/10                04/26/10                CBI                    (S) Polymer for floor  (G) Polyether
                                                                                coatings               polyurethane
P-10-0202                            01/27/10                04/26/10                CBI                    (S) Light stabilizer   (G) Substituted
                                                                                for plastic articles   piperidinol,
                                                                                alkanoate
P-10-0203                            01/29/10                04/28/10                CBI                    (G) Polyurethane       (G) Aqueous,
                                                                                dispersion for         aliphatic
                                                                                coatings               polyurethane
                                                                                dispersion
P-10-0204                            01/29/10                04/28/10                CBI                    (S) Resin for          (G) Acrylate capped
                                                                                ultraviolet or         polyurethane
                                                                                electron beam          oligomer
                                                                                radiation curable
                                                                                coatings for wood
P-10-0205                            01/29/10                04/28/10                CBI                    (S) (1) Compound for   (G) Poly(aryl ether)
                                                                                use in producing       polymers
                                                                                films that will be
                                                                                applied to plastic
                                                                                substrates (open /
                                                                                non-dipersive use);
                                                                                (2) Compound for use
                                                                                in producing
                                                                                reinforced plastic
                                                                                parts (open / non-
                                                                                dispersive use)
P-10-0206                            01/29/10                04/28/10                CBI                    (S) (1) Compound for   (G) Poly(aryl ether)
                                                                                use in producing       polymers
                                                                                films that will be
                                                                                applied to plastic
                                                                                substrates (open /
                                                                                non-dipersive use);
                                                                                (2) Compound for use
                                                                                in producing
                                                                                reinforced plastic
                                                                                parts (open / non-
                                                                                dispersive use)
P-10-0207                            01/29/10                04/28/10                CBI                    (S) (1) Compound for   (G) Poly(aryl ether)
                                                                                use in producing       polymers
                                                                                films that will be
                                                                                applied to plastic
                                                                                substrates (open /
                                                                                non-dipersive use);
                                                                                (2) Compound for use
                                                                                in producing
                                                                                reinforced plastic
                                                                                parts (open / non-
                                                                                dispersive use)
P-10-0208                            01/29/10                04/28/10                CBI                    (G) Formulated         (G) Coal gasification
                                                                                agricultural product   products
                                                                                for export
P-10-0209                            02/02/10                05/02/10                CBI                    (S) Reactive hotmelt   (G) Polyurethane
                                                                                adhesive               resin
P-10-0210                            02/02/10                05/02/10                CBI                    (S) Reactive hotmelt   (G) Polyurethane
                                                                                adhesive               resin
P-10-0211                            02/02/10                05/02/10                CBI                    (S) Reactive hotmelt   (G) Polyurethane
                                                                                adhesive               resin
P-10-0212                            02/02/10                05/02/10                CBI                    (S) Reactive hotmelt   (G) Polyurethane
                                                                                adhesive               resin
P-10-0213                            02/02/10                05/02/10                CBI                    (S) Reactive hotmelt   (G) Polyurethane
                                                                                adhesive               resin

