[Federal Register Volume 87, Number 162 (Tuesday, August 23, 2022)]
[Notices]
[Pages 51679-51680]
[FR Doc No: 2022-18083]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0447]

Charging for Investigational Drugs Under an Investigational New
Drug Application: Questions and Answers; Revised Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Charging for Investigational Drugs Under an IND: Questions and
Answers.'' Since issuance of the final guidance in 2016, FDA has
received questions from stakeholders through the docket and in the form
of communications with review divisions. These questions relate to the
implementation of FDA's regulation on charging for investigational
drugs under an investigational new drug application (IND) for the
purpose of either clinical trials or expanded access for treatment use.
FDA is providing this revised draft guidance in a question-and-answer
format, addressing the most recently asked questions. When finalized,
this revised draft guidance will replace the final guidance of the same
title issued in June 2016.

DATES: Submit either electronic or written comments on the draft
guidance by October 24, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-0447 for ``Charging for Investigational Drugs Under an IND:
Questions and Answers.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states

``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Charging for Investigational Drugs Under an IND:
Questions and Answers.'' When finalized, the revised draft guidance
will replace the guidance for industry of the same title issued in June
2016. FDA's regulation on charging for investigational drugs under an
IND for the purpose of either clinical trials or expanded access for
treatment use (21 CFR 312.8) allows sponsors to charge for
investigational drugs under certain circumstances. FDA issued a
guidance in 2016 in a question-and-answer format to respond to the most
frequently asked questions concerning various provisions of the
regulation.
    This revised draft guidance includes responses to stakeholder
questions received since publication of the final guidance in 2016. In
addition to editorial changes for clarity, significant changes from the
2016 version of the guidance include additional recommendations related
to (1) submission of a copy of the receipt or invoice from the
manufacturer as documentation when the expanded access sponsor intends
to charge only the amount the manufacturer charged for the
investigational drug and (2) distribution of the manufacturing,
administrative, or monitoring costs from the first year over the
expected duration of the expanded IND or protocol.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Charging for Investigational Drugs Under an IND: Questions and
Answers.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the revised draft
guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18083 Filed 8-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Proposed Rules]
[Pages 7103-7105]
[FR Doc No: 2014-02520]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0053; Directorate Identifier 2013-NM-174-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 777 airplanes. This proposed AD was
prompted by reports of corroded, migrated, or broken spring pins of the
girt bar floor fitting; in one case the broken pins prevented a door
escape slide from deploying during a maintenance test. This proposed AD
would require replacing the existing spring pins at each passenger
entry door at both girt bar floor fittings with new spring pins. We are
proposing this AD to prevent broken or migrated spring pins of the girt
bar floor fittings, which could result in improper deployment of the
escape slide/raft and consequent delay and injury during evacuation of
passengers and crew from the cabin in the event of an emergency.

DATES: We must receive comments on this proposed AD by March 24, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, Washington. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0053; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Ana Martinez Hueto, Aerospace
Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA,
Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW.,
Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-

2014-0053; Directorate Identifier 2013-NM-174-AD'' at the beginning of
your comments. We specifically invite comments on the overall
regulatory, economic, environmental, and energy aspects of this
proposed AD. We will consider all comments received by the closing date
and may amend this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports of a total of 23 corroded, migrated, or
broken spring pins of the girt bar floor fitting on nine different
airplanes; in one case the broken pins prevented a door escape slide
from deploying during a maintenance test. Analysis of the broken spring
pins revealed that the spring pins failed due to stress corrosion
cracking. This condition, if not corrected, could result in improper
deployment of the escape slide/raft and consequent delay and injury
during evacuation of passengers and crew from the cabin in the event of
an emergency.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin 777-52A0050, dated June
18, 2013. For information on the procedures and compliance times, see
this service information at http://www.regulations.gov by searching for
Docket No. FAA-2014-0053.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information identified previously, except as discussed
under ``Difference Between the Proposed AD and the Service
Information.''

Difference Between the Proposed AD and the Service Information

    Although Boeing Alert Service Bulletin 777-52A0050, dated June 18,
2013, recommends replacing the spring pins within 1,175 days (3 years,
80 days), we and Boeing have determined a 36-month compliance time is
appropriate. We have advised Boeing to correct the compliance time
statement in the next revision of the service information to specify a
36-month compliance time. In developing an appropriate compliance time
for this AD, we considered the degree of urgency associated with the
subject unsafe condition, and the average utilization of the affected
fleet and time necessary to perform the replacement. In light of these
factors, we find that a 36-month compliance time represents an
appropriate interval of time for affected airplanes to continue to
operate without compromising safety.

Costs of Compliance

    We estimate that this proposed AD affects 189 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
            Action                  Labor cost        Parts cost       Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Replacement...................  Up to 40 work-                 $0   Up to $3,400.........  Up to $642,600.
                                 hours x $85 per
                                 hour = Up to
                                 $3,400.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This proposed regulation is
within the scope of that authority because it addresses an unsafe
condition that is likely to exist or develop on products identified in
this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2014-0053; Directorate Identifier
2013-NM-174-AD.

(a) Comments Due Date

    We must receive comments by March 24, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, -300ER, and

777F series airplanes, certificated in any category, as identified
in Boeing Alert Service Bulletin 777-52A0050, dated June 18, 2013.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Unsafe Condition

    This AD was prompted by reports of corroded, migrated, or broken
spring pins of the girt bar floor fitting; in one case the broken
pins prevented a door escape slide from deploying during a
maintenance test. We are issuing this AD to prevent broken or
migrated spring pins of the girt bar floor fittings, which could
result in improper deployment of the escape slide/raft and
consequent delay and injury during evacuation of passengers and crew
from the cabin in the event of an emergency.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Spring Pin Replacement

    Within 36 months after the effective date of this AD: Replace
the spring pin at both girt bar floor fittings at each passenger
entry door with a new spring pin, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 777-
52A0050, dated June 18, 2013.

