[Federal Register Volume 86, Number 113 (Tuesday, June 15, 2021)]
[Notices]
[Pages 31722-31724]
[FR Doc No: 2021-12505]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0493]

Medical Devices; Exemption From Premarket Notification: Powered
Patient Transport, All Other Powered Patient Transport

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it has received a petition requesting exemption from the premarket
notification requirements for the generic device type, powered patient
transport, all other powered patient transport. These devices are
motorized devices used to mitigate mobility impairment caused by injury
or other disease by moving a person from one location or level to
another, such as up and down flights of stairs. This device type does
not include motorized three-wheeled vehicles or wheelchairs, and is
distinct from the device type, powered patient transport, powered
patient stairway chair lifts, which is classified separately within the
same regulation. FDA is publishing this notice to obtain comments in
accordance with procedures established by the Federal Food, Drug, and
Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments by August 16, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 16, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 16, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

do not wish to be made available to the public, submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0493 for ``Medical Devices; Exemption from Premarket
Notification: Powered Patient Transport, All Other Powered Patient
Transport.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan Reed, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1526, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Regulatory Background

    Under section 513 of the FD&C Act (21 U.S.C. 360c), FDA classifies
devices into one of three regulatory classes: Class I, class II, or
class III. FDA classification of a device is determined by the amount
of regulation necessary to provide a reasonable assurance of safety and
effectiveness. Pursuant to section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and the implementing regulations, part 807 (21 CFR part 807),
persons who intend to market a new device are required to submit and
obtain clearance of a premarket notification (510(k)) containing
information that allows FDA to determine whether the new device is
``substantially equivalent'' within the meaning of section 513(i) of
the FD&C Act to a legally marketed device that does not require
premarket approval.
    On November 21, 1997, section 206 of the Food and Drug
Administration Modernization Act (Pub. L. 105-115) added new section
510(m) to the FD&C Act. On December 13, 2016, section 3054 of the 21st
Century Cures Act (Pub. L. 114-255) (Cures Act) amended section 510(m)
of the FD&C Act. As amended, section 510(m)(1) of the FD&C Act requires
FDA, within 90 days after enactment of the Cures Act and once every 5
years thereafter, to publish in the Federal Register a list of each
type of class II device that does not require a report under section
510(k) of the FD&C Act to provide reasonable assurance of safety and
effectiveness.
    As amended by the Cures Act, section 510(m)(2) of the FD&C Act
provides that, 1 calendar day after the date of publication of the
final list mentioned in section 510(m)(1)(B), FDA may exempt a class II
device from the requirement to submit a report under section 510(k) of
the FD&C Act, upon its own initiative or receipt of a petition from an
interested person, if FDA determines that a report under section 510(k)
is not necessary to assure the safety and effectiveness of the device.
To do so, FDA must publish in the Federal Register notice of its intent
to exempt the device, or the petition, and provide a 60-calendar day
period for public comment. Within 120 days after the issuance of this
notice, FDA must publish an order in the Federal Register that sets
forth its final determination regarding the exemption of the device
that was the subject of the notice. If FDA fails to respond to a
petition under this section within 180 days of receiving it, the
petition shall be deemed granted.
    The generic device type, powered patient transport is classified
under Sec.  890.5150 (21 CFR 890.5150). On March 4, 2013, in response
to a petition, FDA created a separate classification for powered
patient stairway chair lifts (Sec.  890.5150(a)), providing a
conditional exemption from premarket notification for this device type,
product code PCD (78 FR 14015). The classification change retained
premarket notification requirements for all other powered patient
transport, product code ILK (Sec.  890.5150(b)).

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the Agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff'' (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance6Documents/UCM080199.pdf).
    As discussed in the guidance document, FDA generally considers the
following factors to determine whether a report under section 510(k) is
necessary for class II devices: (1) The device does not have a
significant history of false or misleading claims or of risks
associated with inherent characteristics of the device; (2)
characteristics of the device necessary for its safe and effective
performance are well established; (3) changes in the device that could
affect safety and effectiveness will either (a) be readily detectable
by users by visual examination or other means such as routine testing,
before causing harm or (b) not materially increase the risk of injury,
incorrect diagnosis, or ineffective

treatment; and (4) any changes to the device would not be likely to
result in a change in the device's classification. FDA may also
consider that, even when exempting devices, these devices would still
be subject to the general limitations on exemptions.

