[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Notices]
[Page 17985-17986]
[DOCID:fr02ap08-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0203] (formerly Docket No. 2003E-0402)

Determination of Regulatory Review Period for Purposes of Patent
Extension; ACRYSOF

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for ACRYSOF and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that medical device.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman,Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (half
the testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA approved for marketing the medical device ACRYSOF. ACRYSOF is
indicated for replacement of the human lens to achieve visual
correction of aphakia in adults when extracapsular cataract extraction
or phacoemulsification are performed. These lenses are intended for
placement in the capsular bag. Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
ACRYSOF (U.S. Patent No. 5,470,932) from Alcon Manufacturing, Ltd., and
the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated April 6, 2004, FDA advised the Patent and Trademark Office
that this medical device had undergone a regulatory review period and
that the approval of ACRYSOF represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
ACRYSOF is 1,084 days. Of this time, 538 days occurred during the
testing phase of the regulatory review period, while 546 days occurred
during the approval phase. These periods of time were derived from the
following dates:

    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this
device became effective: July 7, 2000. The applicant claims that the
investigational device exemption (IDE) required under section 520(g) of
the act for human tests to begin became effective on June 8, 2000.
However, FDA records indicate that the IDE was determined substantially
complete for clinical studies to have begun on July 7, 2000, which
represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the act (21 U.S.C. 360e): December 26,
2001. The applicant claims December 21, 2001, as the date the premarket
approval application (PMA) for ACRYSOF (PMA P930014/S009) was initially
submitted. However, FDA records indicate that PMA P930014/S009 was
submitted on December 26, 2001.
    3. The date the application was approved: June 24, 2003. FDA has
verified the applicant's claim that PMA P930014/S009 was approved on
June 24, 2003.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 832 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by June 2, 2008. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by September 29,
2008. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 16, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-6851 Filed 4-1-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 71 (Tuesday, April 14, 2015)]
[Notices]
[Pages 20053-20057]
[FR Doc No: 2015-08450]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74678; File No. SR-NYSE-2015-15]

Self-Regulatory Organizations; New York Stock Exchange, LLC;
Notice of Filing of Proposed Rule Change Amending Rule 13 and Related
Rules Governing Order Types and Modifiers

April 8, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on March 24, 2015, 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 prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 13 and related rules governing
order types and modifiers. 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.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    On June 5, 2014, in a speech entitled ``Enhancing Our Market Equity
Structure,'' Mary Jo White, Chair of the Securities and Exchange
Commission (``SEC'' or the ``Commission'') requested the equity
exchanges to conduct a comprehensive review of their order types and
how they operate in practice, and as part of this review, consider
appropriate rule changes to help clarify the nature of their order
types.\4\ Subsequent to the Chair's speech, the SEC's Division of
Trading and Markets requested that the equity exchanges complete their
reviews and submit any proposed rule changes.\5\
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    \4\ See Mary Jo White, Chair, Securities and Exchange
Commission, Speech at the Sandler, O'Neill & Partners, L.P. Global
Exchange and Brokerage Conference (June 5, 2014) (available at
www.sec.gov/News/Speech/Detail/Speech/1370542004312#.U5HI-fmwJiw).
    \5\ See Letter from James Burns, Deputy Director, Division of
Trading and Markets, Securities and Exchange Commission, to Jeffrey
C. Sprecher, Chief Executive Officer, Intercontinental Exchange,
Inc., dated June 20, 2014.
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    The Exchange notes that it continually assesses its rules governing
order types and undertook on its own initiative a review of its rules
related to order functionality to assure that its various order types,
which have been adopted and amended over the years, accurately describe
the functionality associated with those order types, and more
specifically, how different order types may interact. As a result of
that review, the Exchange submitted a proposed rule change to delete
rules relating to functionality that was not available.\6\ In addition,
over the years, when filing rule changes to adopt new functionality,
the Exchange has used those filings as an opportunity to streamline
related existing rule text for which functionality has not changed.\7\
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    \6\ See Securities Exchange Act Release No. 71897 (April 8,
2014), 79 FR 20953 (April 14, 2014) (SR-NYSE-2014-16) (``2014
Pegging Filing'') (amending rules governing pegging interest to
conform to functionality that is available at the Exchange).
    \7\ See, e.g., Securities Exchange Act Release Nos. 68302 (Nov.
27, 2012), 77 FR 71658 (Dec. 3, 2012) (SR-NYSE-2012-65) (amending
rules governing pegging interest to, among other things, make non-
substantive changes, including moving the rule text from Rule 70.26
to Rule 13, to make the rule text more focused and streamlined)
(``2012 Pegging Filing''), and 71175 (Dec. 23, 2013), 78 FR 79534
(Dec. 30, 2013) (SR-NYSE-2013-21) (approval order for rule proposal
that, among other things, amended Rule 70 governing Floor broker
reserve e-quotes that streamlined the rule text without making
substantive changes) (``2013 Reserve e-Quote Filing'').
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    The Exchange is filing this proposed rule change to continue with
its efforts

