[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Pages 38058-38059]
[FR Doc No: 2013-15100]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0083]

Guidance for Industry on Heparin for Drug and Medical Device Use:
Monitoring Crude Heparin for Quality; 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 for industry entitled ``Heparin for Drug and
Medical Device Use: Monitoring Crude Heparin for Quality.'' This
guidance was initially published as a draft guidance on February 13,
2012. The draft was revised to clarify FDA's expectations and
recommendations and to include references to a recently-developed assay
for detecting ruminant contamination of crude heparin.

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

ADDRESSES: Submit written requests for single copies of this 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. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Frank W. Perrella, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4257, Silver Spring, MD 20993-0002, 301-
796-3265; or Dennis M. Bensley, Jr., Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855,
240-276-8268; or Scott McNamee, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3416, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude
Heparin for Quality.'' This guidance provides recommendations that will
help active pharmaceutical ingredient (API) manufacturers,
pharmaceutical and medical device manufacturers of finished products,
and others, to prevent the use of crude heparin that might contain
oversulfated chondroitin sulfate (OSCS) or non-porcine material
(especially ruminant material) contaminants. This guidance on crude
heparin recommends strategies to test for contamination and should be
used in addition to the United States Pharmacopeia (USP) monograph
testing required for other forms of heparin to detect the presence of
OSCS.
    Following reports of serious adverse events (including deaths)
among patients injected with heparin sodium in 2008, FDA identified the
contaminant OSCS in crude heparin sourced from China. FDA is also
concerned about the potential for contamination of heparin with
ruminant materials. The control of the quality of crude heparin is
important to ensure the safety of drugs and devices and to protect
public health. FDA developed this guidance to alert manufacturers to
the risks of crude heparin contaminants and to recommend strategies to
ensure that the heparin supply chain is not contaminated with OSCS or
any non-porcine ruminant material (unless specifically approved as part
of drug or medical device application).
    The guidance recommends that manufacturers test and confirm the
species origin of crude heparin in each lot of every shipment before
use in the manufacture or preparation of a drug or medical device
containing heparin. The test method should be qualified for use in
testing crude heparin and for the identification of species origin. The
method should be based on good scientific principles (e.g., sufficient
accuracy and specificity) and possess a level of sensitivity
commensurate with the current state of scientific knowledge and risk.
FDA has posted a method entitled ``Heparin Multiplex Real-Time PCR
Assay (hMRTA),'' on the Internet at http://www.fda.gov/AnimalVeterinary/ScienceResearch/ToolsResources/ucm350289.htm. This
method will be updated occasionally and persons performing the assay
should visit the Web site regularly to ensure they are using the most
current version.
    The guidance also recommends that manufacturers test for OSCS in
crude heparin in each lot of every shipment before use, using a
qualified test method that is suitable for detecting low levels of OSCS
concentrations and is based on good scientific principles. FDA has also
made an HPLC method for testing for the presence of OSCS in crude
heparin available on the Internet at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM206230.pdf. Users of this method should also review the Web site
occasionally to ensure they are employing the most current version.
    In addition to testing crude heparin for species of origin and the
presence of OSCS in crude heparin, manufacturers should reject for use
any crude heparin found to contain any amount of OSCS, or to be derived
from, in any amount, ruminant mucosa (unless approved in the drug or
device application). If imported into the United States, any such crude
heparin or heparin products in which it was used should be controlled,
and manufacturers should notify FDA of any such finding. The guidance
also recommends that manufacturers identify and audit crude heparin
suppliers and heparin API suppliers to ensure conformance to
appropriate quality standards. Manufacturers should employ the controls
described in the guidance for industry entitled ``Q7 Good Manufacturing
Practice Guidance for Active Pharmaceutical Ingredients'' and comply
with the quality system regulations (as applicable).
    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 Heparin for Drug and Medical Device Use:
Monitoring Crude Heparin for Quality. 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 either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In the
guidance, FDA advises drug and medical device manufacturers who receive
and use crude heparin to manufacture drugs and medical devices to
notify the Agency of crude heparin found to contain any amount of OSCS,
or to be derived from, in any amount, ruminant mucosa (unless approved
in the drug or device application) (for human drugs, 21 CFR
314.81(b)(1)(ii); for animal drugs, 21 CFR 514.80(b); for medical
devices, 21 CFR 803.50). The collections of information in 21 CFR
314.81(b)(1)(ii) have been approved under OMB control number 0910-0001;
in 21 CFR 514.80(b) under OMB control number 0910-0284; and in 21 CFR
803.50 under OMB control number 0910-0437.