III. Proposed Class II Device Exemptions

    FDA has received the following petition requesting an exemption
from premarket notification for a class II device: Sam DeMarco, Staff
Regulatory Affairs Specialist, on behalf of Stryker Medical, 3800 E
Centre Ave., Portage, MI 49002, for powered patient transport, all
other powered patient transport, classified under Sec.  890.5150(b).
FDA seeks comment on the petition in accordance with section 510(m)(2)
of the FD&C Act.

IV. Paperwork Reduction Act of 1995

    While this notice contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this notice. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in part 807, subpart E, regarding premarket notification
submissions, have been approved under OMB control number 0910-0120.

    Dated: June 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12505 Filed 6-14-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22262-22264]
[FR Doc No: 2022-07953]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94653; File No. SR-MEMX-2022-07]

Self-Regulatory Organizations; MEMX LLC; Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change To Clarify the
Information Disseminated in the MEMOIR Top Data Feed

April 8, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the

``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 1, 2022, MEMX LLC (``MEMX'' 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 Exchange. The Exchange filed the
proposal as a ``non-controversial'' proposed rule change pursuant to
Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6)
thereunder.\4\ The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing with the Commission a proposed rule change
to amend Rule 13.8(b) to clarify what information is disseminated in
the MEMOIR Top data feed. The text of the proposed rule change is
provided in Exhibit 5.

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 Rule 13.8(b) to clarify what
information is disseminated in the MEMOIR Top data feed. The Exchange
does not propose any changes to the information that is disseminated in
the MEMOIR Top data feed, or any changes to the Exchange's System
functionality, order handling, or operation, in this filing. Instead,
this proposed change merely corrects an inadvertent drafting error
contained in the Exchange's initial Rules in order to clarify what
information is disseminated in the MEMOIR Top data feed today.
Specifically, the Exchange's Rule 13.8(b) currently states that MEMOIR
Top is an uncompressed data feed that offers top of book quotations and
execution information based on equity orders entered into the System,
however, the information actually published through MEMOIR Top is
limited to top of book quotations. Accordingly, the Exchange proposes
to eliminate the reference to execution information from Rule 13.8(b).
The proposed change is therefore intended to add clarity and promote
transparency around the Exchange's current operation and Rules for the
benefit of its Users and all market participants.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\5\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\6\ 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 mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
As described above, the Exchange simply proposes to eliminate the
reference to execution information from Rule 13.8(b) to correct an
inadvertent drafting error contained in the Exchange's initial Rules
and clarify what information is disseminated in the MEMOIR Top data
feed today. Accordingly, the Exchange believes the proposed change is
consistent with the Act because it is intended to add clarity and
promote transparency around the Exchange's current operation and Rules,
which would help to avoid confusion for the benefit of its Users and
all market participants.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposal would impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. Rather, the proposed change
would add clarity and promote transparency around the Exchange's
current operation and its Rules for the benefit of its Users and all
market participants, as described above. No changes to the Exchange's
System functionality, order handling, or operation are contemplated by
these proposed changes, which would merely clarify the Exchange's
current operation and its Rules. As such, the proposal does not address
competitive issues but is concerned solely with the administration of
the Exchange and its Rules. Accordingly, as the Exchange is not
proposing any changes to the Exchange's System functionality, order
handling, or operation, the Exchange does not believe the proposed rule
change could have any impact on competition (intermarket or
intramarket).

