[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20714-20716]
[FR Doc No: 2016-08041]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77505; File No. SR-FINRA-2016-012]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend FINRA Rule 6184 (Transactions in
Exchange-Traded Managed Fund Shares (``NextShares''))

April 4, 2016.
    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 March 29, 2016, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as constituting a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 under the Act,\3\ which
renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 6184 (Transactions in
Exchange-Traded Managed Fund Shares (``NextShares'')) to provide that
the FINRA/Nasdaq Trade Reporting Facility (``FINRA/Nasdaq TRF'') will
make available to market participants a daily file with the final trade
price for each over-the-counter transaction in exchange-traded managed
fund shares (``NextShares'') reported to the FINRA/Nasdaq TRF for
public dissemination purposes.
    Below is the text of the proposed rule change. Proposed new
language is in italics; proposed deletions are in brackets.
* * * * *

6000.  QUOTATION AND TRANSACTION REPORTING FACILITIES

6100.  QUOTING AND TRADING IN NMS STOCKS

* * * * *

6180.  Transaction Reporting

* * * * *

6184.  Transactions in Exchange-Traded Managed Fund Shares
(``NextShares'')

    (a) through (d) No Change.

. . . Supplementary Material:

.01  No Change.

.02  End of Day Processing

    Members that clear transactions in NextShares directly at NSCC,
e.g., via direct QSR submission, must ensure that they submit to NSCC
all pricing information, including the IIV-based price on intraday
submissions and the final NAV-based trade price after market close, in
accordance with NSCC requirements; such information will not be
provided to NSCC by FINRA.
    Following publication of the NAV, the FINRA/Nasdaq Trade Reporting
Facility will make available to market participants a daily file with
the final NAV-based trade price for each transaction in NextShares
reported during the trading day to the FINRA/Nasdaq Trade Reporting
Facility for public dissemination purposes.
* * * * *

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

    In its filing with the Commission, FINRA 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 these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    FINRA recently adopted Rule 6184 \4\ relating to the reporting of
over-the-counter (``OTC'') transactions in NextShares, which have been
approved by the SEC for listing and trading on the Nasdaq Stock Market
LLC (``Nasdaq'').\5\ As described more fully in SR-FINRA-2015-043 and
SR-NASDAQ-2014-020, NextShares will trade in the secondary market using
a new trading protocol called ``NAV-Based Trading.'' In NAV-Based
Trading, all bids, offers and execution prices will be expressed as a
premium or discount (which may be zero) to the fund's next-determined
net asset value per share (``NAV''), e.g., NAV-$0.01 or NAV+$0.01. A
NextShares Fund's NAV will be determined each business day after the
close of trading, and consequently, the final value of a transaction
will not be known until the end of the trading day. Because existing
order transmission and processing systems commonly used by exchanges
and firms are generally not designed to accommodate pricing
arrangements such as NAV-Based Trading, the prices of NextShares trades
and quotes will be represented intraday using a ``proxy price'' format
(discussed more fully in SR-FINRA-2015-043 and SR-NASDAQ-2014-020). The
securities information processor (``SIP'') will publicly disseminate
trades in the proxy price format.
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    \4\ See Securities Exchange Act Release No. 76213 (October 21,
2015), 80 FR 65838 (October 27, 2015) (Notice of Filing and
Immediate Effectiveness; File No. SR-FINRA-2015-043). Rule 6184
became operative on February 26, 2016.
    \5\ See Securities Exchange Act Release No. 73562 (November 7,
2014), 79 FR 68309 (November 14, 2014) (Notice of Filing of
Amendment No. 1 and Order Granting Accelerated Approval of File No.
SR-NASDAQ-2014-020).
---------------------------------------------------------------------------

    In SR-NASDAQ-2015-036, Nasdaq stated that after a NextShares Fund's
NAV is calculated, Nasdaq will price each NextShares trade executed on
the exchange during the day at the Fund's NAV plus or minus the trade's
executed premium or discount.\6\ Using the final trade price, each
NextShares trade executed on the exchange will be disseminated to
Nasdaq member firms and market data services via a File Transfer
Protocol (``FTP'') file to be created for NextShares to supplement the
previously provided information to include final pricing.\7\
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    \6\ See Securities Exchange Act Release No. 75499 (July 21,
2015), 80 FR 44406 (July 27, 2015) (Order Granting Approval of
Proposed Rule Change, as Modified by Amendments Nos. 1 and 2; File
No. SR-NASDAQ-2015-036).
    \7\ As described in SR-NASDAQ-2015-036, FTP is a standard
network protocol used to transfer computer files on the Internet,
and Nasdaq will arrange for the daily dissemination of an FTP file
with executed NextShares trades to Nasdaq member firms and market
data services. See also Frequently Asked Questions: NextShares
Exchange-Traded Managed Funds, #35, available at
www.nasdaqtrader.com/content/ETFs/ETMF_FAQs.pdf.
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    Similarly, Nasdaq, Inc., as the ``Business Member'' under the
limited liability company agreement with FINRA establishing the FINRA/
Nasdaq TRF, has determined to make available to market participants a
daily file in FTP format with the final NAV-adjusted trade price for
each OTC transaction in NextShares reported during the trading day to
the FINRA/Nasdaq TRF for public dissemination purposes. Nasdaq has
represented to FINRA that the daily FTP files will be accessible at no
cost to market participants on Nasdaq's public Web site. FINRA is
proposing to amend Rule 6184.02 to reflect the proposed FTP file.
    FINRA has filed the proposed rule change for immediate
effectiveness and proposes that the operative date will be on or about
April 4, 2016, the date that the systems development work to support
the proposed FTP file is expected to be completed by the FINRA/Nasdaq
TRF.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\8\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change is
consistent with the Act because it will further enhance market
transparency and price discovery by ensuring that additional pricing
information relating to OTC transactions in NextShares, i.e., the final
NAV-adjusted trade price on a transaction-by-transaction basis, is
available to market participants.
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    \8\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA 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. The proposed rule change will
enhance the pricing information relating to OTC transactions in
NextShares available to market participants. The proposed rule change
will not impose any reporting or other requirements on member firms,
and as a result, will have no impact on member firms from a systems
development and reporting perspective. Member firms that choose to
trade NextShares may incur some costs to integrate the pricing
information that will be provided pursuant to the proposed rule change.
However, FINRA anticipates these costs to be minor because the pricing
information will be accessible at no cost to market participants on
Nasdaq's public Web site and also provided through data vendors, and
firms will factor in any attendant costs when making the decision to
enter into the market for NextShares.

