[Federal Register: March 2, 2007 (Volume 72, Number 41)]
[Notices]
[Page 9522-9523]
[DOCID:fr02mr07-39]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8282-7; Docket ID No. EPA-HQ-ORD-2007-0108]

External Review Draft, Evaluating Ecological Risk to Invertebrate
Receptors From PAHs in Sediments at Hazardous Waste Sites

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a 30-day public comment period for the draft
document titled, ``Evaluating Ecological Risk to Invertebrate Receptors
from PAHs in Sediments at Hazardous Waste Sites'' (EPA/600/R-06/162).
The document was prepared by the Ecological Risk Assessment Support
Center managed by the National Center for Environmental Assessment
within EPA's Office of Research and Development.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination. EPA will consider any public comments
submitted in accordance with this notice when revising the document.

DATES: The 30-day public comment period begins March 2, 2007, and ends
April 2, 2007. Technical comments should be in writing and must be
received by EPA by April 2, 2007.

ADDRESSES: The draft document, ``Evaluating Ecological Risk to
Invertebrate Receptors from PAHs in Sediments at Hazardous Waste
Sites,'' is available primarily via the Internet on the National Center
for Environmental Assessment's home page under the ``Recent Additions''
and ``Publications'' menus at http://www.epa.gov/ncea. A limited number

of paper copies are available from the Technical Information Staff,
NCEA-Cin; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>. If you are
requesting a paper copy, please provide your name, your mailing
address, and the document title, ``Evaluating Ecological Risk to
Invertebrate Receptors from PAHs in Sediments at Hazardous Waste
Sites.''
    Comments may be submitted electronically via http://www.regulations.gov,

by mail, by facsimile, or by hand delivery/courier. Please follow the
detailed instructions provided in the SUPPLEMENTARY INFORMATION section
of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>
    For technical information, contact Michael Kravitz, NCEA;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Information About the Project/Document

    U.S. EPA's Ecological Risk Assessment Support Center (ERASC) is a
knowledge center that provides technical information and addresses
scientific questions on topics relevant to ecological risk assessment
at hazardous waste sites for EPA's Office of Solid Waste and Emergency
Response (OSWER) and Regional Superfund/Resource Conservation and
Recovery Act (RCRA) staff. Topics are submitted to ERASC by users in
EPA program offices and regions. The ERASC is managed by the Office of
Research and Development's (ORD's) National Center for Environmental
Assessment and is located in Cincinnati, Ohio.
    The ERASC recently completed an external review draft document
titled, ``Evaluating Ecological Risk to Invertebrate Receptors from
PAHs in Sediments at Hazardous Waste Sites.'' It provides an overview
of an approach for assessing risk to invertebrate receptors resulting
from exposure to PAHs in contaminated sediments. The approach, based on
procedures described in the EPA document, Procedures for the Derivation
of Equilibrium Partitioning Sediment Benchmarks (ESBs) for the
Protection of Benthic Organisms: PAH Mixtures (EPA/600/R-02/013),
involves the use of equilibrium partitioning techniques to determine
exposure/bioavailability and narcosis theory to estimate sublethal
toxicity of PAHs. Examples of how to use this approach with analytical
data resulting from the analysis of contaminated sediments are
provided. The approach offers risk assessors a useful tool for
assessing the risk of PAHs to benthic invertebrates at hazardous waste
sites, particularly when used with other contaminated sediment
assessment methods. The External Review Draft only addresses risks to
benthic invertebrates because reaching a consensus scientific position
on vertebrate risk issues is a longer-term prospect.

II. How To Submit Technical Comments to the Docket at
http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2007-
0108 by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334 EPA West Building, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit
three copies of the comments. For attachments, provide an index, number
pages consecutively with the comments, and submit an unbound original
and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0108. It is EPA's policy to include all comments it receives in
the public

docket without change and to make the comments available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: Documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov or in hard copy at the OEI Docket in the EPA

Headquarters Docket Center.

    Dated: February 22, 2007.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E7-3685 Filed 3-1-07; 8:45 am]

BILLING CODE 6560-50-P


	   U.S. Environmental Protection Agency - October 2007

Compliance and Enforcement National Priority

Clean Air Act, Air Toxics

What is the Environmental Problem?

For the FY 2008-2010 planning cycle, the Air Toxics National Compliance
and Enforcement Strategy will focus on the problem areas of leak
detection and repair (LDAR), industrial flares, and surface coating.  To
address these problem areas, EPA will utilize a combination of
compliance assistance, compliance evaluations and enforcement.