IV. Electronic Access

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

    Dated: June 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15100 Filed 6-24-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 121 (Tuesday, June 23, 2020)]
[Notices]
[Pages 37719-37721]
[FR Doc No: 2020-13430]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89085; File No. SR-MIAX-2020-16]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Exchange Rule 518, Complex Orders

June 17, 2020.
    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 June 12, 2020, Miami International Securities Exchange, LLC
(``MIAX'' or the ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rule 518,
Complex Orders.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/ at MIAX's principal
office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Exchange Rule 518, Complex Orders,
to adopt a new order type, Complex Attributable Order.
    Currently, the Exchange offers an Attributable Order \3\ in its
simple market.\4\ Current Exchange Rule 516(e) states that an
Attributable Order is a market \5\ or limit order \6\ which displays
the user firm ID for purposes of trading on the Exchange. Use of
Attributable Orders is voluntary. Attributable Orders entered into the
Exchange System \7\ will be available for execution but may not display
the user firm ID for all Exchange processes. The Exchange will issue a
Regulatory Circular specifying the Exchange processes and the class(es)
of securities for which the Attributable Order type shall be
available.\8\ Currently, an Attributable Order in the simple market
will display the Executing Broker MPID \9\ when it triggers either a
liquidity refresh pause,\10\ or a Route Timer.\11\ Attributable Orders
were made available on the Exchange on June 17, 2013, for the
aforementioned liquidity seeking events.\12\ The Attributable Order
type is available for all option classes and can be activated on an
order-by-order basis with the default set to off.\13\
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    \3\ See Exchange Rule 516(e).
    \4\ The Exchange has a Simple Order Book, which is the
Exchange's regular electronic book of orders and quotes. See
Exchange Rule 518(a)(15). The Exchange also has a Strategy Order
book, which is the Exchange's electronic book of complex orders and
complex quotes. See Exchange Rule 518(A)(17).
    \5\ A market order is an order to buy or sell a stated number of
option contracts at the best price available at the time of
execution. See Exchange Rule 516(a).
    \6\ A limit order is an order to buy or sell a stated number of
option contracts at a specified price or better. See Exchange Rule
516(b).
    \7\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \8\ See Exchange Rule 516(e).
    \9\ An MPID is a Market Participant Identifier used by the
Exchange.
    \10\ See Exchange Rule 515(c)(3).
    \11\ See Exchange Rule 529(b)(2).
    \12\ See MIAX Options Regulatory Circular 2013-33, Attributable
Order (June 13, 2013) available at https://www.miaxoptions.com/sites/default/files/circular-files/MIAX_RC_2013_33.pdf.
    \13\ Id.