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, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \9\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative before 30 days from the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\11\ the Commission may
designate a shorter time if such action is consistent with the

protection of investors and the public interest.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    FINRA has asked the Commission to waive the 30-day operative delay.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
Such waiver will allow the proposed rule change to become operative on
or about April 4, 2016, the date that Nasdaq has designated (and
represented to FINRA) as the date by which it will complete the systems
development work to support the proposed FTP file. This will ensure
that additional pricing information relating to OTC transactions in
NextShares will be available to market participants without delay and
will supplement the FTP file that is already available for trades in
NextShares executed on the Nasdaq exchange. Therefore, the Commission
hereby waives the 30-day operative delay and designates the proposed
rule change to be operative on or about April 4, 2016.\12\
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    \12\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule 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-FINRA-2016-012 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-FINRA-2016-012. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of FINRA. 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-FINRA-2016-012, and should
be submitted on or before April 29, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-08041 Filed 4-7-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Pages 5468-5469]
[FR Doc No: 2016-01780]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0275]

Regulatory Site Visit Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is announcing an invitation
for participation in its Regulatory Site Visit Training Program (RSVP).
This training program is intended to give CBER regulatory review,
compliance, and other relevant staff an opportunity to visit biologics
facilities. These visits are intended to allow CBER staff to directly
observe routine manufacturing practices and to give CBER staff a better
understanding of the biologics industry, including its challenges and
operations. The purpose of this document is to invite biologics
facilities to contact CBER for more information if they are interested
in participating in this program.

DATES: Submit either an electronic or written request for participation
in this program by March 3, 2016. The request should include a
description of your facility relative to products regulated by CBER.
Please specify the physical address(es) of the site(s) you are
offering.

ADDRESSES: If your biologics facility is interested in offering a site
visit, submit either an electronic request to http://www.regulations.gov or a written request to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. If you previously responded to earlier
requests to participate in this program and you continue to be
interested in participating, please renew your request through a
submission to the Division of Dockets Management.

FOR FURTHER INFORMATION CONTACT: Cynthia Whitmarsh, Division of
Manufacturers Assistance and Training, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-595-1243, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates certain biological products including blood and
blood products, vaccines, and cellular, tissue, and gene therapies.
CBER is committed to advancing the public health through innovative
activities that help ensure the safety, effectiveness, and availability
of biological products to patients. To support this primary goal, CBER
has initiated various training and development programs, including
programs to further enhance performance of its compliance staff,
regulatory review staff, and other relevant staff. CBER seeks to
continuously enhance and update review efficiency and quality, and the
quality of its regulatory efforts and interactions, by providing CBER
staff with a better understanding of the biologics industry and its
operations. Further, CBER seeks to enhance: (1) Its understanding of
current industry practices and regulatory impacts and needs and (2)
communication between CBER staff and industry. CBER initiated its RSVP
in 2005. Through these annual

notices, CBER is requesting that those firms that have previously
applied and are still interested in participating reaffirm their
interest. CBER is also requesting that new interested parties apply.

II. RSVP

A. Regulatory Site Visits

    In this program, over a period of time to be agreed upon with the
facility, small groups of CBER staff may observe operations of
biologics establishments, including for example, blood and tissue
establishments. The visits may include the following: (1) Packaging
facilities, (2) quality control and pathology/toxicology laboratories,
and (3) regulatory affairs operations. These visits, or any part of the
program, are not intended as a mechanism to inspect, assess, judge, or
perform a regulatory function, but are meant to improve mutual
understanding and to provide an avenue for open dialogue between the
biologics industry and CBER.

B. Site Selection

    CBER will be responsible for all travel expenses associated with
the site visits. Therefore, selection of potential facilities will be
based on the coordination of CBER's priorities for staff training as
well as the limited available resources for this program. In addition
to logistical and other resource factors to consider, a key element of
site selection is a successful compliance record with FDA or another
Agency with which we have a memorandum of understanding. If a site
visit involves a visit to a separate physical location of another firm
under contract to the applicant, the other firm also needs to agree to
participate in the program, as well as have a satisfactory compliance
history. If you are a firm with multiple sites, please submit no more
than three specific locations for consideration.