LDAR

Leaking equipment, such as valves, pumps, and connectors, are the
largest source of emissions of volatile organic compounds (VOCs) and
volatile hazardous air pollutants (VHAPs) from petroleum refineries and
chemical manufacturing facilities. The most significant equipment leak
emission sources are pumps, valves, connectors, sampling connections,
compressors, pressure relief devices, and open-ended lines.  The major
cause of emissions from these components is seal or gasket failure due
to normal wear or improper maintenance.

To reduce emissions from leaking equipment, federal, state, and local
regulations require LDAR programs.  However, recent compliance
evaluations conducted by EPA found significantly higher numbers of
leaking components than were reported by regulated entities.  EPA
believes this discrepancy is due to improper monitoring techniques and
ineffective management of the LDAR program.

LDAR was selected as a national initiative in the FY 2005-2007 Air
Toxics Strategy due to widespread noncompliance and the potential for
significant emission reductions when facilities are brought into
compliance.  In FY 2006, EPA achieved over 250,000 pounds in hazardous
air pollutants (HAP) emission reductions from LDAR enforcement and
compliance actions.  With the large universe of sources subject to LDAR
requirements and the high level of noncompliance, EPA will continue to
focus on LDAR in the

FY 2008-2010 Air Toxics Strategy.

Industrial Flares

Industrial facilities such as chemical manufacturing and petroleum
refining facilities utilize industrial flares to control HAP emissions.
Clean Air Act regulations require that flares used for control devices
must be operated under specific conditions including having a pilot
flame present, not producing smoke when operated and only combusting
gases with sufficient heat content.  In addition, facilities must use
good engineering control practices when operating equipment, including
following the manufacturer's design specifications.  Failure to follow
these requirements constitutes non-compliance. EPA has found that
facilities not meeting these operating requirements can release
significant levels of HAP emissions.  Ensuring compliance with
industrial flare requirements could significantly reduce the amount of
HAPs emitted from these facilities.

Surface Coating

Since 1990, EPA has promulgated 14 Maximum Achievable Control Technology
(MACT) standards for surface coating categories.  The surface coating
sector is comprised of many facilities that are engaged in the
application of coatings on various substrates including metals, paper,
wood, etc. The coatings are principally comprised of volatile organic
compounds (VOCs), many of which are HAPS.  During the coatings
application process, HAPs not captured or controlled to the degree
required by the MACT standards are emitted into the atmosphere,
adversely impacting the air quality and impairing the health of the
population both in the vicinity of the facilities and in some cases at
substantial distances from the facilities.  Some of these HAPS are
extremely toxic and are known or suspected carcinogens (e.g., methylene
chloride, formaldehyde, acetaldehyde, toluene diisocyanate).

Why Are We Addressing the Problem?

Experience that EPA and State regulators have had with facilities in
this sector suggests that many of these facilities are currently out of
compliance with the MACT requirements due to lack of understanding of
the regulatory requirements, failure to adhere to the requirements, and
failure to operate and maintain control apparatus according to
manufacturers specifications.  Ensuring compliance with these surface
coating MACTs could significantly reduce the amount of HAPs emitted from
these facilities.

Highlights from the FY 2005-2007 Planning Cycle

Since FY 2005, the EPA regional offices have conducted compliance
evaluations at sources subject to over 40 different MACT standards.
These compliance evaluations and subsequent enforcement actions will
result in over one million pounds of HAP emission reductions by the end
of FY 2007.  The compliance monitoring and enforcement experience gained
across the MACT program over the last three years has been extremely
valuable and has contributed to EPA’s ability to narrow the focus of
the Air Toxics Strategy for the FY 2008-2010 planning cycle.

