[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10171-10173]
[FR Doc No: 2015-03811]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74302; File No. SR-OCC-2014-23]

Self-Regulatory Organizations; the Options Clearing Corporation;
Order Approving Proposed Rule Change To Clarify That OCC Would not
Treat a Futures Transaction That Is an Exchange-for-Physical or Block
Trade as a Non-Competitively Executed Trade if the Exchange on Which
Such Trade Is Executed Has Provided OCC With Representations That it
Has Policies or Procedures Requiring That Such Trades Be Executed at
Reasonable Prices and That Such Price Is Validated by the Exchange

February 19, 2015.
    On December 19, 2014, the Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change File No. SR-OCC-2014-23 pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act''),\1\ and Rule
19b-4 thereunder.\2\ The proposed rule change was published for comment
in the Federal Register on January 6, 2015.\3\ The Commission did not
receive any comments on the proposed rule change. This order approves
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 73961(December 30,
2014), 80 FR 568 (January 6, 2015) (SR-OCC-2014-23).
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I. Description

    OCC is modifying its By-Laws to add an interpretation and policy to
Section 7 of Article XII of its By-Laws to clarify that OCC will not
treat a futures transaction that is an exchange-for-physical (``EFP'')
\4\ or block trade in futures (``Block Trade'') \5\ as a non-
competitively executed trade, and therefore subject to delayed
novation, if the exchange on which the EFP or Block Trade is executed
has provided OCC with representations that it has rules, policies or
procedures requiring that such trades be executed at reasonable prices
and that such prices are validated by the exchange.
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    \4\ According to OCC, an EFP is a transaction between two
parties in which a futures contract on a commodity or security is
exchanged for the actual physical good.
    \5\ According to OCC, a block trade is a trade involving a large
number of shares being traded at an arranged price between parties,
outside of the open markets, in order to lessen the impact of such a
large trade being made public.
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Background

    According to OCC, under OCC's By-Laws, the novation of confirmed
trades (i.e., transactions in options, futures, or other ``cleared
contracts'' effected through an exchange and submitted to OCC for
clearing) occurs at the ``commencement time'' for such transactions.\6\
The ``commencement time'' for most confirmed trades is when daily
position reports are made available to clearing members.\7\ However,
transactions in certain cleared products and certain types of
transactions, including non-competitively executed EFPs and Block
Trades, have delayed commencement times that are tailored to address
risks specific to such products or transactions,\8\ including, but not
limited to, those risks presented by off-market transactions.
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    \6\ Cleared Contracts and Commencement Time are defined terms
set forth in Article 1, Section 1 of OCC's By-Laws.
    \7\ See OCC's By-Laws Article VI, Section 5. According to OCC,
in a practical sense, however, most trades are novated upon proper
submission to OCC for clearing since OCC's By-Laws, with limited
exception, do not permit OCC to reject any confirmed trade due to
the failure of the purchasing clearing member to pay any amount due
to OCC at or before the settlement time. See also Securities
Exchange Act Release No. 65990 (December 16, 2011), 76 FR 79731
(December 22, 2011) (SR-OCC-2011-17).
    \8\ Id.
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    When OCC began clearing EFPs and Block Trades, it established that
the commencement time for such transactions is expressly conditioned
upon the receipt by OCC of variation payments due from purchasing and
selling clearing members because EFPs and Block Trades could be
executed away from the market and be executed at other than market
prices. These factors were viewed as creating heightened exposure to
OCC if a clearing member defaults on a trade executed at an off-market
price and, as a result, Article XII, Section 7 of OCC's By-Laws
establishes that the commencement time for an EFP or Block Trade is the
time of the first variation payment after the trade is reported to OCC
(typically 9:00 a.m. Central Time the following business day).\9\ OCC
delays its novation of these non-competitively executed futures trades
because OCC is bound to pay the first variation settlement amount to
the counterparty once novation has occurred, and if the agreed-upon
price at which the trade is entered differs from the competitive market
price, there is an increased likelihood that OCC may

experience a loss if it is required to close out a defaulting
purchaser's position. Accordingly, OCC does not novate, and thereby
become a counterparty to, a non-competitively executed trade if OCC
fails to receive the first variation payment when due.
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    \9\ See Securities Exchange Act Release No. 44727 (August 20,
2001), 66 FR 45351 (August 28, 2001) (SR-OCC-2001-07).
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EFP and Block Trades Subject to Price Checks

    According to OCC, in the time since OCC adopted Article XII,
Section 7 of its By-Laws, the Commodity Futures Trading Commission
(``CFTC'') has adopted Regulation 1.73, which requires clearing futures
commission merchants (``FCMs'') to establish certain risk controls,
including risk based limits for bilaterally executed transactions and
for Block Trades.\10\ In light of this requirement and other proposed
regulatory developments that may affect EFPs and Block Trades,\11\
certain futures exchanges requested that OCC review its By-Laws
regarding delayed novation of these trades to reassess the impact of
the recently implemented rules, supported by policies and procedures,
which require the exchanges' market participants to execute s EFPs and
Block Trades at reasonable prices that are verified by the exchange.
These rules, policies and procedures leverage risk controls implemented
by FCMs, as applicable. OCC undertook such a review of its practices
with respect to delayed novation of EFPs and Block Trades, and
determined that it is appropriate to novate these trades when daily
position reports are made available, provided that the exchange that
submitted such trades to OCC represents to OCC that the exchange has in
place rules, policies and procedures to verify the reasonableness of
the transaction price of EFPs and Block Trades it submits to OCC for
clearance and settlement, and that such price is validated by the
exchange.
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    \10\ See 17 CFR 1.73. According to OCC, Regulation 1.73 requires
FCMs to: (1) Establish risk-based limits in the proprietary account
and in each customer account based on position size, order size,
margin requirements, or similar factors; (2) screen orders for
compliance with the risk-based limits; and (3) monitor for adherence
to the risk based limits intra-day and overnight.
    \11\ According to OCC, the CFTC has proposed regulations
requiring Designated Contract Markets (i.e., futures exchanges) to
determine whether or not the price of a block trade is fair and
reasonable considering: (1) The size of the block trade, (2) the
price and size of other block trades in any relevant markets at the
applicable time, and (3) the circumstances of the market or the
parties to the block trade. See proposed CFTC Regulation 38.503. 75
FR 80572, 80592. See also proposed Appendix B of part 38 of the
CFTC's proposed regulations concerning Core Principle 9. 75 FR
80572, 80630. The CFTC has also proposed to adopt similar
regulations concerning EFP trades. See proposed CFTC Regulation
38.505. 75 FR 80572, 80593.
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    OCC has determined that EFPs and Block Trades that are subject to
price reasonability checks do not present the same settlement risks
discussed above in relation to non-competitively executed EFPs and
Block Trades. Specifically, should a clearing member that executed a
reasonably priced EFP or Block Trades fail to pay its first variation
payment to OCC on the trade, OCC anticipates it will liquidate the
futures positions at the prevailing market price and obtain sufficient
funds, or OCC will already have sufficient funds in its clearing fund,
to pay or reimburse itself for the first variation settlement to the
counterparty to the trade. This is the same risk management methodology
OCC currently uses for other competitively executed trades in cleared
contracts that OCC accepts for clearance and settlement on a daily
basis.
    Accordingly, OCC is amending Article XII, Section 7, of its By-Laws
by adding an interpretation and policy to exclude EFPs and Block Trades
from the delayed novation and to provide for the treatment of these
trades as competitively executed trades, provided that the s EFPs and
Block Trades are reported by an exchange that represents to OCC that it
performs a price reasonableness check on the trade, and that such price
is validated by the exchange.