P-10-0214                            02/03/10                05/03/10                Best Sanitizers, Inc.  (S) Surfactant         (S) Palm oil, mixed D-
                                                                                glucose and oleic
                                                                                acid, candida
                                                                                bombicola-fermented
P-10-0215                            02/03/10                05/03/10                CBI                    (G) 1. Sealant for     (G) Silane modified
                                                                                construction           polymer
                                                                                industry; 2.
                                                                                Adhesive for graphic
                                                                                art application
P-10-0216                            02/04/10                05/04/10                Coim usa inc.          (S) Packaging          (S) 1,3-
                                                                                adhesives              benzenedicarboxylic
                                                                                acid, polymer with
                                                                                hexanedioic acid,
                                                                                .alpha.-hydro-
                                                                                .omega.-
                                                                                hydroxypoly[oxy(meth
                                                                                yl-1,2-ethanediyl)],
                                                                                1,3-
                                                                                isobenzofurandione
                                                                                and 2,2'-
                                                                                oxybis[ethanol]
P-10-0217                            02/04/10                05/04/10                Loba-Wakol LLC         (S) Wood floor         (G) Fatty acid
                                                                                treatment, finisher    trimetllitate alkyld
                                                                                polymer
P-10-0218                            02/04/10                05/04/10                Loba-Wakol LLC         (S) Wood floor         (G) Aliphatic
                                                                                treatment, finisher    diisocyanate,
                                                                                polycarbonate,
                                                                                polyesterpolyol
                                                                                polymer
P-10-0219                            02/04/10                05/04/10                Loba-Wakol LLC         (S) Wood floor         (G) Aliphatic
                                                                                treatment, finisher    diisocyanate,
                                                                                polyesterpolyol,
                                                                                bishydroxymethylalka
                                                                                noic acid polymer
P-10-0220                            02/04/10                05/04/10                Solvay Fluorides, LLC  (G) Raw material       (S) 3-buten-2-one, 4-
                                                                                - A subsidiary of                             ethoxy-1,1,1-
                                                                                Solvay Chemicals,                             trifluoro-, (3E)-
                                                                                Inc.
P-10-0221                            02/05/10                05/05/10                Coim USA Inc.          (S) Packaging          (S) 1,3-
                                                                                adhesives              benzenedicarboxylic
                                                                                acid, polymer with
                                                                                hexanedioic acid,
                                                                                .alpha.-hydro-
                                                                                .omega.-
                                                                                hydroxypoly[oxy(meth
                                                                                yl-1,2-ethanediyl)],
                                                                                1,3-
                                                                                isobenzofurandione
                                                                                and 2,2'-
                                                                                oxybis[ethanol], N-
                                                                                [[(isocyanatophenyl)
                                                                                methyl]phenyl]carbam
                                                                                ate
P-10-0222                            02/05/10                05/05/10                CBI                    (G) Alkylating agent   (G) Alkyltin halide
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the
Notices of Commencement to manufacture received:

                             II. 16 Notices of Commencement From: 1/25/10 to 2/12/10
----------------------------------------------------------------------------------------------------------------
                                                                Commencement Notice
              Case No.                     Received Date             End Date                  Chemical
----------------------------------------------------------------------------------------------------------------
P-02-0988                             01/26/10                01/13/10                (G) Urethane modified
                                                                                acyrlate
P-08-0556                             02/02/10                01/19/10                (G) Aromatic prepolymer
                                                                                based on tdi
P-08-0611                             02/01/10                01/13/10                (G) Isocyanate polymer
P-09-0004                             02/01/10                01/14/10                (G) Isocyanate polymer
P-09-0037                             01/27/10                01/20/10                (G) Fluoroalkyl
                                                                                methacrylate copolymer
P-09-0071                             01/22/10                01/13/10                (G) N,N-dialkylamine
P-09-0239                             02/01/10                01/15/10                (G) Siloxanes and
                                                                                silicones, di-me,
                                                                                polymers with
                                                                                (chloromethylsilyl)-
                                                                                functional alkane, vinyl-
                                                                                group terminated
P-09-0241                             01/28/10                01/25/10                (S) 1,2-ethanediol,
                                                                                reaction products with
                                                                                epichlorohydrin
P-09-0281                             01/22/10                01/15/10                (G) Styrene-maleic
                                                                                anhydride copolymer,
                                                                                reaction product with
                                                                                amino compounds
P-09-0285                             01/25/10                09/23/09                (G) Unsaturated polyester
                                                                                resin
P-09-0350                             02/03/10                01/22/10                (S) Oils, Evodia
                                                                                Rutaecarpa
P-09-0440                             01/27/10                11/06/09                (G) Unsaturated polyester
                                                                                resin
P-09-0489                             02/03/10                01/22/10                (S) Definition:
                                                                                Extractives and their
                                                                                physically modified
                                                                                derivatives. Periploca
                                                                                Sepium
P-09-0489                             02/03/10                01/22/10                (S) Oils, Periploca Sepium
P-09-0630                             01/25/10                01/19/10                (G) Silane derivative
P-10-0006                             01/28/10                01/20/10                (G) Aliphatic alcohol,
                                                                                polymer with 1,3-
                                                                                diisocyanatomethylbenzene
                                                                                and .alpha.-hydro-.omega.-
                                                                                hydroxypoly (oxy-1,4-
                                                                                butanediyl), 2-
                                                                                hydroxypropyl
                                                                                methacrylate-blocked

P-10-0009                             02/01/10                01/26/10                (G) Diglycidylaniline
----------------------------------------------------------------------------------------------------------------

List of Subjects

    Environmental protection, Chemicals, Premanufacturer notices.