(h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install a
spring pin having part number MS39086-261 or MS16562-252 on any
airplane.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (i) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane.

(j) Related Information

    (1) For more information about this AD, contact Ana Martinez
Hueto, Aerospace Engineer, Cabin Safety and Environmental Systems
Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO),
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207;
telephone<PHONE_NUMBER>, extension 1; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on January 18, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-02520 Filed 2-5-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Notices]
[Pages 45544-45546]
[FR Doc No: 2014-18387]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72713; File No. SR-Phlx-2014-49]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Disclose
Publicly the Sources of Data Used for Exchange Functions

July 29, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on July 16, 2014, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    Phlx proposes a rule change to disclose publicly the sources of
data, whether from the network processors or from direct data feeds,
that Phlx utilizes when performing (1) order handling and execution;
(2) order routing; and (3) related compliance processes.

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

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

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

1. Purpose
    In her June 5, 2014 market structure speech, the Chair requested
that all national securities exchanges review and disclose their
policies and procedures governing the market data used when performing
important exchange functions.\3\ In a letter dated June 20, 2014, the
Director of the Division of Trading and Markets codified this request:
---------------------------------------------------------------------------

    \3\ 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).
---------------------------------------------------------------------------

    We believe there is a need for clarity regarding whether (1) the
SIP data feeds, (2) proprietary data feeds, or (3) a combination
thereof, are used by the exchanges for purposes of (1) order
handling and execution (e.g., with pegged or midpoint orders), (2)
order routing, and (3) regulatory compliance, as applicable. . . .
Accordingly, we ask that proposed rule changes be filed that
disclose the particular market data feeds that are used for each of
these purposes. Consistent with your recent discussions with
Commission staff, we ask that each SRO file these proposed rule
changes with the Commission by July 15, 2014.\4\
---------------------------------------------------------------------------

    \4\ See Letter from Steven Luparello, Director, SEC Division of
Trading and Markets, to Robert Greifeld, Chief Executive Officer,
NASDAQ OMX Group, Inc., dated June 20, 2014.

    Phlx fully supports the Commission's efforts to provide more
clarity in this area. Through this proposed rule change, Phlx is
publicly clarifying on a market-by-market basis the specific network
processor and proprietary data feeds that Phlx utilizes for the
handling, routing, and execution of orders, and for performing the
regulatory compliance checks related to each of those functions. These
complex practices are governed by a few, simple principles that are
designed to ensure that Phlx has the most accurate view of the trading
interest available across multiple markets, and to maximize the
synchronization of the many exchange functions that depend upon the
calculation of an accurate NBBO and top-of-book for each market. These
principles are:
    1. Phlx uses a proprietary data feed from each exchange that
provides a reliable proprietary data feed. Where no reliable
proprietary data feed is available, Phlx uses the network processor
feed;
    2. Where Phlx uses a proprietary data feed for an exchange quote,
it also maintains access to the network processor feed as a back-up in
the event a specific proprietary feed become unavailable or unusable
for any reason;
    3. Phlx uses the same proprietary data feed when performing order
handling, routing, and execution functions, and also when the execution
and routing system performs internal compliance checks related to those
functions; and
    4. Phlx acquires and processes all proprietary and network
processor feeds via the same technological configuration (i.e.,
telecommunication circuitry, switches, and feed handlers) to the
greatest extent possible.
    5. Phlx calculates the National Best Bid and Offer (``NBBO'') and
top-of-book for each exchange at a single point within the Phlx system,
and then distributes that data simultaneously to numerous applications
performing order handling,\5\ routing, execution, and internal
compliance functions throughout the Phlx system.
---------------------------------------------------------------------------

    \5\ With respect to order handling, the NBBO and top-of-book
calculation feeds applications governing the proper processing
midpoint orders, pegged orders, price-to-comply orders, and retail
orders.
---------------------------------------------------------------------------

    As of the date of this filing, Phlx utilizes the following data
feeds for the handling, execution and routing of orders, as well as for
performing related compliance checks:

------------------------------------------------------------------------
          Market center             Primary source     Secondary source
------------------------------------------------------------------------
A--NYSE MKT (AMEX)..............  CQS/UQDF..........  n/a.

B--NASDAQ OMX BX................  BX ITCH 4.1.......  CQS/UQDF.
D--FINRA ADF....................  CQS/UQDF..........  n/a.
J--DirectEdge A.................  EdgeBook..........  CQS/UQDF.
K--DirectEdge X.................  EdgeBook..........  CQS/UQDF.
M--CSX..........................  CQS/UQDF..........  n/a.
N--NYSE.........................  NYSE OpenBook       CQS/UQDF.
                                   Ultra.
P--NYSE Arca....................  ArcaBook Binary     CQS/UQDF.
                                   uncompacted.
T/Q--NASDAQ.....................  ITCH 4.1..........  CQS/UQDF.
W--CBOE.........................  CQS/UQDF..........  n/a.
X--NASDAQ OMX PSX...............  PSX ITCH 4.1......  CQS/UQDF.
Y--BATS Y-Exchange..............  BATS PITCH........  CQS/UQDF.
Z--BATS Exchange................  BATS PITCH........  CQS/UQDF.
------------------------------------------------------------------------

    Phlx uses these feeds to calculate the NBBO via an application
called the ``NMSFeed.'' The NMSFeed consumes the Phlx Protected Quote
Service (``NPQS''), which provides an internal view of that exchange's
own market data as ITCH, plus the proprietary and network processor
market data feeds listed above. The NMSFeed calculates a Regulation
NMS-Compliant ``Best Bid or Offer'' (``Compliant BBO''), and then
delivers that information throughout the Phlx System, including to the
``OUCH'' order entry ports,\6\ the routing system, and various
compliance applications described below.
---------------------------------------------------------------------------

