[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Proposed Rules]
[Pages 61485-61488]
[FR Doc No: 2023-19080]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1816; Project Identifier MCAI-2021-01460-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
(AHD) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus Helicopters Deutschland GmbH (AHD) Model MBB-BK 117 D-3
helicopters. This proposed AD was prompted by recalculations of the
inspection intervals for certain parts. This proposed AD would require
revising the airworthiness limitations section (ALS) of the existing
helicopter maintenance manual or instructions for continued
airworthiness for your helicopter and the existing approved maintenance
or inspection program for your helicopter, as applicable, to reduce the
inspection interval of certain parts, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is proposed for incorporation
by reference (IBR). The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by October 23,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1816; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, any comments received, and other
information. The street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For EASA material that is proposed for IBR in this NPRM,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; internet easa.europa.eu.
You may find the EASA material on the EASA website at
ad.easa.europa.eu.
     You may view this material at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. The EASA material is also
available at regulations.gov under Docket No. FAA-2023-1816.
    Other Related Service Information: For Airbus Helicopters service
information identified in this NPRM, contact Airbus Helicopters, 2701
North Forum Drive, Grand Prairie, TX 75052; telephone<PHONE_NUMBER> or
(800) 232-0323; fax<PHONE_NUMBER>; or at airbus.com/en/products-services/helicopters/hcare-services/airbusworld. You may also view this
service information at the FAA contact information under Material
Incorporated by Reference above.

FOR FURTHER INFORMATION CONTACT: Dan McCully, Aviation Safety Engineer,
FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone
(303) 342-1080; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-1816; Project Identifier
MCAI-2021-01460-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
McCully, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email
[email protected]. Any commentary that the FAA receives that is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0290, dated and corrected
December 23, 2021 (EASA AD 2021-0290), to correct an unsafe condition
for all serial-numbered Airbus Helicopters Deutschland GmbH Model MBB-
BK117 D-3 and D-3m helicopters.
    This proposed AD was prompted by recalculations of the inspection
intervals for certain parts. The FAA is proposing this AD to reduce the
inspection intervals for certain parts. See EASA AD 2021-0290 for
additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0290 requires replacing components before exceeding
their life limits and accomplishing maintenance tasks within thresholds
and intervals specified in the applicable ALS. Depending on the results
of the maintenance tasks, EASA AD 2021-0290 requires accomplishing
corrective action(s) or contacting AHD [Airbus Helicopters Deutschland
GmbH] for approved instructions and accomplishing those instructions.
EASA AD 2021-0290 also requires revising the Aircraft Maintenance
Programme (AMP) by incorporating the limitations, tasks, and associated
thresholds and intervals described in the specified ALS as applicable
to helicopter model and configuration. Revising the AMP constitutes
terminating action for the requirements to replace components before
exceeding their life limits and accomplish maintenance tasks within
thresholds and intervals specified in the applicable ALS as required by
EASA AD 2021-0290.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed Airbus Helicopters Alert Service Bulletin ASB MBB-
BK117 D-3-04A-001, Revision 0, dated December 22, 2021. This service
information specifies checking the total accumulated flight hours since
new for bolt part number (P/N) D671M7501201, bolt P/N D671M7501211, and
mast bolt P/N D620M0501203, and accomplishing the airworthiness
inspection within the reduced airworthiness inspection interval of 400
flight hours.
    The FAA also reviewed Airbus MBB-BK117 D-3 Chapter 04, ALS,
Revision 1, dated December 14, 2021. This service information specifies
airworthiness limitations, tasks, and associated thresholds and
intervals for various parts. Revision 1 of this service information
specifies various updates for certain components.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that
the unsafe condition described previously is likely to exist or develop
on other helicopters of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0290, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD and except as discussed under
``Differences Between this Proposed AD and the EASA AD.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0290 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0290 through that incorporation, except for any
differences identified as exceptions in the regulatory text of this
proposed AD. Using common terms that are the same as the heading of a
particular section in EASA AD 2021-0290 does not mean that operators
need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0290. Service information referenced in EASA AD 2021-0290 for
compliance will be available at regulations.gov under Docket No. FAA-
2023-1816 after the FAA final rule is published.