to review and clarify its rules governing order types, as appropriate.
Specifically, the Exchange notes that Rule 13 is currently structured
alphabetically, and does not include subsection numbering. The Exchange
proposes to provide additional clarity to Rule 13 by re-grouping and
re-numbering current rule text and making other non-substantive,
clarifying changes. The proposed rule changes are not intended to
reflect changes to functionality but rather to clarify Rule 13 to make
it easier to navigate.\8\ In addition, the Exchange proposes to amend
certain rules to remove references to functionality that is no longer
operative.
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    \8\ The Exchange notes that its affiliated exchanges, NYSE MKT
LLC and NYSE Arca, Inc. are proposing similar restructuring of their
respective order type rules to group order types and modifiers. See
SR-NYSEMKT-2015-22 and SR-NYSEArca-2015-08.
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Proposed Rule 13 Restructure
    The Exchange proposes to re-structure Rule 13 to re-group existing
order types and modifiers together along functional lines.
    Proposed new subsection (a) of Rule 13 would set forth the
Exchange's order types that are the foundation for all other order type
instructions, i.e., the primary order types. The proposed primary order
types would be:
     Market Orders. Rule text governing Market Orders would be
moved to new Rule 13(a)(1). The Exchange proposes a non-substantive
change to replace the reference to ``Display Book'' with a reference to
``Exchange systems.'' \9\ The Exchange notes that it proposes to
capitalize the term ``Market Order'' throughout new Rule 13.
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    \9\ The Exchange proposes to replace the term ``Display book''
with the term ``Exchange systems'' when use of the term refers to
the Exchange systems that receive and execute orders. The Exchange
proposes to replace the term ``Display Book'' with the term
``Exchange's book'' when use of the term refers to the interest that
has been entered and ranked in Exchange systems.
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     Limit Orders. Rule text governing Limit Orders would be
moved to new Rule 13(a)(2). The Exchange proposes a non-substantive
change to capitalize the term ``Limit Order,'' and to shorten the
definition in a manner that streamlines the rule text without changing
the meaning of the rule. The Exchange notes that it proposes to
capitalize the term ``Limit Order'' throughout new Rule 13.
    The Exchange notes that it proposes to delete the definition of
``Auto Ex Order'' because all orders entered electronically at the
Exchange are eligible for automatic execution in accordance with Rules
1000-1004 and therefore the Exchange does not believe that it needs to
separately define an Auto Ex Order. Rather than maintain a separate
definition, the Exchange proposes to specify in proposed Rule 13(a)
that all orders entered electronically at the Exchange are eligible for
automatic execution consistent with the terms of the order and Rules
1000-1004. The Exchange notes that Rule 13 currently provides for
specified instructions for orders that may not execute on arrival, even
if marketable, e.g., a Limit Order designated ALO, or may only be
eligible to participate in an auction, accordingly, the terms of the
order also control whether a marketable order would automatically
execute upon arrival. The Exchange further proposes to specify that
interest represented manually by Floor brokers, i.e., orally bid or
offered at the point of sale on the Trading Floor, is not eligible for
automatic execution. The Exchange notes that the order types currently
specified in the definition for auto ex order are already separately
defined in Rule 13 or Rule 70(a)(ii) (definition of G order).
    Proposed new subsection (b) of Rule 13 would set forth the existing
Time in Force Modifiers that the Exchange makes available for orders
entered at the Exchange. The Exchange proposes to: (i) Move rule text
governing Day Orders to new Rule 13(b)(1), without any substantive
changes to the rule text; (ii) move rule text governing Good til
Cancelled Orders to new Rule 13(b)(2), without any substantive changes
to the rule text; and (iii) move rule text governing Immediate or
Cancel Orders to new Rule 13(b)(3) without any changes to rule text.
The Exchange notes that these time-in-force conditions are not separate
order types, but rather are modifiers to orders. Accordingly, the
Exchange proposes to re-classify them as modifiers and remove the
references to the term ``Order.'' In addition, as noted above, the
Exchange proposes to capitalize the term ``Limit Order'' in Rule 13(b).
    Proposed new subsection (c) of Rule 13 would specify the Exchange's
existing Auction-Only Orders. In moving the rule text, the Exchange
proposes the following non-substantive changes: (i) Capitalize the
terms ``Limit Order,'' ``CO Order,'' and ``Market Order''; (ii) move
the rule text for CO Orders to new Rule 13(c)(1); (iii) rename a
``Limit `At the Close' Order'' as a ``Limit-on-Close (LOC) Order'' and
move the rule text to new Rule 13(c)(2); (iv) rename a ``Limit `On-the-
Open' Order'' as a ``Limit-on-Open (LOO) Order'' and move the rule text
to new Rule 13(c)(3); (v) rename a ``Market `At-the-Close' Order'' as a
``Market-on-Close (MOC) Order'' and move the rule text to new Rule
13(c)(4); and (vi) rename a ``Market `On-the-Open' Order'' as a
``Market-on-Open (MOO) Order'' and move the rule text to new Rule
13(c)(5).
    Proposed new subsection (d) of Rule 13 would specify the Exchange's
existing orders that include instructions not to display all or a
portion of the order. The order types proposed to be included in this
new subsection are:
     Mid-point Passive Liquidity (``MPL'') Orders. Existing
rule text governing MPL Orders would be moved to new Rule 13(d)(1) with
non-substantive changes to capitalize the term Limit Order, update
cross references, and refer to ``Add Liquidity Only'' as ALO, since ALO
is now a separately defined term in new Rule 13(e)(1). The Exchange
also proposes to clarify the rule text by deleting the term
``including'' from the phrase ``[a]n MPL Order is not eligible for
manual executions, including openings, re-openings, and closings,''
because MPL Orders would not participate in an opening, re-opening, or
closing that is effectuated electronically.\10\ The Exchange further
proposes to make a substantive amendment to the rule text set forth in
new Rule 13(d)(1)(C) to specify that Exchange systems would reject an
MPL Order on entry if the Minimum Triggering Volume (``MTV'') is larger
than the size of the order and would reject a request to partially
cancel a resting MPL Order if it would result in the MTV being larger
than the size of the order and make conforming changes to the existing
rule text. The Exchange would continue to enforce an MTV restriction if
the unexecuted portion of an MPL Order with an MTV is less than the
MTV. The Exchange believes that this proposed rule change would prevent
an entering firm from causing an MPL Order to have an MTV that is
larger than the order, thereby bypassing contra-side interest that is
larger than the size of the MPL Order.\11\ Finally, the Exchange
proposes to make a non-substantive change to new Rule 13(d)(1)(E) to
replace the term ``discretionary trade'' with ``d-Quote,'' because d-
Quotes are the only type of Exchange interest that is eligible to
include discretionary pricing instructions.\12\
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    \10\ See Rule 123C.10 (``Closings may be effectuated manually or
electronically'') and Rule 123D(1) (``Openings may be effectuated
manually or electronically'').
    \11\ The Exchange notes that because of technology changes
associated with rejecting MPL Orders that have an MTV larger than
the size of the order, the Exchange will announce by Trader Update
when this element of the proposed rule change will be implemented.
    \12\ See Rule 70.25 (Discretionary Instructions for Bids and
Offers Represented via Floor Broker Agency Interest Files (e-
QuotesSM)).

