[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Proposed Rules]
[Pages 52044-52047]
[FR Doc No: 2019-21221]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0703; Product Identifier 2019-NM-106-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Fokker Services B.V. Model F28 Mark 0100 airplanes. This
proposed AD was prompted by reports of smoke in the flight deck, in
conjunction with the loss of electrical power. This proposed AD would
require replacement of affected generator power transfer contactors
(GPTCs), essential bus transfer contactors (EBTCs), and auxiliary power
transfer contactors (APTCs), as specified in a European Union Aviation
Safety Agency (EASA) AD, which will be incorporated by reference. The
FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by November
15, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For the material identified in this proposed AD that will be
incorporated by reference (IBR), contact the EASA, at Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 1000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this IBR
material on the EASA website at https://ad.easa.europa.eu. You may view
this IBR material at the FAA, Transport Standards Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2019-0703.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0703; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0703;
Product Identifier 2019-NM-106-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM based on those comments.
    The FAA will post all comments, without change, to http://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact the agency receives about this NPRM.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0120, dated May 29, 2019
(``EASA AD 2019-0120'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Fokker Services B.V. Model F28 Mark 0100 airplanes.
The MCAI states:

    Occurrences have been reported of smoke in the cockpit on Fokker
100 aeroplanes, in conjunction with loss of electrical power.
Subsequent investigation results revealed that the most likely cause
of the smoke emission, as well as of power loss, was arcing inside
one of the affected parts, GPTC, EBTC and APTC, located in the
electrical power centre.
    This condition, if not corrected, could lead to further events
of smoke in the cockpit, possibly resulting in excessive crew
workload and/or injury to flight deck occupants.
    To address this potential unsafe condition, Fokker Services
published the [service bulletin] SB to provide instructions to
replace the affected parts.
    For the reasons described above, this [EASA] AD requires a one-
time replacement of the affected parts with new parts.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0120 describes procedures for replacing affected parts
(GPTCs, EBTCs, and APTCs having part number DHR18-1) with serviceable
parts. This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the agency's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2019-0120 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2019-0120
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2019-0120 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2019-0120 that is required for compliance with EASA AD 2019-
0120 will be available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2019-0703 after the FAA final
rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 4 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this
proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................          $5,400           $5,570          $22,280
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Fokker Services B.V.: Docket No. FAA-2019-0703; Product Identifier
2019-NM-106-AD.

(a) Comments Due Date

    The FAA must receive comments by November 15, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Fokker Services B.V. Model F28 Mark 0100
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical
power.

(e) Reason

    This AD was prompted by reports of smoke in the flight deck, in
conjunction with the loss of electrical power. The FAA is issuing
this AD to address smoke in the flight deck combined with the loss
of electrical power, which could lead to excessive flightcrew
workload and injury to the flightcrew.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2019-0120, dated May 29, 2019 (``EASA AD 2019-0120'').

(h) Exceptions to EASA AD 2019-0120

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0120 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0120 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Fokker
Services B.V.'s EASA Design Organization Approval (DOA). If approved
by the DOA, the approval must include the DOA-authorized signature.

(j) Related Information

    (1) For information about EASA AD 2019-0120, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this EASA AD at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. EASA AD 2019-0120 may be found in the AD docket on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0703.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on September 19, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-21221 Filed 9-30-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 29 (Thursday, February 12, 2015)]
[Notices]
[Page 7859]
[FR Doc No: 2015-02953]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP11-1711-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Compliance filing per 154.501: 2014 Cash Out Filing.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5019.
    Comments Due: 5 p.m. ET 2/11/15.

    Docket Numbers: RP15-420-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) rate filing per 154.204: 02/02/15
Negotiated Rates--ConEdison Energy Inc. (HUB) 2275-89 to be effective
2/1/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5111.
    Comments Due: 5 p.m. ET 2/17/15.

    Docket Numbers: RP15-421-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) rate filing per 154.204: 02/02/15
Negotiated Rates--Mercuria Energy Gas Trading LLC (HUB) 7540-89 to be
effective 1/31/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5113.
    Comments Due: 5 p.m. ET 2/17/15.