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6) \8\ thereunder.
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4.
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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 change 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 protected]. Please include
File Number SR-MEMX-2022-07 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-MEMX-2022-07. 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-MEMX-2022-07 and should be submitted on
or before May 5, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2022-07953 Filed 4-13-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Notices]
[Pages 7863-7864]
[FR Doc No: 2021-02153]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14635-001]

Village of Gouverneur, New York; Notice of Settlement Agreement

    Take notice that the following settlement agreement has been filed
with the Commission and is available for public inspection.
    a. Type of Application: Settlement Agreement.
    b. Project No.: 14635-001.
    c. Date Filed: January 13, 2021.
    d. Applicant: Village of Gouverneur, New York (Village of
Gouverneur).
    e. Name of Project: Gouverneur Hydroelectric Project (Project).
    f. Location: On the Oswegatchie River, in the Village of
Gouverneur, St. Lawrence County, New York. The project does not occupy
any federal land.
    g. Filed Pursuant to: Rule 602 of the Commission's Rules of
Practice and Procedure, 18 CFR 385.602.
    h. Applicant Contact: Ronald P. McDougall, Mayor, Village of

Gouverneur, 33 Clinton Street, Gouverneur, NY 13642;<PHONE_NUMBER>;
<EMAIL_ADDRESS>    i. FERC Contact: Jody Callihan,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments: Comments on the Settlement
Agreement are due on Tuesday, February 16, 2021. Reply comments are due
on Friday, February 26, 2021.
    The Commission strongly encourages electronic filing. Please file
comments 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_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY).
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. Village of Gouverneur filed an Offer of Settlement (Settlement
Agreement) on behalf of itself, the New York State Department of
Environmental Conservation, and the U.S. Fish and Wildlife Service. The
Settlement Agreement includes protection, mitigation, and enhancement
measures addressing project operation, minimum flows, downstream fish
passage and protection, recreation enhancements, and by reference,
management plans for invasive species (Appendix A) and northern long-
eared bat and bald eagles (Appendix B), as well as an impoundment
drawdown and cofferdam plan (Appendix C). Village of Gouverneur
requests that the measures in the Settlement Agreement be incorporated
as license conditions, without modification, in any original license
issued for the project. The signatories to the Settlement Agreement
also request a 40-year license term for the project.
    l. A copy of the Settlement Agreement is available for review on
the Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number, excluding the last three digits, in the
docket number field to access the document. For assistance, contact
FERC Online Support.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: January 27, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-02153 Filed 2-1-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 203 (Friday, October 19, 2012)]
[Notices]
[Pages 64374-64375]
[FR Doc No: 2012-25784]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2007-0030]

Petition for Waiver of Compliance

    In accordance with Parts 240 and 242 of Title 49 Code of Federal
Regulations (CFR), this document provides the public notice that by a
document dated August 23, 2012, the New Jersey Transit Corporation
(NJT) has petitioned the Federal Railroad Administration (FRA) for a
waiver of compliance from certain provisions of the Federal railroad
safety regulations contained at 49 CFR part 240-Qualification and
Certification of Locomotive Engineers and 49 CFR part 242-Qualification
and Certification of Conductors.
    NJT owns the Southern New Jersey Light Rail Transit (SNJLRT), a
commuter light rail transit system operating for a distance of
approximately 34 miles between the cities of Trenton and Camden, NJ. On
December 3, 1999, FRA granted NJT's petition for approval of Shared Use
and waiver of certain FRA regulations subject to certain exceptions and
conditions set forth in the letter granting the petition waiver.
    FRA also granted additional relief to NJT in a decision letter
dated January 28, 2004. Collectively, these decision letters are
referred to as the ``SNJLRT waiver.'' The SNJLRT system has been in
continuous revenue service since March 14, 2004, operating in
accordance with the strictures, relief requests, and FRA conditions
issued to date. Since the