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     Reserve Orders. Existing rule text governing Reserve
Orders would be moved to new Rule 13(d)(2) with non-substantive changes
to capitalize the term ``Limit Order'' and hyphenate the term ``Non-
Displayed.'' The Exchange proposes further non-substantive changes to
the rule text governing Minimum Display Reserve Orders, which would be
in new Rule 13(d)(2)(C), to clarify that a Minimum Display Reserve
Order would participate in both automatic and manual executions. This
is existing functionality relating to Minimum Display Reserve Orders
\13\ and the proposed rule text aligns with Rule 70(f)(i) governing
Floor broker Minimum Display Reserve e-Quotes.\14\ Similarly, the
Exchange proposes non-substantive changes to the rule text governing
Non-Displayed Reserve Orders, which would be in new Rule 13(d)(2)(D),
to clarify that a Non-Displayed Reserve Order would not participate in
manual executions. This is existing functionality relating to Non-
Displayed Reserve Orders \15\ and the proposed rule text aligns with
Rule 70(f)(ii) governing Non-Display Reserve eQuotes excluded from the
DMM.\16\ Finally, in proposed new Rule 13(d)(2)(E), the Exchange
proposes to clarify that the treatment of reserve interest, which is
available for execution only after all displayable interest at that
price point has been executed, is applicable to all Reserve Orders, and
is not limited to Non-Displayed Reserve Orders.\17\
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    \13\ See Securities Exchange Act Release No. 57688 (April 18,
2008), 73 FR 22194 at 22197 (April 24, 2008) (SR-NYSE-2008-30)
(order approving rule change that, among other things, adopted new
Reserve Order for which the non-displayed portion of the order is
eligible to participate in manual executions) (``2008 Reserve Order
Filing'').
    \14\ See 2013 Reserve e-Quote Filing, supra n. 7.
    \15\ See Securities Exchange Act Release No. 58845 (Oct. 24,
2008), 73 FR 64379 at 64384 (Oct. 29, 2008) (SR-NYSE-2008-46) (order
approving the Exchange's New Market Model, including adopting a Non-
Displayed Reserve Order that would not be eligible to participate in
manual executions).
    \16\ See 2013 Reserve e-Quote Filing, supra n. 7.
    \17\ See 2008 Reserve Order Filing supra n. 13 at 22196
(displayable portion of Reserve Order executed together with other
displayable interest at a price point before executing with reserve
portion of the order).
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    Proposed new subsection (e) of Rule 13 would specify the Exchange's
existing order types that, by definition, do not route. The order types
proposed to be included in this new subsection are:
     Add Liquidity Only (``ALO'') Modifiers. Existing rule text
governing ALO modifiers would be moved to new Rule 13(e)(1) with non-
substantive changes to capitalize the term ``Limit Order'' and update
cross-references. Existing rule text that is being moved to new Rule
13(e)(1)(A) currently provides that Limit Orders designated ALO may
participate in opens and closes, but that the ALO instructions would be
ignored. Because Limit Orders designated ALO could also participate in
re-openings, and the ALO instructions would similarly be ignored, the
Exchange proposes to clarify new Rule 13(e)(1)(A) to provide that Limit
Orders designated ALO could participate in openings, re-openings, and
closings, but that the ALO instructions would be ignored.
     Do Not Ship (``DNS'') Orders. Existing rule text governing
DNS Orders would be moved to new Rule 13(e)(2) with non-substantive
changes to capitalize the term ``Limit Order'' and replace the
reference to ``Display Book'' with a reference to ``Exchange systems.''
     Intermarket Sweep Order. Existing rule text governing ISOs
would be moved to new Rule 13(e)(3) with non-substantive changes to
capitalize the term ``Limit Order'', update cross-references, and
replace the reference to ``Display Book'' with a reference to
``Exchange's book.''
    Proposed new subsection (f) of Rule 13 would specify the Exchange's
other existing order instructions and modifiers, including:
     Do Not Reduce (``DNR'') Modifier. Existing rule text
governing DNR Orders would be moved to new Rule 13(f)(1) with non-
substantive changes to capitalize the terms ``Limit Order'' and ``Stop
Order.'' In addition, the Exchange believes that because DNR
instructions would be added to an order, DNR is more appropriately
referred to as a modifier rather than as an order type.
     Do Not Increase (``DNI'') Modifiers. Existing rule text
governing DNI Orders would be moved to new Rule 13(f)(2) with non-
substantive changes to capitalize the terms ``Limit Order'' and ``Stop
Order.'' In addition, the Exchange believes that because DNI
instructions would be added to an order, DNI is more appropriately
referred to as a modifier rather than as an order type.
     Pegging Interest. Existing rule text governing Pegging
Interest and related subsections would be moved to new Rule 13(f)(3)
with two clarifying changes to the existing rule text. First, because
Pegging Interest is currently available for e-Quotes and d-Quotes only,
the Exchange proposes to replace the term ``can'' with the term
``must'' in new Rule 13(f)(3)(a)(i) to provide that Pegging Interest
``must be an e-Quote or d-Quote.'' Second, the Exchange proposes to
delete reference to the term ``Primary Pegging Interest,'' because the
Exchange has only one form of pegging interest.\18\
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    \18\ See 2014 Pegging Filing, supra n. 6.
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     Retail Modifiers. Existing rule text governing Retail
Modifiers and related subsections would be moved to new Rule 13(f)(4)
with non-substantive changes to update cross-references.
     Self-Trade Prevention (``STP'') Modifier. Existing rule
text governing STP Modifiers and related subsections would be moved to
new Rule 13(f)(5) with non-substantive changes to capitalize the terms
``Limit Orders,'' ``Market Orders,'' and ``Stop Orders'' and hyphenate
the term ``Self-Trade Prevention.''
     Sell ``Plus''--Buy ``Minus'' Instructions. Existing rule
text governing Sell ``Plus''--Buy ``Minus'' Orders would be moved to
new Rule 13(f)(6) with non-substantive changes to break the rule into
subsections, capitalize the terms ``Market Order,'' ``Limit Order,''
and ``Stop Order,'' and replace the references to Display Book with
references to Exchange systems. In addition, the Exchange proposes to
re-classify this as an order instruction rather than as a separate
order.
     Stop Orders. Existing rule text governing Stop Orders
would be moved to new Rule 13(f)(7) with non-substantive changes to
break the rule into subsections, capitalize the term ``Market Order,''
and replace references to ``Exchange's automated order routing system''
with references to ``Exchange systems.''
    As part of the proposed restructure of Rule 13, the Exchange
proposes to move existing rule text in Rule 13 governing the definition
of ``Routing Broker'' to Rule 17(c), without any change to the rule
text. The Exchange believes that Rule 17 is a more logical location for
the definition of Routing Broker because Rule 17(c) governs the
operations of Routing Brokers.
    In addition, the Exchange proposes to delete existing rule text in
Rule 13 governing Not Held Orders and add rule text relating to not
held instructions to supplementary material .20 to Rule 13.
Supplementary material .20 to Rule 13 reflects obligations that members
have in handling customer orders. Because not held instructions are
instructions from a customer to a member or member organization
regarding the handling of an order, and do not relate to instructions
accepted by Exchange systems for execution, the Exchange believes that
references to not held instructions are better suited for this existing
supplementary material.
    Accordingly, the Exchange proposes to amend supplementary material
.20 to

Rule 13 to add that generally, an instruction that an order is ``not
held'' refers to an unpriced, discretionary order voluntarily
categorized as such by the customer and with respect to which the
customer has granted the member or member organization price and time
discretion. The Exchange believes that this proposed amendment aligns
the definition of ``not held'' with guidance from the Financial
Industry Regulatory Authority, Inc. (``FINRA'') and other markets
regarding not held instructions.\19\ The Exchange notes that the
existing Rule 13 text regarding how to mark a Not Held Order, e.g.,
``not held,'' ``disregard tape,'' ``take time,'' etc., are outdated
references regarding order marking between a customer and a member or
member organization. All Exchange members and member organizations that
receive customer orders are subject to Order Audit Trail System
(``OATS'') obligations, consistent with Rule 7400 Series and FINRA Rule
7400 Series, which require that order-handling instructions be
documented in OATS. Among the order-handling instructions that can be
captured in OATS is whether an order is not held.\20\ The Exchange
believes that these OATS-related obligations now govern how a member or
member organization records order-handling instructions from a customer
and therefore the terms currently set forth in Rule 13 relating to Not
Held Orders are no longer necessary.
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    \19\ See FINRA Regulatory Notice 11-29, Answer 3 (June 2011)
(``Generally, a `not held' order is an unpriced, discretionary order
voluntarily categorized as such by the customer and with respect to
which the customer has granted the firm price and time
discretion.''). See also Definition of Market Not Held Order on
Nasdaq.com Glossary of Stock Market Terms, available at http://www.nasdaq.com/investing/glossary/m/market-not-held-order.
    \20\ See FINRA OATS Frequently Asked Questions--Technical, at
T21 (``An order submitted by a customer who gives the broker
discretion as to the price and time of execution is denoted as a
``Not Held'' order.''), available at http://www.finra.org/Industry/Compliance/MarketTransparency/OATS/FAQ/P085542.
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    Finally, the Exchange proposes to amend Rule 70.25 governing d-
Quotes to clarify that certain functionality set forth in the Rule is
no longer available. Specifically, Rule 70.25(c)(ii) currently provides
that a Floor broker may designate a maximum size of contra-side volume
with which it is willing to trade using discretionary pricing
instructions. Because this functionality is not available, the Exchange
proposes to delete references to the maximum discretionary size
parameter from Rules 70.25(c)(ii) and (c)(v). In addition, the Exchange
proposes to amend Rule 70.25(c)(iv) to clarify that the circumstances
of when the Exchange would consider interest displayed by other market
centers at the price at which a d-Quote may trade are not limited to
determining when a d-Quote's minimum or maximum size range is met.
Accordingly, the Exchange proposes to delete the clause ``when
determining if the d-Quote's minimum and/or maximum size range is
met.'' The Exchange believes that the proposed changes to Rule 70.25(c)
will provide clarity and transparency regarding the existing
functionality relating to d-Quotes at the Exchange.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\21\ in general, and
furthers the objectives of Section 6(b)(5),\22\ in particular, because
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, 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. Specifically,
the Exchange believes that the proposed restructuring of Rule 13, to
group existing order types to align by functionality, would remove
impediments to and perfect the mechanism of a free and open market by
ensuring that members, regulators, and the public can more easily
navigate the Exchange's rulebook and better understand the order types
available for trading on the Exchange. In addition, the Exchange
believes that the proposed revisions to Rule 13 promote clarity
regarding existing functionality that has been approved in prior rule
filings, but which may not have been codified in rule text.\23\
Moreover, the Exchange believes that moving rule text defining a
Routing Broker to Rule 17 represents a more logical location for such
definition, thereby making it easier for market participants to
navigate Exchange rules. Likewise, the Exchange believes the proposed
changes to ``Not Held Order,'' to move it to supplementary material .20
to Rule 13 and revise the rule text to conform with guidance from FINRA
and OATS requirements, would remove impediments to and perfect the
mechanism of a free and open market and a national market system by
applying a uniform definition of not held instructions across multiple
markets, thereby reducing the potential for confusion regarding the
meaning of not held instructions.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(5).
    \23\ See supra nn. 13-18.
---------------------------------------------------------------------------