    \6\ OUCH is a protocol that allows Phlx participants to enter,
replace and cancel orders and receive executions. In addition to
OUCH, Phlx offers the FLITE protocol as an option for participants.
In this document, references to OUCH also include FLITE because they
are interchangeable for these purposes.
---------------------------------------------------------------------------

    Upon receipt of an update to a protected quote for a specific
venue, the NMSFeed updates its quote for that venue, recalculates the
consolidated BBO based upon the update, and recalculates the Compliant
BBO after applying Phlx's own BBO. Any quote that crosses Phlx's BBO is
ignored. Phlx odd lot orders at the same price are aggregated and
considered in the NBBO calculation if the sum is greater than or equal
to a round lot. Otherwise, they are not considered in the NBBO
calculation. Out of the remaining quotes, the most aggressive remaining
bid and offer (excluding Phlx\7\ and any destination which has been
excluded from the NBBO in compliance with the self-help procedures
under Regulation NMS) is selected and reported as the best quote. If
away markets are crossing the market after applying Phlx's BBO, orders
will be accepted as originally priced and have the potential to
execute. Any order sent to Phlx that is not an Intermarket Sweep Order
(``ISO'') will have the Compliant BBO check enforced by the system.\8\
---------------------------------------------------------------------------

    \7\ Deletion of Phlx's quote at this stage of the process is
necessary because otherwise the system would prevent valid
executions on Phlx in the erroneous belief that such executions
would be ``trade throughs'' in violation of Regulation NMS.
    \8\ In general, any order that is sent to Phlx with an ISO flag
is not re-priced and will be processed at its original price. There
are a limited number of circumstances in which an order marked as an
ISO will be determined not to be executable at its original price
and will be re-priced. These include re-pricing under the Plan to
Address Extraordinary Market Volatility, re-pricing to comply with
Regulation SHO, and the re-pricing of an order with a post-only
condition if Phlx has an order at that price at the time the order
is accepted.
---------------------------------------------------------------------------

    The Phlx OMX Routing and Special Handling System (``RASH'')
utilizes the Compliant BBO to determine if and when an order with
special processing directives is marketable either against one or more
orders in either the Core Matching System or a remote trading venue.
RASH also receives market data feeds from certain venues not displaying
protected quotes in the national market system for use in ``XQDRK''
[sic] and ``XCST'' routing strategies set forth in Phlx Rule
3315(a)(1)(A)(xiii) [sic] and (xiv) [sic], respectively. RASH maintains
a number of routing processes, or Routers, unique to each venue that
the System accesses. These Routers maintain a limited set of details
for orders that are configured as routable by the user, while also
monitoring the current best bid and best offer prices on each exchange.
    The Phlx system includes internal compliance applications related
to locked and crossed markets, trade throughs, limit-up/limit-down, and
Regulation SHO compliance. Each of these applications utilizes the
Compliant BBO to ensure compliance with applicable regulations. Phlx
operates a separate real-time surveillance system that is external to
the execution systems and that monitors the execution system's
compliance with applicable rules and regulations. The real-time
surveillance system utilizes a ``mirrored'' version of the internal
NMSFeed in various realtime surveillance patterns, including (1) Lock/
Cross, which detects lock/cross events across all markets, regardless
of whether or not Phlx is a participant in the event; (2) Trade
Through, which detects potential trade through events for all three
Phlx equity markets; and (3) RegSho, which detects potential RegSho
violations, alerting when a trade executes at or below the NBB at the
time of order entry while the stock is in a RegSho restricted state.
    In addition to the operational transparency provided above, Phlx is
also proposing to add Rule 3304, which will provide for the public
display of the proprietary and network processor feeds that Phlx
utilizes in the order handling, routing, and execution processes
described above, as well as in the compliance functions described
above. Phlx will display this information on www.nasdaqtrader.com,
which is heavily used by Phlx members and their customers.
2. Statutory Basis
    Phlx believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\9\ in general and with Sections
6(b)(5) of the Act,\10\ in particular in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and 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. The Exchange believes that
this proposal is in keeping with those principles by enhancing
transparency through the dissemination of the most accurate quotations
data and by clarifying its contents.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
result in

any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6) \12\ thereunder.\13\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Commission deems this requirement to have been met.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
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-Phlx-2014-49 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2014-49. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2014-49 and should be
submitted on or before August 26, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-18387 Filed 8-4-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Proposed Rules]
[Pages 21144-21146]
[FR Doc No: 2023-07209]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-0333; Airspace Docket No. 23-ASW-5]
RIN 2120-AA66

Amendment of Class E Airspace; Carthage, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend the Class E airspace at
Carthage, TX. The FAA is proposing this action as the result of an
airspace review caused by the decommissioning of the Carthage non
directional beacon (NDB). The name and geographic coordinates of the
airport would also be updated to coincide with the FAA's aeronautical
database.

DATES: Comments must be received on or before May 25, 2023.

ADDRESSES: Send comments identified by FAA Docket No. FAA-2023-0333 and
Airspace Docket No. 23-ASW-5 using any of the following methods:
    * Federal eRulemaking Portal: Go to www.regulations.gov and follow
the online instruction for sending your comments electronically.
    * Mail: Send comments to Docket Operations, M-30; U.S. Department
of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West

Building Ground Floor, Washington, DC 20590-0001.
    * Hand Delivery or Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    * Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. Follow the online instructions for
accessing the docket or go to Docket Operations in Room W12-140 of the
West Building Ground Floor at 1200 New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; 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 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 amend the Class E airspace extending upward from 700 feet
above the surface at Panola County Airport-Sharpe Field, Carthage, TX,
to support instrument flight rule operations at this airport.

