[Federal Register Volume 83, Number 84 (Tuesday, May 1, 2018)]
[Notices]
[Pages 19060-19061]
[FR Doc No: 2018-09203]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0751; FRL-9976-82]

Interim Registration Review Decisions and Case Closures for
Several Pesticides; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's interim
registration review decision for the following chemicals: BT corn
coleopteran PIP, BT corn lepidopteran PIP, clodinafop-propargyl,
cyprodinil, diethylene glycol monomethyl ether (DGME), dimethomorph,
fomesafen, metalaxyl/mefenoxam, methoxyfenozide, mineral acids,
nitrapyrin, noviflumuron, pendimethalin, potassium hypochlorite, sodium
hypochlorite and calcium hypochlorite, and verbenone. It also announces
the case closures for boll weevil attractant (Case 6044 and Docket ID
Number: EPA-HQ-OPP-2009-0335) and octanoate esters (Case 6027 and
Docket ID Number: EPA-HQ-OPP-2017-0087), because the last U.S.
registrations for these pesticides have been canceled.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the pesticide specific contact person listed under FOR FURTHER
INFORMATION CONTACT.
    For pesticide specific information, contact: The Chemical Review
Manager for the pesticide of interest identified in the Table in Unit
IV.
    For general information on the registration review program,
contact: Dana Friedman, Pesticide Re-Evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 347-8827; email address: [email protected].

II. Background

    Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed interim decisions for all pesticides listed in
the Table in

Unit IV. Through this program, EPA is ensuring that each pesticide's
registration is based on current scientific and other knowledge,
including its effects on human health and the environment.

III. Authority

    EPA is conducting its registration review of the chemicals listed
in the Table in Unit IV pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with
widespread and commonly recognized practice, the pesticide product must
perform its intended function without unreasonable adverse effects on
the environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's interim registration review decisions for the pesticides shown
in the following table. The interim registration review decisions are
supported by rationales included in the docket established for each
chemical.

                            Table--Registration Review Interim Decisions Being Issued
----------------------------------------------------------------------------------------------------------------
  Registration review case name and                                                  Chemical review manager and
                 No.                                  Docket ID No.                      contact information
----------------------------------------------------------------------------------------------------------------
BT Corn Coleopteran PIP Case 6502...  EPA-HQ-OPP-2015-0584                          Eric Bohnenblust,
                                                                                [email protected],
<PHONE_NUMBER>.
BT Corn Lepidopteran PIP Case 6501..  EPA-HQ-OPP-2015-0584                          Eric Bohnenblust,
                                                                                [email protected],
<PHONE_NUMBER>.
Clodinafop-propargyl Case 7250......  EPA-HQ-OPP-2012-0424                          Wilhelmena Livingston,
                                                                                [email protected],<PHONE_NUMBER>.
Cyprodinil Case 7025................  EPA-HQ-OPP-2011-1008                          Garland Waleko,
                                                                                [email protected],
<PHONE_NUMBER>.
Diethylene Glycol Monomethyl Ether    EPA-HQ-OPP-2010-0694                          Stephen Savage,
 (DGME) Case 5010.                                                                   [email protected],
<PHONE_NUMBER>.
Dimethomorph Case 7021..............  EPA-HQ-OPP-2013-0045                          Linsey Walsh,
                                                                                [email protected], (703)
                                                                                347-8030.
Fomesafen Case 7211.................  EPA-HQ-OPP-2006-0239                          Leigh Rimmer,
                                                                                [email protected], (703)
                                                                                347-0553.
Metalaxyl/Mefenoxam Case 0081.......  EPA-HQ-OPP-2009-0863                          Leigh Rimmer,
                                                                                [email protected], (703)
                                                                                347-0553.
Methoxyfenozide Case 7431...........  EPA-HQ-OPP-2012-0663                          Mark Baldwin,
                                                                                [email protected], (703)
                                                                                308-0504.
Mineral Acids Case 4064.............  EPA-HQ-OPP-2008-0766                          Rachel Ricciardi,
                                                                                [email protected],
<PHONE_NUMBER>.
Nitrapyrin Case 0213................  EPA-HQ-OPP-2012-0170                          Thomas Harty,
                                                                                [email protected], (703)
                                                                                347-0338.
Noviflumuron Case 7434..............  EPA-HQ-OPP-2014-0566                          Katherine St. Clair,
                                                                                [email protected],
<PHONE_NUMBER>.
Pendimethalin Case 0187.............  EPA-HQ-OPP-2012-0219                          Julie Javier,
                                                                                [email protected], (703)
                                                                                347-0790.
Potassium Hypochlorite Case 5076....  EPA-HQ-OPP-2014-0157                          Jessica Bailey,
                                                                                bailey.jessi[email protected],
<PHONE_NUMBER>.
Sodium Hypochlorite and Calcium       EPA-HQ-OPP-2012-0004                          Jessica Bailey,
 Hypochlorite Case 0029.                                                             [email protected],
<PHONE_NUMBER>.
Verbenone Case 6031.................  EPA-HQ-OPP-2009-0511                          Chris Pfeifer,
                                                                                [email protected],
<PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

    The proposed interim registration review decisions for the
chemicals in the table above were posted to the docket and the public
was invited to submit any comments or new information. EPA addressed
the comments or information received during the 60-day comment period
for the proposed interim decisions in the discussion for each pesticide
listed in the table. Comments from the 60-day comment period that were
received may or may not have affected the Agency's interim decision.
Pursuant to 40 CFR 155.58(c), the registration review case docket for
the chemicals listed in the Table will remain open until all actions
required in the interim decision have been completed.
    This document also announces the closures of the registration
review cases for boll weevil attractant (Case 6044 and Docket ID
Number: EPA-HQ-OPP-2009-0335) and octanoate esters (Case 6027 and
Docket ID Number: EPA-HQ-OPP-2017-0087), because the last U.S.
registrations for these pesticides have been canceled. Background on
the registration review program is provided at: http://www.epa.gov/pesticide-reevaluation.