effective date of the SNJLRT waiver, and the implementation of revenue
service, NJT has identified additional FRA regulations from which it
hereby seeks waivers.
    In the petition, NJT stated that it believes granting this waiver
is in the public interest and consistent with railroad safety for two
reasons. First, SNJLRT and the Consolidated Rail Corporation, the
freight carrier operating on certain portions of the same rail line as
SNJLRT, will continue to maintain a temporal separation plan between
light rail transit operations and freight rail operations. Second, NJT
and SNJLRT will be subject to comparable safety regulation through
equivalent State safety oversight required by the Federal Transit
Administration (FTA).
    NJT states that the SNJLRT System Safety Program Plan (SSPP) and
the System Security Plan have been implemented and administered in
accordance with the FTA's requirements found at 49 CFR part 659-Rail
Fixed Guideway Systems; State Safety Oversight and the New Jersey State
Safety Oversight Program. The State Oversight Program has been found to
be in compliance with FTA requirements at 49 CFR part 659.
    SSPP also requires NJT to conduct annual internal safety audits to
evaluate compliance with SSPP and measure its effectiveness. An annual
report identifying the audits performed and any corrective action must
be submitted to the New Jersey Department of Transportation (NJDOT) and
actions must be taken, as appropriate, to remedy any deficiencies
demonstrated by the audit. In addition, NJDOT conducts a safety review
a minimum of once every 3 years to evaluate the effectiveness of NJT's
implementation of its SSPP and outlines actions that must be taken, as
appropriate, to remedy and deficiencies demonstrated by the review.
    Pursuant to the SSPP, NJDOT is responsible for promulgating
standards and procedures requiring the reporting of accidents,
incidents, and hazardous conditions. SSPP outlines the circumstances
under which NJT and/or NJDOT conducts accident investigations;
articulates that the National Transportation Safety Board, FRA and FTA
can conduct accident investigations; and describes how SNJLRT
coordinates with these external agencies during an investigation. SSPP
requires SNJLRT to submit to the a corrective action plan to the NJDOT
State Safety Oversight Office that sets forth in detail the actions
SNJLRT will take to eliminate, minimize, or control the occurrence of
the accident, incident, or hazardous condition, including an
implementation schedule, where appropriate (SSPP, Section 10 and
Appendix J).
    For the reasons stated above, NJT explained their request is
consistent with the waiver process for Shared Use. See Statement of
Agency Policy Concerning Jurisdiction Over the Safety of Railroad
Passenger Operations and Waivers Related to Shared Use of the Tracks of
the General Railroad System by Light Rail and Conventional Equipment,
    65 FR 42529 (July 10, 2000); see also Joint Statement of Agency
Policy Concerning Shared Use of the Tracks of the General Railroad
System by Conventional Railroads and Light Rail Transit Systems, 65 FR
42626 (July 10, 2000).
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Avenue
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.
    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, 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:
     Web site: http://www.regulations.gov/. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by December 3, 2012 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to 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 comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78), or online at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on October 15, 2012.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2012-25784 Filed 10-18-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: May 13, 2008 (Volume 73, Number 93)]
[Notices]
[Page 27606-27607]
[DOCID:fr13my08-113]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice Before Waiver With Respect to Land at Lynchburg Regional
Airport, Lynchburg, VA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent of waiver with respect to land.

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SUMMARY: The FAA is publishing notice of proposed release of 0.02 acres
of land at the Lynchburg Regional Airport, Campbell County, Virginia to
the Virginia Department of Transportation for the Improvement of U.S.
Route 29. There are no impacts to the Airport and the land is not
needed for airport development as shown on the Airport Layout Plan.
Fair Market Value of the land will be paid to the Airport Sponsor, and
used for Airport purposes.

DATES: Comments must be received on or before June 12, 2008.

ADDRESSES: Comments on this application may be mailed or delivered in
triplicate to the FAA at the following address: Terry J. Page, Manager,
FAA Washington Airports District Office, 23723 Air Freight Lane, Suite
210, Dulles, VA 20166.

    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mark Courtney, Director, Lynchburg Regional
Airport, at the following address: Mark Courtney, A.A.E., Airport
Director, Lynchburg Regional Airport, 4308 Wards Road, Lynchburg,
Virginia 24502.

FOR FURTHER INFORMATION CONTACT: Mr. Terry Page, Manager, Washington
Airports District Office, 23723 Air Freight Lane, Suite 210, Dulles, VA
20166; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 5, 2000, new authorizing
legislation became effective. That bill, the Wendell H. Ford Aviation
Investment and Reform Act for the 21st Century, Public Law 10-181 (Apr.
5, 2000; 114 Stat. 61) (AIR 21) requires that a 30 day public notice
must be provided before the Secretary may waive any condition imposed
on an interest in surplus property.

