[Federal Register Volume 77, Number 121 (Friday, June 22, 2012)]
[Notices]
[Pages 37718-37720]
[FR Doc No: 2012-15262]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30105; 812-13900]

Franklin Advisers, Inc. and Franklin Templeton International
Trust; Notice of Application

June 18, 2012.
AGENCY: Securities and Exchange Commission (the ``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940, as amended (the ``Act''), for an
exemption from section 15(a) of the Act and rule 18f-2 under the Act.

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Summary of Application: Applicants request an order that would permit
them to enter into and materially amend subadvisory agreements without
shareholder approval.

Applicants: Franklin Advisers, Inc. (the ``Manager'') and Franklin
Templeton International Trust (the ``Trust'').

DATES:  Filing Dates: The application was filed on May 4, 2011, and
amended on December 28, 2011, and May 3, 2012.

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 July 16, 2012, and should be accompanied by proof of service on
the applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, 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: Elizabeth M. Murphy, Secretary, U.S. Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants:
Franklin Advisers, Inc., One Franklin Parkway, San Mateo, California
94403-1906.

FOR FURTHER INFORMATION CONTACT: Barbara T. Heussler, Senior Attorney,
at<PHONE_NUMBER>, or Janet M. Grossnickle, Assistant Director, at
(202) 551-6821 (Division of Investment Management, Office of Investment
Company Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site 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>.

Applicants' Representations

    1. The Trust, a Delaware statutory trust, is registered under the
Act as an open-end management investment company that offers series of
shares (each a ``Series''), each with their own distinct investment
objectives, policies and restrictions.\1\ Franklin Advisers, Inc., a
direct, wholly-owned subsidiary of Franklin Resources, is a California
corporation registered with the Commission as an investment adviser
under the Investment Advisers Act of 1940 (the ``Advisers Act'') and
serves as investment manager to each Series pursuant to an investment
advisory agreement with the Trust (each an ``Investment Advisory
Agreement'' and together the ``Investment Advisory Agreements''). Any
future Manager also will be registered with the Commission as an
investment adviser under the Advisers Act. Franklin Resources is a
global investment management organization operating as Franklin
Templeton Investments and is engaged primarily, through various
subsidiaries, in providing investment management, share distribution,
transfer agent and administrative services to a family of registered
funds. Each Investment Advisory Agreement has been or will be approved
by the Trust's board of trustees (the ``Board''),\2\ including a
majority of the trustees who are not ``interested persons,'' as defined
in section 2(a)(19) of the Act, of the Trust or the Adviser (the
``Independent Board Members''), and by the shareholders of the relevant
Subadvised Fund in the manner required by sections 15(a) and 15(c) of
the Act and rule 18f-2 thereunder.\3\
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    \1\ Applicants request that the relief apply to the Applicants,
as well as to any existing or future series of the Trust and any
other existing or future registered open-end management investment
company or series thereof that: (a) Is advised by the Manager or
another registered investment adviser or their successors that now
or in the future is directly or indirectly wholly owned by Franklin
Resources or its successors (included in the term ``Manager''); (b)
uses the multi-manager structure described in the application (the
``Multi-Manager Structure''); and (c) complies with the terms and
conditions of the application (each a ``Subadvised Fund'' and
collectively, the ``Subadvised Funds''). For the 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. The only existing registered open-end
investment company that currently intends to rely on the requested
order is named as an Applicant. Each Series that is or currently
intends to be a Subadvised Fund and each Wholly-Owned Sub-Adviser to
a Subadvised Fund that currently intends to rely on the requested
order is identified in this application.
    \2\ The term ``Board'' also includes the board of trustees or
directors of a future Subadvised Fund.
    \3\ Franklin Advisers, Inc. and other Managers will enter into
investment advisory agreements with respect to future Subadvised
Funds (any such agreement include in the term ``Investment Advisory
Agreements'').
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    2. Under the terms of each Investment Advisory Agreement, the
Manager, subject to oversight of the Board, furnishes a continuous
investment program for each Series. The Manager periodically reviews
each Series'