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

    Dated: April 19, 2018.
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2018-09203 Filed 4-30-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Page 69847]
[FR Doc No: 2013-27955]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Exempt Wholesale Generator Status

Buffalo Dunes Wind Project, LLC.........................     EG13-49-000
Whitetail Wind Energy, LLC..............................     EG13-50-000
Merlin One, LLC.........................................     EG13-51-000
Goal Line L.P...........................................     EG13-52-000
RE Columbia 3 LLC.......................................     EG13-53-000
RE Columbia, LLC........................................     EG13-54-000
RE Yakima LLC...........................................     EG13-55-000
Allegany Generating Station LLC.........................     EG13-56-000

    Take notice that during the month of October 2013, the status of
the above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR
366.7(a).

    Dated: November 15, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-27955 Filed 11-20-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Page 23582]
[FR Doc No: 2011-10154]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-3405-000]

EverPower Wind Holdings, Inc.; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
EverPower Wind Holdings, Inc.'s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 11, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 21, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-10154 Filed 4-26-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Notices]
[Pages 3225-3229]
[FR Doc No: 2016-00900]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76889; File No. SR-NYSEMKT-2015-113]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Amend Market Data
Fees for the NYSE Amex Options Product

January 13, 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 December 31, 2015, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') 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 the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the fees for NYSE Amex Options
Product,\4\ as set forth on the NYSE Amex Options Proprietary Market
Data Fee Schedule (``Fee Schedule''). The Exchange proposes to
establish a multiple data feed fee effective January 1, 2016. The text
of 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.
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    \4\ See Securities Exchange Act Release Nos. 76022 (Sept. 29,
2015), 80 FR 60201 (Oct. 5, 2015) (SR-NYSEMKT-2015-68) (Notice). The
single fee for the NYSE Amex Options Product set forth on the Fee
Schedule is comprised of three data feeds: Amex Options Top, Amex
Options Deep, and Amex Options Complex.
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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 Exchange proposes to amend the fees for NYSE Amex Options
Product,\5\ as set forth on the NYSE Amex Options Proprietary Market
Data Fee Schedule (``Fee Schedule''). The Exchange proposes to
establish a multiple data feed fee effective January 1, 2016.
Specifically, the Exchange proposes to establish a new monthly fee, the
``Multiple Data Feed Fee,'' that would apply to data recipients that
take a data feed for NYSE Amex Options Product in more than two
locations. Data recipients taking NYSE Amex Options Product in more
than two locations would be charged $200 per additional location per
product per month. No new reporting would be required.\6\
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    \5\ See Securities Exchange Act Release Nos. 76022 (Sept. 29,
2015), 80 FR 60201 (Oct. 5, 2015) (SR-NYSEMKT-2015-68) (Notice). The
single fee for the NYSE Amex Options Product set forth on the Fee
Schedule is comprised of three data feeds: Amex Options Top, Amex
Options Deep, and Amex Options Complex.
    \6\ Data vendors currently report a unique Vendor Account Number
for each location at which they provide a data feed to a data
recipient. The Exchange considers each Vendor Account Number a
location. For example, if a data recipient has five Vendor Account
Numbers, representing five locations, for the receipt of the NYSE
Amex Options Product, that data recipient will pay the Multiple Data
Feed fee with respect to three of the five locations, or $600.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of section 6 of the Act,\7\ in general, and
sections 6(b)(4) and 6(b)(5) of the Act,\8\ 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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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4), (5).
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    The fees are also equitable and not unfairly discriminatory because
they will apply to all data recipients that choose to subscribe to NYSE
Amex Options Product.
    The Exchange believes that it is reasonable to require data
recipients to pay a modest additional fee taking a data feed for a
market data product in more than two locations, because such data
recipients can derive substantial value from being able to consume the
product in as many locations as they want. In addition, there are
administrative burdens associated with tracking each location at which
a data recipient receives the product. The Multiple Data Feed Fee is
designed to encourage data recipients to better manage their requests
for additional data feeds and to monitor their usage of data feeds. The
proposed fee is designed to apply to data feeds received in more than
two locations so that each data recipient can have one primary and one
backup data location before having to pay a multiple data feed fee. The
Exchange notes that this pricing is consistent with similar pricing
adopted in 2013 by the Consolidated Tape Association (``CTA'').\9\ The
Exchange also notes that the OPRA Plan imposes a similar charge of $100
per connection for circuit connections in addition to the primary and
backup connections.\10\
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    \9\ See Securities Exchange Act Release No. 70010 (July 19,
2013), 78 FR 44984 (July 25, 2013) (SR-CTA/CQ-2013-04).
    \10\ See ``Direct Access Fee,'' Options Price Reporting
Authority Fee Schedule Fee Schedule PRA Plan at http://www.opradata.com/pdf/fee_schedule.pdf
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    The Exchange notes that NYSE Amex Options Product is entirely
optional.

The Exchange is not required to make NYSE Amex Options Product
available or to offer any specific pricing alternatives to any
customers, nor is any firm required to purchase NYSE Amex Options
Product. Firms that do purchase NYSE Amex Options Product do so for the
primary goals of using it 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
Amex Options Product or any other similar products are attractively
priced or not.
    Firms that do not wish to purchase NYSE Amex Options Product have a
variety of alternative market data products from which to choose,\11\
or if NYSE Amex Options Product does not provide sufficient value to
firms as offered based on the uses those firms have or planned to make
of it, such firms may simply choose to conduct their business
operations in ways that do not use NYSE Amex Options Product or use it
at different levels or in different configurations. The Exchange notes
that broker-dealers are not required to purchase proprietary market
data to comply with their best execution obligations.\12\
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    \11\ For example, Chicago Board Options Exchange (``CBOE'')
charges, for its ``Complex Order Book Feed,'' a Distributor Fee of
$3,000 per month, a Professional User Fee of $25 per month and a
Non-Professional User Fee of $1 per month. See the CBOE ``Complex
Order Book Feed'' product and pricing information, available at
https://www.cboe.org/MDX/CSM/OBOOKMain.aspx. NASDAQ OMX PHLX LLC
(``PHLX'') also offers a market data product entitled ``PHLX
Orders,'' which includes order and last sale information for complex
strategies and other market data, and charges a $3,000 internal
monthly fee ($3,500 for external), $2,000 per Distributor and $500
per subscriber. See PHLX ``PHLX Orders'' market data product and
pricing information, available at http://www.nasdaqtrader.com/Micro.aspx?id=PHLXOrders and http://www.nasdaqtrader.com/Trader.aspx?id=DPPriceListOptions#PHLX, respectively.
    \12\ See FINRA Regulatory Notice 15-46, ``Best Execution,''
November 2015.
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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.' '' \13\
---------------------------------------------------------------------------

