[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Rules and Regulations]
[Pages 53006-53008]
[FR Doc No: 2016-19034]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 50

[EPA-HQ-OAR-2016-0408; FRL-9950-48-OAR]
RIN 2060-AS89

Technical Correction to the National Ambient Air Quality
Standards for Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to make a technical correction to an equation in an
appendix in the National Ambient Air Quality Standards (NAAQS) for
Particle Pollution. Equation 2 describes an intermediate step in the
calculation of the design value for the annual PM2.5
(particles with an aerodynamic diameter less than or equal to a nominal
2.5 micrometers) NAAQS. This action corrects a scrivener's error in one
of the equations used to calculate an annual mean PM2.5
concentration, to properly account for cases where a site does not have
four complete quarters of data and passes one of two substitution
tests. This change accurately reflects the intended calculation of the
annual mean PM2.5 design value and is consistent with the
text elsewhere in the appendix.

DATES: This rule is effective on October 11, 2016 without further
notice, unless the EPA receives adverse comment by September 12, 2016.
If the EPA receives adverse comment, we will publish a timely
withdrawal in the Federal Register informing the public that the rule
will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2016-0408, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (e.g., on the Web,
Cloud, or other file sharing system).
    For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Mr. Brett Gantt, U.S. EPA, Office of
Air Quality Planning and Standards, Air Quality Assessment Division,
Air Quality Analysis Group (Mail Code: C304-04), Research Triangle
Park, NC 27711; telephone number:<PHONE_NUMBER>; fax number: (919)
541-3613; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. Why is the EPA using a direct final rule?
    B. Does this action apply to me?
    C. What should I consider as I prepare my comments for the EPA?
II. This Action
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act (CRA)

I. General Information

A. Why is the EPA using a direct final rule?

    The EPA is publishing this rule without a prior proposed rule
because we view this as a non-controversial action and anticipate no
adverse comment. This action corrects a scrivener's error in an
intermediate equation in the calculation of the annual PM2.5
design value to properly account for cases where a site does not have
four complete quarters of data in a specific year and passes the
minimum quarterly value substitution test. In the ``Proposed Rules''
section of today's Federal Register, we are publishing a separate
proposed rule to correct this scrivener's error if any adverse comments
are received on this direct final rule. We will not institute a second
comment period on this action. Any parties interested in commenting
must do so at this time. For further information about commenting on
this rule, see the ADDRESSES section of this document.
    If EPA receives adverse comment, we will publish a timely
withdrawal in the Federal Register informing the public that this
direct final rule will not take effect. We would address all public
comments in any subsequent final rule based on the proposed rule.

B. Does this action apply to me?

    This action applies to you if you are calculating the annual
PM2.5 design value for a site which does not have four
complete quarters of data for a specific year and passes the minimum
quarterly value substitution test.

C. What should I consider as I prepare my comments for the EPA?

    (1) Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 Code of Federal Regulations (CFR) part 2.
    (2) Tips for Preparing Your Comments. When submitting comments,
remember to:

     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a CFR part or
section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to
be reproduced.

     Provide specific examples to illustrate your concerns,
and suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. This Action

    On December 14, 2012, the EPA revised the NAAQS for Particle
Pollution (78 FR 3086). Appendix N to part 50 of this document
described the data handling conventions and computations necessary for
determining when the NAAQS for PM2.5 are met. Section 4.4
described the annual PM2.5 design value calculations, with
equations 1, 2, and 3 used to calculate the quarterly, annual, and 3-
year average concentrations. Equation 2 erroneously described the
annual mean as the average of the four quarterly values despite the
availability of substitution tests for cases when quarterly values do
not meet the completeness requirements in section 4.1.
    Specifically, the minimum quarterly value substitution test
described in section 4.1(c)(i) allows for a valid annual
PM2.5 design value to be calculated when a test design
value, having deficient quarters substituted with quarter-specific low
values, is found to be greater than the level of the standard. If the
minimum quarterly value substitution test is passed, the annual
PM2.5 design value is calculated from annual means of the
non-deficient quarterly values, which can range in number from one to
four for a specific year.
    As currently written, equation 2 is not appropriate for use during
a minimum quarterly value substitution test and does not accurately
reflect the intended calculation of the annual mean PM2.5
concentration in these cases.\1\ Therefore, this action generalizes
equation 2 to account for cases that pass the minimum quarterly value
substitution test, yet do not have four non-deficient quarterly values
in each of the years in the 3-year design value period. This technical
correction to equation 2 is currently used in the calculation of the
PM2.5 annual design value, is consistent with the text of
section 4.1 within appendix N to part 50, and does not affect the
calculation of annual mean PM2.5 concentrations when four
complete quarters of data are available.
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    \1\ If read literally with the scrivener's error, it would be
erroneous to use Equation 2 to calculate the annual PM2.5
NAAQS for any year with a deficient quarter of data because the
equation instructs the user to sum all four quarters when at least
one of those quarters contains missing data.
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III. Statutory and Executive Order Reviews

    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA. This action generalizes the calculation of the annual
PM2.5 NAAQS design values and does not impose additional
regulatory requirements on organizations monitoring air quality.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. This action
corrects the calculation of annual mean PM2.5 concentrations
and does not impose additional regulatory requirements on sources.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate of $100 million
or more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. This action imposes
no enforceable duty on any state, local or tribal governments, or the
private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175. This regulatory action is a technical correction
to a previously promulgated regulatory action and does not have any
impact on human health or the environment. Thus, Executive Order 13175
does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard. This regulatory action is a
technical correction to a previously promulgated regulatory action and
does not have any impact on human health or the environment.

K. Congressional Review Act

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 50

    Air pollution control, Carbon monoxide, Lead, Nitrogen dioxide,
Ozone, Particulate matter, Sulfur oxides.

    Dated: August 3, 2016.
Gina McCarthy,
Administrator.