investment policies and strategies and based on the need of a
particular Series may recommend changes to the investment policies and
strategies of the Series for consideration by its Board. For its
services to each Series, the Manager receives an investment advisory
fee from that Series as specified in the applicable Investment Advisory
Agreement.
    3. The terms of each Subadvised Fund's Investment Advisory
Agreement permit the Manager, subject to the approval of the Board,
including a majority of the Independent Board Members, and the
shareholders of the applicable Subadvised Fund (if required by
applicable law), to delegate portfolio management responsibilities of
all or a portion of the assets of the Subadvised Fund to sub-advisers
that are directly or indirectly wholly-owned, as defined in section
2(a)(43) of the Act, by Franklin Resources (each, a ``Wholly-Owned Sub-
Adviser'') pursuant to an investment sub-advisory agreement (each, a
``Sub-Advisory Agreement'').\4\ The Manager has overall responsibility
for the management and investment of the assets of each Series, and
with respect to each Subadvised Fund, the Manager's responsibilities
include, recommending the removal or replacement of Wholly-Owned Sub-
Advisers, and determining the portion of that Subadvised Fund's assets
to be managed by any given Wholly-Owned Sub-Adviser and reallocating
those assets as necessary from time to time.\5\ Each existing Sub-
Advisory Agreement was approved by the Board, including a majority of
the Independent Board Members and the shareholders of the applicable
Subadvised Fund, in accordance with sections 15(a) and 15(c) under the
Act and rule 18f-2 thereunder. The terms of each Sub-Advisory Agreement
comply fully with the requirements of section 15(a) of the Act. The
Wholly-Owned Sub-Advisers, subject to the supervision of the Manager
and oversight of the Board, determine the securities and other
instruments to be purchased, sold or entered into by a Subadvised
Fund's portfolio and place orders with brokers or dealers that they
select. The Manager is responsible for paying subadvisory fees to each
Wholly-Owned Sub-Adviser out of the fee paid to the Manager under the
relevant Investment Advisory Agreement.
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    \4\ The Manager has entered into Sub-Advisory Agreements with
multiple Wholly-Owned Sub-Advisers to serve as sub-advisers to
Franklin World Perspectives Fund and Franklin Templeton Global
Allocation Fund.
    \5\ If the name of any Subadvised Fund contains the name of a
Wholly-Owned Sub-Adviser, the name of the Manager that serves as the
primary adviser to the Subadvised Fund, or a trademark or trade name
owned by that Manager, will precede the name of the Wholly-Owned
Sub-Adviser.
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    4. Applicants request an order to permit the Manager, subject to
the approval of the Board, including a majority of the Independent
Board Members, to take certain actions without obtaining shareholder
approval: (i) Select Wholly-Owned Sub-Advisers to manage all or a
portion of the assets of one or more of the Series pursuant to a Sub-
Advisory Agreement; and (ii) materially amend Sub-Advisory Agreements
with the Wholly-Owned Sub-Advisers.\6\
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    \6\ The requested relief set forth in the Application will not
extend to sub-advisers other than Wholly-Owned Sub-Advisers.
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Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that it is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by the vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of securities in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. 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
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that the relief sought with respect to Wholly-
Owned Sub-Advisers would be appropriate in the public interest and
consistent with the protection of investors and the purposes fairly
intended by the policy and provisions of the Act.
    3. Applicants assert that the shareholders expect the Manager,
subject to the review and approval of the Board, to select the Wholly-
Owned Sub-Advisers who are best suited to achieve the Subadvised Fund's
investment objective. Applicants assert that, from the perspective of
the shareholder, the role of the Wholly-Owned Sub-Adviser is
substantially equivalent to the role of the individual portfolio
managers employed by an investment adviser to a traditional investment
company. Applicants state that requiring shareholder approval of each
Sub-Advisory Agreement would impose unnecessary delays and expenses on
the Subadvised Funds and may preclude the Manager from acting promptly
in a manner considered advisable by the Board. Applicants note that the
Investment Advisory Agreement for each Subadvised Fund and sub-advisory
agreements with sub-advisers other than Wholly-Owned Sub-Advisers, if
any, will continue to be subject to the shareholder approval
requirement of section 15(a) of the Act and rule 18f-2 thereunder the
Act.
    4. Subadvised Funds will inform shareholders of the hiring of a new
Wholly-Owned Sub-Adviser pursuant to the following procedures
(``Modified Notice and Access Procedures''): (a) Within 90 days after a
new Wholly-Owned Sub-Adviser is hired for any Subadvised Fund, that
Subadvised Fund will send its shareholders either a Multi-manager
Notice or a Multi-manager Notice and Multi-manager Information
Statement; \7\ and (b) the Subadvised Fund will make the Multi-manager
Information Statement available on the Web site identified in the
Multi-manager Notice no later than when the Multi-manager Notice (or
Multi-manager Notice and Multi-manager Information Statement) is first
sent to shareholders, and will maintain it on that Web site for at
least 90 days. In the circumstances described in this Application, a
proxy solicitation to approve the appointment of new Wholly-Owned Sub-
Advisers provides no more meaningful information to shareholders than
the proposed Multi-manager Information Statement. Moreover, as
indicated above, the Board would comply with the requirements of
Sections 15(a) and 15(c) of the Act before entering into or amending
Sub-Advisory Agreements.
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    \7\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Securities
Exchange Act of 1934 (``Exchange Act''), and specifically will,
among other things: (a) Summarize the relevant information regarding
the new Wholly-Owned Sub-Adviser; (b) inform shareholders that the
Multi-manager Information Statement is available on a Web site; (c)
provide the Web site address; (d) state the time period during which
the Multi-manager Information Statement will remain available on
that Web site; (e) provide instructions for accessing and printing
the Multi-manager Information Statement; and (f) instruct the
shareholder that a paper or email copy of the Multi-manager
Information Statement may be obtained, without charge, by contacting
the Subadvised Funds.
    A ``Multi-manager Information Statement'' will meet the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the Exchange Act for an information statement. Multi-
manager Information Statements will be filed electronically with the
Commission via the EDGAR system.