    \13\ NetCoalition, 615 F.3d at 535.
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    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.\14\ In addition, the
existence of alternatives to these data products, such as options data
from other sources, as described below, further ensures that the
Exchange cannot set unreasonable fees, or fees that are unreasonably
discriminatory, when vendors and subscribers can select such
alternatives.
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    \14\ Section 916 of the Dodd-Frank Wall Street Reform and
Consumer Protection Act of 2010 (the ``Dodd-Frank Act'') amended
paragraph (A) of section 19(b)(3) of the Act, 15 U.S.C. 78s(b)(3),
to make clear that all exchange fees for market data may be filed by
exchanges on an immediately effective basis.
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    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.\15\
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    \15\ 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.
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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.
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 each other for options trades 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 options market data. Proprietary options 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.'' \16\ Similarly, the options markets

vigorously compete with respect to options data products.\17\
---------------------------------------------------------------------------

    \16\ 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.'').
    \17\ See, e.g., Securities Exchange Act Release No. 67466 (July
19, 2012), 77 FR 43629 (July 25, 2012) (SR-Phlx-2012-93), which
describes a variety of options market data products and their
pricing.
---------------------------------------------------------------------------

    Moreover, competitive markets for order flow, executions, and
transaction reports provide pricing discipline for the inputs of
proprietary options data products and therefore constrain markets from
overpricing proprietary options market data. Broker-dealers send their
order flow to multiple venues, rather than providing them all to a
single venue, which in turn reinforces this competitive constraint.
Options markets, similar to the equities markets, are highly
fragmented.\18\
---------------------------------------------------------------------------

    \18\ See, e.g., Press Release, TABB Says US Equity Options
Market Makers Need Scalable Technology to Compete in Today's Complex
Market Structure (February 25, 2013), available at http://www.tabbgroup.com/PageDetail.aspx?PageID=16&ItemID=1231;
Fragmentation Vexes Options Markets (April 21, 2014), available at
http://marketsmedia.com/fragmentation-vexes-options-market/.
---------------------------------------------------------------------------

    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 options 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 options market data products may be less desirable
to customers using them in support of order routing and trading
decisions in light of the diminished content; options data products
offered by competing venues may become correspondingly 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 Amex Options
Product unless their customers request it, and customers will not elect
to pay the proposed fees unless NYSE Amex Options Product can provide
value by sufficiently increasing revenues or reducing costs in the
customer's business in a manner that will offset the fees. All of these
factors operate as constraints on pricing proprietary data products.
Joint Product Nature of Exchange Platform
    Transaction execution and proprietary data products are
complementary in that market data is both an input and a byproduct of
the execution service. In fact, proprietary market data and trade
executions are a paradigmatic example of joint products with joint
costs. The decision of whether and on which platform to post an order
will depend on the attributes of the platforms where the order can be
posted, including the execution fees, data availability and quality,
and price and distribution of data products. Without a platform to post
quotations, receive orders, and execute trades, exchange data products
would not exist.
    The costs of producing market data include not only the costs of
the data distribution infrastructure, but also the costs of designing,
maintaining, and operating the exchange's platform for posting quotes,
accepting orders, and executing transactions and the cost of regulating
the exchange to ensure its fair operation and maintain investor
confidence. The total return that a trading platform earns reflects the
revenues it receives from both products and the joint costs it incurs.
    Moreover, an exchange's broker-dealer customers generally view the
costs of transaction executions and market data as a unified cost of
doing business with the exchange. A broker-dealer will only choose to
direct orders to an exchange if the revenue from the transaction
exceeds its cost, including the cost of any market data that the
broker-dealer chooses to buy in support of its order routing and
trading decisions. If the costs of the transaction are not offset by
its value, then the broker-dealer may choose instead not to purchase
the product and trade away from that exchange. There is substantial
evidence of the strong correlation between order flow and market data
purchases. For example, in September 2015, more than 80% of the
transaction volume on each of NYSE MKT and NYSE MKT's affiliates New
York Stock Exchange LLC (``NYSE'') and NYSE Arca, Inc. (``NYSE Arca'')
was executed by market participants that purchased one or more
proprietary market data products (the 20 firms were not the same for
each market). A supra-competitive increase in the fees for either
executions or market data would create a risk of reducing an exchange's
revenues from both products.
    Other market participants have noted that proprietary market data
and trade executions are joint products of a joint platform and have
common costs.\19\ The Exchange agrees with and adopts those discussions
and the arguments therein. The Exchange also notes that the economics
literature confirms that there is no way to allocate common costs
between joint products that would shed any light on competitive or
efficient pricing.\20\
---------------------------------------------------------------------------

    \19\ See Securities Exchange Act Release No. 72153 (May 12,
2014), 79 FR 28575, 28578 n.15 (May 16, 2014) (SR-NASDAQ-2014-045)
(``[A]ll of the exchange's costs are incurred for the unified
purposes of attracting order flow, executing and/or routing orders,
and generating and selling data about market activity. The total
return that an exchange earns reflects the revenues it receives from
the joint products and the total costs of the joint products.'').
See also Securities Exchange Act Release No. 62907 (Sept. 14, 2010),
75 FR 57314, 57317 (Sept. 20, 2010) (SR-NASDAQ-2010-110), and
Securities Exchange Act Release No. 62908 (Sept. 14, 2010), 75 FR
57321, 57324 (Sept. 20, 2010) (SR-NASDAQ-2010-111).
    \20\ See generally Mark Hirschey, ``Fundamentals of Managerial
Economics,'' at 600 (2009) (``It is important to note, however, that
although it is possible to determine the separate marginal costs of
goods produced in variable proportions, it is impossible to
determine their individual average costs. This is because common
costs are expenses necessary for manufacture of a joint product.
Common costs of production--raw material and equipment costs,
management expenses, and other overhead--cannot be allocated to each
individual by-product on any economically sound basis. . . . Any
allocation of common costs is wrong and arbitrary.''). This is not
new economic theory. See, e.g., F.W. Taussig, ``A Contribution to
the Theory of Railway Rates,'' Quarterly Journal of Economics V(4)
438, 465 (July 1891) (``Yet, surely, the division is purely
arbitrary. These items of cost, in fact, are jointly incurred for
both sorts of traffic; and I cannot share the hope entertained by
the statistician of the Commission, Professor Henry C. Adams, that
we shall ever reach a mode of apportionment that will lead to
trustworthy results.'').
---------------------------------------------------------------------------