    For the reasons stated in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:

PART 50--NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY
STANDARDS

0
1. The authority citation for part 50 continues to read as follows:

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

0
2. In appendix N to part 50, in section 4.4, Equation 2 is revised to
read as follows:

Appendix N to Part 50--Interpretation of the National Ambient Air
Quality Standards for PM2.5

* * * * *
    4.4 Equations for the Annual PM2.5 NAAQS
* * * * *
    (b) * * *
    [GRAPHIC] [TIFF OMITTED] TR11AU16.002

Where:

Xy = the annual mean concentration for year y (y = 1, 2, or 3);
nQy = the number of complete quarters Q in year y; and
Xqy = the mean for quarter q of year y (result of equation 1).
* * * * *
[FR Doc. 2016-19034 Filed 8-10-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30667-30668]
[FR Doc No: 2014-12221]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72203; File No. SR-NYSE-2014-12]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Designation of Longer Period for Commission Action on
Proposed Rule Change To Amend Rule 98 To Adopt a Principles-Based
Approach To Prohibit the Misuse of Material Nonpublic Information and
Make Conforming Changes to Other Exchange Rules

May 21, 2014.
    On March 18, 2014, New York Stock Exchange LLC (``NYSE'' or the
``Exchange''), pursuant to Section 19(b)(1) of the Securities Exchange
Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ filed with the
Securities and Exchange Commission (the ``Commission'') a proposed rule
change to amend Rule 98 to adopt a principles-based approach to
prohibit the misuse of material non-public information. The proposed
rule change was published for

public comment in the Federal Register on April 7, 2014.\3\ The
Commission received one comment on the proposal.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 71837 (April 1, 2014),
75 FR 19146.
    \4\ See email from Dr. Leee Jackson, Esq., April 15, 2014
(``Jackson Comment'').
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    Section 19(b)(2) of the Act \5\ 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 these proposed rule changes should be disapproved.
The 45th day for this filing is May 22, 2014.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
take action on the Exchange's proposed rule change.
    Accordingly, pursuant to Section 19(b)(2)(A)(ii)(I) of the Act \6\
and for the reasons stated above, the Commission designates July 3,
2014, as the date by which the Commission should either approve or
disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSE-2014-12).
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    \6\ 15 U.S.C. 78s(b)(2)(A)(ii)(I).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-12221 Filed 5-27-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Notices]
[Pages 53138-53141]
[FR Doc No: 2018-22779]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84426; File No. SR-DTC-2018-008]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Clearing Agency Policy on Capital Requirements and the
Clearing Agency Capital Replenishment Plan

October 15, 2018.
    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 October 4, 2018, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared by the clearing agency. DTC filed the proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(4) thereunder.\4\ 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\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of amendments to (i) the Clearing
Agency Policy on Capital Requirements (``Capital Policy'' or
``Policy'') of DTC and its affiliates, National Securities Clearing
Corporation (``NSCC'') and Fixed Income Clearing Corporation (``FICC,''
and together with DTC and NSCC, the ``Clearing Agencies''); and (ii)
the Clearing Agency Capital Replenishment Plan (``Capital Replenishment
Plan'' or ``Plan'') of the