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    The Exchange now proposes to adopt new subparagraph (8) to Exchange
Rule 518(b) which will similarly provide that a Complex Attributable
Order is a market or limit order which displays the user firm ID for
purposes of trading on the Exchange. Use of Complex Attributable Orders
is voluntary. Complex Attributable Orders entered into the Exchange
System will be available for execution but may not display the user
firm ID for all Exchange processes. Complex Attributable Orders will be
used similarly for liquidity seeking events that occur on the
Exchange's Strategy Book, such as Complex Auctions. If enabled, the
MPID will be displayed on the MIAX Order Feed (``MOR'') and the MIAX
Administrator Information Subscriber (``AIS'') Feed. The Exchange will
issue a Regulatory Circular specifying the Exchange processes and the
class(es) of securities for which the Complex Attributable Order type
shall be available.\14\
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    \14\ The ability to display information pertaining to a single
order depends upon the Exchange's ability to broadcast that
information to its members. This is currently accomplished through
the Exchange's market data products, which for example includes the
Administrative Information Subscriber Feed (``AIS''). Thus, the
functionality of a Complex Attributable Order is linked to what is
technologically feasible through the Exchange's market data
products. The definition of a Complex Attributable Order will
acknowledge this relationship and allow the functionality of the
Complex Attributable Order type to develop and be deployed
correspondingly with technical advances related to its market data
products. In its definition of a Complex Attributable Order the
Exchange proposes to state that, ``Complex Attributable Orders
entered into the Exchange System will be available for execution but
may not display the user firm ID for all Exchange processes.'' This
will serve to put MIAX members on notice that the functionality of a
Complex Attributable Order to display the user firm ID, as it
continually develops, may not be available during all Exchange
processes.
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    The Exchange will announce the implementation date of the proposed
rule change by Regulatory Circular to be published no later than 90
days following the operative date of the proposed rule. The
implementation date will be no later than 90 days following the
issuance of the Regulatory Circular.
2. Statutory Basis
    MIAX believes that its proposed rule change is consistent with
Section 6(b) of the Act \15\ in general, and furthers the objectives of
Section 6(b)(5) of the Act \16\ in particular, in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in, securities, to remove impediments to and perfect the mechanisms 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(b).
    \16\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes its proposal to adopt a Complex Attributable
Order promotes just and equitable principles of trade, and removes
impediments to and perfects the mechanisms of a free and open market
system and, in general, protects investors and the public interest by
introducing an order type for use on the complex market that is
currently available for use on the Exchange's simple market. Use of
Complex Attributable Orders is voluntary and provides Members \17\ of
the Exchange similar order types for use on both the simple market and
the complex market for use during liquidity seeking events to
facilitate executions.
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    \17\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associate with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.
    The Exchange does not believe that the proposed rule change to
adopt a Complex Attributable Order will impose any burden on inter-
market competition but rather may increase competition among
exchanges.\18\ The Exchange notes that it operates in a highly
competitive market in which market participants can readily direct
order flow to competing venues who offer similar functionality. The
Exchange believes the proposed rule change will enhance competition
among the various markets for complex order execution, potentially
resulting in more active complex order trading on all exchanges.
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    \18\ The Nasdaq ISE Exchange and Nasdaq MRX Exchange currently
offer Attributable Complex Orders. See Nasdaq ISE Exchange, Options
3, Section 14, Complex Orders (b)(4); and Nasdaq MRX Exchange,
Options 3, Section 14, Complex Orders (b)(4).
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    The Exchange does not believe that the proposed rule change to
adopt a Complex Attributable Order will impose any burden on intra-
market competition as use of a Complex Attributable Order is voluntary
and all Members of the Exchange have the option to use a Complex
Attributable Order when submitting a complex order to the Exchange.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \19\ and Rule 19b-4(f)(6) \20\
thereunder.
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 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 Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2020-16 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MIAX-2020-16. 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 the Exchange. 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-
MIAX-2020-16 and should be submitted on or before July 14, 2020.
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    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-13430 Filed 6-22-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Proposed Rules]
[Page 2876]
[FR Doc No: 2023-00368]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2020-0730; EPA-R05-OAR-2020-0731; FRL-9746-01-R5]