Comments Invited

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

Availability of Rulemaking Documents

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

Incorporation by Reference

    Class E airspace is published in paragraph 6005 of FAA Order JO
7400.11, Airspace Designations and Reporting Points, which is
incorporated by reference in 14 CFR 71.1 on an annual basis. This
document proposes to amend the current version of that order, FAA Order
JO 7400.11G, dated August 19, 2022, and effective September 15, 2022.
These updates would be published subsequently in the next update to FAA
Order JO 7400.11. That order is publicly available as listed in the
ADDRESSES section of this document.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 by modifying
the Class E airspace extending upward from 700 feet above the surface
to within an 6.7-mile (decreased from a 7-mile) radius of Panola County
Airport-Sharpe Field, Carthage, TX; removing the city associated with
the airport in the airspace legal description to comply with changes to
FAA Order JO 7400.2N, Procedures for Handling Airspace Matters; and
updating the name (previously Panola County-Sharpe Field) and
geographic coordinates of the airport to coincide with the FAA's
aeronautical database.
    This action is the result of an airspace review caused by the
decommissioning of the Carthage NDB which provided navigation
information for the instrument procedures at this airport.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

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

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

* * * * *

ASW TX E5 Carthage, TX [Amended]

Panola County Airport-Sharpe Field, TX
(Lat. 32[deg]10'24'' N, long. 94[deg]17'56'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of the Panola County Airport-Sharpe Field.

    Issued in Fort Worth, Texas, on April 1, 2023.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2023-07209 Filed 4-7-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 97 (Monday, May 20, 2013)]
[Proposed Rules]
[Pages 29314-29317]
[FR Doc No: 2013-11974]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2012-0350; FRL-9815-2]

Approval and Promulgation of State Implementation Plans; State of
Utah; Interstate Transport of Pollution for the 2006 PM2.5 NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to disapprove a portion of a State
Implementation Plan (SIP) submission from the State of Utah that is
intended to demonstrate that its SIP meets certain interstate transport
requirements of the Clean Air Act (``Act'' or ``CAA'') for the 2006
fine particulate matter (``PM2.5'') National Ambient Air
Quality Standards (NAAQS). This SIP submission addresses the
requirement that Utah's SIP contain adequate provisions to prohibit air
emissions from adversely affecting another state's air quality through
interstate transport. Specifically, EPA is proposing to disapprove the
portion of the Utah SIP submission that addresses the CAA requirement
prohibiting emissions from Utah sources from significantly contributing
to nonattainment of the 2006 PM2.5 NAAQS in any other state
or interfering with maintenance of the 2006 PM2.5 NAAQS by
any other state. Under a recent court decision, this disapproval does
not trigger an obligation for EPA to promulgate a Federal
Implementation Plan (FIP) to address these interstate transport
requirements.

DATES: Comments must be received on or before June 19, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2012-0350, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Carl Daly, Director, Air Program, Environmental
Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street,
Denver, Colorado 80202-1129.
     Hand Delivery: Carl Daly, Director, Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129. Such deliveries are only accepted
Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding Federal
holidays. Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2012-0350. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA, without
going through http://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional instructions on submitting
comments, go to Section I. General Information of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly-available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129. EPA requests that if at all
possible, you contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. You
may view the hard copy of the docket Monday through Friday, 8:00 a.m.
to 4:00 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Adam Clark, Air Program, U.S.
Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The initials CAIR mean or refer to the Clean Air Interstate
Rule
    (iii) The initials CSAPR mean or refer to the Cross-State Air
Pollution Rule
    (iv) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (v) The initials SIP mean or refer to State Implementation Plan.
    (vi) The initials UDEQ mean or refer to the Utah Department of
Environmental Quality.
    (vii) The words Utah and State mean the State of Utah.

Table of Contents

I. General Information
II. Background

    A. 2006 PM2.5 NAAQS and Interstate Transport
    B. EPA Rules Addressing Interstate Transport for the 2006 PM2.5
NAAQS in the Eastern Portion of the United States
    C. EPA Guidance for SIP Submissions To Address Interstate
Transport for the 2006 PM2.5 NAAQS
III. Utah's Submittal
IV. EPA's Evaluation
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. General Information

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

II. Background

A. 2006 PM2.5 NAAQS and Interstate Transport

    Section 110(a)(2)(D)(i) of the CAA identifies four distinct
elements related to the evaluation of impacts of interstate transport
of air pollutants. In this action for the state of Utah, EPA is
addressing the first two elements of section 110(a)(2)(D)(i)--the two
elements contained in section 110(a)(2)(D)(i)(I)--with respect to the
2006 PM2.5 NAAQS.\1\ The first element requires that each
SIP for a new or revised NAAQS contain adequate provisions to prohibit
any source or other type of emissions activity within the state from
emitting air pollutants that will ``contribute significantly to
nonattainment'' of the NAAQS in another state. The second element
requires that each SIP for a new or revised NAAQS contain adequate
provisions to prohibit any source or other type of emissions activity
in the state from emitting pollutants that will ``interfere with
maintenance'' of the applicable NAAQS in any other state.
---------------------------------------------------------------------------

    \1\ This proposed action does not address the two elements of
section 110(a)(2)(D)(i)(II) regarding interference with measures
required to prevent significant deterioration of air quality or to
protect visibility in another state. We will act on these elements
in a separate rulemaking.
---------------------------------------------------------------------------