Clearing Agencies. In particular, the proposed revisions to the Capital
Policy and Capital Replenishment Plan would (1) correct typographical
errors and make other technical revisions to correct and simplify
statements in the Policy and Plan; (2) replace references in the Policy
and Plan to the ``Credit Risk Capital Requirement'' with the
``Corporate Contribution;'' and (3) update references in the Policy to
the Recovery & Wind-down Plans of each of the Clearing Agencies, which
were recently adopted by the Clearing Agencies, as described in greater
detail below.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency 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. The clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The Clearing Agencies are proposing to revise the Capital Policy
and Capital Replenishment Plan, which were adopted by the Clearing
Agencies in July 2017 \5\ and are maintained by the Clearing Agencies
in compliance with Rule 17Ad-22(e)(15) under the Act.\6\
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    \5\ See Securities Exchange Act Release No. 81105 (July 7,
2017), 82 FR 32399 (July 13, 2017) (SR-DTC-2017-003, SR-FICC-2017-
007, SR-NSCC-2017-004).
    \6\ 17 CFR 240.17Ad-22(e)(15).
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Overview of the Capital Policy and Capital Replenishment Plan
    The Capital Policy sets forth the manner in which each Clearing
Agency identifies, monitors, and manages its general business risk with
respect to the requirement to hold sufficient liquid net assets
(``LNA'') funded by equity to cover potential general business losses
so the Clearing Agency can continue operations and services as a going
concern if such losses materialize.\7\ The amount of LNA funded by
equity to be held by each of the Clearing Agencies for this purpose is
defined in the Policy as the General Business Risk Capital Requirement.
The Policy provides that the General Business Risk Requirement is
calculated for each Clearing Agency as the greatest of three separate
calculations--(1) an amount based on that Clearing Agency's general
business risk profile (``Risk-Based Capital Requirement''), (2) an
amount based on the time estimated to execute a recovery or orderly
wind-down of the critical operations of that Clearing Agency
(``Recovery/Wind-down Capital Requirement''), and (3) an amount based
on an analysis of that Clearing Agency's estimated operating expenses
for a six month period (``Operating Expense Capital Requirement''). On
an annual basis, each of these three capital requirements are measured,
and the General Business Risk Capital Requirement for each Clearing
Agency are determined as the greatest of these calculations.
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    \7\ Id.
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    Currently, the Capital Policy also addresses how each Clearing
Agency maintains a portion of retained earnings as LNA funded by equity
as its Credit Risk Capital Requirement, as a part of its management of
credit risk \8\ and pursuant to their respective rules.\9\ These
resources are maintained to address losses due to a participant
default, and are held in addition to the LNA funded by equity held by
each of the Clearing Agencies as its General Business Risk Capital
Requirement. The Capital Policy describes how each Clearing Agency's
General Business Risk Capital Requirement and Credit Risk Capital
Requirement fit within the Clearing Agencies' Capital Framework, where
the Total Capital Requirement of each Clearing Agency is calculated as
the sum of its General Business Risk Capital Requirement and Credit
Risk Capital Requirement.
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    \8\ LNA funded by equity held as the Clearing Agencies' Credit
Risk Capital Requirement is held in addition to resources held by
the Clearing Agencies for credit risk in compliance with Rule 17Ad-
22(e)(4) under the Act and in addition to resources held by the
Clearing Agencies for liquidity risk in compliance with Rule 17Ad-
22(e)(7). 17 CFR 240.17Ad-22(e)(4), (7).
    \9\ The Rules, By-laws and Organizational Certificate of DTC
(``DTC Rules''), the Rulebook of the Government Securities Division
of FICC (``GSD Rules''), the Clearing Rules of the Mortgage-Backed
Securities Division of FICC (``MBSD Rules''), or the Rules &
Procedures of NSCC (``NSCC Rules,'' together with the DTC Rules, GSD
Rules and MBSD Rules, the ``Clearing Agencies' Rules'' or
``Rules''), available at http://dtcc.com/legal/rules-and-procedures.
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    The Policy also provides a plan for the replenishment of capital
through the Capital Replenishment Plan. The Capital Replenishment Plan
was adopted by the Clearing Agencies as a plan for the replenishment of
capital by each Clearing Agency should its equity fall close to or
below the amount being held as its Total Capital Requirement pursuant
to the Capital Policy. The Capital Replenishment Plan identifies the
circumstances that would trigger implementation of the Plan; the roles,
responsibilities, and guiding principles for implementation of the
Plan; and an overview and description of each of the tools that may be
used to replenish capital.
Proposed Revisions to the Capital Policy and Capital Replenishment Plan
    As described in greater detail below, the Clearing Agencies are
proposing to make certain revisions to the Capital Policy and Capital
Replenishment Plan.
    First, the proposed revisions would correct typographical errors
and make other technical revisions to correct and simplify statements
in the Capital Policy and Capital Replenishment Plan. Second, the
proposed revisions would replace references to the ``Credit Risk
Capital Requirement'' with ``Corporate Contribution.'' This proposed
change would reflect the implementation of recent revisions to the
Clearing Agencies' Rules regarding allocation of losses.\10\ Finally,
the proposed revisions would update the description of the calculation
of the Recovery/Wind-down Capital Requirement in the Capital Policy to
clarify that the Recovery & Wind-down Plans of each of the Clearing
Agencies have been adopted by the Clearing Agencies.\11\
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    \10\ See Securities Exchange Act Release Nos. 83969 (August 28,
2018), 83 FR 44955 (September 4, 2018) (SR-DTC-2017-022); 83950
(August 27, 2018), 83 FR 44393 (August 30, 2018) (SR-DTC-2017-804).
    \11\ See Securities Exchange Act Release Nos. 83972 (August 28,
2018), 83 FR 44964 (September 4, 2018) (SR-DTC-2017-021); 83953
(August 27, 2018), 83 FR 44381 (August 30, 2018) (SR-DTC-2017-803).
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    These proposed revisions are designed to enhance the clarity of the
Policy and Plan and help ensure that they continue to operate as
intended.
1. Technical Revisions
    DTC is proposing technical revisions to the descriptions within the
Capital Policy and Capital Replenishment Plan that would correct
typographical errors, including, for example, removing a phrase that
was incorrectly repeated in the same sentence. These revisions would
also correct an error in Section 3 of the Policy, where the document
was incorrectly referred to as the Plan.
    Such revisions would also update the documents. For example, the
proposed changes would replace references in the Capital Policy and
Capital Replenishment Plan to the Finance/Capital Committee of the
Boards, which was disbanded September 2017, with