Air Plan Approval; Michigan; Base Year Emissions Inventory and
Emissions Statement Rule for the 2015 Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve, under the Clean Air Act (CAA), a request submitted by the
Michigan Department of Environment, Great Lakes, and Energy (EGLE) on
December 18, 2020, to revise the Michigan State Implementation Plan
(SIP). EGLE's submittal addresses the emissions inventory and emissions
statement requirements for the Allegan County, Berrien County, Detroit
(Livingston, Macomb, Monroe, Oakland, St. Clair, Washtenaw, and Wayne
Counties) and Muskegon County nonattainment areas under the 2015 ozone
National Ambient Air Quality Standard (NAAQS or standard). The CAA
requires states to develop and submit, as SIP revisions, emission
inventories for all ozone nonattainment areas. In this action, EPA is
proposing to approve EGLE's emissions inventories for the Allegan
County, Berrien County, and Muskegon County nonattainment areas under
the 2015 ozone NAAQS and the removal of the repealed Act 348, Section
14a. EPA approved the portions of EGLE's December 18, 2020, submittal
pertaining to the certification of EGLE's stationary annual emissions
statement regulation and emissions inventories for the Detroit
nonattainment area under the 2015 ozone NAAQS in a separate action on
July 6, 2022.

DATES: Comments must be received on or before February 17, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2020-0730 (regarding emissions statement) or EPA-R05-OAR-2020-0731
(regarding emissions inventory) at https://www.regulations.gov or via
email to [email protected]. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. For either manner of submission, 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. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Emily Crispell, Environmental
Scientist, Control Strategies Section, Air Programs Branch (AR18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, [email protected]. The
EPA Region 5 office is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding Federal holidays and facility closures due to COVID-
19.

SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
rule, no further activity is contemplated. If EPA receives such
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: January 5, 2023.
Debra Shore,
Regional Administrator, Region 5.
[FR Doc. 2023-00368 Filed 1-17-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77590-77591]
[FR Doc No: 2022-27460]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2197-143]

Cube Yadkin Generation, LLC; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters.
    b. Project No: 2197-143.
    c. Date Filed: November 17, 2022.
    d. Applicant: Cube Yadkin Generation, LLC.
    e. Name of Project: Yadkin Hydroelectric Project.
    f. Location: Tuckertown Development in Montgomery County, North
Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Joyce Foster,<PHONE_NUMBER>,
[email protected].
    i. FERC Contact: Mark Carter,<PHONE_NUMBER>, [email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: January 12, 2023.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include docket number P-2197-143. Comments emailed to Commission staff
are not considered part of the Commission record.
    k. Description of Request: Cube Yadkin Generation, LLC proposes to

install a solar photovoltaic system on project lands near the
Tuckertown Dam. The solar facility would consist of two solar arrays
occupying 0.74 acre of project lands total, would result in 2.22 acres
of land disturbance to construct the facilities, and would provide 500
kilowatts of power to the electric grid. The licensee's proposal is
associated with a grant from the U.S. Department of Energy to study the
control and coordination of multiple generation sources (i.e., in this
case, solar energy and hydroelectric energy) connecting to the electric
grid.
    l. Locations of the Application: 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://www.ferc.gov) using the ``elibrary'' link. Enter the docket
number excluding the last three digits in the document 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 FERC
at [email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659. Agencies may obtain copies of the application directly
from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: December 13, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-27460 Filed 12-16-22; 8:45 am]
BILLING CODE 6717-01-P


"Christian Richter"<EMAIL_ADDRESS>10/26/2007 12:02 AM	To
Conrad Chin/RTP/USEPA/US@EPA, <EMAIL_ADDRESS>cc
"'Jeff Hannapel'"<EMAIL_ADDRESS>Steve
Fruh/RTP/USEPA/US@EPA
bcc

Subject
International Trade Commission Report on Foundry Industry Competitiveness
Challenges - 2005

	History:
This message has been forwarded.

Greetings Conrad/Jeff:

Per the competitiveness concerns we have raised re the impact of the area
source rule on the U.S. foundry industry, we would like to share the
International Trade Commission study of the U.S. foundry industry from
2005.  We will be referencing it in the AFS comments as well.

Thanks very much.  Let me know if you have questions in the meantime.