    Dated: March 1, 2010.
Chandler Sirmons,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.

[FR Doc. 2010-5131 Filed 3-9-10; 8:45 am]
BILLING CODE 6560-50-S


propenoate, alkane acid,
                                                                              hexanedioic acid, 1,6-hexanediol,
                                                                              substituted poly[oxy(methyl-1,2-
                                                                              ethanediyl)], 2-hydroxyethyl 2-
                                                                              methyl-2-propenoate, 1,1'-
                                                                              methylenebis[4-isocyanatobenzene],
                                                                              methyl 2-methyl-2-propenoate, 2-
                                                                              methyl-2-propenoic acid and 2-
                                                                              oxepanone.
P-14-0196..................................        6/5/2014        6/3/2014  (G) Poly(oxy-1,2-ethanediyl),
                                                                              .alpha.-sulfo-.omega.-substituted
                                                                              carbomonocycle, ammonium salts.
P-98-1214..................................        6/5/2014        6/5/2014  (G) Epoxidized polyol.
P-14-0411..................................        6/6/2014       5/18/2014  (S) Fats and glyceridic oils,
                                                                              limnanthes alba seed.
P-13-0360..................................        6/6/2014       5/31/2014  (G) Alkane acid, polymer with
                                                                              alkanediol, 1,6-hexanediol,
                                                                              .alpha.-hydro-.omega.-
                                                                              hydroxypoly(oxy-1,4-butanediyl),
                                                                              1,3-
                                                                             isobenzofurandione, 1,1'-
                                                                              methylenebis[4-isocyanatobenzene]
                                                                              and poly(oxy-alkanediyl) glyceryl
                                                                              ether.
P-14-0054..................................        6/6/2014        6/5/2014  (G) Amine-functional oligomer.
P-14-0216..................................       6/11/2014        6/5/2014  (G) Mixed alkyltin mercaptoester
                                                                              sulfides.
P-14-0218..................................       6/11/2014       6/10/2014  (G) Mixed alkyltin mercaptoester
                                                                              sulfides.
P-13-0559..................................       6/12/2014       5/30/2014  (G) Amine salt of vegetable oil,
                                                                              polymer with cycloaliphatic
                                                                              glycol, hydroxy substituted
                                                                              carboxylic acid, aliphatic
                                                                              diisocyanate and tetra hydroxy
                                                                              alkane.
P-14-0400..................................       6/12/2014        6/6/2014  (G) Substituted acid, electrophilic
                                                                              aromatic substitution products.
P-14-0217..................................       6/12/2014        6/9/2014  (G) Mixed alkyltin mercaptoester
                                                                              sulfides.
P-14-0234..................................       6/13/2014        6/2/2014  (G) Trisubstituted ethoxylated
                                                                              carbomonocycle.
P-14-0269..................................       6/13/2014        6/9/2014  (G) Peek-pedek copolymer.
P-13-0837..................................       6/13/2014       6/10/2014  (S) Fatty acids, C18-unsaturated,
                                                                              dimers, polymers with 2,2'-
                                                                              dithiobis[ethanol] and 1-
                                                                              piperazineethanamine.
P-14-0235..................................       6/15/2014        6/6/2014  (G) Styrene-maleic anhydride
                                                                              copolymer, reaction product with
                                                                              amino compounds.