Differences Between This Proposed AD and the EASA AD

    EASA AD 2021-0290 applies to Model MBB-BK117 D-3m helicopters,
whereas this proposed AD would not because that model is not FAA type-
certificated.
    EASA AD 2021-0290 requires replacing certain components before
exceeding applicable life limits, accomplishing certain maintenance
tasks within thresholds and intervals as specified in the ALS, as
defined within, and depending on the results, accomplishing corrective
action within the compliance time specified in that ALS. EASA AD 2021-
0290 also requires revising the approved AMP to incorporate the
limitations, tasks, and associated thresholds and intervals described
in that ALS within 12 months after its effective date. Whereas, this
proposed AD would require revising existing documents and programs
within 30 days to incorporate the limitations, tasks, and associated
thresholds and intervals described in that ALS, and clarifies that if
an incorporated limitation or threshold therein is reached before 30
days after the effective date of the final rule of this proposed AD,
you still have up to 30 days after the effective date of the final rule
of this proposed AD to accomplish the corresponding task.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 29 helicopters of U.S. Registry. Labor rates are estimated at
$85 per work-hour. Based on these numbers, the FAA estimates the
following costs to comply with this proposed AD.
    Revising the ALS of the existing helicopter maintenance manual or
instructions for continued airworthiness for your helicopter and the
existing approved maintenance or inspection program for your
helicopter, as applicable, would take about 2 work-hours for an
estimated cost of $170 per helicopter and $4,930 for the U.S. fleet.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Airbus Helicopters Deutschland GmbH (AHD): Docket No. FAA-2023-1816;
Project Identifier MCAI-2021-01460-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by October 23, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH (AHD)
Model MBB-BK 117 D-3 helicopters, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6710, Main Rotor
Control.

(e) Unsafe Condition

    This AD was prompted by recalculations of the inspection
intervals for certain parts. The FAA is issuing this AD to reduce
the inspection intervals for certain parts. The unsafe condition, if
not addressed, could result in failure of a part and loss of control
of the helicopter.

(f) Compliance

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

(g) Required Actions

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0290, dated and corrected December 23, 2021 (EASA AD 2021-
0290).

(h) Exceptions to EASA AD 2021-0290

    (1) Where EASA AD 2021-0290 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) This AD does not adopt the requirements specified in
paragraphs (1), (2), (4), and (5) of EASA AD 2021-0290.
    (3) Where paragraph (3) of EASA AD 2021-0290 specifies revising
``the approved AMP'' within 12 months after its effective date, this
AD requires revising the airworthiness limitations section of your
existing helicopter maintenance manual or instructions for continued
airworthiness and your existing approved maintenance or inspection
program, as applicable, within 30 days after the effective date of
this AD.
    (4) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2021-0290 is on or before the applicable
``limitations'' and ``associated thresholds'' as incorporated by the
requirements of paragraph (3) of EASA AD 2021-0290, or within 30
days after the effective date of this AD, whichever occurs later.
    (5) This AD does not adopt the ``Remarks'' section of EASA AD
2021-0290.

(i) Provisions for Alternative Actions and Intervals

    After the airworthiness limitations section of the existing
helicopter maintenance manual or instructions for continued
airworthiness; and the existing approved maintenance or inspection
program, as applicable, has been revised as required by paragraph
(g) of this AD, no alternative actions (e.g., inspections) and
associated thresholds and intervals, including life limits, are
allowed unless they are approved as specified in the provisions of
the ``Ref. Publications'' section of EASA AD 2021-0290.

(j) Special Flight Permit

    Special flight permits are prohibited.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (l) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    For more information about this AD, contact Dan McCully,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email
[email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0290,
dated and corrected December 23, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0290, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet easa.europa.eu. You may find the EASA
material on the EASA website at ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 30, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-19080 Filed 9-6-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37079-37082]
[FR Doc No: 2012-15059]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30103; File No. 812-14008]

Versus Capital Multi-Manager Real Estate Income Fund LLC and
Versus Capital Advisors; Notice of Application

June 14, 2012.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (the ``Act'') for an exemption from sections 18(c)
and 18(i) of the Act, under sections 6(c) and 23(c)(3) of the Act for
an exemption from rule 23c-3 under the Act, and for an order pursuant
to section 17(d) of the Act and rule 17d-1 under the Act.