the Boards, which has taken on the responsibilities of this Committee
set forth in the Policy and Plan. These revisions would also include
updating the Capital Replenishment Plan to revise the name of the
``Capital Contributions to DTCC Subsidiaries and Joint Ventures
Policy'' to the new name of this document, the ``Capital Contributions
Policy.'' \12\
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    \12\ This document is an internal policy that governs how The
Depository Trust & Clearing Corporation may invest capital in its
subsidiaries, including the Clearing Agencies, as well as affiliated
joint ventures and non-affiliated companies.
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    Finally, the proposed revisions would also simplify the
descriptions in these documents. For example, these revisions would add
a defined term for the Clearing Agencies' Rules to the Policy in order
to simplify references to such rules and procedures in this document.
2. Addition of Corporate Contribution
    The proposed revisions would also replace references in the Capital
Policy and Capital Replenishment Plan to the ``Credit Risk Capital
Requirement'' with the ``Corporate Contribution.'' Currently, the
Capital Policy describes how each Clearing Agency maintains a portion
of retained earnings as LNA funded by equity as its Credit Risk Capital
Requirement, in accordance with their respective Rules. Recently, the
Clearing Agencies implemented revisions to their respective Rules to
enhance the process by which they may allocate losses to their
participants if the size of the losses exceed their prefunded
resources.\13\ Such revisions included an amendment to the calculation
and application of the amount of LNA funded by equity that are
currently referred to in the Capital Policy and Capital Replenishment
Plan as the Credit Risk Capital Requirement.
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    \13\ Supra note 10.
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    Specifically, the DTC Rules previously provided that DTC could, in
its discretion and in such amounts as it would determine, charge its
existing retained earnings and undivided profits to a loss or
liability, to the extent that it is not satisfied by the Actual
Participants Fund Deposit and Preferred Stock of the defaulting
Participant. Pursuant to these recent changes, the DTC Rules require
that DTC contribute an amount equal to 50 percent of DTC's General
Business Risk Capital Requirement (as such amount is defined in the
Capital Policy) (``Corporate Contribution'') towards losses or
liabilities arising from a Participant default or non-default event.
DTC may also voluntarily apply amounts greater than the Corporate
Contribution, as the DTC Board of Directors may determine. The
Corporate Contribution applied to any losses arising from events that
may occur during the next 250 business days would be reduced to the
remaining unused portion of Corporate Contribution, if any.\14\
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    \14\ See supra notes 9 and 10.
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    The amendments to the calculation and application of the resources
that are now referred to as the Corporate Contribution did not change
how these resources are described within the Policy or the Plan. The
Corporate Contribution continues to represent resources maintained by
the Clearing Agencies to address losses due to a participant default,
as a part of their management of credit risk.\15\ These resources also
are still held in addition to the LNA funded by equity held by each of
the Clearing Agencies as its General Business Risk Capital Requirement.
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    \15\ As noted above, unlike the resources referred to in the
Policy and Plan as the Credit Risk Capital Requirement, the
Corporate Contribution would also be available to the Clearing
Agencies to address losses due to events other than a participant
default.
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    Therefore, the Capital Policy and Capital Replenishment Plan would
be revised to replace references to the Credit Risk Capital Requirement
with references to the Corporate Contribution, and no other changes are
needed to the description of this amount.
3. Update References to the Recovery & Wind-Down Plans of the Clearing
Agencies
    The proposed revisions would also update the Capital Policy to make
clear that the Recovery & Wind-down Plans of the Clearing Agencies have
been adopted by the Clearing Agencies.\16\ Such references are
currently made in connection with the description of the calculation of
the Recovery/Wind-down Capital Requirement.
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    \16\ Supra note 11.
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    The Recovery/Wind-down Capital Requirement is an amount based on
the time estimated to execute a recovery or orderly wind-down of the
critical operations of that Clearing Agency and is used by the Clearing
Agencies to determine their General Business Risk Capital Requirement.
Each of the Clearing Agencies recently adopted a Recovery & Wind-down
Plan, which provide plans for the recovery and orderly wind-down of
each of the Clearing Agencies necessitated by credit losses, liquidity
shortfalls, losses from general business risk, or any other losses.\17\
The Recovery & Wind-down Plans each include an analysis of the
calculation of the Recovery/Wind-down Capital Requirement, based on the
formula that is set forth in the Capital Policy.
---------------------------------------------------------------------------

    \17\ Id.
---------------------------------------------------------------------------

    The Clearing Agencies are proposing to revise the Capital Policy to
make clear that the Recovery & Wind-down Plans have now been adopted by
the Clearing Agencies.
2. Statutory Basis
    The Clearing Agencies believe that the proposed rule change is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a registered clearing agency. In
particular, the Clearing Agencies believe that the Capital Policy and
the Capital Replenishment Plan are both consistent with Section
17A(b)(3)(F) of the Act \18\ and Rule 17Ad-22(e)(15) under the Act,\19\
for the reasons described below.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78q-1(b)(3)(F).
    \19\ 17 CFR 240.17Ad-22(e)(15).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of the Clearing Agencies be designed to promote the prompt and accurate
clearance and settlement of securities transactions, and to assure the
safeguarding of securities and funds which are in the custody or
control of the Clearing Agency or for which it is responsible.\20\
Together, the Capital Policy and the Capital Replenishment Plan are
designed to ensure that each of the Clearing Agencies hold sufficient
LNA funded by equity to cover potential general business losses so that
it can continue the prompt and accurate clearance and settlement of
securities transactions and can continue to assure the safeguarding of
securities and funds which are in its custody or control or for which
it is responsible if those losses materialize. By correcting errors and
updating the Capital Policy and Capital Replenishment Plan to be
consistent with recent changes implemented by the Clearing Agencies,
the proposed revisions would allow the Clearing Agencies to maintain
these documents to operate in the way they were intended. Therefore,
such proposed revisions would be consistent with the requirements of
Section 17A(b)(3)(F) of the Act.\21\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78q-1(b)(3)(F).
    \21\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(15) requires the Clearing Agencies to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to identify, monitor, and manage their respective
general business risk and hold sufficient

liquid net assets funded by equity to cover potential general business
losses so that the Clearing Agencies can continue operations and
services as a going concern if those losses materialize.\22\ As
originally implemented, the Capital Policy and the Capital
Replenishment Plan were designed to meet the requirements of Rule 17Ad-
22(e)(15) under the Act.\23\ As stated above, the proposed revisions
would update the Capital Policy and Capital Replenishment Plan to be
consistent with recent changes implemented by the Clearing Agencies. In
this way, the proposed changes would allow the Clearing Agencies to
maintain these documents in a way that to meet these requirements.
Therefore, such proposed revisions would be consistent with the
requirements of Rule 17Ad-22(e)(15) under the Act.\24\
---------------------------------------------------------------------------

    \22\ 17 CFR 240.17Ad-22(e)(15).
    \23\ See supra note 5.
    \24\ 17 CFR 240.17Ad-22(e)(15).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    Each of the Clearing Agencies believes that none of the proposed
revisions to the Capital Policy and the Capital Replenishment Plan
would have any impact, or impose any burden, on competition. The Policy
and the Plan are maintained by the Clearing Agencies in order to
satisfy their regulatory requirements and generally reflect internal
tools and procedures. Tools and procedures that have a direct impact on
the rights, responsibilities or obligations of members or participants
of the Clearing Agencies are reflected in the Clearing Agencies' Rules.
Accordingly, the Capital Policy and Capital Replenishment Plan
themselves are documents that enhance the Clearing Agencies' regulatory
compliance and internal management and do not have any impact, or
impose any burden, on competition.
    The proposed revisions to correct and update the Capital Policy and
Capital Replenishment Plan would not affect any changes on the
fundamental purpose or operation of these documents and, as such, would
also not have any impact, or impose any burden, on competition.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    The Clearing Agencies have not solicited or received any written
comments relating to this proposal. The Clearing Agencies will notify
the Commission of any written comments received by the Clearing
Agencies.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \25\ and paragraph (f) of Rule 19b-4
thereunder.\26\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(3)(A).
    \26\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-DTC-2018-008 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2018-008. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of DTC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-DTC-2018-008 and should be submitted on
or before November 9, 2018