III. Requests for Participation

    Identify requests for participation with the docket number found in
brackets in the heading of this document. Received requests are
available for public examination in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01780 Filed 2-1-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Notices]
[Pages 31051-31052]
[FR Doc No: 2017-14019]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP17-841-000.
    Applicants: Black Hills Shoshone Pipeline, LLC.
    Description: Black Hills Shoshone Pipeline, LLC submits tariff
filing per 154.203: Cost and Revenue Study--Re Docket No. CP15-32-000
and CP15-33-000.
    Filed Date: 06/26/2017.
    Accession Number: 20170626-5003.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 10, 2017.

    Docket Numbers: RP17-842-000.
    Applicants: Texas Gas Transmission, LLC.

    Description: Texas Gas Transmission, LLC submits tariff filing per
154.204: Replacement Ex As for N/C Agmts due to Meter Change to be
effective 7/1/2017.
    Filed Date: 06/26/2017.
    Accession Number: 20170626-5007.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 10, 2017.

    Docket Numbers: RP17-843-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits tariff filing per
154.204: Replacement Ex A for Neg Rate Agmt due to Meter Change to be
effective 7/1/2017.
    Filed Date: 06/26/2017.
    Accession Number: 20170626-5008.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 10, 2017.

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

    Dated: June 27, 2017.
Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2017-14019 Filed 7-3-17; 8:45 am]
 BILLING CODE 6717-01-P


Larry Sorrels/RTP/USEPA/US

05/01/2008 09:54 AM

To

Kathy Kaufman/RTP/USEPA/US@EPA

cc

Subject

Fw: Question for you

Kathy,  below is the email that is the reference 8 and 9 for chapter 6 that needs to go into the docket.   This email is the sole reference; I just referred to it twice in the PM2.5 RIA.  Thanks.

Larry Sorrels

Economist

US EPA/OAQPS/HEID/ABCG

C439-02

RTP, NC 27711

(919) 541-5041

fax:<PHONE_NUMBER>

----- Forwarded by Larry Sorrels/RTP/USEPA/US on 05/01/2008 09:52 AM -----

Sikander Khan/DC/USEPA/US

03/16/2006 06:55 PM

To

Larry Sorrels/RTP/USEPA/US@EPA

cc

Tim Smith/RTP/USEPA/US@EPA, Kevin Culligan/DC/USEPA/US, Mikhail Adamantiades/DC/USEPA/US

Subject

Re: Question for you

Larry/Tim,

The attached file lists the ballpark cost estimating factors for three ESP modification options: 1) adding an agglomerator, 2) adding equivalent of one field surface area, and 3) adding equivalent of two field surface area.

Please note that these costs cover only EGUs, i.e., not small industrial units.  The costs are very preliminary and must be eventually confirmed via detailed estimates.  The following cost factors should be used for converting these costs to $/ton of PM2.5 removed (I explained this to Larry today via a phone call).:

				Capacity factor:			85%

				Capital recovery factor:		12%

				Amount of PM2.5 removed:	Should be estimated based on the ESP efficiency increases I have provided earlier

Sikander Khan

US EPA

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

Email Address<EMAIL_ADDRESS> Larry Sorrels/RTP/USEPA/US

03/16/2006 09:21 AM

To

Sikander Khan/DC/USEPA/US@EPA

cc

Tim Smith/RTP/USEPA/US@EPA

Subject

Question for you

Sikander, will you be able to provide some costs for the ESP upgrades (addtion of plates in series) you recommend we consider as a PM control measure?  We have the control efficiency data, but not the cost data.   Also, will you be able to send us today your estimate of cost for the Indigo Agglomerator that includes the energy costs related to pressure drop?   We are interested in this information, and we need it this week if at all possible.   Thanks.

Larry Sorrels

Economist

US EPA/OAQPS/HEID/ABCG

C504-02

RTP, NC 27711

(919) 541-5041

fax:<PHONE_NUMBER>


[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4098-4099]
[FR Doc No: 2021-00838]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1657]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey of Drug
Product Manufacturing, Processing, and Packing Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments (including recommendations) on the
collection of information by February 16, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comment'' or by using the search function. The title of this
information collection is ``Survey of Drug Product Manufacturing,
Processing, and Packing Facilities.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Survey of Drug Product Manufacturing, Processing, and Packing
Facilities--21 CFR parts 210 and 211

OMB Control Number 0910-NEW

    FDA has the responsibility to regulate the safety, as well as the
efficacy and quality, of drugs in the United States. Under the Food and
Drug Administration Safety and Innovation Act, enacted in 2012, the
term current good manufacturing practice (CGMP) includes the
implementation of oversight and controls over the manufacturing,
processing, and packing of drugs to ensure quality, including managing
the risk of, and establishing the safety of, raw materials used in the
manufacture of drugs. The safety and availability of drugs can be
affected by raw material suppliers, the material supply chain, and the
facility's controls over raw material quality. Risk management enables
manufacturers to make proper choices and ensure the continued
suitability of these materials and supply chains. The Agency needs to
better understand how manufacturers, processors, and packers of drug
products approach managing risks related to components, containers, and
closures as well as the supply and distribution chains between the
producers of raw materials and drug product manufacturers, processors,
and packers. Such information will allow FDA to examine the potential
economic impact of changes to regulations that govern the
manufacturing, processing, and packing of drugs.
    In the Federal Register of September 18, 2020 (85 FR 58370), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
    This is a one-time information collection, the primary purpose of
which is to collect industry-wide data on how facilities that
manufacture, process, and pack drug products for use in humans and/or
animals ensure the quality of their operations, including their current
risk management approaches and practices for ensuring the quality and
suitability of the drug components, containers, and closures that they
use. FDA intends to use this information to inform its economic
analyses of potential updates to CGMPs for human and animal drug
product manufacturing, processing, and packing facilities under 21 CFR
parts 210 and 211. Survey respondents will be contacted by email or, if
necessary, by regular mail. Respondents will be able to take the survey
online or, if requested, they can return a hard copy by mail. FDA
estimates the maximum burden of this collection of information as
follows:

                        Table 1.--Estimated Burden Hours for One-Time Data Collection\1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
 Type of respondent/facility      Number of     responses per   Total annual     Average burden     Total hours
                                 respondents     respondent       responses       per response
----------------------------------------------------------------------------------------------------------------
Group 1: Facilities in United             394               1             394  1.1..............             433
 States engaged in drug
 manufacturing (in addition
 to other possible
 activities).
Group 2: Facilities in United             333               1             333  0.75.............             250
 States not engaged in                                                         (45 minutes).....
 manufacturing but engaged in
 other forms of drug
 processing or packing (e.g.,
 labeling, repacking, etc.).
Group 3: Facilities outside               407               1             407  2.20.............             895
 United States engaged in
 drug manufacturing (in
 addition to other possible
 activities).
Group 4: Facilities outside               261               1             261  1.5..............             392
 United States not engaged in
 manufacturing but engaged in
 other forms of drug
 processing or packing (e.g.,
 labeling, repacking, etc.).
Total........................           1,395  ..............           1,395  .................           1,970
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Burden hours are based on pretests of the survey and interviews
with industry representatives and reflect the time required by each
type of respondent to read the survey invitation and instructions and
complete the survey questions. The total estimated one-time burden
hours are 1,970.

    Dated: January 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00838 Filed 1-14-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Rules and Regulations]
[Page 32312]
[FR Doc No: 2015-13920]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0401]

Drawbridge Operation Regulation; Reynolds Channel, Nassau, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Long Beach Bridge, across Reynolds
Channel, mile 4.7, at Nassau, New York. This temporary deviation is
necessary to facilitate the Annual Salute to Veterans and Fireworks
Display. This deviation allows the bridge to remain in the closed
position during this public event.

DATES: This deviation is effective from 9:30 p.m. on June 27, 2015 to
12 a.m. on June 28, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0401] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC, 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, contact Ms. Judy K. Leung-Yee, Project Officer,
First Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Ms. Cheryl Collins, Program Manager, Docket Operations, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION: The Long Beach Bridge, mile 4.7, across
Reynolds Channel has a vertical clearance in the closed position of 22
feet at mean high water and 24 feet at mean low water. The existing
bridge operating regulations are found at 33 CFR 117.799(g).
    Reynolds Channel is transited by commercial fishing and
recreational vessel traffic.
    Nassau County Department of Public Works requested this temporary
deviation from the normal operating schedule to facilitate a public
event, the City of Long Beach Annual Fireworks Display.
    Under this temporary deviation, the Long Beach Bridge may remain in
the closed position between 9:30 p.m. on June 27, 2015 and 12:00 a.m.
on June 28, 2015 (rain date June 28, 2015).
    There is no alternate route for vessel traffic; however, vessels
that can pass under the closed draws during this closure may do so at
any time. The bridge will be able to open in the event of an emergency.
    The Coast Guard will inform the users of the waterway through our
Local and Broadcast Notice to Mariners of the change in operating
schedule for the bridge so that vessels can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: May 27, 2015.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2015-13920 Filed 6-5-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Proposed Rules]
[Pages 24486-24488]
[FR Doc No: 2022-08882]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0275]
RIN 1625-AA00

Safety Zone; Cumberland River, Nashville, TN

AGENCY: Coast Guard, Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to a temporary safety zone from
mile marker 191.1 to 191.5 of the Cumberland River. This action is
necessary to provide for the safety of life on these navigable waters
near Korean Veterans Bridge, Nashville, TN, during Music City Grand
Prix on August 5 through August 7, 2022. This proposed rulemaking would
prohibit persons and vessels from being in the safety zone unless
authorized by the Captain of the Port Sector Ohio Valley (COTP) or a
designated representative. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before May 26, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0275 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Petty Officer Third Class Benjamin
Gardner and Marine Safety Detachment Nashville, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The Coast Guard was notified by Indy Car of a proposed racing event
that goes over the Cumberland River. The event would take place from
August 5, 2022, to August 7, 2022. On August 5, 2022 the river closure
would be from 2:00 p.m. to 6:30 p.m. On August 6, 2022, the river
closure would be from 11:00 a.m. to 5:00 p.m. On August 7, 2022, the
river closure would be from 2:00 p.m. to 4:30 p.m. The COTP has
determined that there is a need to protect the river users while the
Indy cars are on the track between MM 191.1 and MM 191.5 on the
Cumberland River. This propsed rule is needed to protect life and the
marine environment in the navigable waters within the temporary safety
zone during the racing portion of the event.
    The Coast Guard is proposing this rulemaking under authority in 46
U.S.C. 70034 (previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone that would be
enforced from 2 p.m. to 6:30 p.m. on August 5, 2022, from 11 a.m. to 5
p.m. on August 6, 2022, and from 2 p.m. to 4:30 p.m. on August 7, 2022.
The safety zone would cover all navigable waters within .4 miles of the
Korean Veterans Bridge on the Cumberland River in Nashville, TN. The
duration of the zone is intended to ensure the safety of vessels and
these navigable waters before, during, and after the scheduled Indy Car
races. No vessel or person would be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. The safety zone
will be 13 hours spread over the course of 3 days during daylight hours
in Nashville, TN. The safety zone will only encompass .4 miles of the
Cumberland River. Vessel traffic will be able to safely transit around
this safety zone which would impact a small designated area of the
Cumberland River before or after the time of the events on each day.
Moreover, the Coast Guard would issue a Broadcast Notice to Mariners
via VHF-FM marine channel 16 about the zone, and the rulemaking would
allow vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this propsed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this proposed rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has 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. We have analyzed this proposed rule under that order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. 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 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this
propsed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1,