Final: Air Toxics Summary		09/24/07

 PAGE

 PAGE   2


[Federal Register: August 10, 2009 (Volume 74, Number 152)]
[Notices]
[Page 39987-39989]
[DOCID:fr10au09-71]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60419; File No. SR-NYSE-2009-79]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Extending Until August 10, 2009 the Operation of Interim NYSE Rule 128,
Which Permits the Exchange To Cancel or Adjust Clearly Erroneous
Executions

August 3, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 31, 2009, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. NYSE has
designated the proposed rule change as constituting a rule change under
Rule 19b-4(f)(6) under the Act,\3\ which renders the proposal effective
upon filing with 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 Substance
of the Proposed Rule Change

    The Exchange proposes to proposes to [sic] extend until August 10,
2009, the operation of interim NYSE Rule 128 (``Clearly Erroneous
Executions for NYSE Equities'') which permits the Exchange to cancel or
adjust clearly erroneous executions if they arise out of the use or
operation of any quotation, execution or communication system owned or
operated by the Exchange, including those executions that occur in the
event of a system disruption or system malfunction. The text of the
proposed rule change is available at the Exchange, the Commission's
Public Reference Room, and http://www.nyse.com.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received

on the proposed rule change. The text of those statements may be
examined at the places specified in Item IV below. The Exchange has
prepared summaries, set forth in sections A, B, and C below, of the
most significant parts of such statements.

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

1. Purpose
    The Exchange proposes to extend until August 10, 2009, the
operation of interim NYSE Rule 128 (``Clearly Erroneous Executions for
NYSE Equities'') which permits the Exchange to cancel or adjust clearly
erroneous executions if they arise out of the use or operation of any
quotation, execution or communication system owned or operated by the
Exchange, including those executions that occur in the event of a
system disruption or system malfunction.
    Prior to the implementation of NYSE Rule 128 on January 28,
2008,\4\ the NYSE did not have a rule providing the Exchange with the
authority to cancel or adjust clearly erroneous trades of securities
executed on or through the systems and facilities of the NYSE.
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    \4\ See Securities Exchange Act Release No. 57323 (February 13,
2008), 73 FR 9371 (February 20, 2008) (SR-NYSE-2008-09).
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    In order for the NYSE to be consistent with other national
securities exchanges which have some version of a clearly erroneous
execution rule, the Exchange is drafting an amended clearly erroneous
rule which will accommodate such other exchanges but will be
appropriate for the NYSE market model.
    The NYSE notes that the Commission approved an amended clearly
erroneous execution rule for Nasdaq in May 2008.\5\ On July 28, 2008,
the Exchange filed with the SEC a request to extend the operation of
interim Rule 128 until October 1, 2008 \6\ in order to review the
provisions of Nasdaq's clearly erroneous rule and to consider
integrating similar standards into its own amendment to Rule 128. On
October 1, 2008,\7\ the Exchange filed with the SEC a further request
to extend the operation of interim Rule 128 until January 9, 2009 in
order to consider integrating similar standards into the amendment to
Rule 128. On January 9, 2009,\8\ the Exchange filed with the SEC a
request to extend the operation of interim Rule 128 until March 9,
2009, indicating that the Exchange was still in the process of
reviewing the Nasdaq rule with a view towards incorporating certain
provisions into the amendment of interim Rule 128.
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    \5\ See Securities Exchange Act Release No. 57826 (May 15,
2008), 73 FR 29802 (May 22, 2008) (SR-NASDAQ-2007-001).
    \6\ See Securities Exchange Act Release No. 58328 (August 8,
2008), 73 FR 47247 (August 13, 2008) (SR-NYSE-2008-63).
    \7\ See Securities Exchange Act Release No. 58732 (October 3,
2008), 73 FR 61183 (October 15, 2008) (SR-NYSE-2008-99).
    \8\ See Securities Exchange Act Release No. 59255 (January 15,
2009) 74 FR 4496 (January 26, 2009) (SR-NYSE-2009-02).
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    On February 10, 2009, NYSE Arca submitted a proposal to the SEC to
amend its clearly erroneous rule. The NYSE Arca proposed rule differed
in certain respects from the Nasdaq clearly erroneous rule. On March 9,
2009, the Exchange filed with the SEC a request to extend the operation
of interim Rule 128 until June 9, 2009 \9\ to finalize review of NYSE
Arca's proposed amended CEE rule, which included market wide CEE
initiatives, to determine if it was appropriate to incorporate such
provisions into the Rule 128 amendment.
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    \9\ See Securities Exchange Act Release No. 59581 (March 9,
2009) 74 FR 12431 (March 24, 2009) (SR-NYSE-2009-26).
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    Thereafter, on April 24, 2009, NYSE Arca filed a revised rule
change with the Commission to amend its clearly erroneous rule (NYSE
Arca Rule 7.10).\10\ The Exchange was in the process of finalizing its
review of NYSE Arca's revised CEE rule change, which also included
market wide CEE initiatives, to determine if it was appropriate to
incorporate all such provisions into NYSE's interim Rule 128 amendment.
On June 9, 2009, the Exchange filed with the SEC a request to extend
the operation of interim Rule 128 until July 15, 2009 \11\ to finalize
review of NYSE Arca's proposed amended CEE rule.\12\ On July 15, 2009,
the Exchange filed with the SEC a request to extend the operation of
interim Rule 128 until August 1, 2009 \13\ to finalize review of NYSE
Arca's proposed amended CEE rule.\14\
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    \10\ See Securities Exchange Act Release No. 59838 (April 28,
2009) 74 FR 20767 (May 5, 2009) (SR-NYSEArca-2009-36) (See NYSE Arca
Rule 7.10).
    \11\ See Securities Exchange Act Release No. 59581 (March 9,
2009) 74 FR 12431 (March 24, 2009) (SR-NYSE-2009-26).
    \12\ See Securities Exchange Act Release No. 60131 (June 17,
2009) 74 FR 30196 (June 24, 2009) (SR-NYSEArca-2009-57)
    \13\ See Securities Exchange Act Release No. 59581 (March 9,
2009) 74 FR 12431 (March 24, 2009) (SR-NYSE-2009-26).
    \14\ See Securities Exchange Act Release No. 60312 (July 15,
2009) 74 FR 36298 (July 22, 2009) (SR-NYSE-2009-70).
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    The Exchange anticipates finalizing proposed rule text of its
clearly erroneous execution rule shortly, and is, therefore, requesting
to extend the operation of interim Rule 128 until August 10, 2009.
Prior to August 10, 2009, the Exchange intends to formally file a 19b-4
rule change amending interim Rule 128.
2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (the ``Act'')
\15\ for this proposed rule change is the requirement under Section
6(b)(5) \16\ that an Exchange have rules that are designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system and, in general, to protect investors and the public interest.
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    \15\ 15 U.S.C. 78f(a).
    \16\ 15 U.S.C. 78f(b)(5).
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    As articulated more fully in the ``Purpose'' Section above, the
proposed rule would place the NYSE on equal footing with other national
securities exchanges. This will promote the integrity of the market and
protect the public interest, since it would permit all exchanges to
cancel or adjust clearly erroneous trades when such trades occur,
rather than canceling them on all other markets, but leaving them
standing on only one market.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    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) of the Act \17\ and Rule 19b-
4(f)(6) thereunder.\18\
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    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Commission has determined to waive the five-day pre-filing
period in this case.