Terry J. Page,
Manager, Washington Airports District Office, Eastern Region.
 [FR Doc. E8-10419 Filed 5-12-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)]
[Notices]
[Pages 43008-43009]
[FR Doc No: 2017-19461]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0440; FRL-9966-08]

Agency Information Collection Activities; Proposed Renewal of an
Existing Collection; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: ``Plant-Incorporated Protectants; CBI Substantiation
and Adverse Effects Reporting,'' and identified by EPA ICR No. 1693.09
and OMB Control No. 2070-0142, represents the renewal of an existing
ICR that is scheduled to expire on May 31, 2018. Before submitting the
ICR to OMB for review and approval, EPA is soliciting comments on
specific aspects of the proposed information collection that is
summarized in this document. The ICR and accompanying material are
available in the docket for public review and comment.

DATES: Comments must be received on or before November 13, 2017.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0440, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Ryne Yarger, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.

    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Plant-Incorporated Protectants; CBI Substantiation and
Adverse Effects Reporting.
    ICR number: EPA ICR No. 1693.09.
    OMB control number: OMB Control No. 2070-0142.
    ICR status: This ICR is currently scheduled to expire on May 31,
2018. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR addresses the two information collection
requirements described in regulations pertaining to pesticidal
substances that are produced by plants (plant-incorporated protectants)
and which are codified in 40 CFR part 174. A plant-incorporated
protectant (PIP) is defined as ``the pesticidal substance that is
intended to be produced and used in a living plant and the genetic
material necessary for the production of such a substance.'' Many, but
not all, PIPs are exempt from registration requirements under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Registrants sometimes include in a submission to EPA for registration
of PIPs information that they claim to be CBI. CBI is protected by
FIFRA and generally cannot be released to the public. For most
pesticide registration applications, the current CBI regulations at 40
CFR part 2 require that claimants substantiate their CBI claims for
their own records when the claim is made, and subsequently provide the
substantiation to EPA only if requested. However, under 40 CFR part
174, whenever a registrant claims that information submitted to EPA in
support of a PIP registration application contains CBI, the registrant
must substantiate such claims to EPA when they are made. In addition,
40 CFR part 174 also requires manufacturers of PIPs that are otherwise
exempted from registration requirements to report any adverse effects
of the PIP to the Agency within 30 days of when the information is
first obtained. Such reporting will allow the Agency to determine
whether further action is needed to prevent unreasonable adverse
effects to human health or the environment.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 21.5
hours per CBI substantiation and 7 hours per adverse effects reporting
response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by
this ICR include producers and importers of PIPs. The NAICS codes for
respondents under this ICR include: 325320 (Pesticide and other
Agricultural Chemical Manufacturing), 325414 (Biological Products
(except Diagnostic) Manufacturing), 422910 (Farm Supplies Wholesalers),
422930 (Flower, Nursery Stock, and Florist's Suppliers), 541710
(Research and Development in the Physical, Engineering, and Life
Sciences), and 611310 (Colleges, Universities, and Professional
Schools).
    Estimated total number of potential respondents: 24.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 518 hours.
    Estimated total annual costs: $41,892. There are no non-burden hour
paperwork costs, e.g., investment or maintenance and operational costs,
included in this information collection.

III. Are there changes in the estimates from the last approval?

    There is an increase of 86 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This increase reflects EPA's updating of burden estimates for this
collection based upon historical information on the number of CBI
substantiations per year. Based upon revised estimates, the number of
CBI substantiations per year has increased from 20 to 24, with a
corresponding increase in the associated burden. This change is an
adjustment.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: August 17, 2017.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2017-19461 Filed 9-12-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58109-58110]
[FR Doc No: 2022-20710]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0316]

Roy Tuccillo, Sr.: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Roy
Tuccillo, Sr. for a period of 5 years from importing articles of food
or offering such articles for importation into the United States. FDA
bases this order on a finding that Mr. Tuccillo was convicted of a
felony count under Federal law for conduct relating to the importation
into the United States of an article of food. Mr. Tuccillo was given
notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of July 17,
2022 (30 days after receipt of the notice), Mr. Tuccillo has not
responded. Mr. Tuccillo's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this matter.