associated implementing instructions, and Environmental Planning
COMDTINST 5090.1 (series), which guide the Coast Guard in complying
with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-
4370f), and have made a preliminary determination that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This proposed rule
involves a safety zone lasting 12 hours spread over the course of 3
days that would prohibit entry within .4 miles of the Korean Veterans
Bridge. Normally such actions are categorically excluded from further
review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. A preliminary Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2022-0275 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 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:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T08-0275 to read as follows:

Sec.  165.T08-0275  Safety Zone; Cumberland River, Nashville, TN.

    (a) Location. The following area is a safety zone: All navigable
waters of the Cumberland River from mile marker 191.1 to mile marker
191.5.
    (b) Definitions: As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Sector Ohio Valley (COTP) in the enforcement of the
safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-FM radio channel 16 or phone at 1-800-253-7465.
Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (d) Enforcement periods. This section will be enforced from 2 p.m.
until 6:30 p.m. on August 5, 2022, from 11 a.m. until 5 p.m. on August
6, 2021, and from 2 p.m. until 4:30 p.m. on August 7, 2022.

    Dated: April 20, 2022.
A.M. Beach,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2022-08882 Filed 4-25-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: September 11, 2006 (Volume 71, Number 175)]
[Notices]
[Page 53429]
[DOCID:fr11se06-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-537-000]

CenterPoint Energy-Mississippi River Transmission Corporation;
Notice of Tariff Filing

September 5, 2006.
    Take notice that on August 30, 2006, CenterPoint Energy-Mississippi
River Transmission Corporation (MRT) tendered for filing as part of its
FERC Gas Tariff, Third Revised Volume No. 1, the following tariff
sheets to be effective October 1, 2006:

Twelfth Revised Sheet No. 2.
Fifty-Eighth Revised Sheet No. 5.
Fifty-Eighth Revised Sheet No. 6.
Fifty-Fifth Revised Sheet No. 7.
Fifth Revised Sheet No. 227.
Fifth Revised Sheet No. 228.

    MRT states that the purpose of this filing is to remove language
from its tariff that references GRI surcharges.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-14975 Filed 9-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Page 54780]
[FR Doc No: 2021-21486]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93156; File No. SR-BOX-2021-19]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change Related to BOX Exchange LLC and BOX Holdings Group LLC Ownership
Transfer Transactions

September 28, 2021.
    On August 27, 2021, BOX Exchange LLC (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to accomplish
ownership transfer transactions of the Exchange and BOX Holdings Group
LLC, an affiliate of the Exchange (``BOX Holdings''). The proposed rule
change was published for comment in the Federal Register on September
15, 2021.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 92926 (September 9,
2021), 86 FR 51410. Comments on the proposed rule change can be
found at https://www.sec.gov/comments/sr-box-2021-19/srbox202119.htm.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is October 30, 2021. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

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

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change and any comments
received. Accordingly, the Commission, pursuant to Section 19(b)(2) of
the Act,\5\ designates December 14, 2021 as the date by which the
Commission shall either approve or disapprove, or institute proceedings
to determine whether to disapprove, the proposed rule change (File No.
SR-BOX-2021-19).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21486 Filed 10-1-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 23, 2008 (Volume 73, Number 79)]
[Notices]
[Page 21999]
[DOCID:fr23ap08-142]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; General Operating and Flight Rules--FAR
91

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. Part A of Subtitle VII of the Revised Title 49
U.S.C. authorizes the issuance of regulations governing the use of
navigable airspace. Information is collected to determine compliance
with Federal regulations.

DATES: Please submit comments by June 23, 2008.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: General Operating and Flight Rules--FAR 91.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0005.
    Form(s): There are no FAA forms associated with this collection.
    Affected Public: A total of 21,197 respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 11 hours per
response.
    Estimated Annual Burden Hours: An estimated 235,164 annually.
    Abstract: Part A of Subtitle VII of the Revised Title 49 U.S.C.
authorizes the issuance of regulations governing the use of navigable
airspace. Information is collected to determine compliance with Federal
regulations. Respondents are individual airmen, state or local
governments, and businesses.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on April 17, 2008.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
 [FR Doc. E8-8731 Filed 4-22-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Notices]
[Page 2707]
[FR Doc No: 2013-00680]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, January
17, 2013 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Consideration of amicus participation; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

     Dated: January 10, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-00680 Filed 1-10-13; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Rules and Regulations]
[Pages 47383-47385]
[FR Doc No: 2017-21930]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2017-0174; FRL-9969-24-Region 4]

Air Plan Approval: Alabama; Transportation Conformity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
portion of a revision to the Alabama State Implementation plan (SIP)
submitted by the State of Alabama on May 8, 2013, for the purpose of
amending the transportation conformity rules to be consistent with
Federal requirements.