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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \19\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6) \20\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. NYSE requests that the
Commission waive the 30-day operative delay because the Exchange
believes that the absence of such a rule in an automated and fast-paced
trading environment poses a danger to the integrity of the markets and
the public interest. NYSE notes that immediate effectiveness of the
proposed rule change will immediately and timely enable NYSE to cancel
or adjust clearly erroneous trades that may present a risk to the
integrity of the equities markets and all related markets. The
Commission believes that waiving the 30-day operative delay \21\ is
consistent with the protection of investors and the public interest
because such waiver will permit the Exchange to continue operation of
interim NYSE Rule 128 on an uninterrupted basis, and therefore
designates the proposal operative upon filing.
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    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2009-79 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2009-79. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-NYSE-2009-79 and should be
submitted on or before August 31, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-19033 Filed 8-7-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: April 5, 2010 (Volume 75, Number 64)]
[Notices]
[Page 17147-17148]
[DOCID:fr05ap10-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0343]

International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 9 on Tablet
Friability General Chapter; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet
Friability General Chapter.'' The guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The guidance provides the results of the ICH Q4B evaluation of the
Tablet Friability General Chapter harmonized text from each of the
three pharmacopoeias (United States, European, and Japanese)
represented by the Pharmacopoeial Discussion Group (PDG). The guidance
conveys recognition of the three pharmacopoeial methods by the three
ICH regulatory regions and provides specific information regarding the
recognition. The guidance is intended to recognize the
interchangeability between the local regional pharmacopoeias, thus
avoiding redundant testing in favor of a common testing strategy in
each regulatory region. This guidance is in the form of an annex to the
core guidance on the Q4B process entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions''
(core ICH Q4B guidance).