Verification of Exchange Rules, Policies and Procedures Related to
Price Reasonableness

    Before permitting an exchange to submit EFPs and Block Trades that
will not be subject to delayed novation, OCC will require an exchange
to provide OCC with a certification that the exchange has rules,
policies or procedures as they relate to verifying the reasonableness
of the price of the EFP and Block Trade. Specifically, OCC will require
an exchange to certify that its rules, policies or procedures provide
that the price at which a EFP or Block Trade is executed must be fair
and reasonable in light of: (i) The size of the EFP or Block Trade;
(ii) the prices and sizes of other transactions in the same contract at
the relevant time; and (iii) the prices and sizes of transactions in
other relevant markets, including, without limitation, the underlying
cash market or related futures markets, at the relevant time.\12\ An
exchange will also have to certify that its rules, policies or
procedures require one or both parties to an EFP or Block Trade to
report the trade details of the trade to the exchange within a
reasonable period of time (i.e., within 10 minutes of the time of
execution or, if the EFP or Block Trade is executed outside of regular
trading hours, within 15 minutes of the commencement of trading on the
next business day). OCC believes that it is appropriate to rely on
price reasonableness checks performed by exchanges trading futures
because they are self-regulatory organizations subject to regulatory
oversight, including routine examinations. Moreover, OCC will presume
that all EFPs and Block Trades submitted by an exchange that represents
that it has price reasonableness rules, policies or procedures in place
will submit to OCC EFPs and Block Trades that have undergone a price
reasonableness check.
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    \12\ For example, according to OCC, OneChicago LLC (``OCX'')
Rule 417 governs EFP and Block Trades executed on OCX and provides
that such trades be executed on a designated trading platform that
will automatically verify that EFPs and Block Trades were executed
at competitive prices by price verification software for price
reasonableness.
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    In addition to exchanges implementing rules, policies or procedures
regarding the price reasonableness checks for EFPs and Block Trades,
exchanges may continue to use their existing authority to notify OCC
pursuant to Article VI, Section 7(c) of OCC's By-Laws, to disregard any
EFP or Block Trade submitted to OCC that was executed at an
unreasonable price. The notification will be delivered to OCC along
with other trades ``busted'' by an exchange, in accordance with an
operational process that currently occurs every day before daily
position reports are distributed. Such trades could not be properly
cleared under amended Article XII, Section 7, but instead would fall
within the non-competitively executed category and therefore be subject
to delayed novation. Taken together, OCC believes that these measures
appropriately protect OCC in the event OCC receives a EFP or Block
Trade at an unreasonable price. Moreover, OCC and the exchanges will
continue to maintain an ongoing dialogue about operational matters,
which OCC will use to confirm the continued application of price
reasonableness controls.

II. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \13\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that the proposed rule change is consistent with the requirements
of the Act and the

rules and regulations thereunder applicable to such organization.
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    \13\ 15 U.S.C. 78s(b)(2)(C).
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    The Commission finds that the proposed rule change is consistent
with Section 17A(b)(3)(F) of the Act \14\ which requires the rules of a
clearing agency to, among other things, assure the safeguarding of
securities and funds which are in the custody or control of the
clearing agency or for which it is responsible. OCC is amending Article
XII, Section 7, to include a new policy and interpretation setting
forth the specific criteria a futures exchange must meet in order for
EFPs and Block Trades to not be subject to the delayed novation times
set forth in Article XII of OCC's By-Laws. Specifically the exchange
must provide OCC with a certification that the exchange has rules,
policies or procedures as they relate to verifying the reasonableness
of the price of the EFP and Block Trade. OCC's proposal, as approved,
does not affect the novation time for any securities transactions.
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    \14\ 15 U.S.C. 78q-1(b)(3)(F).
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    OCC has determined that EFPs and Block Trades that are subject to
price reasonability checks do not present the same settlement risks as
those executed on exchanges without price reasonability checks, and as
such has determined that OCC's requirement that exchanges certify price
reasonableness policies and procedures are sufficiently appropriate to
mitigate the risks associated with non-competitively executed trades.
In addition, in the event a clearing member fails to its first
variation payment to OCC on an EFP or Block Trade that was executed on
an exchange with price reasonability checks, OCC will employ the same
risk management methodology used for all other competitively executed
trades accept for clearing at OCC, which should in turn reduce
settlement risks that could expose OCC to loss if it is required to
close out a defaulting purchaser's EFP or Block Trade position.
Combining OCC's price reasonableness requirements for exchanges and
OCC's ability to liquidate futures positions or use its clearing fund
to management risks associated with non-payment of premiums for those
trades accepted for clearance and settlement, OCC should have
sufficient risk management controls in place in to assure the
safeguarding of securities and funds which are in the custody of
control of OCC or for which it is responsible.

III. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \15\ and the
rules and regulations thereunder.
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    \15\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change File No. SR-OCC-2014-23 be, and
it hereby is, approved.
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    \16\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-03811 Filed 2-24-15; 8:45 am]
BILLING CODE 8011-01-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

                                   	    Issued by the Department of
Transportation on November 22, 2000

		       NOTICE OF ACTION TAKEN -- DOCKET OST-97-3124

________________________________________________________________________
______

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of   Delta Air Lines, Inc.      filed  11/1/00  to:

XX  Renew for two years exemption under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between Atlanta, Georgia, and Lima, Peru, and to combine this authority
with its existing certificate and exemption authority.

Applicant rep.:   Robert E. Cohn,<PHONE_NUMBER>     DOT analyst:
Sylvia Moore,<PHONE_NUMBER>

DISPOSITION

XX  Granted  (subject to conditions, see below)

The above action was effective when taken:  November 22, 2000, through
November 22, 2002

Action taken by:   Paul L. Gretch, Director

	               Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Peru.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX  Holder’s
certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

________________________

Conditions:  The route integration authority requested is granted
subject to the condition that any service provided under this exemption
shall be consistent with all applicable agreements between the United
States and the foreign countries involved.  Furthermore, (a) nothing in
the award of the route integration authority requested should be
construed as conferring upon Delta rights (including fifth freedom
intermediate and/or beyond rights) to serve markets where U.S. carrier
entry is limited unless Delta notifies us of its intent to serve such a
market and unless and until the Department has completed any necessary
selection procedures to determine which carrier(s) should be authorized
to exercise such rights; and (b) should there be a request by any
carrier to use the limited-entry route rights that are included in
Delta’s authority by virtue of the route integration exemption granted
here, but that are not then being used by Delta, the holding of such
authority by route integration will not be considered as providing any
preference for Delta in a competitive carrier selection proceeding to
determine which carrier(s) should be entitled to use the authority at
issue.