    Docket Numbers: RP15-422-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) rate filing per 154.204: 02/02/15
Negotiated Rates--Sequent Energy Management (HUB) 3075-89 to be
effective 2/1/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5114.
    Comments Due: 5 p.m. ET 2/17/15.

    Docket Numbers: RP15-423-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Amendment to Neg
Rate Agmt (Chevron 41610-5) to be effective 2/1/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5118.
    Comments Due: 5 p.m. ET 2/17/15.

    Docket Numbers: RP15-424-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) rate filing per 154.204: 02/02/15
Negotiated Rates--Trafigura Trading LLC (HUB) 7445-89 to be effective
1/30/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5120.
    Comments Due: 5 p.m. ET 2/17/15.

    Docket Numbers: RP15-425-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Neg Rate 2015-02-
02 Mieco to be effective 2/1/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5232.
    Comments Due: 5 p.m. ET 2/17/15.

    Docket Numbers: RP15-426-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) rate filing per 154.204: 20150202
Negotiated Rate to be effective 2/3/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5257.
    Comments Due: 5 p.m. ET 2/17/15.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP15-271-001.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Compliance filing per 154.203: Negotiated & Non-
Conforming Service Agmt--PacSum Compliance Filing to be effective 1/1/
2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5254.
    Comments Due: 5 p.m. ET 2/17/15.

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

    Dated: February 3, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-02953 Filed 2-11-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27677-27679]
[FR Doc No: 2022-09857]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94840; File No. SR-NYSEAMER-2022-19]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing of Proposed Rule Change To Modify Rule 7.31E To Add Subparagraph
(f)(4) Regarding Directed Orders