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Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Subadvised Fund may rely on the requested order, the
operation of the Subadvised Fund in the manner described in the
application, will be approved by a majority of the Subadvised Fund's
outstanding voting securities, as defined in the Act, or in the case of
a Subadvised Fund whose public shareholders purchase shares on the
basis of a prospectus containing the disclosure contemplated by
condition 2 below, by the initial shareholder before such Subadvised
Fund's shares are offered to the public.
    2. The prospectus for each Subadvised Fund will disclose the
existence, substance, and effect of any order granted pursuant to the
application. In addition, each Subadvised Fund will hold itself out to
the public as employing the Multi-Manager Structure described in the
application. The prospectus will prominently disclose that the Manager
has the ultimate responsibility, subject to oversight by the Board, to
oversee the Wholly-Owned Sub-Advisers and recommend their hiring,
termination, and replacement.
    3. Subadvised Funds will inform shareholders of the hiring of a new
Wholly-Owned Sub-Adviser within 90 days after the hiring of the new
Wholly-Owned Sub-Adviser pursuant to the Modified Notice and Access
Procedures.
    4. The Manager will not enter into a Sub-Advisory Agreement with
any sub-adviser that is not a Wholly-Owned Sub-Adviser without that
agreement, including the compensation to be paid thereunder, being
approved by the shareholders of the applicable Subadvised Fund.
    5. At all times, at least a majority of the Board will be
Independent Members, and the nomination of new or additional
Independent Board Members will be placed within the discretion of the
then-existing Independent Board Members.
    6. Whenever a sub-adviser change is proposed for a Subadvised Fund,
the applicable Board, including a majority of the Independent Board
Members, will make a separate finding, reflected in the applicable
Board minutes, that such change is in the best interests of the
Subadvised Fund and its shareholders, and does not involve a conflict
of interest from which the Manager or any sub-adviser that is an
affiliated person of the Manager derives an inappropriate advantage.
    7. The Manager will provide general management services to each
Subadvised Fund, including overall supervisory responsibility for the
general management and investment of each Subadvised Fund's assets and,
subject to review and approval of the Board, will: (a) Set each
Subadvised Fund's overall investment strategies; (b) evaluate, select
and recommend Wholly-Owned Sub-Advisers to manage all or a portion of
each Subadvised Fund's assets; (c) allocate and, when appropriate,
reallocate each Subadvised Fund's assets among Wholly-Owned Sub-
Advisers; (d) monitor and evaluate the Wholly-Owned Sub-Advisers'
performance; and (e) implement procedures reasonably designed to ensure
that the Wholly-Owned Sub-Advisers comply with each Subadvised Fund's
investment objective, policies and restrictions.
    8. No trustee or officer of the Trust or a Subadvised Fund, or
director or officer of the Manager will own directly or indirectly
(other than through a pooled investment vehicle that is not controlled
by such person), any interest in a sub-adviser to a Subadvised Fund
except for ownership of interests in the Manager or any entity, except
a Wholly-Owned Sub-Adviser, that controls, is controlled by, or is
under common control with the Manager.
    9. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the application, the requested order will expire on the effective
date of that rule.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-15262 Filed 6-21-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 137 (Wednesday, July 19, 2023)]
[Notices]
[Pages 46150-46151]
[FR Doc No: 2023-15313]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15309-000]

Nature and People First Arizona PHS, LLC; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

    On May 2, 2023, Nature and People First Arizona PHS, LLC, filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Chuska Mountain North Pumped Storage Project to be located in Apache
County, Arizona, near the San Juan River, approximately 1.6 miles north
of the town of Lukachukai on Navajo Nation Lands. The sole purpose of a
preliminary permit 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 pumped storage hydropower project will consist of: (1) a new
upper reservoir with a surface area of 4,800 acres and a storage volume
of 400,000 acre-feet at a maximum water-surface elevation of 8,810 feet
mean sea level; (2) a new lower reservoir with a surface area of 5,400
acres and a storage volume of 400,000 acre-feet at a maximum water-
surface elevation of 5,910 MSL; (3) a 60-foot-wide, 1,200-foot-long and
100-foot-high subterranean powerhouse with twelve pump/turbines rated
at 250 megawatts; (4) a 40-foot wide and 33,000-foot-long conduit to
the powerhouse; (5) 12-foot-wide, 1,000-foot-long powerhouse lower
conduit; and (6) approximately 50 miles of 550-kilovolt transmission
line for connection to existing lines. The estimated annual energy
production of the project would be approximately 6,570,000 megawatt-
hours.
    Applicant Contact: Mr. Denis Payre, Nature and People First Arizona
PHS, LLC, 405 Waltham St., Suite 145, Lexington, MA 02421; email:
[email protected]; phone:<PHONE_NUMBER>.
    FERC Contact: Shannon Archuleta; email; [email protected];
phone<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members, and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with filings such as interventions,
comments, or requests for rehearing, the public is encouraged to
contact OPP at<PHONE_NUMBER> or [email protected]. Comments, motions to
intervene, competing applications (without notices of intent), or
notices of intent to file competing applications should be submitted
within 60 days from the issuance of this notice. Competing applications
and notices of intent must meet the requirements of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief
comments up to 6,000 characters without prior registration using the
eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You
must include your name and contact information at the end of your
comments. For assistance, please get in touch with FERC Online Support
at [email protected],<PHONE_NUMBER> (toll-free), or (202)
502-8659 (TTY). Instead of electronic filing, you may submit a paper
copy. Submissions sent via the U.S. Postal Service must be addressed
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent
via any other carrier must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue,
Rockville, Maryland 20852. The first page of any filing should include
docket number P-15309-000.
    More information about this project, including a copy of the
application, can be viewed on the Commission's website (http://www.ferc.gov) using the ``eLibrary'' link. Enter the docket number (P-
15309) in the docket number field to access the document. For
assistance, do not hesitate to get in touch with FERC Online Support.