(See Reverse Side)

2

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that

(1) our action was consistent with Department policy; (2) grant of the
authority was consistent with the public interest; and (3) grant of the
authority would not constitute a major regulatory action under the
Energy Policy and Conservation Act of 1975.  To the extent not granted,
we denied all requests in the referenced Docket.  We may amend, modify,
or revoke the authority granted in this Notice at any time without
hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within ten (10) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

APPENDIX

U.S. CARRIER

Standard Exemption Conditions

In the conduct of operations authorized by the attached notice, the
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with the applicable requirements of the Federal Aviation
Administration Regulations, including all FAA requirements concerning
security; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.


[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Pages 28860-28861]
[FR Doc No: 2016-10902]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC16-108-000.
    Applicants: Tenaska Alabama II Partners, L.P.
    Description: Tenaska Alabama II Partners, L.P. Application for
Approval Under Section 203 of the Federal Power Act and Request for
Expedited Action.
    Filed Date: 4/27/16.
    Accession Number: 20160427-5340.
    Comments Due: 5 p.m. ET 5/18/16.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER16-1051-001.
    Applicants: Graphic Packaging International Inc.
    Description: Tariff Amendment: Supplement to Application for Order
Accepting Initial Market-Based Rate Tariff to be effective 3/1/2016.
    Filed Date: 4/28/16.
    Accession Number: 20160428-5085.
    Comments Due: 5 p.m. ET 5/19/16.

    Docket Numbers: ER16-1152-001.
    Applicants: Jericho Rise Wind Farm LLC.
    Description: Tariff Amendment: Revised Proposed MBR Tariff to be
effective 5/14/2016.
    Filed Date: 4/27/16.
    Accession Number: 20160427-5244.
    Comments Due: 5 p.m. ET 5/18/16.

    Docket Numbers: ER16-1154-001.
    Applicants: Parrey, LLC.
    Description: Tariff Amendment: Supplement to App. for MBR
Authorization in Response to Informal Staff Request to be effective 4/
1/2016.
    Filed Date: 4/27/16.
    Accession Number: 20160427-5243.
    Comments Due: 5 p.m. ET 5/18/16.

    Docket Numbers: ER16-1509-000.
    Applicants: New Wave Energy Corp.
    Description: Baseline eTariff Filing: New Wave Energy Corporation
to be effective 6/27/2016.
    Filed Date: 4/27/16.
    Accession Number: 20160427-5291.

    Comments Due: 5 p.m. ET 5/18/16.

    Docket Numbers: ER16-1510-000.
    Applicants: PPL Electric Utilities Corporation, PJM
Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: PPL Electric submits
revised Interconnection Agreement No. 746 to be effective 6/1/2016.
    Filed Date: 4/28/16.
    Accession Number: 20160428-5055.
    Comments Due: 5 p.m. ET 5/19/16.

    Docket Numbers: ER16-1511-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: 1st Quarter 2016 Updates
to OA and RAA Member Lists to be effective 3/31/2016.
    Filed Date: 4/28/16.
    Accession Number: 20160428-5200.
    Comments Due: 5 p.m. ET 5/19/16.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM16-3-000.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Application Pursuant to Section 292.310(A) for
Authorization to Terminate Mandatory Purchase Obligation in ERCOT of
Golden Spread Electric Cooperative, Inc.
    Filed Date: 4/27/16.
    Accession Number: 20160427-5337.
    Comments Due: 5 p.m. ET 5/25/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 28, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-10902 Filed 5-9-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 88 (Monday, May 8, 2023)]
[Proposed Rules]
[Pages 29573-29575]
[FR Doc No: 2023-08824]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-1026; Airspace Docket No. 23-AGL-7]
RIN 2120-AA66

Amendment of Multiple Air Traffic Service (ATS) Routes and
Establishment of Area Navigation (RNAV) Route T-478 in the Vicinity of
Danville, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Jet Route J-84, United States
Area Navigation (RNAV) route Q-42, and Very High Frequency (VHF) Omni-
directional Range (VOR) Federal airways V-171 and V-251, and establish
RNAV route T-478. The FAA is proposing this action due to the planned
decommissioning of the VOR portion of the Danville, IL (DNV), VOR/
Tactical Air Navigation (VORTAC) navigational aid (NAVAID). The
Danville VOR is being decommissioned in support of the FAA's VOR
Minimum Operational Network (MON) program.

DATES: Comments must be received on or before June 22, 2023.

ADDRESSES: Send comments identified by FAA Docket No. FAA-2023-1026 and
Airspace Docket No. 23-AGL-7 using any of the following methods:
    * Federal eRulemaking Portal: Go to www.regulations.gov and follow
the online instructions for sending your comments electronically.
    * Mail: Send comments to Docket Operations, M-30; U.S. Department
of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West
Building Ground Floor, Washington, DC 20590-0001.
    * Hand Delivery or Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    * Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. Follow the online instructions for
accessing the docket or go to the Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the National Airspace System (NAS) as
necessary to preserve the safe and efficient flow of air traffic.

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal. The most
helpful comments reference a specific portion of the proposal, explain
the reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should submit only one time if comments are filed electronically, or
commenters should send only one copy of written comments if comments
are filed in writing.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it receives on or before
the closing date for comments. The FAA will consider comments filed
after the comment period has closed if it is possible to do so without
incurring expense or delay. The FAA may change this proposal in light
of the comments it receives.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

Availability of Rulemaking Documents

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Operations office (see ADDRESSES section for address, phone number, and
hours of operations). An informal docket may also be examined during
normal business hours at the office of the Operations Support Group,
Central Service Center, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX, 76177.