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
Eduardo A. Aleman,
Assistant Secretary.
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2018-22779 Filed 10-18-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 132 (Tuesday, July 10, 2012)]
[Notices]
[Pages 40622-40623]
[FR Doc No: 2012-16811]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Anti-Infective Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 5, 2012, from
8 a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Diane Goyette, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area) to find
out further information regarding FDA advisory committee information. 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 appropriate advisory
committee information line to learn about possible modifications before
coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA)
201688,

tobramycin inhalation powder, application submitted by Novartis
Pharmaceuticals Corporation, and the requested indication of management
of cystic fibrosis patients infected with the bacterium Pseudomonas
aeruginosa.
    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 link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 21, 2012. 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 13, 2012. 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 14, 2012.
    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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Diane Goyette 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 5, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-16811 Filed 7-9-12; 8:45 am]
BILLING CODE 4160-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

March 6, 2008

SUBJECT:	Sodium Nitrate (076104) and Potassium Nitrate (076103).  Human
Health Assessment Problem Formulation Document in Support of
Registration Review.  Registration Review Case No. 4052  Nitrates and
Nitrites.  DP# 342935.

FROM:	Susan V. Hummel, Chemist and Senior Scientist

		Reregistration Branch 4

		Health Effects Division (7509P)

THRU:	Ray Kent, Chief

		Reregistration Branch 4

		Health Effects Division (7509P)

TO:	Eric Miederhoff, CRM Team 53

		Reregistration Branch 3

		Special Review and Reregistration Division (7508P)

Executive Summary

Attached is the Health Effects Division’s (HED) human health risk
assessment problem formulation document for the nitrate and nitrites
reregistration case to support Registration Review.

Two pesticide active ingredients are part of the nitrates and nitrites
reregistration case, sodium nitrate, and potassium nitrate.  Both of
these pesticide ingredients are used in multiple active ingredient
products also containing carbon, sulfur, and/or sawdust; these products
are fumigant gas cartridge products intended to be placed in burrows to
control small mammals.  The use is outdoors only.  The products have a
fuse, which the user lights, and then the cartridge is immediately
placed inside the burrow, and the burrow entrance covered with dirt.
The contents of the cartridge burn and release carbon dioxide and toxic
gases.

HED has considered recent risk assessments for sodium and potassium
nitrate, updates to its toxicity, exposure and usage databases, and the
most updated Agency science policy and risk assessment methodologies.
The most recent risk assessment for sodium and potassium nitrate was
conducted in 1991 in connection with the Reregistration Eligibility
Document (Engler, 1991).  Risks of concern were mitigated by
cancellation of the products with risk concerns.  There are no other
changes to the registrations or to the database of studies.

HED does not believe that new data are needed for Registration Review
and that existing risk assessments will support Registration Review.
There are no pesticidal food uses, so there is no dietary assessment,
and no aggregate assessment is required.  Residential and occupational
exposure assessments are available for all uses, and there are no
exposure risks of concern.  No additional human health risk assessments
will be needed for the existing uses of sodium nitrate and potassium
nitrate.

Introduction

The most recent risk assessment for sodium nitrate and potassium nitrate
was conducted in 1991 in connection with the Nitrates and Nitrites
Reregistration Eligibility Document (Engler, 1991), with a supporting
occupational and residential exposure assessment (Morris, 1991), and an
undated, unsigned toxicology assessment.  Risks of concern were
mitigated by cancellation of the products with risk concerns.

Databases consulted for this problem formulation document include HED
databases, OPPIN databases, including the label database.  HED also
conducted an open literature search using Google Scholar.

The only pesticidal use of sodium nitrate and potassium nitrate is in
multiple active ingredient products also containing carbon, sulfur,
and/or sawdust; these products are fumigant gas cartridge products
intended to be placed in burrows to control small mammals.

OPPIN lists 3 products containing 46.2 – 53% sodium nitrate, and 3
products containing 38.8 – 45 % potassium nitrate.  There are no
technical products containing sodium nitrate or potassium nitrate.

The product labels contain instructions on how to find the burrow,
prepare the burrow for the use of these products, and the treatment.
For treatment, the user is instructed to light the fuse, place the
cartridge into the burrow, fuse end first, and then close the burrow
with plenty of dirt.  The following cautions are on the product labels:
Do Not Inhale!  TOXIC FUMES!  If smoke is seen coming from burrow
entrance, plug firmly with soil.

Chemical Identity

The chemical identity for sodium nitrate and potassium nitrate are
described in the following Tables 1a and 2b.

Table 1a. Chemical Identity of Sodium Nitrate

Common Name	Sodium Nitrate

Chemical Name	Sodium Nitrate

PC Code	076104

Chemical Abstracts No.	7631-99-4

Registration Review Case No.	4052

Chemical Class	Inorganic salt

Chemical Structure	NaNO3

Table 1b. Chemical Identity of Potassium Nitrate

Common Name	Potassium Nitrate

Chemical Name	Potassium Nitrate

PC Code	076103

Chemical Abstracts No.	7757-79-1

Registration Review Case No.	4052

Chemical Class	Inorganic salt

Chemical Structure	KNO3

The registered products of sodium and potassium nitrate also contain
sulfur, carbon, and/or sawdust.  These products will undergo chemical
reactions and produce toxic fumes after ignition.  Although no toxicity
data are available on the fume by products, HED believes that worker and
bystander exposure scenarios are not likely to exist based on the use
patterns (underground) and with current label precautions.