B. EPA Rules Addressing Interstate Transport for the 2006
PM2.5 NAAQS in the Eastern Portion of the United States

    EPA has addressed the requirements of section 110(a)(2)(D)(i)(I)
for many states in the eastern portion of the country in three
regulatory actions.\2\ Most recently, EPA published the final Cross-
State Air Pollution Rule (``CSAPR'' or ``Transport Rule'') to address
the two elements of CAA section 110(a)(2)(D)(i)(I) in the Eastern
United States with respect to the 2006 24-hour PM2.5 NAAQS,
the 1997 annual PM2.5 NAAQS, and the 1997 8-hour ozone NAAQS
(August 8, 2011, 76 FR 48208). CSAPR was intended to replace the
earlier Clean Air Interstate Rule (CAIR) which was judicially
remanded.\3\ See North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008).
On August 21, 2012, the U.S. Court of Appeals for the D.C. Circuit
issued a decision to vacate CSAPR. See EME Homer City Generation, L.P.
v. E.P.A., 696 F.3d 7 (D.C. Cir. 2012). The court also ordered EPA to
continue implementing CAIR in the interim. On March 29, 2013, the
United States and other parties asked the Supreme Court to review the
EME Homer City decision. In the meantime, and unless the EME Homer City
decision is reversed or otherwise modified, EPA intends to act in
accordance with the opinion in EME Homer City.
---------------------------------------------------------------------------

    \2\ See NOx SIP Call, 63 FR 57371 (October 27, 1998); Clean Air
Interstate Rule (CAIR), 70 FR 25172 (May 12, 2005); and Transport
Rule or Cross-State Air Pollution Rule, 76 FR 48208 (August 8,
2011).
    \3\ CAIR addressed the 1997 annual and 24-hour PM2.5
NAAQS, and the 1997 8-hour ozone NAAQS. It did not address the 2006
24-hour PM2.5 NAAQS.
---------------------------------------------------------------------------

    Certain aspects of the EME Homer City opinion are potentially
relevant to this proposed disapproval. First, the opinion concludes
that a section 110(a)(2)(D)(i)(I) SIP submission cannot be considered a
``required'' SIP submission until EPA has defined a state's obligations
pursuant to that section. See EME Homer City, 696 F.3d at 32 (``A SIP
logically cannot be deemed to lack a `required submission' or deemed to
be deficient for failure to meet the good neighbor obligation before
EPA quantifies the good neighbor obligation.'') EPA historically has
interpreted section 110(a)(1) of the CAA as establishing the required
submittal date for SIPs addressing all of the ``interstate transport''
requirements in section 110(a)(2)(D), including the provisions in
section 110(a)(2)(D)(i)(I) regarding significant contribution to
nonattainment and interference with maintenance. However, at this time
in light of the EME Homer City opinion, EPA is not treating the section
110(a)(2)(D)(i)(I) SIP submission from Utah as a required SIP
submission. Second, the EME Homer City opinion provides that EPA does
not have authority to promulgate a FIP to address the requirements of
section 110(a)(a)(2)(D)(i)(I) until EPA has identified emissions in a
state that significantly contribute to nonattainment or interfere with
maintenance of the NAAQS in another state and given the state an
opportunity to submit a SIP to address those emissions. EME Homer City,
696 F.3d at 28. Therefore, unless the EME Homer City decision is
reversed or otherwise modified, any final disapproval would not
obligate Utah to take any action or make a new SIP submission. Nor
would it trigger an obligation for EPA to promulgate a FIP to address
these interstate transport requirements.

C. EPA Guidance for SIP Submissions To Address Interstate Transport for
the 2006 PM2.5 NAAQS

    On September 25, 2009, EPA issued a guidance memorandum that
provides recommendations to states for making SIP submissions to meet
the requirements of CAA section 110(a)(2)(D)(i) for the 2006
PM2.5 standards (``2006 PM2.5 NAAQS
Infrastructure Guidance'' or

``Guidance'').\4\ With respect to the requirement in section
110(a)(2)(D)(i)(I) to prohibit emissions that would contribute
significantly to nonattainment of the NAAQS in any other state, the
2006 PM2.5 NAAQS Infrastructure Guidance essentially
reiterated the recommendations for western states made by EPA in
previous guidance addressing the 110(a)(2)(D)(i) requirements for the
1997 8-hour Ozone and 1997 PM2.5 NAAQS.\5\ The 2006
PM2.5 NAAQS Infrastructure Guidance advised states outside
of the CAIR region to include in their section 110(a)(2)(D)(i)(I) SIP
submissions an adequate technical analysis to support their conclusions
regarding interstate pollution transport, e.g., information concerning
emissions in the state, meteorological conditions in the state and in
potentially impacted states, monitored ambient pollutant concentrations
in the state and in potentially impacted states, distances to the
nearest areas not attaining the NAAQS in other states, and air quality
modeling.\6\ With respect to the requirement in section
110(a)(2)(D)(i)(I) to prohibit emissions that would interfere with
maintenance of the NAAQS by any other state, the Guidance stated that
SIP submissions must address this independent and distinct requirement
of the statute and provide technical information appropriate to support
the state's conclusions, such as information concerning emissions in
the state, meteorological conditions in the state and in potentially
impacted states, monitored ambient concentrations in the state and in
potentially impacted states, and air quality modeling.
---------------------------------------------------------------------------

    \4\ See Memorandum from William T. Harnett entitled ``Guidance
on SIP Elements Required Under Sections 110(a)(1) and (2) for the
2006 24-Hour Fine Particle (PM2.5) National Ambient Air
Quality Standards (NAAQS),'' September 25, 2009, available at http://www.epa.gov/ttn/caaa/t1/memoranda/20090925_harnett_pm25_sip_110a12.pdf.
    \5\ See Memorandum from William T. Harnett entitled ``Guidance
for State Implementation Plan (SIP) Submission to Meet Current
Outstanding Obligations Under Section 110(a)(2)(D)(i) for the 8-hour
ozone and PM2.5 National Ambient Air Quality Standards,''
August 15, 2006, available at http://www.epa.gov/ttn/caaa/t1/memoranda/section110a2di_sip_guidance.pdf.
    \6\ The 2006 PM2.5 NAAQS Infrastructure Guidance
stated that EPA was working on a new rule to replace CAIR that would
address issues raised by the court in the North Carolina case and
that would provide guidance to states in addressing the requirements
related to interstate transport in CAA section 110(a)(2)(D)(i)(I)
for the 2006 PM2.5 NAAQS. It also noted that states could
not rely on the CAIR rule for section 110(a)(2)(D)(i)(I) submissions
for the 2006 24-hour PM2.5 NAAQS because the CAIR rule
did not address this NAAQS. See 2006 PM2.5 NAAQS
Infrastructure Guidance at 3.
---------------------------------------------------------------------------