Incorporation by Reference

    Jet Routes are published in paragraph 2004, United States RNAV
Routes (Q-routes) are published in paragraph 2006, VOR Federal airways
are published in paragraph 6010(a), and United States RNAV Routes (T-
routes) are published in paragraph 6011 of FAA Order JO 7400.11,
Airspace Designations and Reporting Points, which is incorporated by
reference in 14 CFR 71.1 on an annual basis. This document proposes to
amend the current version of that order, FAA Order JO 7400.11G, dated
August 19, 2022, and effective September 15, 2022. These updates would
be published in the next update to FAA Order JO 7400.11. That order is
publicly available as listed in the ADDRESSES section of this document.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

Background

    The FAA is planning to decommission the VOR portion of the
Danville, IL, VORTAC in January 2024. The Danville VOR was one of the
candidate VORs identified for discontinuance by the FAA's VOR MON
program and listed in the Final policy statement notice, ``Provision of
Navigation Services for the Next Generation Air Transportation System
(NextGen) Transition to Performance-Based Navigation (PBN) (Plan for
Establishing a VOR Minimum Operational Network),'' published in the
Federal Register on July 26, 2016 (81 FR 48694), Docket No. FAA-2011-
1082.
    Although the VOR portion of the Danville VORTAC is planned for
decommissioning, the co-located Tactical Air Navigation (TACAN) portion
of the NAVAID is being retained. The TACAN would continue to provide
navigational service for military operations and Distance Measuring
Equipment (DME) service supporting current and future NextGen PBN
flight procedure requirements.
    The ATS routes affected by the planned decommissioning of the
Danville VOR are J-84, Q-42, V-171, and V-251. With the planned
decommissioning of the Danville VOR, the remaining ground-based NAVAID
coverage in the area is insufficient to enable the continuity of the
affected routes. As such, proposed modifications to J-84 and V-251
would result in the ATS routes being shortened; to V-171 would result
in a second gap being added in the route; and to Q-42 would result in
the route being amended to replace the Danville VORTAC route point, as
well as the Kirksville, MO, VORTAC and the Muncie, IN, VOR/DME route
points, with a waypoint (WP).
    To address the affected ATS route proposed amendments, instrument
flight rules (IFR) traffic could use adjacent Jet Routes J-73, J-80,
and J-89 in the high-altitude stratum, VOR Federal airways V-55, V-274,
or V-277 in the low-altitude stratum, or request air traffic control
(ATC) radar vectors to fly around or through the affected area.
Additionally, pilots equipped with RNAV capabilities could also
navigate point to point using the existing fixes that would remain in
place to support continued operations though the affected area. Visual
flight rules (VFR) pilots who elect to navigate via the affected ATS
routes could also take advantage of the adjacent routes or ATC services
listed previously.
    Additionally, the FAA proposes to establish RNAV route T-478
between the Champaign, IL, VORTAC and the Boiler, IN, VORTAC as a
mitigation to the portion of V-251 affected by the planned Danville VOR
decommissioning. The new T-478 would also provide non-radar routing
between the RIVRS Fix located near the Bowling Green, MO, area and the
Champaign VORTAC.
    Prior to this NPRM, the FAA published a rule for Docket No. FAA-
2022-1395 in the Federal Register (88 FR 18023; March 27, 2023)
amending J-84 by removing the route segment overlying the Wolbach, NE,
VORTAC between the Sidney, NE, VOR/DME and the Dubuque, IA, VORTAC. The
J-84 route amendment is effective June 15, 2023 and is reflected in
this action.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to amend Jet
Route J-84, RNAV route Q-42, and VOR Federal airways V-171 and V-251,
and to establish RNAV route T-478 due to the planned decommissioning of
the VOR portion of the Danville, IL, VORTAC. The proposed ATS route
actions are described below.
    J-84: J-84 currently extends between the Oakland, CA, VOR/DME and
the Sidney, NE, VOR/DME; and between the Dubuque, IA, VORTAC and the
Danville, IL, VORTAC. The FAA proposes to remove the route segment
between the Northbrook, IL, VOR/DME and the Danville, IL, VORTAC. As
amended, the route would be changed to extend between the Oakland VOR/
DME and the Sidney VOR/DME and between the Dubuque VORTAC and the
Northbrook VOR/DME.
    Q-42: Q-42 currently extends between the Kirksville, MO, VORTAC and
the ZIMMZ, PA, Fix. The FAA proposes to replace the Kirksville VORTAC
route point with the LEWRP, MO, WP; replace the Danville, IL, VORTAC
route point with the LCOLN, IL, WP; and replace the Muncie, IN, VOR/DME
route point with the SNKPT, IN, WP. Additionally, editorial corrections
to the state abbreviation and the type of route point for the ZIMMZ Fix
would be made to match the National Airspace System Resource (NASR)
database information. As amended, the route would be changed to extend
between the LEWRP, MO, WP and the ZIMMZ, PA, Fix.
    V-171: V-171 currently extends between the Lexington, KY, VOR/DME
and the Joliet, IL, VOR/DME; and between the Nodine, MN, VORTAC and the
Roseau, MN, VOR/DME. The FAA proposes to remove the airway segment
between the Terre Haute, IN, VORTAC and the Peotone, IL, VORTAC. As
amended, the airway would be changed to extend between the Lexington
VOR/DME and the Terre Haute VORTAC, between the Peotone VORTAC and the
Joliet VOR/DME, and between the Nodine VORTAC and the Roseau VOR/DME.
Additional amendments to the airway have been proposed in a separate
rulemaking action.
    V-251: V-251 currently extends between the Adders, IL, VORTAC and
the Boiler, IN, VORTAC. The FAA proposes to remove the airway segment
between the Champaign, IL, VORTAC and the Boiler, IN, VORTAC. As
amended, the airway would be changed to extend between the Adders
VORTAC and the Champaign VORTAC.
    T-478: T-478 is a new RNAV route the FAA proposes to establish
between the RIVRS, MO, Fix located northeast of the Bolling Green, MO,
area and the BOLRR, IN, WP that is being established near the Boiler,
IN, VORTAC. This proposed T-route would provide routing between the
Champaign, IL, VORTAC and the Lafayette, IN, area to mitigate the
proposed removal of the V-251 airway segment addressed above and
provide non-radar routing between the RIVRS Fix and the Champaign
VORTAC, when needed.
    All NAVAID radials listed in the VOR Federal airway V-171
description below are unchanged and stated in degrees True north.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant

regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified that this proposed rule, when
promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 2004 Jet Routes.

* * * * *

J-84 [Amended]

    From Oakland, CA; Linden, CA; Mina, NV; Delta, UT; Meeker, CO;
to Sidney, NE. From Dubuque, IA; to Northbrook, IL.
* * * * *

Paragraph 2006 United States Area Navigation Routes.