Hazard Identification/Toxicology

There is very little potential for exposure to sodium or potassium
nitrate from the registered pesticide uses – gas producing cartridges
placed in animal burrows.   Because of the registered use pattern, many
of the normally required toxicity studies were considered unnecessary
for sodium and potassium nitrate.  In addition, these compounds are
normally present in the environment. Nitrates are in the soil and in
plants that take up the nitrates from the soil. Thus, there is no reason
to expect reasonable pesticide usage to constitute any hazard beyond
ordinary exposure.

Sodium nitrate is in Category III for acute oral and dermal toxicity,
toxicity Category II for primary eye irritation, and toxicity Category
IV for primary dermal irritation.  Acute inhalation toxicity has not
been determined.  No subchronic toxicity studies are available.  In some
chronic and carcinogenicity studies, sodium nitrate has been reported as
carcinogenic, in others it has not.  There are several positive
mutagenicity studies.  Nitrate in food may be converted to nitrite,
which, in large doses, converts the hemoglobin in the blood to
methemoglobin, which cannot carry oxygen.  In addition, nitrite produced
can combine with amines to form nitrosamines. Many nitrosamines are
mutagens and carcinogens under laboratory conditions.

Potassium nitrate is in Category III for acute oral toxicity.  No other
toxicity studies were found, with the exception of some mutagenicity
studies.  Some of the mutagenicity studies with potassium nitrate were
positive.  There is no reason to believe that the toxicity of potassium
nitrate is different from the toxicity of sodium nitrate.

No additional toxicity data were required as a condition of
reregistration.  The most recent endpoint table for sodium and potassium
nitrate is found in the HED chapter for the RED (Engler, 1991).

The product labels contain different first aid instructions, in case the
product gets into eyes, skin, or on clothing.  Cartridge produces oxide
of sulfur gasses.   Fumes may be harmful if inhaled.  If inhaled, and
person has poisoning symptoms (headache, nausea, dizziness, and
weakness, transfer victim to fresh air.  Have victim lie down and keep
warm.  If respiration is adequate recovery will be rapid…   Once
ignited by the fuse, this cartridge will burn vigorously until
completely spent and is capable of causing severe burns to exposed skin
and clothes, and of igniting dry grass, leaves, and other combustible
materials.

Conclusions: The toxicological database on potassium and sodium nitrate
is adequate for human health risk assessment and to support the
continuing registration of sodium nitrate and potassium nitrate.  No new
toxicity studies have been received since the last assessment.  No
re-evaluation of toxicological endpoints and/or safety factors is
required.  Label first aid statements should be standardized.

Dietary Exposure

There are no pesticidal food uses of potassium and sodium nitrate.
Nitrates are listed by the Food and Drug Administration as food
additives that may be used in curing of fish, meat, and meat products
and color fixatives (21 CFR 170.60, 21 CFR 172.170).  In 21 CFR 181.33,
the Food and Drug Administration regulations cite prior sanctions issued
by the U.S. Department of Agriculture for the use of sodium and
potassium nitrates in cured red meat products and cured poultry
products.

No dietary exposure assessment is required.  There is very little
possibility of sodium and potassium nitrate reaching drinking water
sources from the current use pattern.

Conclusions:  No dietary exposure assessment is required.  There is very
little possibility of sodium and potassium nitrate reaching drinking
water sources from the current use pattern.

Residential Exposure

For both sodium and potassium nitrates, the potential for applicator and
post-application residential exposure should be minimal, providing the
products are used in accordance with label instructions.  There is no
mixing/loading involved with the end use products; therefore, there
should be no human exposure.

Aggregate Risk Assessment

There are no food uses for sodium and potassium nitrate.  Residential
exposure should be minimal.  No aggregate risk assessment is required.

Occupational Exposure

For both sodium and potassium nitrates, the potential for applicator and
post-application worker exposure should be minimal, providing the
products are used in accordance with label instructions.  There is no
mixing/loading involved with the end use products; therefore, there
should be no human exposure.

There are no dislodgeable foliar residue data available. Soil
dissipation residue data are not required; nitrates are naturally
present in soils and plants that absorb nitrates from the soil.

There is the potential for dermal burns following premature flare
ignition.

Conclusions:  There is sufficient information available to assess
occupational exposure.  All of the occupational exposure scenarios for
the registered uses of sodium and potassium nitrates have been assessed
adequately. No new assessment required.

Public Health and Pesticide Epidemiology Data

The Agency’s incident database shows 17 incidents involving sodium
nitrate products between January 1992 and October 2007.  Several of the
incidents (4) were listed as property damage.  One incident cited an
injury to a domestic animal, and ten (10) incidents involved injury to
humans when flames exploded from the gas cartridge and burned hands,
legs, or face.

The Agency’s incident database shows 16 incidents involving potassium
nitrate products between January 1992 and October 2007.  Many of the
incidents (10) involved injury to humans when flames exploded from the
gas cartridge and burned hands, legs, or face.  The other incidents (6)
involved are listed as damage to property.

Severe incidents reported at the time of the RED, resulted in the
cancellation of products containing higher levels of sodium nitrate.

Tolerance Assessment and International Harmonization

There are no pesticidal food uses of potassium and sodium nitrate.
There are several food additive regulations established by FDA for
curing and color-fixing in fish, and meat and meat products.   There is
no problem with harmonization of tolerances with international MRLs.

Environmental Justice

Potential areas of environmental justice concerns, to the extent
possible, were considered in this human health risk assessment, in
accordance with U.S. Executive Order 12898, "Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations,"   HYPERLINK
"http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf"
http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf ).  The Office
of Pesticide Programs (OPP) typically considers the highest potential
exposures from the legal use of a pesticide when conducting human health
risk assessments, including, but not limited to, people who obtain
drinking water from sources near agricultural areas, the variability of
diets within the U.S. (including different ages, regions, and
ethnicities), and people who may be exposed when harvesting crops.
Should these highest exposures indicate potential risks of concern, OPP
further refines the risk assessments to ensure that the risk estimates
are based on the best available information.