May 3, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on April 20, 2022, NYSE American LLC (``NYSE American'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. 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\ 15 U.S.C. 78a.
    \3\ 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 proposes to modify Rule 7.31E to add subparagraph
(f)(4) regarding Directed Orders and make other conforming changes. The
proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, 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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to modify Rule 7.31E (Orders and Modifiers)
to add new subparagraph (f)(4) to provide for Directed Orders and to
make other conforming changes to its Rules in connection with the
addition of this new order type on the Exchange. The Directed Order, as
further defined below, would be an order sent to the Exchange to be
routed directly to an alternative trading system (``ATS'') specified by
an ATP Holder.
    The Exchange proposes to add Rule 7.31E(f)(4), which would define a
Directed Order as a Limit Order with instructions to route on arrival
at its limit price to a specified ATS with which the Exchange maintains
an electronic linkage. Proposed Rule 7.31E(f)(4) would further provide
that Directed Orders would be available for all securities eligible to
trade on the Exchange. Proposed Rule 7.31E(f)(4) would also provide
that a Directed Order would not be assigned a working time or interact
with interest on the Exchange Book. The Exchange also proposes to
provide in Rule 7.31E(f)(4) that the ATS to which a Directed Order is
routed would be responsible for validating whether the order is
eligible to be accepted, and if such ATS determines to reject the
order, the order would be cancelled.
    Proposed Rule 7.31E(f)(4)(A) would provide that a Directed Order
must be designated for the Exchange's Core Trading Session, as defined
in Rule 7.34E(a)(2).\4\
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    \4\ Because the Exchange proposes that Directed Orders may only
be designated for the Core Trading Session, the Exchange also
proposes conforming changes to Rule 7.34E (Trading Sessions).
Specifically, the Exchange proposes to modify Rule 7.34E(c)(1)(E) to
provide that Directed Orders designated for the Early Trading
Session would be rejected and Rule 7.34E(c)(3)(C) to provide that
Directed Orders designated for the Late Trading Session would be
rejected. The Exchange also proposes an additional change to correct
a typographical error in Rule 7.34E(c)(1), to update the reference
to ``paragraphs (c)(1)(A)-(E)'' to ``paragraphs (c)(1)(A)-(F)'' to
accurately reflect the number of subparagraphs under Rule
7.34E(c)(1).
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    Proposed Rule 7.31E(f)(4)(A) would further provide that a Directed
Order must be designated with a Time in Force modifier of IOC \5\ or
Day \6\ and would be routed to the specified ATS with such modifier.
The Exchange proposes that a Directed Order designated IOC would be
traded in whole or in part on the ATS to which it is routed after
receipt of the order, and any untraded quantity would be cancelled. The
Exchange proposes that a Directed Order designated Day would expire at
the end of the Core Trading Session on the day it is entered. Proposed
Rule 7.31E(f)(1)(A) would also provide that a Directed Order may not be
designated with any other modifiers defined in Rule 7.31E.
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    \5\ See Rule 7.31E(b)(2), which provides that a Limit Order may
be designated with an Immediate-or-Cancel (``IOC'') modifier.
    \6\ See Rule 7.31E(b)(1), which provides that orders may be
designated with a Day modifier, and that an order to buy or sell
designated Day, if not traded, will expire at the end of the
designated session on the day on which it was entered.
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    Proposed Rule 7.31E(f)(4)(B) would provide that a Directed Order in
a security that is having its initial listing on the Exchange would be
rejected if received before the IPO Auction concludes.
    Proposed Rule 7.31E(f)(4)(C) would provide that, during a trading
halt or pause, an incoming Directed Order would be rejected.
    Proposed Rule 7.31E(f)(4)(D) would provide that a request to cancel
a Directed Order designated Day would be routed to the ATS to which the
order was routed.
    The Exchange also proposes a conforming change to Rule 7.19E (Pre-
Trade Risk Controls). The Exchange proposes to modify Rule 7.19E(a)(5),
which sets forth the definition of Gross Credit Risk Limit and
currently provides that unexecuted orders in the Exchange Book, orders
routed on arrival pursuant to Rule 7.37E(a)(1), and executed orders are
included for purposes of calculating the Gross Credit Risk Limit. The
Exchange proposes to modify Rule 7.19E(a)(5) to specify that orders
routed on arrival pursuant to Rule 7.31E(f)(4) would also be included
for purposes of the Gross Credit Risk Limit calculation.
    The Exchange believes that the proposed rule change would
facilitate additional trading opportunities by offering ATP Holders the
ability to designate orders submitted to the

Exchange to be routed to an ATS of their choosing for execution. The
Exchange believes the proposed change would encourage ATP Holders to
utilize the Exchange as a venue for order entry and further believes
that the proposed change could create efficiencies for ATP Holders by
enabling them to send orders that they wish to route to an alternate
destination through the Exchange, thereby enabling them to leverage
order entry protocols and specifications already configured for their
interactions with the Exchange. The Exchange notes that the Directed
Order, as proposed, would operate similarly to the Primary Only Order
already offered by the Exchange, which is an order that is routed
directly to the primary listing market on arrival, without being
assigned a working time or interacting with interest on the Exchange
Book.\7\ The Exchange also believes that the Directed Order would offer
ATP Holders functionality akin to order types and routing options that
currently exist on other equities exchanges.\8\
---------------------------------------------------------------------------