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Summary of Application: Applicants request an order to permit certain
registered closed-end management investment companies to issue multiple
classes of shares and to impose asset-based distribution fees and early
withdrawal charges (``EWCs'').

Applicants: Versus Capital Multi-Manager Real Estate Income Fund LLC
(``Initial Fund'') and Versus Capital Advisors LLC (``Adviser'').

Filing Dates: The application was filed on February 23, 2012, and
amended on April 30, 2012 and June 8, 2012.

Hearing or Notification of Hearing: An order granting the requested
relief 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 9, 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: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090; Applicants, c/o Mark D. Quam,
Versus Capital Advisors LLC, 7100 E. Belleview Avenue, Suite 306,
Greenwood Village, CO 80111-1632.

FOR FURTHER INFORMATION CONTACT: Courtney S. Thornton, Senior Counsel,
at<PHONE_NUMBER> or David P. Bartels, Branch Chief, at<PHONE_NUMBER>
(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 for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Initial Fund is a recently-formed Delaware limited liability
company that is registered under the Act as a non-diversified, closed-
end management investment company. The Initial Fund attempts to achieve
its objectives by investing in funds that invest indirectly in real
estate and by retaining institutional asset managers to sub-advise
assets invested in real estate securities.
    2. The Adviser is a Delaware limited liability company and is
registered as an investment adviser under the Investment Advisers Act
of 1940. The Adviser serves as investment adviser to the Initial Fund.
    3. The Applicants seek an order to permit the Initial Fund to issue
multiple classes of shares, each having its own fee and expense
structure, and to impose asset-based distribution fees and EWCs.
    4. Applicants request that the order also apply to any
continuously-offered registered closed-end management investment
company that has been previously organized or that may be organized in
the future for which the Adviser or any entity controlling, controlled
by, or under common control with the Adviser, or any successor in
interest to any such entity,\1\ acts as investment adviser and which
operates as an interval fund pursuant to rule 23c-3 under the Act or
provides periodic liquidity with respect to its shares pursuant to rule
13e-4 under the Securities Exchange Act of 1934 (``Exchange Act'')
(together with the Initial Fund, the ``Funds'').\2\
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    \1\ A successor in interest is limited to an entity that results
from a reorganization into another jurisdiction or a change in the
type of business organization.
    \2\ Any Fund relying on this relief in the future will do so in
a manner consistent with the terms and conditions of the
application. Applicants represent that each entity presently
intending to rely on the requested relief is listed as an applicant.
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    5. The Initial Fund is currently making an initial public offering
of its common shares following the effectiveness of its registration
statement. The Initial Fund anticipates that it will commence a
continuous public offering of its common shares within one year
following the completion of its initial registration under the
Securities Act of 1933 (``Securities Act''). Applicants state that
additional offerings by any Fund relying on the order may be on a
private placement or public offering basis. Shares of the Funds will
not be listed on any securities exchange, nor quoted on any quotation
medium. The Funds do not expect there to be a secondary trading market
for their shares.
    6. If the requested relief is granted, the Initial Fund intends to
redesignate its common shares as ``Class F Shares'' and to continuously
offer two additional classes of shares (``Class I Shares'' and ``Class
Y Shares''). Because of the different distribution fees, services and
any other class expenses that may be attributable to the Class F
Shares, Class I and Class Y Shares, the net income attributable to, and
the dividends payable on, each class of shares may differ from each
other.
    7. Applicants state that, from time to time, the Initial Fund may
create additional classes of shares, the terms of which may differ from
the Class F, Class I and Class Y Shares in the following respects: (i)
The amount of fees permitted by different distribution plans or
different service fee arrangements; (ii) voting rights with respect to
a distribution plan of a class; (iii) different class designations;
(iv) the impact of any class expenses directly attributable to a
particular class of shares allocated on a class basis as described in
this application; (v) any differences in dividends and net asset value