Regards,

Christian

The Policy Group
(202) 257-0250 Direct (Mobile)
(202) 457-0630 Washington Office
(703) 992-0083 Virginia Office
<EMAIL_ADDRESS>


[Federal Register Volume 86, Number 164 (Friday, August 27, 2021)]
[Notices]
[Pages 48292-48293]
[FR Doc No: 2021-18510]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2018-0049]

Petition for Extension of Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on August 18, 2021, BNSF
Railway (BNSF) petitioned the Federal Railroad Administration (FRA) for
an expansion of a waiver of compliance from certain provisions of the
Federal railroad safety regulations contained at 49 CFR part 232, Brake
System Safety Standards for Freight and Other Non-Passenger Trains and
Equipment; End-Of-Train Devices. The relevant FRA Docket Number is FRA-
2018-0049.
    The existing waiver provides BNSF certain relief from 49 CFR
232.15, Movement of defective equipment; 49 CFR 232.103(f), General
requirements for all train brake systems; and 49 CFR 232.213, Extended
haul trains; and a statutory exemption from the requirements of title
49, United States Code section 20303. BNSF renews its request to expand
the scope of the waiver to include coal trains operating over the Pikes
Peak Subdivision in Colorado and across the Sand Hills Subdivision in
Nebraska.\1\
---------------------------------------------------------------------------

    \1\ BNSF initially requested expansion of the waiver on March
18, 2021. See https://www.regulations.gov/document/FRA-2018-0049-0018. Public notice of the request was issued on April 5, 2021. See
https://www.regulations.gov/document/FRA-2018-0049-0021. By letter
dated May 5, 2021, BNSF requested an initial 30-day hold on
processing the petition. See https://www.regulations.gov/document/FRA-2018-0049-0022.
---------------------------------------------------------------------------

    On April 12, 2019, FRA granted BNSF a test waiver to conduct a
pilot program on a segment of its system to ``demonstrate that the use
of wheel temperature detectors to prove brake health effectiveness
(BHE) will improve safety, reduce risks to employees, and provide cost
savings to the industry.''
    BNSF asserts the expansion would improve train braking performance
and safety by reducing brake pipe air losses on all BNSF coal trains
(particularly important during winter operations), and accomplish the
following goals:
     Validation of braking performance of BNSF coal trains
moving south through Colorado and east through Alliance, Nebraska;
     Improvement of the braking performance of individual cars
identified with cold or hot wheels;
     Increased testing of car brake systems with Automatic
Single Car Test (ASCT) devices;

     Increased removal of poor performing brake valves and
brake system components identified by the ASCT; and
     Generation of additional important data on air brake valve
performance in a cold weather environment to supplement the program
started with Northern grain trains.
    BNSF proposes that the processes and parameters would follow all
conditions of the Southern Transcon intermodal BHE Program but differ
in that the trains operate as ``cycle trains'' and stay intact in unit
train operations, similar to the Northern Transcon grain trains.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation (DOT), 1200 New Jersey Ave. SE, W12-140, Washington, DC
20590.
    Communications received by October 12, 2021 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. Anyone can search the electronic
form of any written communications and comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its processes. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2021-18510 Filed 8-26-21; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Proposed Rules]
[Page 28543]
[FR Doc No: 2012-11625]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2012-0292; FRL-9671-8]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Permit To Construct Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the State of Maryland pertaining to sources which
are exempt from preconstruction permitting requirements under
Maryland's New Source Review (NSR) program. In the Final Rules section
of this Federal Register, EPA is approving the State's SIP submittal as
a direct final rule without prior proposal because the Agency views
this as a noncontroversial submittal and anticipates no adverse
comments. A detailed rationale for the approval is set forth in the
direct final rule. If no adverse comments are received in response to
this action, no further activity is contemplated. If EPA receives
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time.

DATES: Comments must be received in writing by June 14, 2012.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2012-0292 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2012-0292, Ms. Kathleen Cox, Associate
Director, Office of Permits and Air Toxics, Mailcode 3AP10, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2012-0292. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at 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 www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Maryland Department of the Environment, 1800
Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Mr. David Talley,<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, also entitled
``Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Permit to Construct Exemptions,'' that is located in the
``Rules and Regulations'' section of this Federal Register publication.

    Dated: May 2, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2012-11625 Filed 5-14-12; 8:45 am]
BILLING CODE 6560-50-P