DATES:  Submit written or electronic comments on agency guidances at
any time.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send two self-addressed adhesive labels to assist the office in
processing your requests. Requests and comments should be identified
with the docket number found in brackets in the heading of this
document. Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Robert H.
King, Sr., Center for Drug Evaluation and Research (HFD-003), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Christopher Joneckis,
Center for Biologics Evaluation and Research (HFM-25), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of August 14, 2009 (74 FR 41144), FDA
published a

notice announcing the availability of a draft tripartite guidance
entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions; Annex 9: Tablet Friability General
Chapter.'' The notice gave interested persons an opportunity to submit
comments by October 13, 2009.
    After consideration of the comments received and revisions to the
guidance, a final draft of the guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 9: Tablet Friability General Chapter'' was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in October 2009.
    The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Tablet Friability General Chapter harmonization
proposal originating from the three-party PDG. This guidance is in the
form of an annex to the core ICH Q4B guidance made available in the
Federal Register of February 21, 2008 (73 FR 9575). When implemented,
the annex will provide guidance for industry and regulators on the use
of the specific pharmacopoeial texts evaluated by the ICH Q4B process.
Following receipt of comments on the draft, no substantive changes were
made to the annex.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: March 31, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7592 Filed 4-2-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Rules and Regulations]
[Pages 52442-52443]
[FR Doc No: 2022-18342]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0758; Airspace Docket No. 22-AGL-24]
RIN 2120-AA66

Amendment of Class E Airspace; Coldwater and Sturgis, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class E airspace at Coldwater and
Sturgis, MI. This action is due to an airspace review conducted as part
of the decommissioning of the Litchfield very high frequency (VHF)
omnidirectional range (VOR) as part of the VOR Minimal Operational
Network (MON) Program. The geographic coordinates of the airports are
also being updated to coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, November 3, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Branch County Memorial Airport, Coldwater, MI, and
Kirsch Municipal Airport, Sturgis, MI, to support instrument flight
rule operations at these airports.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (87 FR 35689; June 13, 2022) for Docket No. FAA-2022-0758 to
amend the Class E airspace at Coldwater and Sturgis, MI. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR part 71:
    Amends the Class E airspace extending upward from 700 feet above
the surface to within a 6.6-mile (decreased from an 8.1-mile) radius of
Branch County Memorial Airport, Coldwater, MI; removes the city
associated with the airport in the airspace legal description to comply
with changes to FAA Order JO 7400.2N, Procedures for Handling Airspace
Matters; and updates the geographic

coordinates of the airport to coincide with the FAA's aeronautical
database;
    And amends the Class E airspace extending upward from 700 feet
above the surface to within a 6.5-mile (decreased from a 7-mile) radius
of Kirsch Municipal Airport, MI; adds an extension 2.5 miles each side
of the 052[deg] bearing from the Sturgis NDB extending from the 6.5-
mile radius of the airport to 7 miles northeast of the NDB; adds an
extension 2.5 miles each side of the 341[deg] bearing from the Sturgis
NDB extending from the 6.5-mile radius of the airport to 7 miles north
of the NDB; removes the city associated with the airport in the
airspace legal description to comply with changes to FAA Order JO
7400.2N; and updates the geographic coordinates of the airport to
coincide with the FAA's aeronautical database.
    This action is due to an airspace review conducted as part of the
decommissioning of the Litchfield VOR, which provided navigation
information for the instrument procedures at these airports, as part of
the VOR MON Program.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

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

* * * * *

AGL MI E5 Coldwater, MI [Amended]

Branch County Memorial Airport, MI
    (Lat. 41[deg]56'01'' N, long. 85[deg]03'08'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Branch County Memorial Airport.
* * * * *

AGL MI E5 Sturgis, MI [Amended]

Kirsch Municipal Airport, MI
    (Lat. 41[deg]48'48'' N, long. 85[deg]26'20'' W)
Sturgis NDB
    (Lat. 41[deg]48'47'' N, long. 85[deg]26'02'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of the Kirsch Municipal Airport; and within
2.5 miles each side of the 052[deg] bearing from the Sturgis NDB
extending from the 6.5-mile radius of the airport to 7 miles
northeast of the Sturgis NDB; and within 2.5 miles each side of the
341[deg] bearing from the Sturgis NDB extending from the 6.5-mile
radius of the airport to 7 miles north of the Sturgis NDB.

    Issued in Fort Worth, Texas, on August 22, 2022.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2022-18342 Filed 8-25-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)]
[Notices]
[Pages 65205-65206]
[FR Doc No: 2011-27127]

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

Coast Guard

[Docket No. USCG-2011-0979]

Commercial Fishing Safety Advisory Committee; Meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee meeting.