    Analyzing the cost of market data product production and
distribution in isolation from the cost of all of the inputs supporting
the creation of market data and market data products will inevitably
underestimate the cost of the data and data products because it is
impossible to obtain the data inputs to create market data products
without a fast, technologically robust, and well-regulated execution
system, and system and regulatory costs affect the price of both
obtaining the market data itself and creating and distributing market
data products. It would be equally misleading, however, to attribute
all of an exchange's costs to the market data portion of an exchange's
joint products. Rather, all of an exchange's costs are incurred for the
unified purposes of attracting order flow, executing and/or routing
orders, and generating and selling data about market activity. The

total return that an exchange earns reflects the revenues it receives
from the joint products and the total costs of the joint products.
    As noted above, the level of competition and contestability in the
market is evident in the numerous alternative venues that compete for
order flow, including 13 options self-regulatory organization (``SRO'')
markets. Three of the 13 have launched operations since December
2012.\21\ The Exchange believes that these new entrants demonstrate
that competition is robust.
---------------------------------------------------------------------------

    \21\ See Securities Exchange Act Release Nos. 70050 (July 26,
2013), 78 FR 46622 (August 1, 2013) (approving exchange registration
for Topaz Exchange, LLC) (known as ISE Gemini); 68341 (December 3,
2012), 77 FR 73065 (December 7, 2012) (approving exchange
registration for Miami International Securities Exchange LLC
(``Miami Exchange'')); and 75650 (August 7, 2015), 80 FR 48600
(August 13, 2015) (establishing rules governing the trading of
options on the EDGX options market).
---------------------------------------------------------------------------

    Competition among trading platforms can be expected to constrain
the aggregate return that each platform earns from the sale of its
joint products, but different trading platforms may choose from a range
of possible, and equally reasonable, pricing strategies as the means of
recovering total costs. For example, some platforms may choose to pay
rebates to attract orders, charge relatively low prices for market data
products (or provide market data products free of charge), and charge
relatively high prices for accessing posted liquidity. Other platforms
may choose a strategy of paying lower rebates (or no rebates) to
attract orders, setting relatively high prices for market data
products, and setting relatively low prices for accessing posted
liquidity. For example, BATS Global Markets (``BATS'') and Direct Edge,
which previously operated as ATSs and obtained exchange status in 2008
and 2010, respectively, provided certain market data at no charge on
their Web sites in order to attract more order flow, and used revenue
rebates from resulting additional executions to maintain low execution
charges for their users.\22\ In this environment, there is no economic
basis for regulating maximum prices for one of the joint products in an
industry in which suppliers face competitive constraints with regard to
the joint offering.
---------------------------------------------------------------------------

    \22\ This is simply a securities market-specific example of the
well-established principle that in certain circumstances more sales
at lower margins can be more profitable than fewer sales at higher
margins; this example is additional evidence that market data is an
inherent part of a market's joint platform.
---------------------------------------------------------------------------

Existence of Alternatives
    The large number of SROs that currently produce proprietary data or
are currently capable of producing it provides further pricing
discipline for proprietary data products. Each SRO is currently
permitted to produce and sell proprietary data products, and many
currently do, including but not limited to the Exchange, NYSE Arca,
CBOE, C2 Options Exchange, Inc., ISE, ISE Gemini, NASDAQ, PHLX, BX,
BATS and Miami Exchange.
    The fact that proprietary data from vendors can bypass SROs is
significant in two respects. First, non-SROs can compete directly with
SROs for the production and sale of proprietary data products. By way
of example, BATS and NYSE Arca both published proprietary data on the
Internet before registering as exchanges. Second, because a single
order or transaction report can appear in an SRO proprietary product, a
non-SRO proprietary product, or both, the amount of data available via
proprietary products is greater in size than the actual number of
orders and transaction reports that exist in the marketplace. Because
market data users can find suitable substitutes for most proprietary
market data products, a market that overprices its market data products
stands a high risk that users may substitute another source of market
data information for its own.
    In addition to the competition and price discipline described
above, the market for proprietary data products is also highly
contestable because market entry is rapid and inexpensive. The history
of electronic trading is replete with examples of entrants that swiftly
grew into some of the largest electronic trading platforms and
proprietary data producers: Archipelago, Bloomberg Tradebook, Island,
RediBook, Attain, TrackECN, BATS and Direct Edge. As noted above, BATS
launched as an ATS in 2006 and became an exchange in 2008, while Direct
Edge began operations in 2007 and obtained exchange status in 2010. As
noted above, three new options exchanges have launched operations since
December 2012.\23\
---------------------------------------------------------------------------

    \23\ See supra note 21.
---------------------------------------------------------------------------

    In determining the proposed fees, the Exchange considered the
competitiveness of the market for proprietary options data and all of
the implications of that competition. The Exchange believes that it has
considered all relevant factors and has not considered irrelevant
factors in order to establish fair, reasonable, and not unreasonably
discriminatory fees and an equitable allocation of fees among all
users. The existence of numerous alternatives to the Exchange's
products, including proprietary data from other sources, ensures that
the Exchange cannot set unreasonable fees, or fees that are
unreasonably discriminatory, when vendors and subscribers can elect
these alternatives or choose not to purchase a specific proprietary
data product if the attendant fees are not justified by the returns
that any particular vendor or data recipient would achieve through the
purchase.