    \7\ See Rule 7.31E(f)(1). NYSE American also offers variations
of the Primary Only Order, including the Primary Only Until 9:45
Order, which is a Limit or Inside Limit Order that, on arrival and
until 9:45 a.m. Eastern Time, routes to the primary listing market,
and the Primary Only Until 3:55 Order, which is a Limit or Inside
Limit Order entered on the Exchange until 3:55 p.m. Eastern Time,
after which time the order is cancelled on the Exchange and routed
to the primary listing market. See Rules 7.31E(f)(2) and (f)(3). The
Exchange's affiliated exchanges NYSE Arca, Inc. (``NYSE Arca''),
NYSE Chicago, Inc. (``NYSE Chicago''), and NYSE National, Inc.
(``NYSE National'') (collectively, the ``Affiliated Exchanges'')
also offer the Primary Only Order and variations thereof. See NYSE
Arca Rules 7.31-E(f)(1)-(f)(3); NYSE Chicago Rules 7.31(f)(1)-
(f)(3); NYSE National Rules 7.31(f)(1)-(f)(3).
    \8\ See, e.g., Nasdaq Stock Market LLC (``Nasdaq''), Equity 4,
Equity Trading Rules, Rule 4758(a)(ix) (defining the Nasdaq Directed
Order as an order designed to use a routing strategy under which the
order is directed to an automated trading center other than Nasdaq,
as directed by the entering party, without checking the Nasdaq
Book); Cboe EDGX Exchange, Inc. (``EDGX'') Rules 11.8(c)(7)
(defining the Routing/Directed ISO order type as an ISO that
bypasses the EDGX system and is immediately routed by EDGX to a
specified away trading center for execution) and 11.11(g)(2)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed); Cboe EDGA Exchange,
Inc. (``EDGA'') Rules 11.8(c)(7) (defining the Routing/Directed ISO
order type as an ISO that bypasses the EDGA system and is
immediately routed by EDGA to a specified away trading center for
execution) and 11.11(g)(2) (providing for the DRT routing option, in
which an order is routed to an alternative trading system as
instructed); Cboe BZX Exchange, Inc. (``BZX'') Rules 11.13(b)(3)(D)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed) and 11.13(b)(3)(F)
(defining the Directed ISO routing option, under which an ISO order
would bypass the BZX system and be sent to a specified away trading
center); Cboe BYX Exchange, Inc. (``BYX'') Rules 11.13(b)(3)(D)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed) and 11.13(b)(3)(F)
(defining the Directed ISO routing option, under which an ISO order
would bypass the BYX system and be sent to a specified away trading
center). The Exchange also believes that the Directed Order would
provide functionality similar to the C-LNK routing strategy formerly
offered by EDGA, in which C-LNK orders bypassed EDGA's local book
and routed directly to a specified Single Dealer Platform
destination. See Securities Exchange Act Release No. 82904 (March
20, 2018), 83 FR 12995 (March 26, 2018) (SR-CboeEDGA-2018-004)
(Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change To Expand an Offering Known a Cboe Connect To Provide
Connectivity to Single-Dealer Platforms Connected to the Exchange's
Network and To Propose a Per Share Executed Fee for Such Service).
---------------------------------------------------------------------------

    Because of the technology changes associated with this proposed
rule change, the Exchange will announce the implementation date by
Trader Update.\9\ Subject to effectiveness of this proposed rule
change, the Exchange anticipates that the proposed change will be
implemented in the second quarter of 2022.
---------------------------------------------------------------------------

    \9\ The Exchange will also provide information regarding the
ATS(s) to which a Directed Order may be designated to route by
Trader Update.
---------------------------------------------------------------------------

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934,\10\ in general, and furthers the
objectives of Section 6(b)(5),\11\ in particular, because 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 facilitating transactions in
securities, to remove impediments to, and perfect the mechanism of, a
free and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is designed to
remove impediments to and perfect the mechanism of a free and open
market and promote just and equitable principles of trade because the
Directed Order would offer ATP Holders access to additional trading
opportunities by permitting them to designate orders submitted to the
Exchange to be routed directly to a specified ATS for execution. The
Exchange further believes that the proposed change would remove
impediments to and perfect the mechanism of a free and open market by
offering ATP Holders the option to send orders that they wish to route
to an alternate destination for execution through the Exchange, which
would create efficiencies to the extent ATP Holders are able to
leverage existing protocols and specifications. Finally, the Exchange
notes that the proposed functionality is not novel, as both the
Exchange and other exchanges offer their members functionality whereby
an exchange routes orders on behalf of a member to a specified trading
center without such order interacting with the exchange's book.\12\
---------------------------------------------------------------------------

    \12\ See notes 7 & 8, supra.
---------------------------------------------------------------------------