    The Exchange further believes that the proposed amendment regarding
MPL Orders to reject both MPL Orders with an MTV larger than the size
of the order and instructions to partially cancel an MPL Order that
would result in an MTV larger than the size of the order would remove
impediments to and perfect the mechanism of a free and open market and
national market system in general because it could potentially reduce
the ability of a member organization from using MPL Orders to bypass
contra-side interest that may be larger than the size of the MPL Order.
    Finally, the Exchange believes that the proposed changes to Rule
70.25(c) would remove impediments to and perfect the mechanism of a
free and open market and national market system in general because it
assures that the Exchange's rules align with the existing functionality
available at the Exchange for d-Quotes.

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. The proposed change is not
designed to address any competitive issue but rather would re-structure
Rule 13 and remove rule text that relates to functionality that is no
longer operative, thereby reducing confusion and making the Exchange's
rules easier to navigate.

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

    Within 45 days of the date of publication of this notice in the
Federal Register, or up to 90 days (i) as the Commission may designate
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 or disapprove the proposed rule change, or

    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2015-15 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2015-15. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing will also be available
for inspection and copying at the NYSE's principal office and on its
Internet Web site at www.nyse.com. 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-2015-15 and should be submitted on or before May 5,
2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-08450 Filed 4-13-15; 8:45 am]
 BILLING CODE 8011-01-P


 MEMORANDUM

DATE:08/6/2014 FROM: 		Laura Farris/EPA Region 8 TO:CLEAN Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602 SUBJECT:	Alliance for Sustainable Colorado Sustainability Series held on 08/5/2014

SUMMARY:         Laura Farris, EPA Region 8 Climate Change Coordinator, presented information on the proposed Clean Power Plan for Existing Power Plants at the Alliance for Sustainable Colorado Sustainability Series event on 08/5/2014. The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.

ATTENDEES:

EPA Region 8 Laura Farris

External Stakeholders Megan Moore Stribling, Events & Community Engagement Manager, Alliance for Sustainable Colorado Members of the Public


[Federal Register: October 27, 2008 (Volume 73, Number 208)]
[Rules and Regulations]
[Page 63630]
[DOCID:fr27oc08-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 417

[Docket No. FAA-2000-7953; Amendment No. 417]
RIN 2120-AG37

Licensing and Safety Requirements for Launch

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; technical amendment.

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

SUMMARY: This action corrects reference errors that appeared in a final
rule the FAA published in the Federal Register on August 25, 2006. The
final rule amended commercial space transportation regulations
governing the launch of expendable launch vehicles. In that final rule,
the FAA inadvertently referenced incorrect sections. The intent of this
action is to correct this minor error in the regulation to ensure the
requirement is clear and accurate.

DATES: Effective October 27, 2008.

FOR FURTHER INFORMATION CONTACT: Ren[eacute] Rey, Licensing and Safety
Division, AST-200, Federal Aviation Administration, 800 Independence
Avenue, SW., Washington, DC 20591; telephone<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>For questions regarding legal interpretation, contact
Laura Montgomery, AGC-200,<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 25, 2006, the FAA published a
final rule in the Federal Register (71 FR 50537) that, among other
changes, amended Sec.  417.25(c)(3). The FAA inadvertently referenced
incorrect sections in 14 CFR 417.25(c)(3). As published, this provision
requires a post launch report to identify any flight environment not
consistent with the maximum predicted environment as required by Sec.
417.307(b) and any measured wind profiles not consistent with the
predictions used for the launch, as required by Sec.  417.217(d)(2).
These references are incorrect. They should refer launch operators to
Appendix D 417.7(b) and Appendix A 417.7(g)(3), respectively.
    This amendment will not impose any additional restrictions on
operators affected by these regulations.

Technical Amendment

    This technical amendment corrects the references in Sec.
417.25(c)(3).

Justification for Immediate Adoption

    Because this action merely corrects a reference made in the
published rule, the FAA finds that notice and public comment under 5
U.S.C. 553(b) is not necessary. For the same reason, the FAA finds good
cause exists under 5 U.S.C. 553(d) for making this rule effective upon
publication.

List of Subjects in 14 CFR Part 417

    Aviation safety, Reporting and recordkeeping requirements, Rockets,
Space transportation and exploration.

0
Accordingly, Title 14 of the Code of Federal Regulations (CFR) part 417
is amended as follows:

PART 417--LAUNCH SAFETY

0
1. The authority citation for part 417 continues to read as follows:

    Authority: 49 U.S.C. 70101-70121.

0
2. Amend Sec.  417.25 by revising paragraph (c)(3) to read as follows:

Sec.  417.25  Post launch report.

    (c) * * *
    (3) For the launch of launch vehicle flown with a flight safety
system, identify any flight environment not consistent with the maximum
predicted environment as required by D 417.7(b) and any measured wind
profiles not consistent with the predictions used for the launch, as
required by Sec.  417.7(g)(3); and
* * * * *

    Issued in Washington, DC on October 22, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. E8-25506 Filed 10-24-08; 8:45 am]

BILLING CODE 4910-13-P


48103 Federal Register / Vol. 64, No. 170 / Thursday, September 2, 1999 / Rules and Regulations Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA submitted a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives and the Comptroller General of the United States prior to publication of the rule in today's Federal Register. This rule is not a `` major rule'' defined by 5 U. S. C. 804( 2).