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) \24\ of the Act and subparagraph (f)(2) of Rule
19b-4 \25\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78s(b)(3)(A).
    \25\ 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) \26\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \26\ 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 No. SR-NYSEMKT-2015-113 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 No. SR-NYSEMKT-2015-113. 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 No. SR-NYSEMKT-2015-113, and should be
submitted on or before February 10, 2016.
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-00900 Filed 1-19-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Pages 60415-60416]
[FR Doc No: 2012-24365]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12962-002]

Newburgh Hydro, LLC, Notice of Application Accepted for Filing,
Soliciting Motions To Intervene and Protests, Ready for Environmental
Analysis, and Soliciting Comments, Recommendations, Preliminary Terms
and Conditions, and Preliminary Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Major License.
    b. Project No.: 12962-002.
    c. Date filed: April 29, 2011.
    d. Applicant: Newburgh Hydro, LLC.
    e. Name of Project: Newburgh Hydroelectric Project.
    f. Location: The project would be located on the Ohio River at the
existing U.S. Army Corps of Engineers' (Corps) Newburgh Locks and Dam
in Henderson County, Kentucky and Warrick County, Indiana.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contacts: Brent L. Smith, COO, Symbiotics LLC, 371
Upper Terrace, Suite 2, Bend, OR 97702,<PHONE_NUMBER>; Dr. Vincent A.
Lamarra, CEO, Symbiotics LLC, 975 South State Highway, Logan, UT 84321,
(435) 752-2580.
    i. FERC Contact: Jennifer Adams,<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 Days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    Motions to intervene, protests, comments, recommendations,
preliminary terms and conditions, and preliminary fishway prescriptions
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.
    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.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The existing Newburgh Locks and Dam is a 2,275.5-foot-long by
122-foot-high dam containing nine Taintor gates, each 110 feet wide by
32 feet high, and a concrete fixed weir. The main and auxiliary locks
are on the Indiana side of the river. The main lock is 110 feet wide by
1,200 feet long and the auxiliary lock is 110 feet wide by 600 feet
long. The impoundment above the Newburgh Locks and Dam has a surface
area of 16,390 acres and a storage capacity of 455,800 acre-feet.
    The proposed Newburgh Project would consist of: (1) An 800-foot-
long forebay; (2) a 144-foot-long, 69-foot-high trashrack, with 4-inch
openings; (3) a 215-foot-long, 167-foot-wide submersible, concrete
powerhouse containing three Kaplan turbine-generators, each with an
installed capacity of 18.9 megawatts (MW), for a total capacity of 56.7
MW; (4) a 1,500-foot-long tailrace with a submerged dike approximately
at the midpoint for navigation purposes; (5) an 800-foot-long
transmission line from the powerhouse to; (6) a switchyard; (7) a 3.8-
mile-long 138 kilovolt transmission line to an existing substation; (8)
a 3,559-foot-long access road that would reroute State Road No. 2 and
include a 8,000 square foot parking lot; and (9) appurtenant
facilities. The estimated average annual generation for the project
would be 169,000 megawatt hours. The project would operate run-of-
river, utilizing the flows released under the current Corps operation
guidelines.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's 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. Copies are also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, and .214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
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
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) Bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``PRELIMINARY TERMS AND CONDITIONS,'' or
``PRELIMINARY FISHWAY PRESCRIPTIONS;'' (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. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). 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. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    o. Procedural Schedule:
    The application will be processed according to the following
revised Hydropower Licensing Schedule.

Revisions to the schedule may be made as appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations, preliminary   November 2012.
 terms and conditions, and preliminary
 fishway prescriptions.
Commission issues EA...................  March 2013.
Comments on EA.........................  April 2013.
Modified terms and conditions..........  June 2013.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in 18 CFR 5.22: (1) A copy of the
water quality certification; (2) a copy of the request for
certification, including proof of the date on which the certifying
agency received the request; or (3) evidence of waiver of water quality
certification.
    r. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.

    Dated: September 26, 2012.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-24365 Filed 10-2-12; 8:45 am]
BILLING CODE 6717-01-P


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

General Comment:I smoked cigarettes for 40 years and never thought I would be able to quit.  I tried everything, you name it, I tried it.  I would quit for awhile, weeks, a few months and then back to the cigarettes.  I obtained an electronic cigarette in August of 2013.  On August 6, 2013 I had my last cigarette and started using the electronic cigarette.  I have not smoked a tobacco cigarette since. I buy the lowest nicotine level and then mix it half and half with a no nicotine level.  So the nicotine is very little.  Sometimes I just have the 0 nicotine. I smoke more like someone who smokes a pipe,  not like the chain smoker I use to be. My hypertension is gone. My heart rate which was anywhere from high 90's to over 100+ is now down to 60.  When I wake up in the morning my throat isn't filled with mucus. I know I never would of been able to quit without an e-cigarette.  It's been a really good thing for me. I have lost weight because I exercise more because I can exercise more. It was the one horrible thing I did to myself and now I am free of it. E-cigs are not tobacco products, there is no tobacco involved. I believe that the tobacco industry wants  them regulated because they are loosing money and wants them to be taxed so they cost more and maybe not as attractive. Electronic cigarettes will save lives, lost time at work and health care costs. Every vape store I have ever been in does not sell their products to minors.  If they want to make that a law that's fine, but I am wondering what other restrictions they want to impose.  If it isn't broke why are you trying to fix it?  Could you please keep this comment area open for 180 days so more people can chime in with their views?


[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Notices]
[Pages 69719-69720]
[FR Doc No: 2011-28988]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ12-1-000]

City of Vernon, CA; Notice of Filing

    Take notice that on October 27, 2011, City of Vernon, California
submitted its tariff filing per 35.25(e): 2012 TRR/TRBAA Update Filing
and Ministerial Changes to be effective 1/1/2012.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the

Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 17, 2011.