    In assessing interstate transport of emissions from Utah, EPA
continues to consider relevant the types of information that were
suggested in the 2006 PM2.5 NAAQS Infrastructure Guidance.
Such information may include, but is not limited to, the amount of
emissions in the state relevant to the NAAQS in question, the
meteorological conditions in the area, the distance from the state to
the nearest monitors in other states that are appropriate receptors, or
such other information as may be probative to consider whether sources
in the state may contribute significantly to nonattainment or interfere
with maintenance of the 2006 PM2.5 NAAQS in other states.
Modeling can be relied on when acceptable modeling technical analyses
are available, but EPA does not believe that modeling is required if
other available information is sufficient to evaluate the presence or
degree of interstate transport in a specific situation.

III. Utah's Submittal

    On September 21, 2010, the Utah Department of Environmental Quality
(UDEQ) made a submission certifying that Utah's SIP is adequate to
implement the 2006 PM2.5 NAAQS for all the
``infrastructure'' requirements of CAA section 110(a)(2)(D), including
the requirements of CAA section 110(a)(2)(D)(i)(I).\7\ UDEQ points to
the CSAPR proposal as evidence that the State does not contribute
significantly to PM2.5 NAAQS violations in down-wind states.
Specifically, the submission states;
---------------------------------------------------------------------------

    \7\ UDEQ's submission, dated September 21, 2010 is included in
the docket for this action.

    On August 2, 2010, EPA proposed a new rule to replace the CAIR
as a means to address interstate transport (see FR 75 No. 147, pp
45210). Again, there are certain western states that were found not
to contribute in a significant way to any NAAQS violation, for
either PM2.5 or ozone, in the down-wind states. Utah is
among those states. EPA's assessment regarding these western states
is undoubtedly based on a regional scale technical analysis, and
Utah will point to that analysis in order to conclude that there are
no current or future emissions from within its boundaries that
either cause or contribute in a significant way to NAAQS violations
in any of the down-wind states.

IV. EPA's Evaluation

    If a state chooses to submit a SIP to address the requirements of
section 110(a)(2)(D)(i)(I) for a particular NAAQS, and the state
believes that the existing SIP adequately meets those requirements,
then the state should submit a technical demonstration, relying on
information relevant to the particular NAAQS, in support of the state's
conclusion. EPA may supplement the state's demonstration with
information and analyses that EPA determines are relevant and
consistent with EPA's interpretation of section 110(a)(2)(D)(i)(I).
    In this case, Utah's submittal attempted to rely on statements in
the CSAPR proposal to show that the state's current SIP was adequate
for 110(a)(2)(D)(i)(I) for the 2006 PM2.5 NAAQS. The
submittal stated that in CSAPR, ``certain western states . . . were
found not to contribute in a significant way to any NAAQS violation,
for either PM2.5 or ozone, in the down-wind states. Utah is
among those states.'' This statement does not accurately characterize
the analysis done during the development of CSAPR. EPA decided to
conduct modeling to analyze interstate transport of emissions for only
the eastern portion of the country. That decision, however, in no way
constituted a determination about significant contribution or
interference with maintenance for western states such as Utah that were
outside the modeling domain. On the contrary, in the final CSAPR rule,
EPA explained that ``EPA is making no specific finding for states that
are not fully contained within the eastern 12 km modeling domain.'' \8\
(76 FR 48220). As a result, the State's submittal is inadequate to
demonstrate that the Utah SIP meets the requirements of 110(a)(2)(D)(i)
for the 2006 PM2.5 NAAQS. The submittal does not correctly
characterize the conclusions made during the CSAPR rulemaking process.
In addition, it does not include any technical analysis or any
demonstration that the existing SIP is adequate to prohibit emissions
from Utah from significantly contributing to nonattainment or
interfering with maintenance in another state. In particular, the
Logan, Utah-Idaho multistate nonattainment area, which consists of one
airshed in the Cache Valley, is located partially in Utah and partially
in Idaho. Utah's submission provided no relevant information regarding
the potential for interstate transport of emissions from sources in the
Utah portion of the Logan, Utah-Idaho nonattainment area to the Idaho
portion of the nonattainment area. In addition, considering the close
proximity and shared topography between the Utah portion of Cache

Valley and the Franklin, Idaho portion, as well as other factors
suggested in the 2009 Guidance (see section III.C), EPA cannot
determine based on the weight of evidence that emissions from Utah do
not contribute significantly to nonattainment or interfere with
maintenance in another state.
---------------------------------------------------------------------------

    \8\ Utah was not fully contained within the CSAPR 12km modeling
domain. See Air Quality Modeling Final Rule Technical Support
Document (June 2011), at 5-6.
---------------------------------------------------------------------------