Paperwork Reduction Act Under the Paperwork Reduction Act, 44 U. S. C. 3501 et seq., Federal agencies must consider the paperwork burden imposed by any information request contained in a proposed rule or a final rule. This rule will not impose any information requirements upon the regulated community.

Executive Order 12875 Enhancing Intergovernmental Partnerships Under E. O. 12875, the EPA may not issue regulation that is not required by statute and that creates a mandate upon a State, local or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, the EPA must provide to the OMB a description of the extent of EPA's prior consultation with representatives of affected State, local and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, E. O. 12875 requires the EPA to develop an effective process permitting elected officials and other representatives of State, local and tribal governments to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates. This rule does not create a mandate on State, local or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1( a) of E. O. 12875 do not apply to this rule.

Executive Order 13084 Consultation and Coordination With Indian Tribal Governments Under E. O. 13084, the EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance cost incurred by the tribal governments. If the mandate is unfunded, the EPA must provide to the OMB, in a separately identified section of the preamble to the rule, a description of the extent of the EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, E. O. 13084 requires the EPA to develop an effective process permitting elected and other representatives of Indian tribal governments `` to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities. This rule is not subject to E. O. 13084 because it does not significantly or uniquely affect the communities of Indian governments. The State of Louisiana is not authorized to implement the RCRA hazardous waste program in Indian country. This action has no effect on the hazardous waste program that the EPA implements in the Indian country within the State.

List of Subjects in 40 CFR Part 271 Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous materials transportation, Hazardous waste, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Water pollution control, Water supply.

Authority This document is issued under the authority of sections 2002( a), 3006, and 7004( b) of the Solid Waste Disposal Act as amended, 42 U. S. C. 6912( a), 6926, 6974( b).

Dated: June 15, 1999.

Jerry Clifford,

Acting Regional Administrator, Region 6. [ FR Doc. 99   22627 Filed 9   1   99; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 439 [ FRL   6431   8]

RIN 2040   AA13 Pharmaceutical Manufacturing Category Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards; Correcting Amendments AGENCY: Environmental Protection Agency ( EPA). ACTION: Correcting amendments.

SUMMARY: EPA is correcting minor errors in the effluent limitations guidelines and standards for the pharmaceutical manufacturing point source category which appeared in the Federal Register on September 21, 1998. DATES: These corrections shall become effective September 2, 1999. In accordance with 40 CFR 23.2, this rule will be considered promulgated for purposes of judicial review at 1: 00 p. m. Eastern Time on September 16, 1999. FOR FURTHER INFORMATION CONTACT: Dr. Frank H. Hund, Office of Water, Engineering and Analysis Division ( 4303), U. S. Environmental Protection Agency, 401 M St., SW, Washington, DC 20460, ( 202) 260   7182, hund. frank@ epamail. epa. gov. SUPPLEMENTARY INFORMATION:

I. Background In a final rule published on September 21, 1998 ( 63 FR 50388), EPA established final effluent limitations and standards for the pharmaceutical manufacturing point source category for the control of wastewater pollutants. The final rule omitted a clarifying abbreviation and contained four incorrect subsections. This notice inserts a clarifying abbreviation, deletes four incorrect subsections, changes the parenthetical letters identifying two subsections and deletes the parenthetical letters identifying two other subsections. The clarifying abbreviation `` Mg/ L'' ( milligrams per liter) is necessary to avoid confusion with the abbreviation `` Mg `` ( megagrams) which is used in the preamble section devoted to the discussion of the MACT rule which was promulgated at the same time as the pharmaceuticals effluent guidelines rule. The subsection deletions are in the Pretreatment Standards for New Sources ( PSNS) sections of the rule. These subsections contained a cite from the regulations concerning new source direct dischargers which is inconsistent 48104 Federal Register / Vol. 64, No. 170 / Thursday, September 2, 1999 / Rules and Regulations with the definition of new source contained in section 403.3( k) of the general pretreatment regulations. As a result of today's correction, the PSNS sections of the pharmaceuticals effluent guidelines will be consistent with the general pretreatment regulations. The PSNS sections will also be consistent with PSNS sections in other recently promulgated effluent guidelines rules. Today's correction also `` renumbers'' ( by revising or deleting) the labels for the PSNS sections. For example, if paragraph ( d) is deleted, paragraph ( e) is renamed as ( d).

II. Administrative Requirements Under Executive Order 12886 ( 58 FR 51735, October 4, 1993), this is not a `` significant regulatory action'' and, is therefore not subject to review by the Office of Management and Budget. In addition, this action does not impose any enforceable duty, contain any unfunded mandate, or impose any significant or unique impact on small governments as described in the Unfunded Mandates Reform Act of 1995 ( Pub. L. 104   4). This rule also does not require prior consultation with State, local, and tribal government officials as specified by Executive Order 12875 ( 58 FR 58093, October 28, 1993) or Executive Order 13084 ( 63 FR 27655, May 10, 1998), or involve special consideration of environmental justice related issues as required by Executive Order 12898 ( 59 FR 7629, February 16, 1994). Because this action is not subject to the notice and comment requirements under the Administrative Procedure Act, 5 U. S. C. 533, or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act ( 5 U. S. C. 601 et. seq.). This rule also is not subject to Executive Order 13045 ( 62 FR 19885, April 23, 1997) because it is not economically significant as defined under E. O. 12866. Further, EPA interprets E. O. 13045 as applying only to those regulatory actions that are based on health and safety risks, such that the analysis required under section 5   501 of the Order has the potential to influence the regulation. This rule is not subject to E. O. 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. This rule is not subject to the National Technology Transfer and Advancement Act of 1995 ( Pub. L. 104   113) because it does not involve any technical standards. This action contains no information collection requirements. Therefore, it is not subject to the Paperwork Reduction Act of 1980, 44 U. S. C. 1501, et seq. EPA's compliance with these statutes and Executive Orders for the underlying rule is discussed in the Federal Register notice of September 21, 1998. The revisions in this final rule are not substantive. These revisions add a clarifying abbreviation, delete four incorrect subsections of the rule, change parenthetical letters identifying two subsections and delete parenthetical letters identifying two other subsections. For this reason, EPA has determined that public participation in this action is unnecessary and constitutes good cause for issuing this rule without notice and comment. For the same reason, the Agency has determined that good cause exists to waive the requirement for a 30 day period before the amendments become effective. Therefore, the amendments are effective immediately. The Congressional Review Act ( CRA), 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U. S. C. Section 808( 2). As stated previously, EPA has made such a good cause finding, including the reasons therefor, and established an effective date of September 2, 1999. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 439 Environmental protection, Reporting and recordkeeping requirements, Water pollution control.

Dated: August 25, 1999. J. Charles Fox, Assistant Administrator for Water.

For reasons set out in the preamble, part 439, title 40, chapter I of the Code of Federal Regulations is amended as follows:

PART 439   PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY 1. The authority citation for part 439 continues to read: Authority: Secs. 301, 304, 306, 307, 308, 402 and 501 of the Clean Water Act, as amended; 33 U. S. C. 1311, 1314, 1316, 1317, 1318, 1342, and 1361.