P-13-0932..................................       6/17/2014        6/3/2014  (G) Polyester adduct.
P-14-0313..................................       6/18/2014        6/3/2014  (S) Ethanesulfonic acid, 2-[(2-
                                                                              aminoethyl)amino]-, sodium salt
                                                                              (1:1), polymer with 1,6-
                                                                              diisocyanatohexane,
                                                                              alphahydroomega-hydroxypoly(oxy-
                                                                              1,4-butanediyl) and 5-isocyanato-1-
                                                                              (isocyanatomethyl)-1,3,3-
                                                                              trimethylcyclohexane.
P-14-0404..................................       6/18/2014        6/5/2014  (S) Soybean oil, ester with
                                                                              polyethylene glycol ether with
                                                                              glycerol (3:1).
P-14-0403..................................       6/18/2014        6/6/2014  (S) Olive oil, ester with
                                                                              polyethylene glycol ether with
                                                                              glycerol (3:1).
P-14-0405..................................       6/18/2014        6/6/2014  (S) Oils, palm kernel, esters with
                                                                              polyethylene glycol ether with
                                                                              glycerol (3:1).
P-14-0401..................................       6/18/2014        6/9/2014  (S) Fats and glyceridic oils,
                                                                              avocado, esters with polyethylene
                                                                              glycol ether with glycerol (3:1).
P-14-0406..................................       6/18/2014       6/10/2014  (S) Oils, palm, esters with
                                                                              polyethylene glycol ether with
                                                                              glycerol (3:1).
P-14-0402..................................       6/18/2014       6/11/2014  (S) Coconut oil, ester with
                                                                              polyethylene glycol ether with
                                                                              glycerol (3:1).
P-14-0056..................................       6/19/2014       5/19/2014  (G) Amine-terminated epoxy resin.
P-14-0025..................................       6/20/2014       5/16/2014  (G) Polyethylene glycol-acrylic
                                                                              polymer salt.
P-14-0089..................................       6/23/2014       6/17/2014  (G) Fatty acid amide hydrochloride.
P-14-0090..................................       6/23/2014       6/17/2014  (G) Fatty acid amide hydrochloride.
P-14-0370..................................       6/25/2014       6/16/2014  (G) Acrylic esters and methacrylic
                                                                              esters epoxy resin.
P-13-0677..................................       6/26/2014        6/5/2014  (G) 1,3-dioxolan-2-one, polymer
                                                                              with 1,4-alkanediol, 1,2-
                                                                              alkanediol, 1,1'-alkylenebis[4-
                                                                              substitutedmonocarbocycle] and 2-
                                                                              alkyl-1,3-alkanediol.
P-12-0383..................................       6/27/2014       6/10/2014  (G) Alkanes.
P-11-0607..................................       6/27/2014       6/25/2014  (G) Polyaromatic organophosphorus
                                                                              compound.
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA as described in Unit III. to access
additional non-CBI information that may be available.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, Imports,
Notice of commencement, Premanufacturer, Reporting and recordkeeping
requirements, Test marketing exemptions.

    Dated: August 28, 2014.
Chandler Sirmons,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2014-22037 Filed 9-15-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Notices]
[Page 20382]
[FR Doc No: 2012-8019]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14365-000]

FFP Project 108, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On February 17, 2012, FFP Project 108, LLC, filed an application
for a preliminary permit, pursuant to section 4(f) of the Federal Power
Act (FPA), proposing to study the feasibility of hydropower at the U.S.
Army Corps of Engineers (Corps) R. D. Bailey Dam located on the
Guyandotte River in Mingo and Wyoming Counties, West Virginia. 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 R. D. Bailey Water Power Project would consist of the
following: (1) A new 60-foot-long by 40-foot-wide by 25-foot-high
powerhouse to be located downstream on the tailrace side of R. D.
Bailey Dam; (2) a new bifurcating steel structure to be built on the
existing outlet tunnel and consisting of a gated bypassed outlet and a
10-foot-diameter steel penstock; (3) two new turbine generator units
for a total installed capacity of 7.8 megawatts; (4) a new 6.5-mile-
long, 14.7-kilovolt (kV) transmission line; (5) a 4.16/46-kV
substation; and (6) appurtenant facilities. The proposed project would
have an annual generation of 30,000 megawatt-hours, and operate on a
modified run-of-river mode as directed by the Corps.
    Applicant Contact: Ms. Ramya Swaminathan, FFP Project 108, LLC, 239
Causeway Street, Suite 300, Boston, MA 02114; phone:<PHONE_NUMBER>.
    FERC Contact: Monir Chowdhury; phone:<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/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven 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-14365-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: March 28, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-8019 Filed 4-3-12; 8:45 am]
BILLING CODE 6717-01-P