    Dated: November 1, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-28988 Filed 11-8-11; 8:45 am]
BILLING CODE 6717-01-P


SECTION 1 INTRODUCTION 1.0 Introduction This report provides an analysis of the benefits and costs of the final Clean Air Mercury Rule ( CAMR). In Section 2, we discuss the potential health effects of mercury. Section 3 provides a detailed discussion of mercury in the environment, include including how mercury deposited to water bodies transforms into methylmercury in fish tissue. This section also provides an assessment of the response time for systems after a change in mercury deposition. Because fish consumption is the primary pathway for exposure to methylmercury, Section 4 provides a profile of fishing activity in the United States. Section 5 presents information on concentrations of mercury in fish. Because this regulation requires control on coal fired power plants, Section 6 provides a profile of the power sector in the United States, while Section 7 describes the emissions, control requirements, control options considered for CAMR, and the regulatory costs of the final CAMR. In addition, Section 7 also provides an assessment of impacts on small businesses and government entities. Section 8 describes the resulting change in mercury deposition from air quality modeling of the CAMR regulatory options. Section 9 presents a derivation of a dose response function that relates mercury consumption in women of childbearing with changes in IQ seen in children that were exposed prenatally. IQ is used as a surrogate for the neurobehavioral endpoints that EPA relied upon for setting the methylmercury reference dose ( RfD). to the unborn fetus. Chapter 10 presents exposure modeling and benefit methodologies applied to a no threshold model ( i. e., a model that assumes no threshold in effects at low doses of mercury exposure). Chapter 11 presents the final benefit analysis numbers of CAMR giving consideration to established health benchmarks ( i. e., consideration of potential thresholds on effects at low doses of mercury exposure). Finally, Chapter 12 presents a benefit analysis of reductions in PM as a result of controls applied for mercury. Table 1 1 below summarizes the benefits, costs, and net benefits of the CAMR.

Delete table


[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55605-55606]
[FR Doc No: 2017-25234]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-409-000]

Notice of Availability of the Environmental Assessment for the
Proposed Birdsboro Pipeline Project, DTE Midstream Appalachia, LLC

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared this Environmental Assessment (EA) of the
Birdsboro Pipeline Project (Project) proposed by DTE Midstream
Appalachia, LLC (DTE Midstream) in the above-referenced docket. DTE
Midstream requests authorization to construct, operate, and maintain
new natural gas facilities in Berks County, Pennsylvania, consisting of
13.2 miles of 12-inch-diameter pipeline, a new meter station, and
appurtenant facilities.
    The EA assesses the potential environmental effects of the
construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act of 1969 (NEPA).
The FERC staff concludes that approval of the Project, with appropriate
mitigating measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    The U.S. Army Corps of Engineers and U.S. Environmental Protection
Agency participated as cooperating agencies in the preparation of the
EA. Cooperating agencies have jurisdiction by law and/or have special
expertise with respect to resources potentially affected by a proposal.
    The proposed Birdsboro Pipeline Project includes the following
facilities:
     About 13.2 miles of new, 12-inch-diameter pipeline;
     a new meter station associated facilities at the Texas
Eastern Transmission Company Pipeline right-of-way and pig launcher
facility; \1\
---------------------------------------------------------------------------

    \1\ A pig is a tool that the pipeline company inserts into and
pushes through the pipeline for cleaning the pipeline, conducting
internal inspections, or other purposes.
---------------------------------------------------------------------------

     a new pig receiver facility; and
     four mainline valve sites.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; and newspapers and libraries in the Project area. In addition,
the EA is available for public viewing on the FERC's Web site
(www.ferc.gov) using the eLibrary link. A limited number of copies of
the EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street
NE., Room 2A,Washington, DC 20426,<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that your comments are properly recorded and considered prior to
a Commission decision on the proposal, it is important that the FERC
receives your comments in Washington, DC on or before December 15,
2017.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
Project docket number (CP17-409-000) with your submission. The
Commission encourages electronic filing of comments and has dedicated
eFiling expert staff available to assist you at<PHONE_NUMBER> or
[email protected].
    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at www.ferc.gov
under the link to Documents and

Filings. An eComment is an easy method for interested persons to submit
text-only comments on a Project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at www.ferc.gov
under the link to Documents and Filings. With eFiling you can provide
comments in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on eRegister. You will be asked to select the type of filing you are
making. A comment on a particular Project is considered a Comment on a
Filing; or
    (3) You may file a paper copy of your comments at the following
address: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (Title 18 Code of Federal Regulations
385.214).\2\ Only intervenors have the right to seek rehearing of the
Commission's decision. Affected landowners and parties with
environmental concerns may be granted intervenor status upon showing
good cause by stating that they have a clear and direct interest in
this proceeding that would not be adequately represented by any other
parties. You do not need intervenor status to have your comments
considered.
---------------------------------------------------------------------------

    \2\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

    Additional information about the Project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC (3372), or
on the FERC Web site (www.ferc.gov) using the eLibrary link. Click on
the eLibrary link, click on General Search, and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP17-
409). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
[email protected] or toll free at 1-866-208-3676, or for TTY,
contact 1-202-502-8659. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription, which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: November 15, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-25234 Filed 11-21-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13707-13708]
[FR Doc No: 2017-04999]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Scholes International Airport, Galveston, Texas

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release airport property.

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SUMMARY: The FAA proposes to rule and invite public comment on the
release of land at the Scholes International Airport under the
provisions of Section 125 of the Wendell H. Ford Aviation Investment
Reform Act for the 21st Century (AIR 21).

DATES: Comments must be received on or before April 13, 2017.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Mr. Ben Guttery, Manager, Federal
Aviation Administration, Southwest Region, Airports Division, Texas
Airports District Office, ASW-650, 10101 Hillwood Parkway, Fort Worth,
Texas 76177.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Mike Shahan, Airport Director, at the
following address: 2115 Terminal Drive #4, Galveston, Texas 77554.

FOR FURTHER INFORMATION CONTACT:  Mr. Anthony Mekhail, Program Manager,
Federal Aviation Administration, Texas Airports District Office, ASW-
650, 10101 Hillwood Parkway, Fort Worth, TX 76177, Telephone: (817)
222-5663, email<EMAIL_ADDRESS>    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the Scholes International Airport under
the provisions of the AIR 21. The following is a brief overview of the
request:
    City of Galveston requests the release of 5.5 acres of non-
aeronautical airport property. The property is located on the west side
of the airport, along Travel Air Road. The property to be released will
be sold and revenues shall be used to build airport-owned hangars whose
lease revenue will support maintenance and improvement of the airport.
Any person may inspect the request in person at the FAA office listed
above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the application,
notice

and other documents relevant to the application in person at the
Scholes International Airport, telephone number<PHONE_NUMBER>.