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 believes that
the proposed rules governing Directed Orders would promote competition
because they would provide for an order type on the Exchange that would
facilitate additional trading opportunities for market participants.
The Exchange further believes that the proposed rules would allow it to
offer ATP Holders functionality similar to order types and routing
options that exist on other equities exchanges, thereby enabling the
Exchange to compete with such exchanges.\13\
---------------------------------------------------------------------------

    \13\ See note 8, supra.
---------------------------------------------------------------------------

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

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

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

    Within 45 days of the date of publication of this notice in the
Federal Register or up to 90 days (i) as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or (ii) as to which the self-regulatory
organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be 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 protected]. Please include
File Number SR-NYSEAMER-2022-19 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-NYSEAMER-2022-19. 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-NYSEAMER-2022-19 and should be submitted
on or before May 31, 2022.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-09857 Filed 5-6-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53511-53512]
[FR Doc No: 2014-21424]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0298]

Notification of Changes in the New Entrant Safety Assurance
Program Operational Test

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of changes to operational test.

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SUMMARY: FMCSA announces two changes to the New Entrant Safety
Assurance Program Operational Test (Operational Test) discussed in the
Agency's September 4, 2013, notice. First, the Agency will update the
IT systems so that when an automatic failure violation (as listed in 49
CFR 385.321) is identified by the Agency based on the records the motor
carrier provides during the document submission process, the carrier
will automatically fail the new entrant safety audit and be placed into
the corrective action process. This is consistent with the current new
entrant safety audit process for audits conducted at a motor carrier's
principal place of business (PPOB). Second, the Agency will extend the
Operational Test through December 2014 to ensure sufficient data is
available to calculate the established metrics in order to make an
informed decision on any future actions.

DATES: The changes take effect September 9, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2013-0298 using any of the
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.

     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line Federal document management system
is available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System published in the Federal Register on January 17, 2008
(73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Mr. Joseph Bennett, Federal Motor
Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington,
DC 20590, telephone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing or submitting material to the docket,
call Ms. Barbara Hairston, Program Manager, Docket Operations, 202-366-
3024<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. New Entrant Safety Assurance Program Operational Test

    On September 4, 2013, FMCSA published a notice in the Federal
Register announcing the New Entrant Safety Assurance Program
Operational Test (78 FR 54510). The Agency indicated that the
Operational Test began in July 2013 and will be in effect for up to 12
months. The Operational Test procedures allow FMCSA to complete off-
site new entrant safety audits, defined as safety audits not conducted
at the motor carrier's principal place of business (PPOB), of eligible
new entrant motor carriers that can demonstrate basic safety management
controls without going to the motor carrier's PPOB by reviewing
specific compliance documentation submitted by the motor carrier as
requested by FMCSA or its State partners.
    In July 2013, this Operational Test included California, Florida,
Illinois, New York, Montana, and the Canadian Provinces contiguous to
Montana and New York. In December 2013, the state of Alaska was added
to the group of test states.
    The purpose of the Operational Test is to compare these off-site
new entrant audits to the traditional new entrant safety audits
conducted at the motor carriers' PPOB. The Agency is assessing each
approach's impact on both resource allocation and subsequent safety
performance of new entrant motor carriers.
    During the first nine months of the Operational Test, eligible new
entrant motor carriers submitted requested documents to a new entrant
safety auditor who subsequently reviewed the documentation and:
    (1) Prepared a report to document that the motor carrier has passed
the new entrant safety audit; or,
    (2) Contacted the motor carrier to request additional documentation
to determine whether the carrier satisfied the criteria for passing the
audit; or
    (3) Scheduled a new entrant safety audit at the motor carrier's
PPOB, as soon as practicable, based upon violations observed from the
submitted documentation or the carrier's failure to submit adequate
documentation.