DATES: This order is applicable September 23, 2022.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a felony for conduct relating to the
importation into the United States of any food.
    On November 9, 2021, Mr. Tuccillo was convicted as defined in
section 306(l)(1)(A) of the FD&C Act, in the U.S. District Court for
the Eastern District of New York, when the court accepted his plea of
guilty and entered judgment against him for the offense of conspiracy
to commit wire fraud in violation of 18 U.S.C. 371 and 1343.
    FDA's finding that the debarment is appropriate is based on the
felony conviction referenced herein. The factual basis for this
conviction is as follows: as stated in the indictment, filed September
26, 2018, transcript of guilty pleas, filed December 26, 2019, and
Magistrate Judge Steven Locke's report and recommendation, filed May
10, 2020, all from Mr. Tuccillo's case, Mr. Tuccillo was the owner,
president, and chief operating officer of Anchor Foods, Inc. and
Advanced Frozen Foods, Inc. (collectively, ``Anchor Foods''), and had
overall responsibility

for the operation of both businesses and their employees. Both Anchor
Foods companies were located in Westbury, New York.
    From on or about February 2011 and continuing through January 2014,
Mr. Tuccillo knowingly and willfully conspired with Anchor Foods, Roy
Tuccillo, Jr., and others to import giant squid from Peru to Mr.
Tuccillo's companies' location in Westbury, New York and repackage and
sell that squid falsely labeled and identified as ``octopus.'' Mr.
Tuccillo sold the falsely labeled squid in interstate commerce to
grocery stores in New Jersey, Texas, and Massachusetts. Mr. Tuccillo
used email and fax to sell and receive payments for the squid falsely
labeled as octopus. In total, Mr. Tuccillo's companies made
$1,128,388.50 worth of fraudulent sales of squid.
    As a result of this conviction, FDA sent Mr. Tuccillo, by certified
mail on June 6, 2022, a notice proposing to debar him for a period of 5
years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Tuccillo's felony
conviction of conspiracy to commit wire fraud in violation of 18 U.S.C.
371 and 1343, constitutes conduct relating to the importation into the
United States of an article of food because Mr. Tuccillo knowingly and
willfully conspired with Anchor Foods, Roy Tuccillo, Jr., and others to
import giant squid from Peru to his companies' location in Westbury,
New York and repackage and sell that squid falsely labeled and
identified as ``octopus'' in interstate commerce, using email and fax
to sell and receive payments for the falsely labeled squid. The
proposal was also based on a determination, after consideration of the
relevant factors set forth in section 306(c)(3) of the FD&C Act (21
U.S.C. 335a(c)(3)), that Mr. Tuccillo should be subject to a 5-year
period of debarment. The proposal also offered Mr. Tuccillo an
opportunity to request a hearing, providing him 30 days from the date
of receipt of the letter in which to file the request, and advised him
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Mr. Tuccillo failed to respond within the timeframe prescribed
by regulation and has, therefore, waived his opportunity for a hearing
and waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Tuccillo has been convicted of a felony count under Federal law for
conduct relating to the importation into the United States of an
article of food and that he is subject to a 5-year period of debarment.
    As a result of the foregoing finding, Mr. Tuccillo is debarred for
a period of 5 years from importing articles of food or offering such
articles for import into the United States, applicable (see DATES).
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Roy
Tuccillo, Sr., is a prohibited act.
    Any application by Mr. Tuccillo for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2022-N-0316 and sent to the Dockets Management Staff (ADDRESSES).
The public availability of information in these submissions is governed
by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20710 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Page 76409]
[FR Doc No: 2016-26433]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2016-106]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before November 14, 2016.