DATES: This rule is effective November 13, 2017.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2017-0174. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Ms. Sheckler can
also be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On May 8, 2013, the Alabama Department of Environmental Management
submitted a SIP revision to EPA to make two changes to its
transportation conformity requirements. First, the State changed its
regulations at Alabama Administrative Code section 335-3-17-.01,
Transportation Conformity, to reflect the January 24, 2008 (73 FR 4420)
amendments to 40 CFR part 93, subpart A, that address the 2005 SAFETEA-
LU. That change in Alabama's regulation streamlines the State's
transportation conformity SIP to include only Sec. Sec.  93.105,
93.122(a)(4)(ii) and 93.125(c), consistent with Federal requirements,
and not the provisions of 40 CFR part 93 in entirety.
    On March 14, 2012 (77 FR 14979), EPA finalized the rule entitled
``Transportation Conformity Rule Restructuring Amendments.'' Through
that final action, EPA restructured several sections of the
transportation conformity rule so that they apply to any new or revised
NAAQS. Specifically, EPA amended Sec. Sec.  93.101, 93.105, 93.109,
93.116, 93.118, 93.119, and 93.121 of the Transportation Conformity
Rule. In its May 8, 2013, SIP revision, Alabama requests that EPA
incorporates by reference subsequent Federal changes EPA promulgated in
the Transportation Conformity Rule Restructuring Amendments. Although
Alabama's submission mentions that it is incorporating by reference
provisions in EPA's Transportation Conformity Rule Restructuring
Amendments, the only relevant portion for incorporation by reference is
the change that EPA made to Sec.  93.105 because, in this same
submission, Alabama changed the State regulations and transportation
conformity requirements in its SIP to address only Sec. Sec.  93.105,
93.122(a)(4)(ii) and 93.125(c), in accordance with EPA's regulations.
The changes EPA made to Sec.  93.105 were administrative in nature and
involved updates to citations, revision of introductory paragraphs, and
redesignating paragraphs.
    EPA has reviewed Alabama's submittal to ensure consistency with the
current Clean Air Act (CAA or Act), as amended by SAFETEA-LU, and EPA
regulations governing state procedures for transportation and general
conformity (40 CFR part 93, subparts A and B). The May 8, 2013, SIP
revision, upon final approval by EPA, removes specific provisions of
Alabama Administrative Code section 335-3-17-.01, ``Transportation
Conformity,'' from the SIP that are no longer required in light of the
SAFETEA-LU amendments. With the removal of these specific provisions of
335-3-17-.01 from the SIP, the federal rules in 40 CFR part 93, subpart
A, will directly govern transportation conformity of federal actions in
the State of Alabama. This revision complies with the requirements of
CAA section 176(c)(4)(e) and 40 CFR 51.390(b). 40 CFR part 93, subpart
A, continues to subject certain Federal actions to transportation
conformity requirements without the need for identical state rules and
SIPs. Therefore, repealing the State rule will not impact continuity of
the transportation conformity program in Alabama.
    In a direct final rule published on August 17, 2017 (82 FR 39035),
EPA took a direct final action to approve the portions of the May 8,
2013, submittal that removes specific provisions of Alabama
Administrative Code section 335-3-17-.01, ``Transportation
Conformity,'' from the SIP that are no longer required in light of the
SAFETEA-LU amendments. In the direct final rulemaking, EPA established
that the rule would become effective 60 days after publication in the
Federal Register and without further notice, unless EPA received
adverse comment within 30 days of the publication. If EPA received such
comments, it would publish a timely withdrawal of the direct final rule
in the Federal Register and inform the public that the rule will not
take effect. Comments on the rulemaking were due on or before September
18, 2017.
    EPA received one adverse comment on the direct final rulemaking,
and as a result, elsewhere in this issue of the Federal Register, the
EPA has taken a separate action to withdraw the direct final rule.
Nevertheless, the rationale for EPA's action still remains and the only
addition in this final rulemaking is the response to the adverse
comment received. The details of Alabama's SIP revisions and the
rationale for EPA's action are further explained in the direct final
rule published August 17, 2017 (82 FR 39035). Below is a summary of the
comment received and EPA's response.

II. Response to Comment

    Comment: The Commenter mentions that EPA should not allow Alabama
to remove transportation conformity rules from the SIP and asserts that
EPA has loosened the Federal transportation conformity requirements.
The Commenter goes on to say that Alabama should incorporate by
reference the entirety of 40 CFR part 93.

    Response: Alabama's SIP continues to include transportation
conformity requirements. CAA section 176(c) is the statutory authority
for transportation conformity (42 U.S.C. 7506(c)). This section of the
CAA was amended by provisions contained in the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy for Users
(SAFETEA-LU), which was signed into law on August 10, 2005 (Public Law
109-59). Among the changes Congress made to this section of the CAA was
to streamline the requirements for state conformity SIPs. Subsequently,
EPA published a final rule on January 24, 2008 (73 FR 4420), to update
the requirements for conformity SIPs as well as the other CAA
provisions amended by Congress. These streamlined conformity SIP
requirements did not loosen EPA's conformity requirements. The CAA
amendment was merely intended to reduce the burden on states associated
with duplicating federal transportation conformity rules within state
conformity rules.
    CAA section 176(c)(4)(E) and 40 CFR 51.390(b) of the conformity
rule now require states to submit conformity SIPs that address only the
following provisions of the federal conformity rule:
     40 CFR 93.105, which addresses consultation procedures;
     40 CFR 93.122(a)(4)(ii), which states that conformity SIPs
must require that written commitments to control measures be obtained
prior to a conformity determination if the control measures are not
included in a metropolitan planning organization's transportation plan
and transportation improvement programs, and that such commitments be
fulfilled; and
     40 CFR 93.125(c), which states that conformity SIPs must
require that written commitments to mitigation measures be obtained
prior to a project-level conformity determination, and that project
sponsors comply with such commitments.