2. Section 439.1 is amended by adding paragraph ( n) to read as follows:

§ 439.1 General definitions.

* * * * * ( n) The abbreviation Mg/ L means milligrams per liter or parts per million ( ppm).

§ 439.17 [ Amended]

3. Section 439.17 is amended by removing paragraph ( d) and redesignating paragraph ( e) as ( d). 4. Section 439.27 is amended by removing paragraph ( b) and removing the paragraph designation from paragraph ( a) and revising the newly designated introductory text before the table to read as follows:

§ 439.27 Pretreatment standards for new sources ( PSNS).

Except as provided in 40 CFR 403.7, any new source subject to this subpart must achieve the following pretreatment standards: * * * * *

§ 439.37 [ Amended]

5. Section 439.37 is amended by removing paragraph ( d) and redesignating paragraph ( e) as ( d).

§ 439.47 [ Amended]

6. Section 439.47 is amended by removing the paragraph designation from paragraph ( a) and by removing paragraph ( b).

[ FR Doc. 99   22745 Filed 9   1   99; 8: 45 am]

BILLING CODE 6560   50   P DEPARTMENT OF TRANSPORTATION Federal Highway Administration 49 CFR Parts 383 and 384 [ FHWA Docket No. FHWA   97   3103]

RIN 2125   AE28 Commercial Driver Disqualification Provision AGENCY: Federal Highway Administration ( FHWA), DOT. ACTION: Final rule.

SUMMARY: The FHWA revises its regulations to require that commercial motor vehicle ( CMV) drivers who are convicted of violating Federal, State, or local laws or regulations pertaining to railroad highway grade crossings be disqualified from operating a CMV. Penalties also will be assessed against


[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Rules and Regulations]
[Pages 69992-69995]
[FR Doc No: 2013-27917]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2013-N-0002]

Withdrawal of Approval of New Animal Drug Applications;
Carbarsone; Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal approval of three new animal
drug applications (NADAs) for roxarsone or carbarsone Type A medicated
articles at the sponsor's request because the products are no longer
manufactured or marketed.

DATES: This rule is effective December 2, 2013.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007, has requested that FDA withdraw approval of the following three
NADAs because the products, used to manufacture Type B and Type C
medicated feeds, are no longer manufactured or marketed: NADA 007-891
for 3-NITRO (roxarsone) Type A

medicated articles, NADA 092-953 for Roxarsone Type A Medicated
Articles, and NADA 010-285 for CARB-O-SEP (carbarsone) Type A medicated
article.
    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 007-891, 010-285, and 092-953, and all
supplements and amendments thereto, is withdrawn, effective December 2,
2013. As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these voluntary withdrawals of
approval.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.120  [Amended]

0
2. In Sec.  558.120, remove and reserve paragraphs (a)(1) and
(d)(1)(i).

0
3. In Sec.  558.530, remove and reserve paragraphs (a) and (b); and
revise the tables in paragraphs (d)(1) through (3) to read as follows:

Sec.  558.530  Roxarsone.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combinations in
  Roxarsone in grams per ton      grams per ton      Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 45.4............  Chlortetracycline   Growing chickens: For    Feed continuously             054771
                                10 to 50.           increased rate of        throughout growing
                                                    weight gain, improved    period; withdraw 5
                                                    feed efficiency, and     days before slaughter;
                                                    improved pigmentation.   as sole source of
                                                                             organic arsenic; drug
                                                                             overdose or lack of
                                                                             water may result in
                                                                             weakness or paralysis
                                                                             of the legs.
                                                                            Chlortetracycline as
                                                                             provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
(iii) 22.7 to 45.4...........  Chlortetracycline   Growing chickens: For    Feed continuously for 7       054771
                                100 to 200.         increased rate of        to 14 days; withdraw 5
                                                    weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    infectious synovitis     water may result in
                                                    caused by Mycoplasma     weakness or paralysis
                                                    synoviae susceptible     of the legs.
                                                    to chlortetracycline.   Chlortetracycline as
                                                                             provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
(iv) 22.7 to 45.4............  Chlortetracycline   Growing chickens: For    Feed continuously for 7       054771
                                200 to 400.         increased rate of        to 14 days; withdraw 5
                                                    weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    chronic respiratory      water may result in
                                                    disease (CRD) and air    weakness or paralysis
                                                    sac infection caused     of the legs.
                                                    by M. gallisepticum     Chlortetracycline as
                                                    and Escherichia coli     provided by No. 054771
                                                    susceptible to           in Sec.   510.600(c)
                                                    chlortetracycline.       of this chapter.
(v) 22.7 to 45.4.............  Chlortetracycline   Growing chickens: For    Feed continuously for 5       054771
                                500.                increased rate of        days; withdraw 5 days
                                                    weight gain, improved    before slaughter; as
                                                    feed efficiency, and     sole source of organic
                                                    improved pigmentation;   arsenic; drug overdose
                                                    and for reduction of     or lack of water may
                                                    mortality due to E.      result in weakness or
                                                    coli infections          paralysis of the legs.
                                                    susceptible to          Chlortetracycline as
                                                    chlortetracycline.       provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
----------------------------------------------------------------------------------------------------------------

    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combinations in
  Roxarsone in grams per ton      grams per ton      Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 45.4............  Chlortetracycline   Growing turkeys: For     Feed continuously             054771
                                10 to 50.           increased rate of        throughout growing
                                                    weight gain, improved    period; withdraw 5
                                                    feed efficiency, and     days before slaughter;
                                                    improved pigmentation.   as sole source of
                                                                             organic arsenic; drug
                                                                             overdose or lack of
                                                                             water may result in
                                                                             weakness or paralysis
                                                                             of the legs.
                                                                            Chlortetracycline as
                                                                             provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.

(iii) 22.7 to 45.4...........  Chlortetracycline   Growing turkeys: For     Feed continuously for 7       054771
                                200.                increased rate of        to 14 days; withdraw 5
                                                    weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    infectious synovitis     water may result in
                                                    caused by Mycoplasma     weakness or paralysis
                                                    synoviae susceptible     of the legs.
                                                    to chlortetracycline.   Chlortetracycline as
                                                                             provided by No. 054771
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
(iv) 22.7 to 45.4............  Chlortetracycline   1. Growing turkeys: For  Feed continuously for 7       054771
                                400.                increased rate of        to 14 days; withdraw 5
                                                    weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    hexamitiasis caused by   water may result in
                                                    Hexamita meleagrides     weakness or paralysis
                                                    susceptible to           of the legs.
                                                    chlortetracycline.      Chlortetracycline as
                                                   2. Turkey poults not      provided by No. 054771
                                                    over 4 weeks of age:     in Sec.   510.600(c)
                                                    Reduction of mortality   of this chapter.
                                                    due to paratyphoid
                                                    caused by Salmonella
                                                    typhimurium
                                                    susceptible to
                                                    chlortetracycline.
(v) 22.7 to 45.4.............  Chlortetracycline,  Growing turkeys: For     Feed continuously for 7       054771
                                25 mg/lb body       increased rate of        to 14 days; withdraw 5
                                weight daily.       weight gain, improved    days before slaughter;
                                                    feed efficiency, and     as sole source of
                                                    improved pigmentation;   organic arsenic; drug
                                                    and for control of       overdose or lack of
                                                    complicating bacterial   water may result in
                                                    organisms associated     weakness or paralysis
                                                    with bluecomb            of the legs.
                                                    (transmissible          Chlortetracycline as
                                                    enteritis, coronaviral   provided by No. 054771
                                                    enteritis) susceptible   in Sec.   510.600(c)
                                                    to chlortetracycline.    of this chapter.
----------------------------------------------------------------------------------------------------------------