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

SUMMARY: The Commercial Fishing Safety Advisory Committee (CFSAC) will
meet in Seattle, Washington to discuss various issues relating to
safety in the commercial fishing industry. This meeting will be open to
the public.

DATES: The Committee will meet on November 14, 2011, from 9 a.m. to 5
p.m., and on November 15-16, 2011, from 8:30 a.m. to 5 p.m. This
meeting may close early if all business is finished. Written material
and requests to make oral presentations should reach the Coast Guard on
or before November 4, 2011.

ADDRESSES: The Committee will meet at the Henry M. Jackson Federal
Building (Room 440), 915 2nd Ave, Seattle, Washington 98174.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the person listed in the FOR FURTHER INFORMATION CONTACT section, as
soon as possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the committee as listed in the
``Agenda'' section below. You may submit written comments no later than
November 4, 2011, and they must be identified by docket number [USCG-
2011-0979] using one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001. We encourage use of
electronic submissions because security screening may delay delivery of
mail.
     Fax:<PHONE_NUMBER>
     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays. The
telephone number is<PHONE_NUMBER>.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and docket number [USCG-2011-0979].
All submissions

received will be posted without alteration at http://www.regulations.gov, including any personal information provided.
Anyone can search the electronic form of comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.) You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).
    Docket: Any background information or presentations available prior
to the meeting will be published in the docket. For access to the
docket to read background documents or submissions received by the
CFSAC, go to http://www.regulations.gov., insert ``USCG-2011-0979'' in
the ``Keyword'' box, and then click ``Search''.
    Public comments may be taken by the DFO throughout themeetings.
Additionally, a public presentation/comment period will be held during
the meetings on November 14-16, 2011, from 4 p.m. to 5 p.m. Speakers
are requested to limit their comments to 5 minutes. Please note that
the public comment period will end following the last call for
comments. Contact the individual listed below to register as a speaker.

FOR FURTHER INFORMATION CONTACT: Mr. Jack Kemerer, Alternate Designated
Federal Official (ADFO) of CFSAC, Commandant (CG-5433), U.S. Coast
Guard Headquarters, 2100 Second Street, SW., Stop 7581, Washington, DC
20593-7581; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>If you have any questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463). The
CFSAC is authorized by 46 U.S.C. 4508 and the Committee's purpose is to
provide advice and recommendations to the U.S. Coast Guard and the
Department of Homeland Security on matters relating to the safety of
commercial fishing industry vessels.

Agenda

    The CFSAC will meet to review, discuss and formulate
recommendations on the following topics contained in this agenda:
    Day 1 of the meeting and, if necessary, the morning of Day 2 will
include the following reports and presentations:
    (1) Review of Commercial Fishing Vessel Safety Requirements
amended, added or deleted by the Coast Guard Authorization Act of 2010.
    (2) Status of Commercial Fishing Vessel Safety Rulemaking.
    (3) Commercial Fishing Vessel Safety District Coordinators reports
on activities and initiatives.
    (4) Industry Representatives updates including safety and survival
equipment, and class rules for fishing vessels.
    (5) Presentation on fatality rates by regions and fisheries and
update on safety related projects such as wearing of Personal
Floatation Device (PFD) when working on deck by the National Institute
for Occupational Safety and Health.
    (6) Presentation on safety standards by the National Oceanic and
Atmospheric Administration, National Marine Fisheries Service.
    Days 2 and 3 of the meeting will be primarily dedicated to
subcommittee sessions and reports on these topics: USCG communications
and outreach to the fishing industry; risk management for vessel
owners, operators, and crews; operator competency training
requirements; vessel construction standards and alternate safety
compliance program requirements; safety and survival equipment
requirements, inspections, and testing; mandatory safety examinations
and certificates of compliance; and safety program strategies, future
plans, and long range goals.

    Dated: October 14, 2011.
Paul F. Thomas,
Captain, U.S. Coast Guard, Acting Director, Prevention Policy.
[FR Doc. 2011-27127 Filed 10-19-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Page 78111]
[FR Doc No: 2022-27673]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1140]

Enforcement Policy Regarding Federal Veterinarian-Client-Patient
Relationship Requirements To Facilitate Veterinary Telemedicine During
the COVID-19 Outbreak; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of the guidance document entitled ``Enforcement Policy
Regarding Federal VCPR Requirements to Facilitate Veterinary
Telemedicine During the COVID-19 Outbreak,'' which was issued in March
2020. FDA is withdrawing this guidance document in recognition that the
conditions that created the need for the enforcement policy have
evolved, such that the policy is no longer needed.