    Dated: July 13, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-15313 Filed 7-18-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Notices]
[Page 72745]
[FR Doc No: 2023-23352]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER24-116-000]

Rhythm Ops, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Rhythm Ops, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 6, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: October 17, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-23352 Filed 10-20-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Page 39018]
[FR Doc No: 2021-15678]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9057-5]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed July 12, 2021 10 a.m. EST Through July 19, 2021 10 a.m. EST
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20210099, Draft Supplement, CHSRA, CA, California High-Speed
Rail San Francisco to San Jose Project Section Revised Draft
Environmental Impact Report/Supplemental Draft Environmental Impact
Statement, Comment Period Ends: 09/08/2021, Contact: Scott Rothenberg
916-403-6936.
EIS No. 20210100, Draft, FERC, LA, Evangeline Pass Expansion Project,
Comment Period Ends: 09/07/2021, Contact: Office of External Affairs
866-208-3372.

Amended Notice

EIS No. 20210051, Draft, USN, CA, Navy Old Town Campus Revitalization,
Comment Period Ends: 08/12/2021, Contact: Ron Bochenek<PHONE_NUMBER>.

    Revision to FR Notice Published 05/14/2021; Extending the Comment
Period from 07/13/2021 to 08/12/2021.

EIS No. 20210078, Draft, UDOT, UT, Little Cottonwood Canyon
Environmental Impact Statement Wasatch Boulevard to Alta, Comment
Period Ends: 09/03/2021, Contact: Josh Van Jura<PHONE_NUMBER>.

    Revision to FR Notice Published 06/25/2021; Extending the Comment
Period from 08/09/2021 to 09/03/2021.

    Dated: July 19, 2021.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2021-15678 Filed 7-22-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Rules and Regulations]
[Pages 57761-57764]
[FR Doc No: 2016-20292]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 31093; Amdt. No. 528]

IFR Altitudes; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule

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SUMMARY: This amendment adopts miscellaneous amendments to the required
IFR (instrument flight rules) altitudes and changeover points for
certain Federal airways, jet routes, or direct routes for which a
minimum or maximum en route authorized IFR altitude is prescribed. This
regulatory action is needed because of changes occurring in the
National Airspace System. These changes are designed to provide for the
safe and efficient use of the navigable airspace under instrument
conditions in the affected areas.

DATES: Effective Date: 0901 UTC, September 15, 2016.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham, Flight Procedure
Standards Branch (AMCAFS-420), Flight Technologies and Programs
Division, Flight Standards Service,

Federal Aviation Administration, Mike Monroney Aeronautical Center,
6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O.
Box 25082 Oklahoma City, OK 73125) telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal
Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR
altitudes governing the operation of all aircraft in flight over a
specified route or any portion of that route, as well as the changeover
points (COPs) for Federal airways, jet routes, or direct routes as
prescribed in part 95.

The Rule

    The specified IFR altitudes, when used in conjunction with the
prescribed changeover points for those routes, ensure navigation aid
coverage that is adequate for safe flight operations and free of
frequency interference. The reasons and circumstances that create the
need for this amendment involve matters of flight safety and
operational efficiency in the National Airspace System, are related to
published aeronautical charts that are essential to the user, and
provide for the safe and efficient use of the navigable airspace. In
addition, those various reasons or circumstances require making this
amendment effective before the next scheduled charting and publication
date of the flight information to assure its timely availability to the
user. The effective date of this amendment reflects those
considerations. In view of the close and immediate relationship between
these regulatory changes and safety in air commerce, I find that notice
and public procedure before adopting this amendment are impracticable
and contrary to the public interest and that good cause exists for
making the amendment effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 95

    Airspace, Navigation (air).

    Issued in Washington, DC on August 12, 2016.
John Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, part 95 of the Federal Aviation Regulations (14 CFR part
95) is amended as follows effective at 0901 UTC, July 21, 2016.

0
1. The authority citation for part 95 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44719, 44721.