    (3) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combinations in
  Roxarsone in grams per ton      grams per ton      Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...............
(ii) 22.7 to 34.1............  Chlortetracycline   Growing and finishing    Feed for not more than        054771
                                400 (to             swine: For increased     14 days; withdraw 5
                                administer 10 mg/   rate of weight gain      days before slaughter;
                                lb body weight).    and improved feed        as sole source of
                                                    efficiency; and for      organic arsenic.
                                                    treatment of bacterial
                                                    enteritis caused by E.
                                                    coli and S.
                                                    choleraesuis and
                                                    bacterial pneumonia
                                                    caused by Pasteurella
                                                    multocida susceptible
                                                    to chlortetracycline.
(iii) [Reserved].............
(iv) 181.5...................  Chlortetracycline   Growing and finishing    Feed for not more than        054771
                                10 to 50.           swine: For increased     6 consecutive days; if
                                                    rate of weight gain      improvement is not
                                                    and improved feed        observed, consult a
                                                    efficiency; and for      veterinarian; withdraw
                                                    treatment of swine       5 days before
                                                    dysentery.               slaughter; as a sole
                                                                             source of organic
                                                                             arsenic; animals must
                                                                             consume enough
                                                                             medicated feed to
                                                                             provide a therapeutic
                                                                             dose.
(v) 181.5....................  Chlortetracycline   Growing and finishing    Feed for not more than        054771
                                400 (to             swine: For the           6 consecutive days; if
                                administer 10 mg/   treatment of swine       improvement is not
                                lb body weight).    dysentery; and for       observed, consult a
                                                    treatment of bacterial   veterinarian; withdraw
                                                    enteritis caused by E.   5 days before
                                                    coli and S.              slaughter; as a sole
                                                    choleraesuis and         source of organic
                                                    bacterial pneumonia      arsenic; animals must
                                                    caused by P. multocida   consume enough
                                                    susceptible to           medicated feed to
                                                    chlortetracycline.       provide a therapeutic
                                                                             dose.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: November 18, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-27917 Filed 11-21-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 1 (Thursday, January 2, 2014)]
[Notices]
[Pages 124-126]
[FR Doc No: 2013-31385]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG14-22-000.
    Applicants: Macho Springs Solar, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5359.
    Comments Due: 5 p.m. ET 1/10/14.

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

    Docket Numbers: ER04-835-000, EL04-103-000.
    Applicants: California Independent System Operator Corporation,
Pacific Gas and Electric Company.
    Description: Informational Refund Report of California Independent
System Operator Corporation.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5425.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER10-1801-002; ER10-1808-003; ER10-1805-003; ER10-
2370-001; ER10-1811-002.
    Applicants: The Connecticut Light and Power Company, Western
Massachusetts Electric Company, Public Service Company of New
Hampshire, NSTAR Electric Company, Select Energy, Inc.
    Description: Triennial Market Analysis Update of the NU MBR
Companies and Select Energy, Inc.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5414.
    Comments Due: 5 p.m. ET 2/18/14.

    Docket Numbers: ER10-2822-005; ER11-2462-004; ER11-2463-004; ER11-
2464-004; ER11-2465-004; ER10-2994-009; ER11-2466-004; ER11-2467-004;
ER11-2468-004; ER11-2469-004; ER11-2470-004; ER11-2471-004; ER11-2472-
004; ER11-2473-004; ER11-2196-005; ER11-2474-006; ER11-2475-004.
    Applicants: Iberdrola Renewables, LLC, Atlantic Renewable Projects
II LLC, Big Horn Wind Project LLC, Big Horn II Wind Project LLC,
Colorado Green Holdings LLC, Hay Canyon Wind LLC, Juniper Canyon Wind
Power LLC, Klamath Energy LLC, Klamath Generation LLC, Klondike Wind
Power LLC, Klondike Wind Power II LLC, Klondike Wind Power III LLC,
Leaning Juniper Wind Power II LLC, Pebble Springs Wind LLC, San Luis
Solar LLC, Star Point Wind Project LLC, Twin Buttes Wind LLC.
    Description: Updated Market Power Analysis for the Northwest Region
of the Iberdrola MBR Sellers.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5417.
    Comments Due: 5 p.m. ET 2/18/14.

    Docket Numbers: ER10-2997-003; ER10-3003-003; ER10-3018-003; ER10-
3015-003; ER10-3016-003; ER10-2992-003; ER10-3030-003; ER10-2990-003.
    Applicants: Atlantic City Electric Company, Bethlehem Renewable
Energy, LLC, Delmarva Power & Light Company, Eastern Landfill Gas, LLC,
Fauquier Landfill Gas, LLC, Pepco Energy Services, Inc., Potomac
Electric Power Company, Potomac Power Resources, LLC.
    Description: Triennial Market-Based Rate Update Filing for the
Northeast Region of the PHI Entities.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5427.
    Comments Due: 5 p.m. ET 2/18/14.

    Docket Numbers: ER11-47-003; ER11-46-006; ER10-2975-006; ER10-

2981-003; ER11-41-003; ER12-2343-001; ER13-1896-003.
    Applicants: Appalachian Power Company, AEP Energy Partners, Inc.,
CSW Energy Services, Inc., AEP Texas Central Company, AEP Retail Energy
Partners, AEP Energy, Inc. AEP Generation Resources Inc.
    Description: Triennial Market Analysis Update of the AEP MBR
affiliates located in PJM balancing area authority.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5413.
    Comments Due: 5 p.m. ET 2/18/14.

    Docket Numbers: ER12-952-002; ER13-1141-001; ER13-1142-001; ER13-
1143-002; ER13-1144-002; ER10-2196-001.
    Applicants: Essential Power, LLC, Essential Power Massachusetts,
LLC, Essential Power Newington, LLC, Essential Power OPP, LLC,
Essential Power Rock Springs, LLC, Lakewood Cogeneration, L.P.
    Description: Triennial Market-Based Rate Update Filing for the
Northeast Region of the EP Entities.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5428.
    Comments Due: 5 p.m. ET 2/18/14.