II. Changes to the New Entrant Safety Assurance Program Operational
Test

    Effective September 9, 2014, if during the examination of the
submitted documentation, a safety auditor discovers automatic failure
violation(s) as listed in 49 CFR 385.321, the motor carrier will fail
the new entrant safety audit. The carrier will be placed into the
corrective action process pursuant to 49 CFR 385.319(c) and if the
carrier does not provide adequate corrective action it will be
prohibited from operating in interstate commerce. FMCSA notes that the
definition of ``safety audit'' under 49 CFR 385.3 does not limit the
activity to on-site interventions as is the case with the definition of
``compliance review.'' Therefore, the Agency has the discretion under
existing regulations to fail carriers during the Operational Test
without conducting an on-site safety audit.
    FMCSA believes this change needs to be made for the following
reasons:
     This process is consistent with the current method
concerning automatic failure violations for on-site new entrant audits;
     Since the Operational Test began, when automatic failure
violations were discovered during the off-site document review process;
many of those carriers still failed the follow-up new entrant safety
audit conducted at their PPOB; and,
     Allowing a new entrant motor carrier known to be operating
with an automatic failure violation(s) can pose a threat to public
safety.

Based on the Agency's experience with the test to date, the Agency will
monitor this change and compare the results and workload impacts to the
earlier portion of the test. The evaluation will look at the relative
workload of processing the additional corrective action submitted by
motor carriers that fail the off-site audit and the resources needed to
conduct on-site audits in these cases.
    In addition, FMCSA is extending the Operational Test through
December 2014 to ensure sufficient data is available to calculate the
established metrics in order to make an informed decision on any future
actions.

    Issued on: August 29, 2014.
T.F. Scott Darling, III,
Acting Administrator.
[FR Doc. 2014-21424 Filed 9-8-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40555-40556]
[FR Doc No: 2021-16064]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3511-024]

Lower Saranac Hydro, LLC;

Notice of Waiver Period for Water Quality Certification Application

    On July 2, 2021, Lower Saranac Hydro, LLC filed with the Federal
Energy Regulatory Commission a copy of its application for a Clean
Water Act section 401(a)(1) water quality

certification submitted to the New York State Department of
Environmental Conservation (New York DEC), in conjunction with the
above captioned project. Pursuant to 40 CFR 121.6, we hereby notify the
New York DEC of the following:
    Date of Receipt of the Certification Request: July 2, 2021.
    Reasonable Period of Time to Act on the Certification Request: One
year.
    Date Waiver Occurs for Failure to Act: July 2, 2022.
    If New York DEC fails or refuses to act on the water quality
certification request by the above waiver date, then the agency's
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: July 22, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-16064 Filed 7-27-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 74, Number 127 (Monday, July 6, 2009)]
[Notices]
[Pages 31937-31938]
[FR Doc No: E9-15735]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13445-000]

McGinnis, Inc.; Notice of Preliminary Permit Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

June 25, 2009.
    On April 29, 2009, McGinnis, Inc. filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Newburgh Hydrokinetic
Project, located on the Ohio River, Henderson County, Kentucky, and
Warrick County, Indiana. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of: (1) A 100 to 300-foot-long
by 20 to 52-foot-wide barge spudded down to the riverbed; (2) 10 6-8-
foot-long by 6-8-foot-diameter turbine-generators mounted in line along
the side of the barge; (3) one armored, high-voltage cable transmitting
the generated power to the existing transmission line located

adjacent to the proposed project area; and (4) appurtenant facilities.
The proposed project would generate about 1,533 megawatt-hours.
    Applicant Contact: Bruce D. McGinnis, Sr., McGinnis, Inc., P. O.
Box 534, 502 Second St. Ext., South Point, OH 45680, phone: (740) 377-
4391.
    FERC Contact: Sergiu Serban,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-comments.asp.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13445) in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-15735 Filed 7-2-09; 8:45 am]
BILLING CODE P


[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Pages 45536-45537]
[FR Doc No: 2015-18724]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0467; FRL-9931-49-ORD]

Board of Scientific Counselors (BOSC) Safe and Sustainable Water
Resources Subcommittee Meeting--August 2015

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, the U.S. Environmental Protection Agency (EPA), Office of Research
and Development (ORD), gives notice of a meeting of the Board of
Scientific Counselors (BOSC) Safe and Sustainable Water Resources
Subcommittee.