0
2. Part 95 is amended to read as follows:

              Revisions to IFR Altitudes & Changeover Point
           [Amendment 528, Effective Date September 15, 2016]
------------------------------------------------------------------------
               From                           To                 MEA
------------------------------------------------------------------------
                    Sec.   95.6001 VICTOR ROUTES-U.S
     Sec.   95.6005 VOR Federal Airway V5 Is Amended To Read in Part
------------------------------------------------------------------------
Pecan, GA VORTAC.................  Vienna, GA VORTAC.......        *2000
    *1900-MOCA
------------------------------------------------------------------------
     Sec.   95.6006 VOR Federal Airway V6 Is Amended To Read in Part
------------------------------------------------------------------------
Liter, WY FIX....................  Sidney, NE VORTAC.......        *9500
    *7600--MOCA
Sidney, NE VORTAC................  North Platte, NE VORTAC.        *6000
    *5700-MOCA...................
Grand Island, NE.................  VORTAC HUSKR, NE FIX....        *4000
    *3200--MOCA..................
------------------------------------------------------------------------
     Sec.   95.6008 VOR Federal Airway V8 Is Amended To Read in Part
------------------------------------------------------------------------
Grand Island, NE VORTAC..........  Huskr, NE FIX...........        *4000
    *3200--MOCA..................
------------------------------------------------------------------------
    Sec.   95.6020 VOR Federal Airway V20 Is Amended To Read in Part
------------------------------------------------------------------------
Maddi, GA FIX....................  Athens, GA VOR/DME......        *3000
    *2200-MOCA...................
Athens, GA VOR/DME...............  Electric City, SC VORTAC        *2800
    *2300--MOCA..................
------------------------------------------------------------------------
    Sec.   95.6025 VOR Federal Airway V25 Is Amended To Read in Part
------------------------------------------------------------------------
Santy, CA FIX....................  Woodside, CA VORTAC.....         5100
------------------------------------------------------------------------
    Sec.   95.6035 VOR Federal Airway V35 Is Amended To Read in Part
------------------------------------------------------------------------
*Saler, GA FIX...................  Pecan, GA VORTAC........       **2000
    *3000-MRA....................
    **1700-MOCA..................

Maddi, GA FIX....................  Athens, GA VOR/DME......        *3000
    *2200-MOCA...................
Athens, GA VOR/DME...............  Electric City, SC VORTAC        *2800
    *2300-MOCA...................
------------------------------------------------------------------------
    Sec.   95.6039 VOR Federal Airway V39 Is Amended To Read in Part
------------------------------------------------------------------------
Lancaster, PA VORTAC.............  Boyer, PA FIX...........         2900
------------------------------------------------------------------------
    Sec.   95.6066 VOR Federal Airway V66 Is Amended To Read in Part
------------------------------------------------------------------------
Maddi, GA FIX....................  Athens, GA VOR/DME......        *3000
    *2200-MOCA...................
Athens, GA VOR/DME...............  Greenwood, SC VORTAC....        *2500
    *2200-MOCA...................
------------------------------------------------------------------------
    Sec.   95.6087 VOR Federal Airway V87 Is Amended To Read in Part
------------------------------------------------------------------------
Santy, CA FIX....................  Woodside, CA VORTAC.....         5100
------------------------------------------------------------------------
    Sec.   95.6109 VOR Federal Airway V109 Is Amended To Read in Part
------------------------------------------------------------------------
Salad, CA FIX....................  *Oakland, CA VORTAC.....         4000
    *4700-MCA....................  Oakland, CA VORTAC, NE
                                    BND.
------------------------------------------------------------------------
    Sec.   95.6138 VOR Federal Airway V138 Is Amended To Read in Part
------------------------------------------------------------------------
Piety, WY FIX....................  Sidney, NE VORTAC.......        *7600
    *7000-MOCA...................
Grand Island, NE VORTAC..........  Brady, NE FIX...........        *3600
    *3200-MOCA...................
------------------------------------------------------------------------
    Sec.   95.6159 VOR Federal Airway V159 Is Amended To Read in Part
------------------------------------------------------------------------
*Saler, GA FIX...................  Pecan, GA VORTAC........       **2000
    *3000-MRA....................
    **1700-MOCA..................
Pecan, GA VORTAC.................  *Shany, GA FIX..........       **2000
    *2800-MRA....................
    **1800-MOCA..................
------------------------------------------------------------------------
    Sec.   95.6169 VOR Federal Airway V169 Is Amended To Read in Part
------------------------------------------------------------------------
Akron, CO VOR/DME................  Sidney, NE VORTAC.......        *6400
    *6200-MOCA...................
------------------------------------------------------------------------
    Sec.   95.6197 VOR Federal Airway V197 Is Amended To Read in Part
------------------------------------------------------------------------
Palmdale, CA VORTAC..............  *Fisch, CA FIX..........         5000
    *8300-MCA....................  Fisch, CA FIX, NW BND...
------------------------------------------------------------------------
    Sec.   95.6325 VOR Federal Airway V325 Is Amended To Read in Part
------------------------------------------------------------------------
Vesto, GA FIX....................  Athens, GA VOR/DME......        *2500
    *2200-MOCA...................
------------------------------------------------------------------------
    Sec.   95.6380 VOR Federal Airway V380 Is Amended To Read in Part
------------------------------------------------------------------------
Wolbach, NE VORTAC...............  Grand Island, NE VORTAC.        *4000
    *3300-MOCA...................
------------------------------------------------------------------------
    Sec.   95.6417 VOR Federal Airway V417 Is Amended To Read in Part
------------------------------------------------------------------------
Athens, GA VOR/DME...............  Colliers, SC VORTAC.....        *2500
    *2100-MOCA...................
------------------------------------------------------------------------
    Sec.   95.6457 VOR Federal Airway V457 Is Amended To Read in Part
------------------------------------------------------------------------
Broadway, NJ VOR/DME.............  Lancaster, PA VORTAC....         3000
------------------------------------------------------------------------