    Docket Numbers: ER13-738-002; ER11-3097-006; ER10-1212-005; ER10-
1186-005; ER10-1277-005; ER10-1211-005; ER10-1188-005.
    Applicants: DTE Electric Company, DTE Energy Trading, Inc., DTE
River Rouge No. 1, L.L.C., DTE Energy Supply, Inc., DTE East China,
LLC, DTE Pontiac North, LLC, DTE Stoneman, LLC.
    Description: Notice of Change in Status of the DTE MBR Entities.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5412.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER13-1872-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits 2562 KMEA NITSA
NOA--Compliance Filing to be effective 6/1/2013.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5320.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER13-2484-001.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits 2013-12-20--IPE-GIP--Compliance to be effective 12/3/2013.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5333.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-70-001.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits Second Revised Rate
Schedule No. 83 Trilateral Agreement w--SEC and HPP to be effective 12/
20/2013.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5303.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-460-001.
    Applicants: Appalachian Power Company.
    Description: Appalachian Power Company submits 20131220 TCC Att K
Update to be effective 1/24/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5265.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-786-000.
    Applicants: Ameren Illinois Company.
    Description: Ameren Illinois Company submits Sectionalizing Switch
Replacement LA with IMEA and RECC to be effective 11/21/2013.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5330.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-787-000.
    Applicants: Macho Springs Solar, LLC.
    Description: Macho Springs Solar, LLC submits Application for
Initial Market-Based Rate Tariff and Granting Certain Waivers to be
effective 1/1/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5334.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-788-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits 2631 Kansas
Municipal Energy Agency NITSA NOA to be effective 11/2/2013.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5336.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-789-000.
    Applicants: Lake Benton Power Partners LLC.
    Description: Lake Benton Power Partners LLC submits Lake Benton
Amendment 3 Filing to be effective 2/19/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5338.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-790-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Midcontinent Independent System Operator, Inc. submits
12-20-13 Manitoba Hydro JOA Name Change to be effective 2/18/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5350.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-791-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits 1534R4 Kansas
Municipal Energy Agency NITSA NOA to be effective 12/1/2013.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5362.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-792-000.
    Applicants: NorthWestern Corporation.
    Description: NorthWestern Corporation submits SA 697--NITSA with
City of Great Falls to be effective 3/1/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5363.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-793-000.
    Applicants: The Empire District Electric Company.
    Description: The Empire District Electric Company submits Revised
MBR Tariff to be effective 12/31/9998.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5364.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-794-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits Termination of Rate
Schedule 12 Seams Agreement with Entergy Services, Inc. to be effective
12/19/2013.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5369.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-795-000.
    Applicants: Tyr Energy LLC.
    Description: Tyr Energy LLC submits Amendment to MBR--Order 784 to
be effective 12/21/2013.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5370.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-796-000.
    Applicants: Black Hills Power, Inc.
    Description: Black Hills Power, Inc. submits Order No. 784
Compliance Filing to be effective 2/18/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5371.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-797-000.
    Applicants: Black Hills/Colorado Electric Utility Company, LP.
    Description: Black Hills/Colorado Electric Utility Company, LP
submits Order No. 784 Compliance Filing to be effective 2/18/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5372.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-798-000.

    Applicants: Cheyenne Light, Fuel and Power Company.
    Description: Cheyenne Light, Fuel and Power Company submits Order
No. 784 Compliance Filing to be effective 2/18/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5373.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-799-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits Transmission
Access Charge Balancing Account Adjustment (TACBAA) 2014 to be
effective 3/1/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5379.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-800-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits Certificate
of Concurrence re WECC Unscheduled Flow Mitigation Plan in ER14-778 to
be effective 1/1/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5381.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-801-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Midcontinent Independent System Operator, Inc. submits
12-20-2013 GVTC Filing--ER14----000 to be effective 2/21/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5388.
    Comments Due: 5 p.m. ET 1/10/14.

    Docket Numbers: ER14-802-000.
    Applicants: Valley Electric Association, Inc.
    Description: Valley Electric Association, Inc. submits Annual TRBAA
Update to be effective 1/1/2014.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5391.
    Comments Due: 5 p.m. ET 1/10/14.

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

    Docket Numbers: RR13-10-001.
    Applicants: North American Electric Reliability Corporation.
    Description: Compliance filing of North American Electric
Reliability Corporation regarding its Delegation Agreement with the
Western Electricity Coordinating Council.
    Filed Date: 12/20/13.
    Accession Number: 20131220-5407.
    Comments Due: 5 p.m. ET 1/10/14.

    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: December 23, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-31385 Filed 12-31-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 149 (Friday, August 6, 2021)]
[Proposed Rules]
[Pages 43144-43145]
[FR Doc No: 2021-16773]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0600; Airspace Docket No. 21-ANE-4]

Proposed Revocation of Class E Airspace and Proposed Amendment of
Class E Airspace; Concord, NH

AGENCY: Federal Aviation Administration (FAA), Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to remove Class E airspace in Concord,
NH, as Class E surface airspace is no longer required at Concord
Municipal Airport. This action would also amend the Class E airspace
extending upward from 700 feet above the surface and update the
geographic coordinates of the airport. This action would enhance the
safety and management of controlled airspace within the national
airspace system.

DATES: Comments must be received on or before September 20, 2021.

ADDRESSES: Send comments on this proposal to: The U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2021-0600; Airspace Docket No. 21-ANE-4, at the
beginning of your comments. You may also submit comments through the
internet at https://www.regulations.gov.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

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 proposed 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 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 remove Class E surface airspace and amend Class E
airspace extending upward from 700 feet above the surface at Concord
Municipal Airport, Concord, NH.

Comments Invited

    Interested persons are invited to comment on this proposed rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2021-0600 and Airspace Docket No. 21-ANE-4) and be submitted in
triplicate to the DOT Docket Operations (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2021-0600; Airspace Docket No. 21-ANE-4.'' The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://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
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays, at the
office of the Eastern Service Center, Federal Aviation Administration,
Room 350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA proposes an amendment to 14 CFR part 71 to remove Class E
surface airspace as it is no longer required and amending Class E
airspace extending upward from 700 feet above the surface at Concord
Municipal Airport, Concord, NH. An airspace review determined the
navigational aids listed in the airspace description should

be removed, resulting in the removal of existing extensions, and adding
the following extensions; 155[deg] bearing, from the 12 mile radius to
18 miles southeast of the airport, 285[deg] bearing, from the 12 mile
radius to 15 miles west of the airport, and 335[deg] bearing, from the
12 mile radius to 15.4 mile northwest of the airport. Also, the
geographic coordinates would be updated to coincide with the FAA's data
base. This action would enhance the safety and management of controlled
airspace within the national airspace system.
    Class E airspace designations are published in Paragraphs 6002 and
6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and
effective September 15, 2020, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

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 would 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.

Lists 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 Federal Aviation
Administration Order 7400.11E, Airspace Designations and Reporting
Points, dated July 21, 2020, and effective September 15, 2020, is
amended as follows:

Paragraph 6002 Class E Surface Airspace.

* * * * *

ANE NH E2 Concord, NH [Removed]

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE NH E5 Concord, NH [Amended]

Concord Municipal Airport, NH
    (Lat. 43[deg]12'2710'' N, long. 71[deg]30'08'' W)

    That airspace extending upward from 700 feet above the surface
within a 12-mile radius of Concord Municipal Airport, and within
3.1-miles each side of the 155[deg] bearing from the airport,
extending from the 12-mile radius to 18-miles southeast of the
airport; and within 3-miles each side of the 285[deg] bearing from
the airport, extending from the 12-mile radius to 15-miles west of
the airport; and within 2-miles each side of the 335[deg] bearing
from the airport, extending from the 12-mile radius to 15.4-miles
northwest of the airport.

    Issued in College Park, Georgia, on August 2, 2021.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2021-16773 Filed 8-5-21; 8:45 am]
BILLING CODE 4910-13-P