There is no dietary or water exposure from pesticidal uses of sodium and
potassium nitrate.

Cumulative

Sodium and potassium nitrate have not been identified as part of a
common mechanism group.  No cumulative assessment has been conducted.

Human Studies

No human studies have been relied on in previous risk assessments.

Data Requirements

There are no outstanding data requirements for sodium or potassium
nitrate.  No new studies are needed for registration review.

References

Engler, R., 1991.  “Reregistration Eligibility	Document (RED) for
Sodium Nitrate and Potassium Nitrate,” EPA Memorandum from Reto Engler
to Allan Abramson, dated July 18, 1991.

Morris, L.  1991.  “Review of Potential Occupational and Residential
Exposure to Sodium Nitrate and Potassium Nitrate for the Reregistration
Eligibility Document (RED),” EPA Memorandum from Laura Morris to
Esther Saito, dated June 26, 1991.

Page   PAGE  1  of   NUMPAGES  6


[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)]
[Notices]
[Pages 57601-57603]
[FR Doc No: 2017-26226]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0137]

Use of Serological Tests to Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a document entitled ``Use of Serological Tests to
Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood
and Blood Components; Guidance for Industry.'' The guidance document
provides recommendations to blood collection establishments regarding
the use of serological tests to reduce the risk of transmission of
Trypanosoma cruzi (T. cruzi) infection in blood and blood components.
The recommendations apply to the collection of blood and blood
components, except Source Plasma, for transfusion or for use in
manufacturing a product, including donations intended as a component
of, or used to manufacture, a medical device. The guidance announced in
this notice supersedes the guidance entitled ``Guidance for Industry:
Use of Serological Tests to Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Whole Blood and Blood Components
Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance)
and finalizes the draft guidance entitled ``Amendment to `Guidance for
Industry: Use of Serological Tests to Reduce the Risk of Transmission
of Trypanosoma cruzi Infection in Whole Blood and Blood Components
Intended for Transfusion'; Draft Guidance for Industry'' dated November
2016 (2016 Draft Chagas Guidance). The guidance incorporates
recommendations for blood donor testing, deferral, and donor reentry
from the 2016 Draft Chagas Guidance.

DATES: The announcement of the guidance is published in the Federal
Register on December 6, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact

information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-D-0137 for ``Use of Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Blood and Blood
Components; Guidance for Industry.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Use of
Serological Tests to Reduce the Risk of Transmission of Trypanosoma
cruzi Infection in Blood and Blood Components; Guidance for Industry.''
The guidance document addresses the use of serological tests to reduce
the risk of transmission of T. cruzi infection in blood and blood
components. The recommendations apply to the collection of blood and
blood components, except Source Plasma, for transfusion or for use in
manufacturing a product, including donations intended as a component
of, or used to manufacture, a medical device. The guidance incorporates
recommendations for blood donor testing, deferral, notification, and
donor reentry from the 2016 Draft Chagas Guidance. The 2016 Draft
Chagas Guidance amended the 2010 Chagas Guidance by (1) expanding the
scope of the guidance to include the collection of blood and blood
components for use in manufacturing a product, including donations
intended as a component of, or used to manufacture, a medical device;
(2) removing the recommendation to ask donors about a history of Chagas
disease; and (3) providing a recommendation for a reentry algorithm for
certain donors deferred on the basis of screening test results for
antibodies to T. cruzi or on the basis of answering ``yes'' to the
Chagas screening question. The 2016 Draft Chagas Guidance also provided
notice that FDA had licensed a supplemental test for antibodies to T.
cruzi. and further testing of donations found repeatedly reactive to a
screening test for T. cruzi is therefore required under 21 CFR
610.40(e).
    In the Federal Register of December 6, 2010 (75 FR 75810), FDA
announced the availability of the guidance entitled ``Guidance for
Industry: Use of Serological Tests to Reduce the Risk of Transmission
of Trypanosoma cruzi Infection in Whole Blood and Blood Components
Intended for Transfusion'' dated December 2010. In the Federal Register
of November, 10, 2016 (81 FR 79034), FDA announced the availability of
the draft guidance entitled ``Amendment to 'Guidance for Industry: Use
of Serological Tests to Reduce the Risk of Transmission of Trypanosoma
cruzi Infection in Whole Blood and Blood Components Intended for
Transfusion'; Draft Guidance for Industry'' dated November 2016. FDA
received two comments on the 2016 Draft Chagas Guidance and those
comments were considered as the guidance was finalized. The guidance
announced in this notice supersedes the 2010 Chagas Guidance and
finalizes the 2016 Draft Chagas Guidance.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Use of Serological Tests to Reduce the
Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood
Components.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The
guidance refers to the following collections of information: (1)
Establishments notify consignees of all previously collected in-date
blood and blood components from a donor that tests repeatedly reactive
by a licensed test for T. cruzi antibody to quarantine and return the
blood and blood components to the establishments or to destroy them;
(2) establishments notify consignees of all previously distributed
blood and blood components collected from such a donor during the
lookback period; and (3) if such blood components were transfused,
consignees notify the recipient's physician of record of a possible
increased risk of T. cruzi infection. These collections of information
have been approved under OMB control number 0910-0681.
    This guidance also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by OMB under the PRA. The collections of
information in 21 CFR part 601 have been approved under OMB control
number 0910-0338; and the collections of information in 21 CFR parts
606, 610, and 630 have been approved under OMB control numbers 0910-
0116 and 0910-0795.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: November 30, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26226 Filed 12-5-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8507-8508]
[FR Doc No: 2016-03457]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0429 (formerly Docket No. 2007D-0496)]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Questions and Answers Regarding the Labeling of Nonprescription
Human Drug Products Marketed Without an Approved Application as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 (the PRA).

DATES: Fax written comments on the collection of information by March
21, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the title. Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<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.