DATES: The meeting will be held on Thursday, August 27, 2015, from 8:30
a.m. to 5:00 p.m., and will continue on Friday, August 28, 2015, from
8:30 a.m. until 2:15 p.m. All times noted are Eastern Time. The meeting
may adjourn early if all business is finished. Attendees should
register online at: https://www.eventbrite.com/e/us-epa-bosc-safe-and-sustainable-water-resources-subcommittee-tickets-17396457272 by August
19, 2015. Requests for the draft agenda or for making oral
presentations at the meeting will be accepted up to July 25, 2015.

ADDRESSES: The meeting will be held at the EPA's Andrew W. Breidenbach
Environmental Research Center, 26 Martin Luther King Drive, Cincinnati,
Ohio 45268. Submit your comments, identified by Docket ID No. EPA-HQ-

ORD-2015-0467, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0467.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2015-0467.
     Mail: Send comments by mail to: Board of Scientific
Counselors (BOSC) Safe and Sustainable Water Resources Subcommittee
Docket, Mail Code: 2822T, 1301 Constitution Ave. NW., Washington, DC
20004, Attention Docket ID No. EPA-HQ-ORD-2015-0467.
     Hand Delivery or Courier: Deliver comments to: EPA Docket
Center (EPA/DC), Room 3334, William Jefferson Clinton West Building,
1301 Constitution Ave. NW., Washington, DC, Attention Docket ID No.
EPA-HQ-ORD-2015-0467. Note: this is not a mailing address. 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-HQ-ORD-
2015-0467. The 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 the 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 the 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, the 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 the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses. For additional information about the EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets/.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Board of Scientific
Counselors (BOSC) Safe and Sustainable Water Resources Subcommittee
Docket, EPA/DC, William Jefferson Clinton West Building, Room 3334,
1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the ORD Docket is (202)
566-1752.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer (DFO),
via mail at: Cindy Roberts, Mail Code 8104R, Office of Science Policy,
Office of Research and Development, U.S. Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; via phone/
voice mail at:<PHONE_NUMBER>; via fax at:<PHONE_NUMBER>; or via email
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    General Information: The meeting is open to the public. Any member
of the public interested in participating in the meeting should
register online at: https://www.eventbrite.com/e/us-epa-bosc-safe-and-sustainable-water-resources-subcommittee-tickets-17396457272 by August
19, 2015. Any member of the public interested in receiving a draft
agenda, attending the meeting, or making a presentation at the meeting
may contact Cindy Roberts, DFO, via any of the contact methods listed
in the FOR FURTHER INFORMATION CONTACT section above. Members of the
public wishing to provide comment in person should register by August
19, 2015, via the Eventbrite site noted above and contact Cindy
Roberts, DFO, directly.
    Written Statements: Written statements for the public meeting
should be received by Cindy Roberts, DFO, via email at the contact
information listed above by August 25, 2015. Written statements should
be supplied in one of the following electronic formats: Adobe Acrobat
PDF, MS Word, MS Power Point, or Rich Text files in IBM-PC/Windows 98/
2000/XP format.
    Oral Statements: In general, each individual making an oral
presentation at the public meeting will be limited to a total of three
minutes. Each person making an oral statement should also consider
providing written comments so that the points presented orally can be
expanded upon in writing. Interested parties should contact Cindy
Roberts, DFO, in writing (preferably via email) at the contact
information noted above by August 25, 2015 to be placed on the list of
public speakers for the BOSC meeting.
    For security purposes, all attendees must provide their names to
Cindy Roberts, DFO, and register online at: https://www.eventbrite.com/e/us-epa-bosc-safe-and-sustainable-water-resources-subcommittee-tickets-17396457272 by August 19, 2015, and must go through a metal
detector, sign in with the security desk, and show government-issued
photo identification to enter the building. Attendees are encouraged to
arrive at least 15 minutes prior to the start of the meeting to allow
sufficient time for security screening. Proposed agenda items for the
meeting include, but are not limited to, the following: Overview of
materials provided to the subcommittee; overview of ORD's Safe and
Sustainable Water Resources Research program; poster session; and
subcommittee discussion.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Cindy Roberts, DFO, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability, please
contact Cindy Roberts, DFO, preferably at least ten days prior to the
meeting, to give the EPA as much time as possible to process your
request.