    Issued in Fort Worth, Texas, on January 5, 2017.
Ignacio Flores,
Director, Airports Division.
[FR Doc. 2017-04999 Filed 3-13-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Notices]
[Page 9814-9816]
[DOCID:fr05mr07-93]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55343; File No. SR-NYSE-2007-12]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto To
Amend Section 703.16 of the NYSE Listed Company Manual To Eliminate
Requirement Regarding Index Calculation Methodology

February 23, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 5, 2007 the New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. On February 15, 2007, the Exchange filed Amendment No. 1 to
the proposed rule change. The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Section 703.16 of the NYSE Listed
Company Manual (``Manual''), the Exchange's generic listing standard
for investment company units (``ICUs''), to eliminate the requirement
that the calculation methodology for the index underlying a series of
ICUs must be one of those enumerated in Section 703.16(C)(4)(a). The
proposed rule text is available at the NYSE, the Commission's Public
Reference Room, and http://www.nyse.com.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The NYSE has prepared summaries, set forth in sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to amend Section 703.16 of the Manual, which
includes the Exchange's generic listing standard for ICUs (which
include exchange-traded funds), to eliminate the requirement that the
calculation methodology for the index underlying a series of ICUs must
be one of those enumerated in section 703.16(C)(4)(a). This Amendment
No. 1 replaces the Exchange's initial filing in its entirety.
    The Exchange has adopted listing standards applicable to ICUs which
are consistent with the listing criteria currently used by other
national securities exchanges, and trading standards pursuant to which
the Exchange may either list and trade ICUs or trade such ICUs on the
Exchange on an unlisted trading privileges (``UTP'') basis.\3\ An ICU
is defined in Section 703.16 of the Manual as a security that
represents an interest in a registered investment company that could be
organized as a unit investment trust, an open-end management investment
company, or a similar entity. A registered investment company is
registered under the Investment Company Act of 1940.\4\
---------------------------------------------------------------------------

    \3\ In 1996, the Commission approved Section 703.16 of the
Listed Company Manual, which sets forth the rules related to the
listing of ICUs. See Securities Exchange Act Release No. 36923
(March 5, 1996), 61 FR 10410 (March 13, 1996) (SR-NYSE-95-23). In
2000, the Commission also approved the Exchange's generic listing
standards for listing and trading, or the trading pursuant to UTP,
of ICUs under Section 703.16 of the Listed Company Manual and
Exchange Rule 1100. See Securities Exchange Act Release No. 43679
(December 5, 2000), 65 FR 77949 (December 13, 2000) (SR-NYSE-2000-
46).
    \4\ 15 U.S.C. 80a.
---------------------------------------------------------------------------

    The ``generic'' listing criteria of Section 703.16 of the Manual
permit listing of ICUs that satisfy such criteria in reliance upon Rule
19b-4(e) under the Act,\5\ without a filing pursuant to Rule 19b-4
under the Act. Section 703.16(C)(4)(a) of the Manual requires, among
other criteria, that, if a series of ICUs is listed for trading on the
Exchange in reliance upon Rule 19b-4(e), the index underlying the
series must follow one of these calculation weighting methodologies:
Market capitalization, modified market capitalization, price, equal-
dollar, or modified equal-dollar weighting methodology or a methodology
weighting components of the index based on any, some or all of the
following: Sales, cash flow, book value and dividends.
---------------------------------------------------------------------------

    \5\ 17 CFR 240.19b-4(e).
---------------------------------------------------------------------------

    The Exchange proposes to delete Section 703.16(C)(4)(a) and thereby
eliminate the calculation methodology limitation.\6\ In recent years,
academics and market professionals have explored and defined a growing
list of innovations in index construction. Most recently, the
Commission approved amendments to the generic listing criteria to
accommodate new index weighting methodologies based on ranking
companies by financial data such as sales, cash flow, book value and
dividends.\7\ The Exchange believes there are multiple ways for indexes
to be constructed to serve useful market purposes. Additional
methodologies are under active development by academics and market
professionals and permitting only certain specified index weighting
methods does not take into account the rapid innovation in this area.
The Exchange believes that, with respect to ICUs listed pursuant to
Rule 19b-4(e), applying the numerical weighting and liquidity criteria
and index dissemination requirements in Section 703.16, without
imposing constraints on the index methodology, will provide greater
flexibility to indexers and ICU issuers to develop indexes that meet
the investment objectives of investors. In addition, the proposed rule
change would allow ICUs based on a non-traditional weighting
methodology to be brought to market more quickly, thereby reducing
burdens on ICU issuers and other market participants and promoting
competition.
---------------------------------------------------------------------------

    \6\ The Exchange also proposes to redesignate current
subparagraphs (b) and (c) of Section 703.16(C)(4) as (a) and (b),
respectively.
    \7\ See Securities Exchange Act Release No. 54649 (October 24,
2006); 71 FR 63816 (October 31, 2006) (SR-NYSE-2006-88).
---------------------------------------------------------------------------

    The Exchange notes that the numerical criteria in Section 703.16
already define the concentration limits, diversity requirements and
liquidity requirements of the companies in the underlying index. For
example, the generic listing standards for domestic indexes require,
among other things, that an index include at least 13 stocks, that the
most heavily weighted component stock of an index cannot exceed 30% of
the index weight and the five most heavily weighted component stocks of
an index cannot exceed 65% of the index weight. The generic listing
standards for international or global indexes require, among other
things, that the index include at least 20 component stocks, that the
most heavily weighted index component stock cannot exceed 25% of the
index weight, and the five most heavily weighted component stocks
cannot exceed 60% of the index weight. ICUs and their underlying
indexes would continue to be subject to all other requirements of
Section 703.16 of the Manual. Under these circumstances, the Exchange
believes that removal of the index weighting requirements of Section
703.16(C)(4)(a) will not compromise investor protection.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \8\ of the
Act in general and furthers the objectives of Section 6(b)(5) \9\ in
particular in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to, and perfect the
mechanism of a free and open market and, in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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.

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

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

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory

organization consents, the Commission will:
    (A) by order approve the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.
    The Exchange has requested accelerated approval of this proposed
rule change. The Commission has determined that a 15-day comment period
is appropriate in this case.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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 e-mail to<EMAIL_ADDRESS>Please include File

Number SR-NYSE-2007-12 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2007-12. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room. Copies of such
filing will also be available for inspection and copying at the
principal office of the NYSE. 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-2007-12 and should be submitted by March 20, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-3741 Filed 3-2-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Notices]
[Pages 23819-23821]
[FR Doc No: 2011-10254]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0588]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exceptions or
Alternatives to Labeling Requirements for Products Held by the
Strategic National Stockpile

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by May 31,
2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0614.
Also include the FDA docket number found in brackets in the heading of
this document.