* * * * *

Q-42 LEWRP, MO to ZIMMZ, PA [Amended]

LEWRP, MO              WP                    (Lat. 40[deg]08'06.06'' N, long. 092[deg]35'30.15'' W)
STRUK, IL              WP                    (Lat. 40[deg]14'03.66'' N, long. 090[deg]18'21.50'' W)
LCOLN, IL              WP                    (Lat. 40[deg]17'37.55'' N, long. 087[deg]33'25.36'' W)
SNKPT, IN              WP                    (Lat. 40[deg]14'13.96'' N, long. 085[deg]23'39.21'' W)
HIDON, OH              WP                    (Lat. 40[deg]10'00.00'' N, long. 081[deg]37'27.00'' W)
BUBAA, OH              WP                    (Lat. 40[deg]10'27.00'' N, long. 080[deg]58'17.00'' W)
PSYKO, PA              WP                    (Lat. 40[deg]08'37.00'' N, long. 079[deg]09'13.00'' W)
BRNAN, PA              WP                    (Lat. 40[deg]08'07.00'' N, long. 077[deg]50'06.70'' W)
HOTEE, PA              WP                    (Lat. 40[deg]20'36.00'' N, long. 076[deg]29'37.00'' W)
SPOTZ, PA              WP                    (Lat. 40[deg]45'55.00'' N, long. 075[deg]22'59.00'' W)
ZIMMZ, PA              FIX                   (Lat. 40[deg]48'11.00'' N, long. 075[deg]07'25.00'' W)

* * * * *

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-171 [Amended]

    From Lexington, KY; INT Lexington 251[deg] and Louisville, KY,
114[deg] radials; Louisville; to Terre Haute, IN. From Peotone, IL;
INT Peotone 281[deg] and Joliet, IL, 173[deg] radials; to Joliet.
From Nodine, MN; INT Nodine 298[deg] and Farmington, MN, 124[deg]
radials; Farmington; Darwin, MN; Alexandria, MN; INT Alexandria
321[deg] and Grand Forks, ND, 152[deg] radials; Grand Forks; to
Roseau, MN.
* * * * *

V-251 [Amended]

    From Adders, IL; to Champaign, IL.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-478 RIVRS, IL to BOLRR, IN [New]

RIVRS, IL                    FIX                (Lat. 39[deg]25'21.41'' N, long. 090[deg]55'56.70'' W)
Spinner, IL (SPI)            VORTAC             (Lat. 39[deg]50'23.04'' N, long. 089[deg]40'39.85'' W)
Champaign, IL (CMI)          VORTAC             (Lat. 40[deg]02'04.31'' N, long. 088[deg]16'33.87'' W)
SLONI, IL                    WP                 (Lat. 40[deg]11'06.39'' N, long. 087[deg]55'15.88'' W)
LCOLN, IL                    WP                 (Lat. 40[deg]17'37.55'' N, long. 087[deg]33'25.36'' W)
BOLRR, IN                    WP                 (Lat. 40[deg]33'22.03'' N, long. 087[deg]04'09.55'' W)

* * * * *

    Issued in Washington, DC, on April 21, 2023.
Brian Konie,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-08824 Filed 5-5-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Pages 41272-41273]
[FR Doc No: 2014-16658]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting Notice

 July 10, 2014.
    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. No. 94-409), 5
U.S.C. 552b:

Agency Holding Meeting:

Date and Time: July 17, 2014, 10:00 a.m.

Place: Room 2C, 888 First Street NE., Washington, DC 20426.

Status: Open.

Matters to be Considered: Agenda. * Note--Items listed on the agenda
may be deleted without further notice.

Contact Person for More Information: Kimberly D. Bose, Secretary,
Telephone<PHONE_NUMBER>.
    For a recorded message listing items struck from or added to the
meeting, call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does not include a listing of all documents relevant to the items on
the agenda. All public documents, however, may be viewed on line at the
Commission's Web site at http://www.ferc.gov using the eLibrary link,
or may be examined in the Commission's Public Reference Room.

                                                 1007th--Meeting
----------------------------------------------------------------------------------------------------------------
                Item No.                          Docket No.                            Company
----------------------------------------------------------------------------------------------------------------
                                                 Administrative
----------------------------------------------------------------------------------------------------------------
A-1....................................  AD02-1-000.................  Agency Business Matters.
A-2....................................  AD02-7-000.................  Customer Matters, Reliability, Security
                                                                       and Market Operations.
----------------------------------------------------------------------------------------------------------------
                                                    Electric
----------------------------------------------------------------------------------------------------------------
E-1....................................  ER13-102-001...............  New York Independent System Operator, Inc.
                                         ER13-102-002...............
E-2....................................  EL14-73-000................  The Empire District Electric Company.
E-3....................................  EL14-76-000................  Louisville Gas and Electric Company and
                                                                       Kentucky Utilities Company.
E-4....................................  EL14-72-000................  UNS Electric, Inc.
E-5....................................  EL14-77-000................  Westar Energy, Inc.
E-6....................................  EL14-74-000................  Kansas City Power & Light Company.
                                         EL14-75-000................  KCP&L Greater Missouri Operations Company.
E-7....................................  EL14-71-000................  Black Hills Power, Inc.
E-8....................................  RM14-15-000................  Physical Security Reliability Standard.
E-9....................................  RM14-8-000.................  Protection System Maintenance Reliability
                                                                       Standard.
E-10...................................  RM13-19-000................  Generator Relay Loadability and Revised
                                         RM14-3-000.................   Transmission Relay Loadability
                                                                       Reliability Standards.
E-11...................................  PL14-1-000.................  Payment of Dividends from Funds Included
                                                                       in Capital Account.
E-12...................................  ER14-1175-001..............  Southwest Power Pool, Inc.
E-13...................................  EL14-38-000................  Sunflower Electric Power Corporation v.
                                                                       Kansas Municipal Energy Agency and
                                                                       Southwest Power Pool, Inc.
E-14...................................  ER14-480-001...............  California Independent System Operator
                                                                       Corporation.
----------------------------------------------------------------------------------------------------------------
                                                       Gas
----------------------------------------------------------------------------------------------------------------
G-1....................................  RM14-21-000................  Natural Gas Act Pipeline Maps.
G-2....................................  RP14-728-000...............  El Paso Natural Gas Company, L.L.C.
                                         RP14-773-000...............  City of Las Cruces, New Mexico; City of
                                                                       Mesa, Arizona; ConocoPhillips Company;
                                                                       Freeport-McMoRan Corporation; Navajo
                                                                       Tribal Utility Authority; New Mexico Gas
                                                                       Company, Inc. and Southwest Gas
                                                                       Corporation v. El Paso Natural Gas
                                                                       Company, L.L.C. (Not Consolidated).
G-3....................................  RP12-455-002...............  Panhandle Eastern Pipe Line Company, LP.
                                         RP12-455-003...............
----------------------------------------------------------------------------------------------------------------

                                                      Hydro
----------------------------------------------------------------------------------------------------------------
H-1....................................  RM14-20-000................  Format and Dimensions of Maps and Drawings
                                                                       Required by the Commission's Hydropower
                                                                       Program.
H-2....................................  P-2210-244.................  Appalachian Power Company.
H-3....................................  P-12532-005................  Pine Creek Mine, LLC.
H-4....................................  P-7019-061.................  Eastern Hydroelectric Corporation.
----------------------------------------------------------------------------------------------------------------
                                                  Certificates
----------------------------------------------------------------------------------------------------------------
C-1....................................  CP14-132-000...............  Gulf Oil Limited Partnership.
----------------------------------------------------------------------------------------------------------------

 Kimberly D. Bose,
 Secretary.
    A free webcast of this event is available through www.ferc.gov.
Anyone with Internet access who desires to view this event can do so by
navigating to www.ferc.gov's Calendar of Events and locating this event
in the Calendar. The event will contain a link to its webcast. The
Capitol Connection provides technical support for the free webcasts. It
also offers access to this event via television in the DC area and via
phone bridge for a fee. If you have any questions, visit
www.CapitolConnection.org or contact Danelle Springer or David
Reininger at<PHONE_NUMBER>.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in the Commission Meeting Room. Members of
the public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters, but will not be telecast through the Capitol
Connection service.