DATES: The withdrawal date is February 21, 2023.

FOR FURTHER INFORMATION CONTACT: William Flynn, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As part of FDA's commitment to providing timely guidance to support
continuity and response efforts to the Coronavirus Disease 2019 (COVID-
19) \1\ pandemic, in March 2020, the Agency published the guidance
document GFI #269, ``Enforcement Policy Regarding Federal VCPR
Requirements to Facilitate Veterinary Telemedicine During the COVID-19
Outbreak,'' recognizing the vital role veterinarians play in protecting
public health. In accordance with the process announced by the Agency
in the Federal Register on March 25, 2020 (85 FR 16949) for making
COVID-19-related guidances available to the public, the notice of
availability for the guidance published on May 12, 2020 (85 FR 28010).
---------------------------------------------------------------------------

    \1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
---------------------------------------------------------------------------

    When the COVID-19 public health emergency began in January 2020,
FDA understood that veterinarians might face challenges affecting their
ability to make on-premises examination of their patients. Given that
the Federal veterinarian-client-patient relationship (VCPR) definition
(21 CFR 530.3(i)) requires animal examination and/or medically
appropriate and timely visits to the premises where the animal(s) are
kept, the Federal VCPR definition cannot be met solely through
telemedicine. To facilitate veterinarians' ability to utilize
telemedicine to address animal health needs during the COVID-19
outbreak, FDA published GFI #269, stating that it intended to
temporarily suspend enforcement of a portion of the Federal VCPR
requirements. Specifically, FDA generally intended not to enforce the
animal examination and premises visit VCPR requirements relevant to FDA
regulations governing Extralabel Drug Use in Animals (21 CFR part 530)
and Veterinary Feed Directive Drugs (21 CFR 558.6).
    FDA stated in the guidance that, given the temporary nature of this
policy, we planned to reassess it periodically and provide revision or
withdrawal of this guidance as necessary. The Agency acknowledges that
the public health emergency declared by the Secretary of Health and
Human Services for the COVID-19 pandemic continues to exist. However,
the conditions that created the need for the temporary enforcement
policy outlined in GFI #269 have evolved, such that the policy is no
longer needed. After careful review of current industry practices with
regard to on-premises animal examination and comments submitted to the
public docket associated with the guidance, the Agency has determined
the guidance document should be withdrawn.
    Therefore, in accordance with 21 CFR 10.115(k), FDA is withdrawing
the ``Enforcement Policy Regarding Federal VCPR Requirements to
Facilitate Veterinary Telemedicine During the COVID-19 Outbreak''
guidance in its entirety.

II. Withdrawal Date

    The withdrawal date for the guidance document discussed in this
document is February 21, 2023.

    Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27673 Filed 12-20-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 44 (Monday, March 7, 2011)]
[Notices]
[Pages 12404-12405]
[FR Doc No: 2011-5099]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice; Jackson-Evers International Airport,
Jackson, MS

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise exposure maps submitted by the Jackson
Municipal Airport Authority for Jackson-Evers International Airport
under the provisions of 49 U.S.C. 47501 et seq. (Aviation Safety and
Noise Abatement Act) and 14 CFR Part 150 are in compliance with
applicable requirements.

DATES: Effective Date: The effective date of the FAA's determination on
the noise exposure maps is February 18, 2011.

FOR FURTHER INFORMATION CONTACT: Jonathan Linquist, Federal Aviation
Administration, Jackson Airports District Office, 100 West Cross
Street, Suite B, Jackson, Mississippi 39208-2307,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the noise exposure maps submitted for Jackson-Evers International
Airport are in compliance with applicable requirements of Part 150,
effective February 18, 2011. Under 49 U.S.C. 47503 of the Aviation
Safety and Noise Abatement Act (hereinafter referred to as ``the
Act''), an airport operator may submit to the FAA noise exposure maps
which meet applicable regulations and which depict non-compatible land
uses as of the date of submission of such maps, a description of
projected aircraft operations, and the ways in which such operations
will affect such maps. The Act requires such maps to be developed in
consultation with interested and affected parties in the local
community, government agencies, and persons using the airport. An
airport operator who has submitted noise exposure maps that are found
by FAA to be in compliance with the requirements of Federal Aviation
Regulations (FAR) Part 150, promulgated pursuant to the Act, may submit
a noise compatibility program for FAA approval which sets forth the
measures the operator has taken or proposes to take to reduce existing
non-compatible uses and prevent the introduction of additional non-
compatible uses.
    The FAA has completed its review of the noise exposure maps and
accompanying documentation