    As neither EPA's nor Utah's analysis has led to a factual finding
that significant contribution does not exist, there is no basis for EPA
to conclude that the existing SIP is adequate to satisfy the
significant contribution to nonattainment and interference with
maintenance elements of section 110(a)(2)(D)(i)(I). For these reasons,
the SIP does not meet the requirements for approval and EPA thus
proposes to disapprove the 110(a)(2)(D)(i)(I) portion of the SIP
submittal.
    This disapproval, however, neither constitutes a determination that
Utah is significantly contributing to nonattainment in or interfering
with maintenance in another state, nor quantifies Utah's obligations
pursuant to section 110(a)(2)(D)(i)(I). Further, unless the D.C.
Circuit's recent opinion in EME Homer City Generation, L.P. v. E.P.A.,
696 F.3d 7 (D.C. Cir. 2012) is reversed or otherwise modified,\9\ the
disapproval proposed herein by itself would not require Utah to take
any additional action related to the requirements of 110(a)(2)(D)(i)(I)
for the 2006 PM2.5 NAAQS at this time and would not obligate
EPA to promulgate a FIP to address those requirements. As explained
above, in EME Homer City, the D.C. Circuit concluded that a
110(a)(2)(D)(i)(I) SIP cannot be ``required'' until sometime after EPA
quantifies the state's obligations pursuant to that section, and that
EPA therefore cannot promulgate a FIP to address the requirements of
110(a)(2)(D)(i)(I) until after EPA has both quantified the state's
obligation and given the state an initial opportunity to implement the
obligations through a SIP. See EME Homer City, 696 F.3d at 28, 30-31.
EPA has not yet determined whether Utah has any additional obligations
under section 110(a)(2)(D)(i)(I) or quantified any such obligations.
Therefore, pursuant to the EME Homer City decision, this
110(a)(2)(D)(i)(I) SIP submission from Utah was not a required SIP
submission and thus Utah has no obligation at this time to resubmit a
110(a)(2)(D)(i)(I) SIP or take any other action related to the
requirements of this section with respect to the 2006 PM2.5
NAAQS. In addition, unless the EME Homer City opinion is reversed or
modified, final action on the disapproval proposed herein would also
not trigger any FIP obligation under CAA section 110(c), because
pursuant to EME Homer City, at this time EPA lacks authority to
promulgate a FIP to address the 110(a)(2)(D)(i)(I) requirements. See
id. at 28-37.
---------------------------------------------------------------------------

    \9\ On March 29, 2013 the United States and other parties filed
petitions for certiorari asking the Supreme Court to review the DC
Circuit decision in EME Homer City, 696 F.3d 7 (DC Cir. 2012).
---------------------------------------------------------------------------

V. Proposed Action

    EPA is proposing to disapprove the 110(a)(2)(D)(i)(I) portion of
Utah's September 21, 2010 submission. We propose to disapprove this
portion of the submission because it fails to demonstrate that the Utah
SIP is adequate for the requirements of 110(a)(2)(D)(i)(I). As
explained in detail above, unless the EME Homer City decision is
reversed or modified, this disapproval will not trigger an obligation
for EPA to promulgate a FIP to address these interstate transport
requirements, nor will it require Utah to submit a revised interstate
transport SIP to meet the requirements.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations (42 U.S.C. 7410(k), 40 CFR 52.02(a)). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely disapproves some state law because it does not
meet federal requirements; this proposed action does not impose
additional requirements beyond those imposed by state law. For that
reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999); is not an
economically significant regulatory action based on health or safety
risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and,
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have Tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
Tribal governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: May 8, 2013.
Howard M. Cantor,
Acting Regional Administrator, Region 8.
[FR Doc. 2013-11974 Filed 5-17-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 4, 2009 (Volume 74, Number 22)]
[Rules and Regulations]
[Page 5989-5991]
[DOCID:fr04fe09-7]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0121]
RIN 1625-AA11

``McCormick & Baxter'' Regulated Navigation Area, Willamette
River, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is establishing a Regulated Navigation Area on
the Willamette River, Portland, Oregon. This action is necessary to
preserve the integrity of the engineered pilot cap placed over
contaminated sediments as part of an Environmental Protection Agency
(EPA) Superfund cleanup action at the McCormick & Baxter Creosoting
Company Superfund Site. This rule is needed to prohibit activities that
would cause disturbance of pilot cap material, which was placed to
isolate and contain underlying contaminated sediment.

DATES: This rule is effective March 6, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0121 and are available online by going to
http://www.regulations.gov, selecting the Advanced Docket Search option
on the right side of the screen, inserting USCG-2008-0121 in the Docket
ID box, pressing Enter, and then clicking on the item in the Docket ID
column. This material is also available for inspection or copying at
two locations: The Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays and U.S. Coast Guard
Sector Portland, 6767 North Basin Ave., Portland, OR 97217, between 8
a.m. and 2 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call MST1 Jaime Sayers, U.S. Coast Guard Sector Portland, Waterways
Management Branch, telephone<PHONE_NUMBER>. If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On June 3, 2008, we published a notice of proposed rulemaking
(NPRM) entitled ``McCormick and Baxter Regulated Navigation Area,
Willamette River, Portland, OR'' in the Federal Register (73 FR 31652).
We received no letters commenting on the proposed rule. No public
meeting was requested, and none was held.