[FR Doc. 2014-16658 Filed 7-11-14; 11:15 am]
BILLING CODE 6717-01-P


[Federal Register: May 23, 2008 (Volume 73, Number 101)]
[Notices]
[Page 30178-30179]
[DOCID:fr23my08-125]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57833; File No. SR-NYSE-2008-35]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change To Amend Section 703.21 of the Listed Company Manual
Relating to Equity-Linked Debt Securities

May 19, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 2, 2008, 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 and
II below, which Items have been prepared substantially by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons and is granting
accelerated approval to the proposed rule change.
---------------------------------------------------------------------------

    \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 703.21 of the Listed Company
Manual (``Manual'') to clarify the application of Rule 19b-4(e) under
the Act \3\ to the listing of equity-linked debt securities (``ELDS'').
The text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and http://www.nyse.com.
---------------------------------------------------------------------------

    \3\ 17 CFR 240.19b-4(e).
---------------------------------------------------------------------------

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

    In its filing with the Commission, NYSE 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 III below. 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
    Section 703.21 of the Manual provides that the Exchange will
consider listing ELDS that meet the criteria of Section 703.21. ELDS
are non-convertible debt of an issuer where the value of the debt is
based, at least in part, on the value of another issuer's common stock,
non-convertible preferred stock, common units of a master limited
partnership, or any other common equity security of a type classified
for trading as stocks by the Exchange.
    The Exchange proposes to make explicit that Rule 19b-4(e) under the
Act applies to the listing of ELDS that meet the criteria of paragraphs
(A) through (D) of Section 703.21 of the Manual. The Exchange states
that these criteria, therefore, constitute ``generic'' listing criteria
for ELDS, and the Exchange would file an appropriate Form 19b-4(e) with
the Commission within five days of listing a series of ELDS under the
generic listing criteria. The proposed rule change would also provide
that the Exchange may submit a rule filing pursuant to Section 19(b)(2)
of the Act \4\ to permit the listing and trading of ELDS that do not
otherwise meet the standards set forth in paragraphs (A) through (D) of
Section 703.21 of the Manual.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Exchange also proposes to amend paragraph (D) of Section 703.21
to refer to the Commission's Division of Trading and Markets.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \5\ of the Act, in general, and furthers the
objectives of Section 6(b)(5),\6\ in particular, in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, and to remove impediments to and perfect the mechanisms of
a free and open market and a national market system. The Exchange
believes that the proposed rule change clarifies the application of
Rule 19b-4(e) under the Act to the listing of ELDS. This facilitates
the listing and trading of such securities on the Exchange, thereby

enhancing competition among market participants, to the benefit of
investors and the marketplace.
---------------------------------------------------------------------------

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

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

    NYSE 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. 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 (www.sec.gov/
rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2008-35 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-2008-35. 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, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2008-35 and should be
submitted on or before June 13, 2008.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\7\ In particular, the Commission finds that the proposed rule
change is consistent with Section 6(b)(5) of the Act,\8\ which requires
that the rules of an exchange be designed, among other things, 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 a national market system,
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission finds good cause for approving this proposal before
the 30th day after the publication of notice thereof in the Federal
Register. The proposal seeks to clarify that the Exchange's listing and
trading of ELDS under Section 703.21 of the Manual is subject to Rule
19b-4(e) under the Act. The proposal also clarifies the process for
listing and trading ELDS that do not meet the standards of paragraphs
(A) through (D) of Section 703.12 of the Manual. The Commission does
not believe that these clarifications raise any novel regulatory
issues.
    Therefore, the Commission believes that accelerating approval of
this proposal is appropriate and would ensure that the Exchange's rules
clearly reflect the standards for listing and trading of ELDS and
conform the NYSE's rules to those of other exchanges without delay.\9\
---------------------------------------------------------------------------

    \9\ See e.g., Chicago Board Options Exchange Rule 31.5(I) and
NYSE Arca Rule 5.2(j)(2).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-NYSE-2008-35), be, and it
hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-11550 Filed 5-22-08; 8:45 am]

BILLING CODE 8010-01-P


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<META name="creation-date" content="14/09/2009 11:44:10 ">
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[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Proposed Rules]
[Pages 13513-13516]
[FR Doc No: 2012-5476]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2012-N-0170]

Modernizing the Regulation of Clinical Trials and Approaches to
Good Clinical Practice; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 2-day
public hearing to obtain input from interested persons on FDA's scope
and direction in modernizing the regulations, policies, and practices
that apply to the conduct of clinical trials of FDA-regulated products.
Clinical trials are a critical source of evidence to inform medical
policy and practice, and effective regulatory oversight is needed to
ensure that human subjects are protected and resulting clinical trial
data are credible and accurate. FDA is aware of concerns within the
clinical trial community that certain regulations and policies
applicable to the conduct of clinical trials may result in
inefficiencies or increased cost and may not facilitate the use of
innovative methods and technological advances to improve clinical trial
quality. The Agency is involved in an effort to modernize the
regulatory framework that governs clinical trials and approaches to
good clinical practice (GCP). The purpose of this hearing is to solicit
public input from a broad group of stakeholders on the scope and
direction of this effort, including encouraging the use of innovative
models that may enhance the effectiveness and efficiency of the
clinical trial enterprise.

DATES: Date and Time: The public hearing will be held on April 23 and
24, 2012, from 8:30 a.m. to 4:30 p.m.

Individuals who wish to attend or present at the public hearing must
register on or before close of business on April 2, 2012. To register
for the public hearing, email your registration information to
<EMAIL_ADDRESS>Section IV of this document provides
attendance and registration information. Electronic or written comments
will be accepted after the public hearing until May 31, 2012.

ADDRESSES: The public hearing will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD 20993-
0002.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Identify comments with the corresponding docket number found in
brackets in the heading of this document.
    Transcripts of the public hearing will be available for review at
the Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the public hearing (see
section VII of this document).
    A live webcast of this public hearing can be viewed at the
following Web address on the days of the public hearing: http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm. A video record of the
public hearing will be available at the same Web address for 1 year.