ADDRESSES: Send comments identified by docket number FAA-2016-9152
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Nancy Lauck Claussen, Air Transportation Division,
AFS-200, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on October 24, 2016.
Dale Bouffiou,
Deputy Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2016-9152.
    Section(s) of 14 CFR Affected: 14 CFR 121.153(a)(2) and 121.311
(a), (b) and (j).
    Description of Relief Sought: The petitioner requests relief to the
extent required for an individual to use an Orthotic Positioning Device
(OPD) during all phases of flight while aboard a United States-
registered aircraft in an aircraft seat with an inflatable seat belt
while the inflatable seat belt is deactivated. Due to physical
challenges, without an exemption, this individual would be unable to
fly in a way that accommodates his disability. This exemption would
also provide this individual an equivalent level of safety to that of
other passengers because a deactivated inflatable seat belt used as the
primary method of restraint, in conjunction with the internal 5-point
harness in an OPD, would provide an equivalent level of safety to that
of the affected regulations regarding forward occupant excursion.

[FR Doc. 2016-26433 Filed 11-1-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 38 (Tuesday, February 26, 2019)]
[Notices]
[Pages 6183-6184]
[FR Doc No: 2019-03311]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 33379; 812-14881]

Monteagle Funds and Nashville Capital Corporation

February 21, 2019.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements in rule 20a-1 under the Act, Item 19(a)(3) of
Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of
Schedule 14A under the Securities Exchange Act of 1934, and sections 6-
07(2)(a), (b), and (c) of Regulation S-X (``Disclosure Requirements'').
The requested

exemption would permit an investment adviser to hire and replace
certain subadvisers without shareholder approval and grant relief from
the Disclosure Requirements as they relate to fees paid to the
subadvisers.
    Applicants: Monteagle Funds (the ``Trust''), a Delaware statutory
trust registered under the Act as an open-end management investment
company, and Nashville Capital Corporation (the ``Adviser''), a
Tennessee corporation registered as an investment adviser under the
Investment Advisers Act of 1940 (collectively with the Trust, the
``Applicants'').
    Filing Dates: The application was filed on February 27, 2018 and
amended on June 11, 2018, October 23, 2018, and December 21, 2018.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail.
    Hearing requests should be received by the Commission by 5:30 p.m.
on March 18, 2019, and should be accompanied by proof of service on the
Applicants, in the form of an affidavit or, for lawyers, a certificate
of service. Pursuant to rule 0-5 under the Act, hearing requests should
state the nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549-1090. Applicants: Monteagle Funds, 8000
Town Centre Drive, Suite 400, Broadview Heights, OH 44147; Nashville
Capital Corporation, 2506 Winford Avenue, Nashville, TN 37211.

FOR FURTHER INFORMATION CONTACT: Zeena Abdul-Rahman, Senior Counsel, at
(202) 551-4099, or Andrea Ottomanelli Magovern, Branch Chief, at (202)
551-6821 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Summary of the Application

    1. The Adviser will serve as the investment adviser to the Funds
pursuant to an investment advisory agreement with the Trust (the
``Advisory Agreement'').\1\ The Adviser will provide each Fund with
overall investment management services and will continuously review,
supervise and administer each Fund's investment program, subject to the
supervision of, and policies established by, each Fund's board of
trustees (``Board''). The Advisory Agreement permits the Adviser,
subject to the approval of the Board, to delegate to one or more
subadvisers (each, a ``Subadviser'' and collectively, the
``Subadvisers'') the responsibility to provide the day-to-day portfolio
investment management of each Fund, subject to the supervision and
direction of the Adviser.\2\ The primary responsibility for managing
the Funds will remain vested in the Adviser. The Adviser will hire,
evaluate, allocate assets to and oversee the Subadvisers, including
determining whether a Subadviser should be terminated, at all times
subject to the authority of the Board.
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    \1\ Applicants request relief with respect to any existing or
future series of the Trust or any other registered open-end
management company that: (a) Is advised by the Adviser, or any
person controlling, controlled by or under common control with the
Adviser or its successors (each, an ``Adviser''); (b) uses the
manager of managers structure described in the application; and (c)
complies with the terms and conditions of the requested order (any
such series, a ``Fund'' and collectively, the ``Funds''). For
purposes of the requested order, ``successor'' is limited to an
entity that results from a reorganization into another jurisdiction
or a change in the type of business organization.
    \2\ The Trust currently has six series. The Adviser has hired a
Subadviser for each of these Funds in compliance with section 15(a)
of the Act.
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    2. Applicants request an exemption to permit the Adviser, subject
to Board approval, to hire certain Subadvisers pursuant to subadvisory
agreements and materially amend existing subadvisory agreements without
obtaining the shareholder approval required under section 15(a) of the
Act and rule 18f-2 under the Act.\3\ Applicants also seek an exemption
from the Disclosure Requirements to permit a Fund to disclose (as both
a dollar amount and a percentage of the Fund's net assets): (a) The
aggregate fees paid to the Adviser and any Affiliated Subadviser; and
(b) the aggregate fees paid to Subadvisers other than Affiliated
Subadvisers. For any Fund that employs an Affiliated Subadviser, the
Fund will provide separate disclosure of any fees paid to the
Affiliated Subadviser.
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    \3\ The requested relief will not extend to any Subadviser that
is an affiliated person, as defined in section 2(a)(3) of the Act,
of the Trust, a Fund, or the Adviser, other than solely by reason of
serving as a Subadviser to one or more of the Funds, or as an
adviser or subadviser to any series of the Trust other than the
Funds (``Affiliated Subadviser'').
---------------------------------------------------------------------------