Background and Purpose

    The McCormick & Baxter Creosoting Company operated between 1944 and
1991, treating wood products with creosote, pentachlorophenol and
inorganic (arsenic, copper, chromium, and zinc) preservative solutions.
Historically, process wastewaters were discharged directly to the
Willamette River, and other process wastes were dumped in several areas
of the Site. Significant concentrations of wood-treating chemicals have
been found in soil and groundwater at the site and in river sediments
adjacent to the Site. The EPA listed the Site on the National
Priorities List (NPL) in June 1994 based on information collected by
DEQ between September 1990 and September 1992. The EPA also designated
the DEQ as the lead agency for implementing the selected remedy while
funding for remedial design and construction was primarily provided by
EPA. The DEQ implemented a number of interim removal measures between
1992 and 1994, including plant demolition, sludge and soil removals,
and extraction of creosote from the groundwater aquifers. The Record of
Decision (ROD) was issued by WPA and DEQ in April 1996 after
considering public comments on the Proposed Cleanup Plan. The remedy
addressed contaminated ground water, soil and sediment. A component of
the groundwater remedy, initiated in 1994, consisted of an automated
creosote extraction and groundwater treatment system. However, due to
poor product recovery and high operating costs, the automated system
was discontinued in late 2000. Creosote is currently being recovered by
passive and manual methods. Approximately 6,200 gallons have been
recovered since 1991. A contingency groundwater remedy was implemented
in the summer of 2003, with the construction of a combination steel
sheet pile and soil Bentonite slurry wall surrounding 18 acres. The
purpose of the barrier wall is to prevent migration of creosote to the
Willamette River. Implementation of the soil remedy began in March 1999
with the removal of 33,000 tons of highly contaminated soil and debris.
The soil remedy was completed in September 2005 following installation
of a combination impermeable/earthen cap--the impermeable portion
covering the area within the subsurface barrier wall. The sediment
remedy was implemented in 2004 and primarily consisted of an armored
sand cap placed over 23 acres of contaminated sediment. Construction
occurred during the summers of 2004 and 2005. Sediment cap construction
performed in 2005 followed construction work performed by the City of
Portland to stabilize two high pressure sewer lines located within a
one-acre portion of the sediment cap. In addition to the sand layer, an
oil adsorptive material known as organophyllic clay was used in two
creosote seep areas. To protect the cap from erosion, the sand and
organophyllic clay were armored with a combination of rock and
articulated concrete blocks. Erosion forces evaluated in designing the
cap armoring layer included hydraulic-induced stresses due to river
currents associated with a 500-year flood, vessel-induced propeller
velocities from a tractor tug and various sized recreational boats,
wind waves associated with a 100-year wind storm and vessel wakes
associated with various boats including a 100-ft fireboat traveling at
14 knots. These forces were evaluated for river level variations due to
tidal action and flood currents. Additionally, numerical modeling was
used to analyze wave transformation and capping of the riverbank with
two feet of topsoil, turf reinforcement matting and herbaceous
vegetation. Revegitation of the capped riverbank with native trees and
shrubs took place in February 2006 after the soil had been stabilized
with the native grasses planted in November 2004. The DEQ has requested
the issuance of this RNA in order to prohibit activities that may
damage the engineered sediment cap at the Site. Although the sediment
cap is designed to withstand a variety of anticipated erosional forces,
the cap is susceptible to damage, such as from propeller wash,
deployment of barge spuds, deployment and dragging of anchors, and
grounding of large vessels. If the engineered sediment cap were to be
damaged by marine activities, the contaminated sediments which underlie

the cap could be released to the river thereby posing an unacceptable
threat to public health and the environment.

Discussion of Comments and Changes

    No comments were received on this rule during the comment period
such that no changes have been made to the rule.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation is unnecessary. The effect of this
regulation will not be significant based on the fact there will be
minimal if any effect on the navigable waterway around the regulated
area due to the regulated navigation area's proximity to the shore. The
local maritime community will be informed of the regulated navigation
area via marine informational Notice to Mariners.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
transit or anchor in a portion of the Willamette River. This rule will
not have a significant economic impact on a substantial number of small
entities because the regulated navigation area is limited in size
leaving ample room for vessels to navigate around the area. Vessels
engaged in commerce with the existing refueling pipeline located within
the site should not be affected by this regulation in those activities
but are advised to minimize potential impacts such as anchoring, wake
scouring, and dragging in the vicinity of the pilot cap.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of

Management and Budget, with an explanation of why using these standards
would be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards are technical standards (e.g. ,
specifications of materials, performance, design, or operation; test
methods; sampling procedures; and related management systems practices)
that are developed or adopted by voluntary consensus standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 5100.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
under that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. Therefore, this rule is categorically excluded, under
section 2.B.2. Figure 2-1, paragraph (34)(g), of the Instruction and
neither an environmental assessment nor an environmental impact
statement is required. This rule involves the establishing,
disestablishing, or changing Regulated Navigation Areas, and security
or safety zones. An environmental analysis checklist and a categorical
exclusion determination are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.1323 to read as follows:

Sec.  165.1323  Regulated Navigation Area: Willamette River Portland,
Oregon Captain of the Port Zone.

    (a) Location. The following is a regulated navigation area (RNA):
All waters of the Willamette River encompassed by a line commencing at
45[deg]34'.33'' N, 122[deg]44'17'' W to 45[deg]34'32'' N,
122[deg]44'18'' W thence to 45[deg]34'35'' N, 122[deg]44'24'' W thence
to 45[deg]34'35'' N, 122[deg]44'27'' W thence to 45[deg]34'35'' N,
122[deg]44'36'' W thence to 45[deg]34'35'' N, 122[deg]44'37'' W thence
to 45[deg]34'38'' N, 122[deg]44'42'' W to 45[deg]34'39'' N,
122[deg]44'43'' W thence to 45[deg]34'44'' N, 122[deg]44'51'' W thence
to 45[deg]34'45'' N, 122[deg]44'53'' W thence to 45[deg]34'47'' N,
122[deg]44'51'' W thence to 45[deg]34'45'' N, 122[deg]44'46'' W to
45[deg]34'45'' N, 122[deg]44'45'' W thence to 45[deg]34'47'' N,
122[deg]44'43'' W thence to 45[deg]34'46'' N, 122[deg]44'42'' W thence
to 45[deg]34'48'' N, 122[deg]44'40'' W thence to 45[deg]34'48'' N,
122[deg]44'38'' W and along the shoreline to 45[deg]34'46'' N,
122[deg]44'39'' W and back to the point of origin. All coordinates
reference 1983 North American Datum (NAD 83).
    (b) Regulations. (1) Anchoring, spudding, dredging, laying cable,
dragging, trawling, conducting salvage operations, operating commercial
vessels of any size, and operating recreational vessels greater than 30
feet in length are prohibited in the regulated area.
    (2) All vessels transiting or accessing the regulated area shall do
so at no wake speed or at the minimum speed necessary to maintain
steerage.

    Dated: December 2, 2008.
J.P. Currier,
Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard
District.
[FR Doc. E9-2308 Filed 2-3-09; 8:45 am]

BILLING CODE 4910-15-P