    Sec.   95.6499 VOR Federal Airway V499 Is Amended To Read in Part
------------------------------------------------------------------------
Lancaster, PA VORTAC.............  Binghamton, NY VORTAC...         4500
------------------------------------------------------------------------
    Sec.   95.6578 VOR Federal Airway V578 Is Amended To Read in Part
------------------------------------------------------------------------
Pecan, GA VORTAC.................  Tift Myers, GA VOR......        *2500
    *2300-MOCA...................
------------------------------------------------------------------------
    Sec.   95.6579 VOR Federal Airway V579 Is Amended To Read in Part
------------------------------------------------------------------------
Viola, FL FIX....................  Sarasota, FL VORTAC.....        *3000
    *1600-MOCA...................
------------------------------------------------------------------------
Sec.   95.6440 Alaska VOR Federal Airway V440 Is Amended To Read in Part
------------------------------------------------------------------------
Nome, AK VOR/DME.................  *Golos, AK FIX..........         3000
    *4500-MRA....................
*Golos, AK FIX...................  Unalakleet, AK VOR/DME..         3000
    *4500-MRA....................
Unalakleet, AK VOR/DME...........  Yucon, AK FIX...........
    W BND 4600...................
    E BND 8000...................
------------------------------------------------------------------------

                                                                                Changeover points
                   From                                 To              ----------------------------------------
                                                                           Distance              From
----------------------------------------------------------------------------------------------------------------
Sec.   95.8003 VOR Federal Airway Changeover Point Airway Segment Alaska V440 Is Amended To Add Changeover Point
----------------------------------------------------------------------------------------------------------------
Nome, AK VOR/DME.........................  Unalakleet, AK VOR/DME......           45  Nome
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-20292 Filed 8-23-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Rules and Regulations]
[Pages 2042-2045]
[FR Doc No: 2022-00501]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2019-N-3101]
RIN 0910-AI10

Revised Procedures for the Announcement of Approvals and Denials
of Premarket Approval Applications and Humanitarian Device Exemption
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to amend the medical device regulations regarding
the procedures for the announcement of approvals and denials of
premarket approval applications (PMAs) and humanitarian device
exemption applications (HDEs). This final rule discontinues the
publication in the Federal Register after each quarter of a list of PMA
and HDE approvals and denials announced in that quarter. We will
continue to post approval and denial notices for PMAs and HDEs on FDA's
home page on the internet and will also continue to make available on
the internet and place on public display summaries of safety and
effectiveness data (SSED) for PMAs and summaries of safety and probable
benefit (SSPB) for HDEs. FDA is taking this action to improve the
efficiency of announcing approvals and denials of PMAs and HDEs and to
eliminate duplication in the current process for announcing this
information. We are also updating Agency contact information and
statutory references in certain sections of the PMA and HDE regulations
for purposes of accuracy, clarity, and consistency.

DATES: This rule is effective February 14, 2022.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.

FOR FURTHER INFORMATION CONTACT:
    For information concerning the final rule as it relates to devices
regulated by the Center for Biologics Evaluation and Research: Tami
Belouin, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    For information concerning the final rule as it relates to devices
regulated by the Center for Devices and Radiological Health: Joshua
Nipper, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2438, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation
    B. History of the Rulemaking
    C. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Specific Comments and FDA Response
    C. Comments Outside the Scope of This Rulemaking
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. Reference

I. Executive Summary

A. Purpose of the Final Rule

    FDA is amending its medical device regulations regarding the
procedures for the announcement of approvals and denials of PMAs and
HDEs to discontinue the quarterly publication in the Federal Register
of a list of approvals and denials of both PMAs and HDEs. FDA will
continue to post approval and denial notices for PMAs and HDEs on FDA's
home page on the internet (https://www.fda.gov) and will also continue
to make available on the internet and place on public display SSED for
PMAs and SSPB for HDEs. FDA is taking this action to improve the
efficiency of announcing approvals and denials of PMAs and HDEs and
eliminate duplication in the current process for announcing this
information. We are also updating Agency contact information and
statutory references in certain PMA and HDE regulations for purposes of
accuracy, clarity, and consistency.

B. Summary of the Major Provisions of the Final Rule

    FDA is amending its regulations regarding the announcement
procedures for the approval and denial of PMAs and HDEs. FDA is
discontinuing publishing in the Federal Register after each quarter a
list of PMA and HDE approvals and denials announced for that quarter.
We will continue to post approval and denial notices for PMAs and HDEs
on FDA's home page on the internet, and we will also continue to make
SSED for PMAs and SSPB for HDEs available on the internet and place
them on public display.

C. Legal Authority

    FDA is issuing this final rule under sections 515, 520(h), 520(m),
and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360e, 360j(h), 360j(m), and 371(a)).