    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the application.
Such terms and conditions provide for, among other safeguards,
appropriate disclosure to Fund shareholders and notification about
subadvisory changes and enhanced Board oversight to protect the
interests of the Funds' shareholders.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
any rule thereunder, if such relief is necessary or appropriate in the
public interest and consistent with the protection of investors and
purposes fairly intended by the policy and provisions of the Act.
Applicants believe that the requested relief meets this standard
because, as further explained in the application, the Advisory
Agreements will remain subject to shareholder approval while the role
of the Subadvisers is substantially similar to that of individual
portfolio managers, so that requiring shareholder approval of
subadvisory agreements would impose unnecessary delays and expenses on
the Funds. Applicants believe that the requested relief from the
Disclosure Requirements meets this standard because it will improve the
Adviser's ability to negotiate fees paid to the Subadvisers that are
more advantageous for the Funds.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-03311 Filed 2-25-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Rules and Regulations]
[Pages 22416-22417]
[FR Doc No: 2013-08826]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Docket FAA No. FAA-2013-0283; Airspace Docket No. 13-AWP-3

Amendment of Class E Airspace; St. Helena, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; technical amendment.

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SUMMARY: This action changes the name of the heliport listed in the
Class E airspace for St. Helena, CA. St. Helena Fire Department
Heliport has been changed to Napa County Fire Department Heliport, St.
Helena, CA. This action does not change the boundaries of the airspace.

DATES: Effective date, 0901 UTC, June 27, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA's Aeronautical Products Office requested the change to the
airport name of Napa County Fire Department Heliport, St. Helena, CA.
    The Class E airspace designations are published in paragraph 6005,
of FAA Order 7400.9W, dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

The Rule

    The FAA amends Title 14 Code of Federal Regulations (14 CFR) Part
71 by changing the airport name described in Class E airspace extending
upward from 700 feet above the surface at St. Helena, CA, to Napa
County Fire Department Heliport, formerly St. Helena Fire Department
Heliport. Accordingly, since this is an administrative change and does
not involve a change in the dimensions or operation requirements of
that airspace, notice and public procedure under 5 U.S.C. 553 (b) are
unnecessary.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation; (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends

controlled airspace at Napa County Fire Department Heliport, St.
Helena, CA.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9W, Airspace Designations and Reporting
Points, dated August 8, 2012, and effective September 15, 2012, is
amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP CA E5 St. Helena, CA [Amended]

Napa County Fire Department Heliport, CA, Point In Space Coordinates
    (Lat. 38[deg]32'21'' N., long. 122[deg]29'35'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of the Point In Space Coordinates serving the
Napa County Fire Department Heliport.

    Issued in Seattle, Washington, on April 4, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-08826 Filed 4-15-13; 8:45 am]
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