These provisions must be tailored to a state's individual
circumstances, rather than including the federal conformity rule
section verbatim. Alabama's SIP contains the tailored provisions.

III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of ADEM
Regulation, chapter 335-3-17-.01 entitled ``Transportation
Conformity,'' effective May 28, 2013, which incorporates by reference
the Federal Transportation Conformity Rule. EPA has made, and will
continue to make, these materials generally available through
www.regulations.gov and/or at the EPA Region 4 Office (please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information). Therefore, these materials have
been approved by EPA for inclusion in the State implementation plan,
have been incorporated by reference by EPA into that plan, are fully
federally enforceable under sections 110 and 113 of the CAA as of the
effective date of the final rulemaking of EPA's approval, and will be
incorporated by reference by the Director of the Federal Register in
the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

IV. Final Action

    Pursuant to section 110 of the CAA, EPA is approving the revision
to the Alabama SIP regarding the State's transportation conformity
requirements. The approval of Alabama's conformity SIP revisions will
align the Alabama SIP with the current federal conformity requirements,
as amended by SAFETEA-LU, and the most recent EPA regulations governing
state procedures for transportation conformity.

V. 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. See 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. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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 (Public Law 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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 11, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and

shall not postpone the effectiveness of such rule or action. This
action may not be challenged later in proceedings to enforce its
requirements. See section 307(b)(2).

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.

    Dated: September 29, 2017.
Onis ``Trey'' Glenn, III
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart B--Alabama

0
2. Section 52.50(c) is amended under the heading ``Chapter No. 335-3-17
Conformity of Federal Actions to State Implementation Plans'' by
revising the entry for ``Section 335-3-17-.01'' to read as follows:

Sec.  52.50  Identification of plan.

* * * * *
    (c) * * *

                                        EPA Approved Alabama Regulations
----------------------------------------------------------------------------------------------------------------
                                                            State
         State citation              Title/subject     effective date   EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                Chapter No. 335-3-17 Conformity of Federal Actions to State Implementation Plans
----------------------------------------------------------------------------------------------------------------
Section 335-3-17-.01............  Transportation            5/28/2013  10/12/2017           ....................
                                   Conformity.                         [Insert citation of
                                                                        publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-21930 Filed 10-11-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49680-49681]
[FR Doc No: 2016-17864]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Psychopharmacologic Drugs Advisory Committee and the Drug Safety
and Risk Management Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Psychopharmacologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee. The general function of the committees is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public.

DATES: The meeting will be held on September 14, 2016, from 8 a.m. to 5
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committees will discuss a completed postmarketing-
requirement randomized, placebo controlled trial of the
neuropsychiatric effects of CHANTIX (varenicline), ZYBAN (bupropion),
and nicotine replacement therapy, along with relevant published
observational studies to determine whether the findings support changes
to product labeling.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
Written submissions may be made to the contact person on or before
August 30, 2016. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before August 22, 2016. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by August 23, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the

Agency is not responsible for providing access to electrical outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Kalyani Bhatt at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 25, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-17864 Filed 7-27-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Rules and Regulations]
[Pages 84234-84236]
[FR Doc No: 2023-26633]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31519; Amdt. No. 4089]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums
and Obstacle Departure procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective December 5, 2023. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of December 5, 2023

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30. 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Information Services, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations or email
[email protected].

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., STB Annex, Bldg. 26, Room 217,
Oklahoma City, OK 73099. Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by
establishing, amending, suspending, or removes SIAPS, Takeoff Minimums
and/or ODPS. The complete regulatory description of each SIAP and its
associated Takeoff Minimums or ODP for an identified airport is listed
on FAA form documents which are incorporated by reference in this
amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The
applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when
required by an entry on 8260-15A, and 8260-15C.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, pilots do not use
the regulatory

text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their
graphic depiction on charts printed by publishers or aeronautical
materials. Thus, the advantages of incorporation by reference are
realized and publication of the complete description of each SIAP,
Takeoff Minimums and ODP listed on FAA form documents is unnecessary.
This amendment provides the affected CFR sections and specifies the
types of SIAPS, Takeoff Minimums and ODPs with their applicable
effective dates. This amendment also identifies the airport and its
location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPs as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Air Missions (NOTAM) as an emergency action of
immediate flights safety relating directly to published aeronautical
charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C. 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    The FAA has determined that this 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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Lists of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on November 24, 2023.
Thomas J. Nichols,
Manager, Aviation Safety, Flight Standards Service, Standards Section,
Flight Procedures & Airspace Group, Flight Technologies & Procedures
Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, 14 CFR part
97 is amended by establishing, amending, suspending, or removing
Standard Instrument Approach Procedures and/or Takeoff Minimums and
Obstacle Departure Procedures effective at 0901 UTC on the dates
specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 28 December 2023