D. Costs and Benefits

    The benefit of this final rule is that it will result in cost
savings to FDA from discontinuing publishing in the Federal Register,
on a quarterly basis, a list of medical device PMA and HDE approvals
and denials. Annualized over 10 years, the estimated benefits (i.e.,
cost savings) to FDA range from $0.008 million to $0.013 million at
both 3 and 7 percent discount rate, with a primary estimate of $0.010
million. We estimate that this final rule will result in no additional
costs to industry because the

rule will not require performance of any additional tasks and,
therefore, will not impose any additional regulatory burden on the
industry.

II. Background

A. Need for the Regulation

    FDA is amending its medical device regulations regarding the
procedures for the announcement of approvals and denials of PMAs and
HDEs to discontinue the quarterly publication in the Federal Register
of a list of approvals and denials of both PMAs and HDEs. FDA is taking
this action to improve the efficiency of announcing approvals and
denials of PMAs and HDEs and eliminate duplication in announcing this
information. The final rule allows FDA staff to focus on other Agency
priorities and utilize FDA staff resources more efficiently. FDA is
also revising Sec.  814.44(d)(2) (21 CFR 814.44(d)(2)) to be consistent
with Sec.  814.45(d)(2) (21 CFR 814.45(d)(2)), which states that
requests for copies of the current PMA approvals and denials document
and copies of SSED must be sent in writing to FDA's Freedom of
Information Staff. In addition, FDA is updating outdated references to
section 515(d)(3) of the FD&C Act in the PMA (Sec. Sec.  814.40 (21 CFR
814.40), 814.44, and 814.45) and HDE (Sec.  814.118 (21 CFR 814.118))
regulations.

B. History of the Rulemaking

    Section 515(d)(4) of the FD&C Act permits an interested person to
obtain review of an order approving a PMA in accordance with section
515(g) of the FD&C Act. The statute does not require the Agency to
publish the approval of a PMA in the Federal Register; however, FDA
issued in the Federal Register of July 22, 1986 (51 FR 26342) a final
rule that provided, among other things, that notice of approval of a
PMA, notice of an order denying approval of a PMA, and notice of an
order withdrawing approval of a PMA will be published in the Federal
Register. In the Federal Register of June 26, 1996 (61 FR 33232), FDA
issued a final rule prescribing, among other things, the procedures for
submitting HDEs, HDE amendments, and HDE supplements, and the criteria
for FDA review and approval of HDEs. Furthermore, the final rule of
June 26, 1996, provided that the notice of approval of an HDE be
published in the Federal Register in accordance with the rules and
policies applicable to PMAs submitted under 21 CFR 814.20. That final
rule also provided that, if FDA issues an order denying approval of an
HDE, FDA will comply with the same notice and disclosure provisions
required for PMAs under Sec.  814.45(b) and (d), as applicable.
    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
issued a final rule discontinuing the publication of individual PMA
approvals and denials in the Federal Register. The final rule provided
that FDA would notify the public of PMA approvals and denials by
posting them on FDA's home page on the internet, by making available on
the internet and placing on public display SSED, and by publishing in
the Federal Register after each quarter a list of the PMA approvals and
denials announced in that quarter. FDA stated that it believed that
this procedure would expedite public notification of these actions
because announcements could be placed on the internet more quickly than
they could be published in the Federal Register, and FDA believed that
the internet would be accessible to more people than the Federal
Register.
    In the Federal Register of December 17, 2019 (84 FR 68829), FDA
published a proposed rule entitled ``Revised Procedures for the
Announcement of Approvals and Denials of Premarket Approval
Applications and Humanitarian Device Exemption Applications'' to
discontinue publishing in the Federal Register after each quarter a
list of PMA and HDE approvals and denials announced in that quarter. We
also proposed to update Agency contact information and statutory
references in certain sections of the PMA and HDE regulations for
purposes of accuracy, clarity, and consistency. After consideration of
the comments received, we are now finalizing the proposed rule without
change.

C. Summary of Comments to the Proposed Rule

    We received comments on the proposed rule from individual
submitters. We received one comment in support of the proposed rule and
one comment against discontinuing the quarterly publication in the
Federal Register of a list of approvals and denials of PMAs and HDEs.
These comments are further summarized in section IV.

III. Legal Authority

    We are issuing this final rule under the authority of sections 515,
520(h), and 520(m) of the FD&C Act, which set forth requirements for
device premarket approval, release of detailed summaries of information
respecting the safety and effectiveness of devices, and humanitarian
device exemptions, and under section 701(a) of the FD&C Act, which
provides FDA the authority to issue regulations for the efficient
enforcement of the FD&C Act.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received comments on the proposed rule from individual
submitters. We describe and respond to the comments in sections IV.B
and C of this document. We have numbered each comment to help
distinguish between different comments. The number assigned to each
comment or comment topic is purely for organizational purposes and does
not signify the comment's value or importance or the order in which
comments were received.