submitted by the Jackson Municipal Airport Authority. The documentation
that constitutes the ``noise exposure maps'' as defined in section
150.7 of Part 150 includes: Figure 1-1, Jackson-Evers International
Airport and Surrounding Communities; Figure 3-1, Locations of Noise
Measurement Sites; Figure 5-1, Existing Airport Diagram; Figure 5-2,
Runways 16L/16R Radar and Modeled Flight Tracks for Departures and
Arrivals; Figure 5-3, Runways 34L/34R Radar and Modeled Flight Tracks
for Departures and Arrivals; Figure 5-4, Runways 16L/16R Radar and
Modeled Flight Tracks for Flight Patterns; Figure 5-5, Runways 34L/34R
Radar and Modeled Flight Tracks for Flight Patterns; Figure 5-6,
Helicopter Radar and Modeled Flight Tracks for Departures and Arrivals;
Figure 6-1, Existing Condition (2010) Noise Exposure Map; Figure 6-2,
Forecast Condition (2015) Noise Exposure Map; Figure 6-3, Comparison of
Existing (2010) and Forecast (2015) Noise Exposure Maps; Table 1-1,
Land Use Compatibility with Yearly Day-Night Average Sound Levels;
Table 1-2, Part 150 Noise Exposure Maps Checklist; Table 3-1, Summary
of Noise Measurement Sites; Table 3-2, Summary of Day-Night Average
Sound Level Measurements; Table 5-1, Airport Runway Data; Table 5-2,
Aircraft Operations; Table 5-3, Existing Conditions (2010) Modeled
Average Daily Aircraft Operations; Table 5-4, Forecast Conditions
(2015) Modeled Average Daily Aircraft Operations; Table 5-5, Modeled
Runway Use; Table 5-6, Jet Aircraft Model Track Utilization; Table 5-7,
Propeller Aircraft Model Track Utilization; Table 5-8, Helicopter Model
Track Utilization; and Table 5-9, Pattern Model Track Utilization. The
FAA has determined that these noise exposure maps and accompanying
documentation are in compliance with applicable requirements. This
determination is effective on February 18, 2011.
    FAA's determination on an airport operator's noise exposure maps is
limited to a finding that the maps were developed in accordance with
the procedures contained in appendix A of FAR Part 150. Such
determination does not constitute approval of the applicant's data,
information or plans, or a commitment to approve a noise compatibility
program or to fund the implementation of that program. If questions
arise concerning the precise relationship of specific properties to
noise exposure contours depicted on a noise exposure map submitted
under section 47503 of the Act, it should be noted that the FAA is not
involved in any way in determining the relative locations of specific
properties with regard to the depicted noise contours, or in
interpreting the noise exposure maps to resolve questions concerning,
for example, which properties should be covered by the provisions of
section 47506 of the Act. These functions are inseparable from the
ultimate land use control and planning responsibilities of local
government. These local responsibilities are not changed in any way
under Part 150 or through FAA's review of noise exposure maps.
Therefore, the responsibility for the detailed overlaying of noise
exposure contours onto the map depicting properties on the surface
rests exclusively with the airport operator that submitted those maps,
or with those public agencies and planning agencies with which
consultation is required under section 47503 of the Act. The FAA has
relied on the certification by the airport operator, under section
150.21 of FAR Part 150, that the statutorily required consultation has
been accomplished.
    Copies of the full noise exposure map documentation and of the
FAA's evaluation of the maps are available for examination at the
following locations: Federal Aviation Administration, Jackson Airports
District Office, 100 West Cross Street, Suite B, Jackson, MS 39208-
2307.
    Questions may be directed to the individual named above under the
heading FOR FURTHER INFORMATION CONTACT.

    Issued in Jackson, Mississippi, on February 18, 2011.
Rans Black,
Manager, Jackson Airports District Office.
[FR Doc. 2011-5099 Filed 3-4-11; 8:45 am]
BILLING CODE 4910-13-P