FOR FURTHER INFORMATION CONTACT: Jennifer Hymiller, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6333, Silver Spring, MD 20993-0002, 301-
796-2147, FAX:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Clinical trials that yield reliable data are critical to FDA's
mission to ensure that drugs, biologics, and medical devices are safe
and effective. The regulations that govern the conduct of clinical
trials and the protection of human subjects have been in existence for
more than 25 years. In the intervening years, there have been dramatic
changes in the clinical trial enterprise, including increased size and
complexity of clinical trials, increases in the number of clinical
trials performed globally, greater use of contract research
organizations (CROs), participation of vulnerable populations, and
numerous scientific and technological advances. Given these changes and
the evolution of the clinical trial enterprise, FDA is evaluating its
regulatory approach to clinical trial oversight to ensure that it meets
the regulatory objectives of ensuring human subject protection and the
quality and integrity of data supporting regulatory decision-making,
without being unnecessarily burdensome or unduly impeding
implementation of innovative approaches. FDA has already taken a number
of steps to improve and modernize its regulations, policies, and
practices to ensure they provide for optimal clinical trial quality,
data integrity, human subject protection, and flexibility.
    In 2004, FDA introduced the Critical Path Initiative (CPI),\1\
intended to transform the way medical products are developed,
evaluated, and manufactured. One of the CPI's key areas of focus is
modernizing clinical trial sciences to make trials safer and more
efficient. As part of this larger initiative, FDA launched two
initiatives to specifically address human subject protection, data
integrity, and clinical trial quality and efficiency.
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    \1\ For more information on FDA's Critical Path Initiative, see
http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm.
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    In 2006, FDA launched the Human Subject Protection and Bioresearch
Monitoring Initiative \2\ aimed at modernizing and strengthening FDA's
oversight and protection of human subjects and the integrity of data in
clinical trials. FDA's Office of Good Clinical Practice in the Office
of the Commissioner is leading this effort. FDA also established a
Human Subject Protection and Bioresearch Monitoring Council that
manages and sets FDA policy on bioresearch monitoring, GCP, and human
subject protection.
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    \2\ For more information on FDA's Human Subject Protection and
Bioresearch Monitoring Initiative, see http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm226306.htm.
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    In 2007, FDA and Duke University formed the Clinical Trials
Transformation Initiative (CTTI),\3\ a public-private partnership with
the goal of improving the quality and efficiency of clinical trials.
CTTI has been involved in a range of projects, including projects to
identify best practices for monitoring and designing quality into
clinical trials, improve serious adverse event reporting to
investigators, and gather best practices for premarket safety
surveillance.
---------------------------------------------------------------------------

    \3\ For more information on the Clinical Trials Transformation
Initiative, see https://www.trialstransformation.org/.
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    In 2011, FDA published a Federal Register notice requesting comment
on the development of a plan for the retrospective review of existing
FDA regulations \4\ in accordance with Executive Order 13563,
``Improving Regulation and Regulatory Review.'' As part of this plan,
FDA is conducting a review of existing regulations to determine which,
if any, of its rules are outmoded, ineffective, insufficient or
excessively burdensome and may be good candidates to be modified,
streamlined, expanded or repealed. The Agency is also evaluating its
framework for periodically analyzing existing rules.\5\
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    \4\ 76 FR 23520; April 27, 2011.
    \5\ 76 FR 3821.
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    Over the past few years, FDA has issued a number of regulations and
guidance documents related to clinical trial conduct. The following
regulations and guidances are highlighted below to exemplify the
direction and scope of FDA's effort to modernize the regulations,
policies, and practices that apply to the conduct of clinical trials.
The CPI, Human Subject Protection and Bioresearch Monitoring
Initiative, and CTTI have helped inform these regulations and
guidances:
    1. Investigational New Drug Safety Reporting Requirements for Human
Drug and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies--Final Rule, published
September 29, 2010 (75 FR 59935);
    2. Investigator Responsibilities--Protecting the Rights, Safety,
and Welfare of Study Subjects--Final Guidance, published October 26,
2009 (74 FR 55052);
    3. Oversight of Clinical Investigations: A Risk-Based Approach to
Monitoring--Draft Guidance, published August 29, 2011 (76 FR 53683);
    4. Electronic Source Documentation in Clinical Investigations--
Draft Guidance, published January 7, 2011 (76 FR 1173);
    5. Adverse Event Reporting to IRBs--Improving Human Subject
Protection--Final Guidance, published January 15, 2009 (74 FR 2599);
    6. Exception from Informed Consent Requirements for Emergency
Research--Final Guidance, published April 4, 2011 (76 FR 18558);
    The collaborative effort with CTTI also identified Quality Risk
Management (QRM) principles and Quality by Design (QbD) as models that,
with adaptations, could contribute to improved data quality and
integrity in clinical trials. QRM is a systematic process to identify,
assess, control,

communicate, and review the risks associated with a process or
activity. QbD, a risk-based, quality approach that has been successful
in the manufacturing arena, emphasizes building quality into a process
from the beginning. Applied to clinical trials, this approach would
prospectively define factors most critical to trial quality and data
integrity (e.g., proper randomization, effective blinding to ensure
unbiased ascertainment and analysis of study outcomes) and
prospectively identify risks critical to those factors. The sponsor
would then design the protocol, oversight and monitoring mechanisms, as
well as data management, archiving, and analysis processes to eliminate
or mitigate those risks.
    FDA has also taken steps to improve its clinical trial inspection
processes and coordinate inspection processes globally. Ongoing efforts
are aimed at developing new approaches for selecting clinical
investigator sites for inspection and for improving the warning letter
process. FDA is also involved in a Good Clinical Practice Initiative
\6\ with the European Medicines Agency (EMA), in which FDA and the EMA
have shared information on applications, collaborated on joint and
observational inspections, participated in bilateral training, and kept
each other informed of GCP-related legislation, regulatory guidance,
and related documents. These steps have facilitated improvements in
FDA's inspection coverage and decision-making processes.
---------------------------------------------------------------------------

    \6\ For more information on the EMA-FDA Good Clinical Practice
Initiative, see http://www.fda.gov/downloads/InternationalPrograms/FDABeyondOurBordersForeignOffices/EuropeanUnion/EuropeanUnion/EuropeanCommission/UCM266259.pdf.
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    In various forums, FDA has been told that certain regulations and
compliance practices may result in inefficiencies or may not facilitate
the use of innovative methods to improve clinical trial quality or the
use of technological advances (e.g., use of the Internet to gather
data, conduct certain types of research, obtain informed consent). FDA
has also heard from clinical trial sponsors and CROs that sponsors and
CROs are reluctant to change their processes related to clinical trial
oversight and management because of uncertainty about whether new
processes would be in compliance with applicable regulations. FDA
recognizes that it must effectively leverage its available resources
and take additional steps to strategically evolve and modernize its
regulatory approach to the conduct of clinical trials. FDA is striving
to align regulatory processes to meet the needs of its many
stakeholders, including those who design and conduct trials, those who
participate in trials, and those who depend on the results of those
trials to make informed health care decisions.