B. Specific Comments and FDA Response

    (Comment 1) One comment supported the proposed rule.
    (Response 1) We acknowledge and appreciate the supportive comment.
    (Comment 2) One comment opposed discontinuing the publication in
the Federal Register after each quarter of a list of PMA and HDE
approvals and denials announced in that quarter. The comment stated
that the Federal Register provides a complete, archivable, and
reviewable record of Federal Agency decisions, that the FDA website
does not provide. The comment further noted that the quarterly Federal
Register summary may be useful to persons searching for aggregate
trends in FDA actions.
    (Response 2) We do not believe the quarterly Federal Register
notice is needed to provide an adequate record of PMA and HDE approvals
and denials. The Federal Register notice merely summarizes the
quarterly PMA and HDE approvals and denials; it does not provide
information on those approvals and denials beyond what can be obtained
in other formats on the FDA website. Additionally, we will continue to
give the public notice of PMA and HDE approvals and denials by placing
notices of approvals and denials on FDA's home page on the internet.
These notices, along with certain supporting documentation, are also
maintained and can be viewed online at https://www.regulations.gov.
    Furthermore, we do not believe it is necessary to publish the
quarterly Federal Register notices as a search tool for ``aggregate
trends in FDA actions.'' We note that there are existing tools such as
FDA's searchable PMA database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm) and HDE database (https://

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm; https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/premarket-approvals-and-humanitarian-device-exemptions-supporting-documents) that
the public can utilize to search for information on PMA and HDE
approvals over a certain period of time.

C. Comment Outside the Scope of This Rulemaking

    (Comment 3) One comment questioned which products FDA evaluates
before they are sold.
    (Response 3) We decline to respond because this comment is outside
the scope of this final rule.

V. Effective Date

    This final rule will become effective 30 days after the date of its
publication in the Federal Register.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this final rule will not impose any additional
regulatory burden on the industry, we certify that the rule will not
have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    The benefit of this final rule is that it will result in cost
savings to FDA from discontinuing publishing in the Federal Register,
on a quarterly basis, a list of approvals and denials of PMAs and HDEs.
Discontinuing publishing Federal Register notices with these approval
and denial lists will eliminate duplication in announcing this
information; information on these approvals and denials will continue
being readily available to the public on FDA's home page on the
internet (https://www.fda.gov).
    We estimate that this final rule will result in no additional costs
to industry because the rule will not require performance of any
additional tasks. The rule, therefore, will not impose any additional
regulatory burden on the industry.
    Table 1 summarizes the estimated benefits and costs of the final
rule. Annualized over 10 years, the estimated benefits (i.e., cost
savings) of the final rule range from $0.008 million to $0.013 million
at both 3 and 7 percent discount rate, with a primary estimate of
$0.010 million. The present value of the estimated benefits (i.e. cost
savings) of the final rule ranges from $0.068 million to $0.111 million
at a 3 percent discount rate and from $0.056 million to $0.091 million
at a 7 percent discount rate. The annualized costs of the final rule
are $0 at both 3 and 7 percent discount rate. The present value of
costs of the final rule is also $0 at both 3 and 7 percent discount
rate.

                                      Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/         $0.010      $0.008      $0.013        2020           7          10  Benefits are cost savings.
     year.
                                             0.010       0.008       0.013        2020           3          10  Benefits are cost savings.
    Annualized Quantified.
    Qualitative.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/              0           0           0        2020           7          10
     year.
                                                 0           0           0        2020           3          10
    Annualized Quantified.
    Qualitative.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized
     $millions/year.
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized
     $millions/year.
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No significant effect............................................................................................
    Small Business: No significant effect...............................................................................................................
    Wages: N/A..........................................................................................................................................
    Growth: N/A.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

IX. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

XI. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. FDA/Economics Staff, ``Revised Procedures for the Announcement of
Approvals and Denials of Premarket Approval Applications and
Humanitarian Device Exemption Applications, Regulatory Impact
Analysis, Regulatory Flexibility Analysis, Unfunded Mandates Reform
Act Analysis,'' 2020 (available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations).

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
1. The authority citation for part 814 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

Sec.  814.40  [Amended]

0
2. In Sec.  814.40, remove ``515(d)(3)'' and add in its place
``515(d)(4)''.

Sec.  814.44  [Amended]

0
3. Amend Sec.  814.44 as follows:
0
a. In the fourth sentence in paragraph (d)(1), remove ``515(d)(3)'' and
add in its place ``515(d)(4)'' and remove the sixth sentence;
0
b. In paragraph (d)(2), remove ``Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852'' and add in its place ``Freedom of Information
Staff's address listed on the Agency's website at https://www.fda.gov.''; and
0
c. In paragraphs (e)(2)(ii) and (f)(2), remove ``515(d)(3)'' and add in
its place ``515(d)(4)''.

Sec.  814.45  [Amended]

0
4. Amend Sec.  814.45 as follows:
0
a. In paragraph (d)(1), remove the third sentence and
0
b. In paragraph (e)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.

0
5. In Sec.  814.116 revise the fourth sentence in paragraph (b) to read
as follows:

 Sec.  814.116  Procedures for review of an HDE.

* * * * *
    (b) * * * The notice of approval of an HDE will be placed on the
FDA's home page on the internet (https://www.fda.gov) in accordance
with the rules and policies applicable to PMAs submitted under Sec.
814.20. * * *
* * * * *

Sec.  814.118  [Amended]

0
6. In Sec.  814.118(c)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.

    Dated: January 6, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-00501 Filed 1-12-22; 8:45 am]
BILLING CODE 4164-01-P