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

Exceptions or Alternatives to Labeling Requirements for Products Held
by the Strategic National Stockpile; Interim Final Rule--(OMB Control
Number 0910-0614)--Extension

    Under the Public Health Service Act (PHS Act), the Department of
Health and Human Services stockpiles medical products that are
essential to the health security of the nation (see PHS Act, section
319F-2, 42 U.S.C. 247d-6b). This collection of medical products for use
during national health emergencies, known as the Strategic National
Stockpile (SNS), is to ``provide for the emergency health security of
the United States, including the emergency health security of children
and other vulnerable populations, in the event of a bioterrorist attack
or other public health emergency.''
    It may be appropriate for certain medical products that are or will
be held in the SNS to be labeled in a manner that would not comply with
certain FDA labeling regulations given their anticipated circumstances
of use in an emergency. However, noncompliance with these labeling
requirements could render such products misbranded under section 502 of
the Federal Food, Drug, and Cosmetic Act (the FD& C Act) (21 U.S.C.
352).
    In the Federal Register of December 28, 2007 (72 FR 73589), FDA
published an interim final rule entitled ``Exceptions or Alternatives
to Labeling Requirements for Products Held by the Strategic National
Stockpile.'' In the interim final rule, FDA issued regulations under
Sec. Sec.  201.26, 610.68, 801.128, and 809.11 (21 CFR 201.26, 610.68,
801.128, and 809.11), which allow the appropriate FDA Center Director
to grant a request for an exception or alternative to certain
regulatory provisions pertaining to the labeling of human drugs,
biological products, medical devices, and in vitro diagnostics that
currently are or will be included in the SNS if certain criteria are
met. The appropriate FDA Center Director may grant an exception or
alternative to certain FDA labeling requirements if compliance with
these labeling requirements could adversely affect the safety,
effectiveness, or availability of products that are or will be included
in the SNS. An exception or alternative granted under the

regulations may include conditions or safeguards so that the labeling
for such products includes appropriate information necessary for the
safe and effective use of the product given the product's anticipated
circumstances of use. Any grant of an exception or alternative will
only apply to the specified lots, batches, or other units of medical
products in the request. The appropriate FDA Center Director may also
grant an exception or alternative to the labeling provisions specified
in the regulations on his or her own initiative.
    Under Sec. Sec.  201.26(b)(1)(i) (human drug products),
610.68(b)(1)(i) (biological products), 801.128(b)(1)(i) (medical
devices), and 809.11(b)(1)(i) (in vitro diagnostic products for human
use), an SNS official or any entity that manufactures (including
labeling, packing, relabeling, or repackaging), distributes, or stores
such products that are or will be included in the SNS may submit, with
written concurrence from a SNS official, a written request for an
exception or alternative to certain labeling requirements to the
appropriate FDA Center Director. Except when initiated by an FDA Center
Director, a request for an exception or alternative must be in writing
and must:
     Identify the specified lots, batches, or other units of
the affected product;
     Identify the specific labeling provisions under this rule
that are the subject of the request;
     Explain why compliance with the specified labeling
provisions could adversely affect the safety, effectiveness, or
availability of the product subject to the request;
     Describe any proposed safeguards or conditions that will
be implemented so that the labeling of the product includes appropriate
information necessary for the safe and effective use of the product
given the anticipated circumstances of use of the product;
     Provide copies of the proposed labeling of the specified
lots, batches, or other units of the affected product that will be
subject to the exception or alternative; and
     Provide any other information requested by the FDA Center
Director in support of the request.
    If the request is granted, the manufacturer may need to report to
FDA any resulting changes to the New Drug Application, Biologics
License Application, Premarket Approval Application, or Premarket
Notification (510(k)) in effect, if any. The submission and grant of an
exception or an alternative to the labeling requirements specified in
the interim final may be used to satisfy certain reporting obligations
relating to changes to product applications under Sec.  314.70 (21 CFR
314.70) (human drugs), Sec.  601.12 (21 CFR 601.12) (biological
products), Sec.  814.39 (21 CFR 814.39) (medical devices subject to
premarket approval), or Sec.  807.81 (21 CFR 807.81) (medical devices
subject to 510(k) clearance requirements). The information collection
provisions in Sec. Sec.  314.70, 601.12, 807.81, and 814.39 have been
approved under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and
0910-0231, respectively. On a case-by-case basis, the appropriate FDA
Center Director may also determine when an exception or alternative is
granted that certain safeguards and conditions are appropriate, such as
additional labeling on the SNS products, so that the labeling of such
products would include information needed for safe and effective use
under the anticipated circumstances of use.
    Respondents to this collection of information are entities that
manufacture (including labeling, packing, relabeling, or repackaging),
distribute, or store affected SNS products. Based on the number of
requests for an exception or alternative received by FDA since issuance
of the interim final rule, FDA estimates an average of two requests
annually. FDA is estimating that each respondent will spend an average
of 24 hours preparing each request. The hours per response for each
submission are based on the estimated time that it takes to prepare a
supplement to an application, which may be considered similar to a
request for an exception or alternative. To the extent that labeling
changes not already required by FDA regulations are made in connection
with an exception or alternative granted under the interim rule, FDA is
estimating one occurrence annually in the event FDA would require any
additional labeling changes not already covered by FDA regulations, and
that it would take 8 hours to develop and revise the labeling to make
such changes.
    In the Federal Register of November 30, 2010 (75 FR 74062), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                           Average burden
                       21 CFR Part                             Number of        responses per       Total annual    per response  (in     Total hours
                                                              respondents         respondent         responses            hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and                    2                  1                  2                 24                 48
 809.119(b)(1)(i)........................................
201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and                    1                  1                  1                  8                  8
 809.11(b)(1)(i).........................................
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................                 56
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The information collection provisions in Sec. Sec.  314.70, 601.12,
807.81, and 814.39 have been approved under OMB control numbers 0910-
0001, 0910-0338, 0910-0120, and 0910-0231, respectively.

    Dated: April 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10254 Filed 4-27-11; 8:45 am]
BILLING CODE 4160-01-P