II. Purpose of Hearing

    The purpose of this public hearing is to obtain input from clinical
trial sponsors, CROs, clinical investigators, academic institutions,
institutional review boards (IRBs), professional societies, trade
organizations, patient and consumer groups, and other interested
parties on the scope and direction of FDA's future efforts to evolve
and modernize its regulatory approach to the conduct and oversight of
clinical trials. FDA's primary focus is on good clinical practice,
including clinical protocol design to ensure the reliability of data,
safety surveillance and reporting, quality control processes (e.g.,
monitoring and training), quality assurance (e.g., auditing), and any
other processes directed at ensuring trial quality, data integrity, or
human subject protection. FDA is interested in ways (e.g., workshops,
strategic alliances) to foster implementation of innovative methods to
ensure human subject protection and data quality and integrity,
including risk-based approaches in the design, oversight, and conduct
of clinical investigations. FDA is seeking feedback on specific GCP
regulations, policies, and practices that may need clarification or
revision to facilitate advances in the ways that clinical trials are
conducted, remove impediments to the use of innovative approaches, or
otherwise improve the conduct of clinical trials. FDA also welcomes
comments on additional issues that will help the Agency modernize its
oversight and improve the quality and efficiency of clinical trials.

III. Issues for Discussion

    In addition to the general information requests in section II of
this document, FDA is interested in obtaining information and public
comment on the following specific issues.
    1. Increasing clinical trial complexity (e.g., participation of
vulnerable populations, increased frequency of outsourcing) and
globalization are posing challenges for sponsors, clinical
investigators, IRBs, patients, and FDA. FDA has been involved in a
number of efforts to ensure that the Agency's GCP regulations,
policies, and practices are optimal for ensuring clinical trial
quality, data integrity, and human subject protection while providing
flexibility to conduct trials in the 21st century.
    a. What additional efforts should FDA pursue to modernize the
Agency's GCP regulations, policies, and practices? For example, are
there specific FDA regulations, guidances, or practices (e.g.,
compliance programs) that should be a high priority for clarification
or revision? Are there other steps (e.g., pilot projects, strategic
alliances) that would help ensure clinical trial quality and subject
safety, provide flexibility, or improve the efficiency of the clinical
trial process? For each of the suggested efforts, specifically identify
the reasons that the current approach is not optimal, how the suggested
effort would ensure clinical trial quality, subject safety, and/or
improve the efficiency of the clinical trial process, and what the
preferred priority of the efforts should be.
    b. What efforts could FDA consider that could help mitigate some of
the challenges resulting from increased clinical trial complexity and
globalization? For each of the suggested efforts, specifically identify
how the effort could help mitigate these challenges.
    2. FDA is interested in fostering the use of innovative methods and
models, including QRM principles and QbD, as well as the use of
technological advances (e.g., use of the Internet to gather data,
conduct certain types of research, obtain informed consent). The Agency
seeks comments on how the use of innovative methods, models, and
technological advances could contribute to data integrity, clinical
trial quality, and the safety of human subjects, as well as streamline
the conduct of clinical trials.
    a. What are some innovative methods or models that facilitate
building quality into the conduct of trials (e.g., by identifying,
preventing, or minimizing errors that have the potential to compromise
human subject safety and data integrity)? FDA requests feedback on
experiences with implementing such methods or models (e.g., lessons
learned), as well as data supporting the use of any suggested methods
or models.
    b. FDA recognizes that the clinical trial process involves various
stakeholders (e.g., sponsors, CROs, IRBs, investigators, patients) with
different roles and responsibilities in ensuring human subject
protection and generating valid study data. What are the specific
stakeholder challenges presented by FDA's GCP regulations, policies,
and/or practices to building quality into the clinical trial process
(e.g., for a study that is conducted and overseen by multiple
entities)?
    c. What are some ways in which FDA could encourage adoption of
these

methods and models? For example, how can FDA support effective
communication and coordination among all entities involved in the
conduct of a trial to ensure a focus on the protection of human
subjects and quality across the clinical trial process?
    d. How should FDA focus its efforts in GCP regulations, policies,
or practices to facilitate the use of technological advances, while
maintaining the protection of research participants and the quality and
integrity of data supporting regulatory decision-making?

IV. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance is
free and will be on a first-come, first-serve basis. Individuals who
wish to attend the public hearing must register by sending an email to
<EMAIL_ADDRESS>on or before April 2, 2012, and provide
complete contact information, including: Name, title, affiliation,
address, email, and phone number. Those without email access may
register by contacting Jennifer Hymiller (see FOR FURTHER INFORMATION
CONTACT). Because seating is limited, FDA may limit the numbers of
participants from each organization. Registrants will receive
confirmation once they have been accepted for participation in the
hearing. Onsite registration on the day of the hearing will be based on
space availability on the day of the event starting at 7:30 a.m. If
registration reaches maximum capacity, FDA will post a notice closing
the meeting registration for the hearing at http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm.
    Individuals who wish to present at the public hearing must register
on or before April 2, 2012, through the email
<EMAIL_ADDRESS>and state this intention on their notice
of participation. You must provide complete contact information,
including: Name, title, affiliation, address, email, and phone number.
FDA has included questions for comment in section III of this document.
You should identify the topic or section and the number of each
question you wish to address in your presentation, so that FDA can
consider that in organizing the presentations. Individuals and
organizations with common interests should consolidate or coordinate
their presentations and request time for a joint presentation. FDA will
do its best to accommodate requests to speak and will determine the
amount of time allotted for each oral presentation, and the approximate
time that each oral presentation is scheduled to begin. FDA will notify
registered presenters of their scheduled times, and make available a
draft agenda on http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm
approximately 2 weeks before the public hearing. Once FDA notifies
registered presenters of their scheduled times, presenters should
submit to electronic copy of their presentation to
<EMAIL_ADDRESS>on or before April 16, 2012.
    If you need special accommodations because of disability, please
contact Jennifer Hymiller (see FOR FURTHER INFORMATION CONTACT) at
least 7 days before the meeting.
    A live webcast of this public hearing can be viewed at the
following Web address on the days of the public hearing: http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm. A video record of the
public hearing will be available at the same Web address for 1 year.

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner, the Center for Drug Evaluation and Research, the Center
for Biologics Evaluation and Research, and the Center for Devices and
Radiological Health.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under
Sec.  10.205, representatives of the electronic media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see section VII of this document). To the extent that the
conditions for the hearing, as described in this notice, conflict with
any provisions set out in part 15, this notice acts as a waiver of
those provisions as specified in Sec.  15.30(h).

VI. Request for Comments

    Regardless of attendance at the public hearing, interested persons
may submit either electronic or written comments to the Division of
Dockets Management (see ADDRESSES). It is only necessary to send one
set of comments. Identify comments with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

VII. Transcripts

    Transcripts of the public hearing will be available for review at
the Division of Dockets Management (see ADDRESSES) and on the Internet
at http://www.regulations.gov approximately 30 days after the public
hearing. A transcript will also be made available in either hard copy
or on CD-ROM, upon submission of a Freedom of Information request.
Written requests are to be sent to the Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.

    Dated: March 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5476 Filed 3-6-12; 8:45 am]
BILLING CODE 4160-01-P