Guidance for Industry on Questions and Answers Regarding the Labeling
of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act; OMB Control Number 0910-0641--Extension

    Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), which was added
by the Dietary Supplement and Nonprescription Drug Consumer Protection
Act (Pub. L. 109-462), requires the label of a nonprescription drug
product marketed without an approved application in the United States
to include a domestic address or domestic telephone number through
which a manufacturer, packer, and distributor may receive a report of a
serious adverse event associated with the product. The guidance
document contains questions and answers relating to this labeling
requirement and provides guidance to industry on the following topics:
(1) The meaning of ``domestic address'' for purposes of the labeling
requirements of section 502(x) of the FD&C Act; (2) FDA's
recommendation for the use of an introductory statement before the
domestic address or phone number that is required to appear on the
product label under section 502(x) of the FD&C Act; and (3) FDA's
intent regarding enforcing the labeling requirements of section 502(x)
of the FD&C Act.
    Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors whose name
(issued in section 502(b)(1) of the FD&C Act) appears on the label of a
nonprescription drug product marketed in the United States without an
approved application.
    In the Federal Register of July 17, 2015 (80 FR 42502), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment. However, these
comments did not address the information collection.
    FDA estimates the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Including a domestic address or phone number and a statement of its             300                3              900                4            3,600
 purpose on OTC drug labeling (21 U.S.C. 502(x))...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03457 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Page 65108]
[FR Doc No: 2022-23356]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96122; File No. SR-MIAX-2022-20]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Withdrawal of Proposed Rule Change To Amend
the MIAX Fee Schedule To Increase Certain Connectivity Fees and Adopt a
Tiered-Pricing Structure for Additional Limited Service MIAX Express
Interface Ports

October 21, 2022.
    On May 2, 2022, Miami International Securities Exchange, LLC
(``MIAX'' or ``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 amend the Exchange's Fee
Schedule to increase certain connectivity fees and adopt a tiered-
pricing structure for additional limited service express interface
ports.
---------------------------------------------------------------------------

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

    The proposed rule change was immediately effective upon filing with
the Commission pursuant to section 19(b)(3)(A) of the Act.\3\ The
proposed rule change was published for comment in the Federal Register
and, pursuant to section 19(b)(3)(C) of the Act,\4\ the Commission: (1)
temporarily suspended the proposed rule change; and (2) instituted
proceedings under section 19(b)(2)(B) of the Act \5\ to determine
whether to approve or disapprove the proposed rule change.\6\ On
October 19, 2022, the Exchange withdrew the proposed rule change (SR-
MIAX-2022-20).
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 15 U.S.C. 78s(b)(3)(C).
    \5\ 15 U.S.C. 78s(b)(2)(B).
    \6\ See Securities Exchange Act Release No. 94890 (May 11,
2022), 87 FR 29945 (May 17, 2022).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-23356 Filed 10-26-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 245 (Wednesday, December 21, 2011)]
[Proposed Rules]
[Pages 79140-79141]
[FR Doc No: 2011-32558]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0654; Airspace Docket No. 11-AWP-8]
RIN 2120-AA66

Proposed Modification of VOR Federal Airways V-135 and V-137;
Southwest United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to modify very high frequency
omnidirectional range (VOR) Federal airways V-135 and V-137 by
extending the airways to the Mexicali, Mexico VOR/DME. This action
would enhance navigation and air traffic control coordination for
aircraft proceeding across the United States-Mexican border.

DATES: Comments must be received on or before February 6, 2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone:<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2011-
0654 and Airspace Docket No. 11-AWP-8 at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2011-0654 and Airspace Docket No. 11-AWP-8) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2011-0654 and Airspace Docket No. 11-AWP-8.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Western Service Center, Federal Aviation
Administration, 1601 Lind Avenue SW., Renton, WA 98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to extend two existing VOR Federal airways
to the Mexicali, Mexico VOR/DME. V-135 would be amended by adding a
segment between the Mexicali VOR/DME and the Bard, AZ VORTAC. V-137
would be amended by adding a segment between the Mexicali VOR/DME and
the Imperial, CA VORTAC. These amendments would benefit cross-border
navigation. Additionally, fixes would be established at the border
crossing points to simplify air traffic control coordination of
flights.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.9V signed August 9, 2011 and effective September 15, 2011, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document would be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under Department of Transportation (DOT)
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies the route structure as

required to preserve the safe and efficient flow of air traffic.

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9V, Airspace Designations and Reporting Points, signed August 9,
2011 and effective September 15, 2011, is amended as follows:

Paragraph 6010 VOR Federal airways.

* * * * *

V-135 [Amended]

    From Mexicali, Mexico; VIA Bard, AZ; Blythe, CA; Parker, CA;
Needles, CA; Goffs, CA; Beatty, NV; INT Beatty 326[deg](T)/
310[deg](M) and Tonopah, NV, 223[deg](T)/206[deg](M) radials; to
Tonopah. The airspace within R-4807 and the airspace within Mexico
is excluded.

V-137 [Amended]

    From Mexicali, Mexico; via Imperial, CA; INT Imperial
350[deg](T)/336[deg](M) and Thermal, CA 144[deg](T)/131[deg](M)
radials; Palm Springs, CA; Palmdale, CA; Gorman, CA; Avenal, CA;
Priest, CA; Salinas, CA. The airspace within Mexico is excluded.

    Issued in Washington, DC, on December 14, 2011.
Gary A. Norek,
Acting Manager, Airspace, Regulations and ATC Procedures Rules Group.
[FR Doc. 2011-32558 Filed 12-20-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Page 18313]
[FR Doc No: 2023-06359]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF23-4-000]

Western Area Power Administration; Notice of Filing

    Take notice that on March 17, 2023, Western Area Power
Administration submits tariff filing: CRSP_OLM_WAPA205-20230316 to be
effective 5/1/2023.
    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, 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 on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 17, 2023.

    Dated: March 22, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-06359 Filed 3-27-23; 8:45 am]
BILLING CODE 6717-01-P