Los Angeles, CA, LAX, ILS OR LOC RWY 25L, ILS RWY 25L (CAT II), ILS
RWY 25L (CAT III), Amdt 15A
Mason City, IA, KMCW, RNAV (GPS) RWY 30, Amdt 1E
Mason City, IA, KMCW, RNAV (GPS) RWY 36, Amdt 1E
Springfield, IL, SPI, RNAV (GPS) RWY 4, Orig-E
Springfield, IL, KSPI, RNAV (GPS) RWY 13, Amdt 1D
Indianapolis, IN, UMP, RNAV (GPS) RWY 15, Amdt 2A
South Bend, IN, KSBN, RNAV (GPS) RWY 18, Amdt 1E
Beverly, MA, BVY, RNAV (GPS) RWY 9, Amdt 1
Beverly, MA, KBVY, RNAV (GPS) RWY 27, Amdt 1C
Luverne, MN, KLYV, RNAV (GPS) RWY 36, Orig-C
Luverne, MN, KLYV, Takeoff Minimums and Obstacle DP, Orig-A
Miles City, MT, KMLS, RNAV (GPS) RWY 4, Amdt 4A
Miles City, MT, KMLS, VOR RWY 4, Amdt 14B
Lincoln, NE, LNK, RNAV (GPS) RWY 35, Orig-B
Jackson, TN, KMKL, VOR RWY 2, Amdt 1
Bonham, TX, F00, RNAV (GPS) RWY 17, Amdt 2C
Bonham, TX, F00, RNAV (GPS) RWY 35, Amdt 1C

Effective 25 January 2024

Little Rock, AR, LIT, RNAV (GPS) RWY 18, Amdt 2
Colorado City, AZ, KAZC, NDB-A, Amdt 1, CANCELED
Colorado City, AZ, KAZC, NORRA (RNAV) ONE, Graphic DP
Colorado City, AZ, KAZC, Takeoff Minimums and Obstacle DP, Amdt 1
Rifle, CO, KRIL, RNAV (GPS) Y RWY 8, Amdt 2A
Valdosta, GA, VLD, ILS OR LOC RWY 36, Amdt 8
Valdosta, GA, VLD, RNAV (GPS) RWY 4, Amdt 2
Valdosta, GA, VLD, RNAV (GPS) RWY 18, Amdt 3
Valdosta, GA, VLD, RNAV (GPS) RWY 36, Amdt 2
Valdosta, GA, KVLD, Takeoff Minimums and Obstacle DP, Amdt 2A
Valdosta, GA, VLD, VOR RWY 18, Amdt 1C
Valdosta, GA, VLD, VOR RWY 36, Amdt 1C
Champaign/Urbana, IL, KCMI, ILS OR LOC RWY 32R, Amdt 14A
Champaign/Urbana, IL, CMI, NDB RWY 32R, Amdt 11B
Champaign/Urbana, IL, CMI, RNAV (GPS) RWY 22, Amdt 1C
Champaign/Urbana, IL, KCMI, VOR RWY 22, Amdt 8B
Decatur, IL, DEC, ILS OR LOC RWY 6, Amdt 15
Dixon, IL, C73, RNAV (GPS) RWY 8, Amdt 2
Dixon, IL, C73, RNAV (GPS) RWY 26, Amdt 1
Dixon, IL, C73, VOR-A, Amdt 10C, CANCELED
Litchfield, IL, 3LF, RNAV (GPS) RWY 18, Amdt 1
Litchfield, IL, 3LF, RNAV (GPS) RWY 27, Amdt 1
Litchfield, IL, 3LF, RNAV (GPS) RWY 36, Amdt 1
Bloomington, IN, BMG, VOR/DME RWY 6, Amdt 19D
Indianapolis, IN, IND, ILS OR LOC RWY 23L, ILS RWY 23L (SA CAT II),
Amdt 8
Indianapolis, IN, IND, RNAV (GPS) Y RWY 23L, Amdt 5
Indianapolis, IN, IND, RNAV (RNP) Z RWY 23L, Amdt 3
Portland, IN, KPLD, RNAV (GPS) RWY 27, Amdt 2A
Lexington, KY, KLEX, ILS OR LOC RWY 4, Amdt 18

Lexington, KY, KLEX, ILS OR LOC RWY 22, Amdt 21
Lexington, KY, LEX, RNAV (GPS) RWY 4, Amdt 2
Lexington, KY, LEX, RNAV (GPS) RWY 22, Amdt 2
Maple Lake, MN, MGG, RNAV (GPS)-A, Orig
Maple Lake, MN, MGG, VOR-A, Amdt 4C, CANCELED
Helena, MT, KHLN, RNAV (RNP) Y RWY 27, Amdt 2
Helena, MT, KHLN, RNAV (RNP) Z RWY 9, Amdt 2
Helena, MT, KHLN, RNAV (RNP) Z RWY 27, Amdt 2
Hickory, NC, KHKY, HICKORY THREE, Graphic DP, CANCELED
Hickory, NC, KHKY, ILS OR LOC RWY 24, Amdt 9
Hickory, NC, KHKY, RNAV (GPS) RWY 1, Amdt 1C, CANCELED
Hickory, NC, KHKY, RNAV (GPS) RWY 6, Amdt 2
Hickory, NC, KHKY, RNAV (GPS) RWY 19, Amdt 1B, CANCELED
Hickory, NC, KHKY, RNAV (GPS) RWY 24, Amdt 2
North Platte, NE, LBF, ILS OR LOC RWY 30, Amdt 8
Eureka, NV, 05U, RNAV (GPS) RWY 18, Amdt 1
Cincinnati, OH, LUK, LOC BC RWY 3R, Amdt 9, CANCELED
Huntington, WV, KHTS, ILS OR LOC RWY 12, Amdt 17
Huntington, WV, KHTS, RNAV (GPS) RWY 12, Amdt 4

[FR Doc. 2023-26633 Filed 12-4-23; 8:45 am]
BILLING CODE 4910-13-P