    Dated: July 22, 2015.
Fred S. Hauchman,
Director, Office of Science Policy.
[FR Doc. 2015-18724 Filed 7-29-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57056-57057]
[FR Doc No: 2011-23491]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0166]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Guidance for Industry on Studies To Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue
Depletion Studies To Establish Product Withdrawal Periods; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (207) entitled
``Guidance for Industry on Studies To Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker
Residue Depletion Studies To Establish Product Withdrawal Periods,''
(VICH GL48). This guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This VICH
guidance document is intended to provide study design recommendations
that will facilitate the universal acceptance of the generated residue
depletion data to fulfill the national/regional requirements.

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

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your request. 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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
(207) entitled ``Guidance for Industry on Studies To Evaluate
the Metabolism and Residue Kinetics of Veterinary Drugs in Food-
Producing Animals: Marker Residue Depletion Studies To Establish
Product Withdrawal Periods,'' (VICH GL48). In recent years, many
important initiatives have been undertaken by regulatory authorities
and industry associations to promote the international harmonization of
regulatory requirements. FDA has participated in efforts to enhance
harmonization and has expressed its commitment to seek scientifically
based harmonized technical procedures for the development of
pharmaceutical products. One of the goals of harmonization is to
identify and then reduce differences in technical requirements for drug
development among regulatory agencies in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
VICH is a parallel initiative for veterinary medicinal products. The
VICH is concerned with developing harmonized technical requirements for
the approval of veterinary medicinal products in the European Union,
Japan, and the United States, and includes input from both regulatory
and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal
Health Institute, the Japanese Veterinary Pharmaceutical Association,
the Japanese Association of Veterinary Biologics, and the Japanese
Ministry of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH Steering Committee
meetings.

II. Guidance on Marker Residue Depletion Studies To Establish Product
Withdrawal Periods

    In the Federal Register of April 12, 2010 (75 FR 18504), FDA
published a notice of availability for a draft guidance entitled
``Draft Guidance for Industry on Studies To Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker
Residue Depletion Studies To Establish Product Withdrawal Periods,''
(VICH GL48), which gave interested persons until May 12, 2010, to
comment on the draft guidance. FDA received a few comments on the draft
guidance and those comments, as well as those received by other VICH
member regulatory agencies, were considered as the guidance was
finalized. At a meeting held in February 2011, the VICH Steering
Committee endorsed the final guidance for industry (VICH GL48). The
guidance announced in this notice finalizes the draft guidance dated
April 12, 2010.
    This VICH guidance document is one of a series developed to
facilitate the mutual acceptance by national/regional regulators of
residue chemistry data for veterinary drugs used in food-producing
animals. This guidance was prepared after consideration of the current
national/regional requirements and recommendations for evaluating
veterinary drug residues in the European Union, Japan, the United
States, Australia, New Zealand, and Canada.
    As part of the approval process for veterinary medicinal products
in food-producing animals, national/regional regulatory authorities
require data from marker residue depletion studies in order to
establish appropriate withdrawal periods in edible tissues, including
meat, milk, and eggs. The objective of this guidance is to provide
study design recommendations that will facilitate the universal
acceptance of the generated residue depletion data to

fulfill the national/regional requirements.

III. Significance of Guidance

    This guidance, developed under the VICH process, has been revised
to conform to FDA's good guidance practices regulation (21 CFR 10.115).
For example, the document has been designated ``guidance'' rather than
``guideline.'' In addition, guidance documents must not include
mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    This guidance represents the Agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of applicable
statutes and regulations.

IV. 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). The
collections of information in this guidance have been approved under
OMB control number 0910-0032.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

VI. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: September 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23491 Filed 9-14-11; 8:45 am]
BILLING CODE 4160-01-P