resulting from differences in fees under a distribution plan or in
class expenses; (vi) any EWC or other sales load structure; and (vii)
exchange or conversion privileges of the classes as permitted under the
Act.
    8. Applicants state that the Initial Fund has adopted a fundamental
policy to repurchase a specified percentage of its shares (no less than
5%) at net asset value on a quarterly basis. Such repurchase offers
will be conducted pursuant to rule 23c-3 under the Act. Each of the
other Funds will likewise adopt fundamental investment policies in
compliance with rule 23c-3 and make quarterly repurchase offers to its
shareholders or provide periodic liquidity with respect to its shares
pursuant to rule 13e-4 under the Exchange Act.\3\ Any repurchase offers
made by the Funds will be made to all holders of shares of each such
Fund.
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    \3\ Applicants submit that rule 23c-3 and Regulation M under the
Exchange Act permit an interval fund to make repurchase offers to
repurchase its shares while engaging in a continuous offering of its
shares pursuant to Rule 415 under the Securities Act.
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    9. Applicants represent that any asset-based service and
distribution fees for each class of shares will comply with the
provisions of NASD Rule 2830(d) (``NASD Sales Charge Rule'').\4\
Applicants also represent that each Fund will disclose in its
prospectus, the fees, expenses and other characteristics of each class
of shares offered for sale by the prospectus, as is required for open-
end multiple class funds under Form N-1A. As is required for open-end
funds, each Fund will disclose its expenses in shareholder reports, and
disclose any arrangements that result in breakpoints in or elimination
of sales loads in its prospectus.\5\ In addition, applicants will
comply with applicable enhanced fee disclosure requirements for fund of
funds, including registered funds of hedge funds.\6\
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    \4\ Any reference to the NASD Sales Charge Rule includes any
successor or replacement rule that may be adopted by the Financial
Industry Regulatory Authority (``FINRA'').
    \5\ See Shareholder Reports and Quarterly Portfolio Disclosure
of Registered Management Investment Companies, Investment Company
Act Release No. 26372 (Feb. 27, 2004) (adopting release) (requiring
open-end investment companies to disclose fund expenses in
shareholder reports); and Disclosure of Breakpoint Discounts by
Mutual Funds, Investment Company Act Release No. 26464 (June 7,
2004) (adopting release) (requiring open-end investment companies to
provide prospectus disclosure of certain sales load information).
    \6\ Fund of Funds Investments, Investment Company Act Rel. Nos.
26198 (Oct. 1 2003) (proposing release) and 27399 (Jun. 20, 2006)
(adopting release). See also Rules 12d1-1, et seq. of the Act.
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    10. Each of the Funds will comply with any requirements that the
Commission or FINRA may adopt regarding disclosure at the point of sale
and in transaction confirmations about the costs and conflicts of
interest arising out of the distribution of open-end investment company
shares, and regarding prospectus disclosure of sales loads and revenue
sharing arrangements, as if those requirements applied to the Fund. In
addition, each Fund will contractually require that any

distributor of the Fund's shares comply with such requirements in
connection with the distribution of such Fund's shares.
    11. Each Fund will allocate all expenses incurred by it among the
various classes of shares based on the net assets of the Fund
attributable to each class, except that the net asset value and
expenses of each class will reflect distribution fees, service fees,
and any other incremental expenses of that class. Expenses of the Fund
allocated to a particular class of shares will be borne on a pro rata
basis by each outstanding share of that class. Applicants state that
each Fund will comply with the provisions of rule 18f-3 under the Act
as if it were an open-end investment company.
    12. Each Fund may impose an EWC on shares submitted for repurchase
that have been held less than a specified period and may waive the EWC
for certain categories of shareholders or transactions to be
established from time to time. Each of the Funds will apply the EWC
(and any waivers or scheduled variations of the EWC) uniformly to all
shareholders in a given class and consistently with the requirements of
rule 22d-1 under the Act as if the Funds were open-end investment
companies.
    13. Each Fund operating as an interval fund pursuant to rule 23c-3
under the Act may offer its shareholders an exchange feature under
which the shareholders of the Fund may, in connection with the Fund's
periodic repurchase offers, exchange their shares of the Fund for
shares of the same class of (i) registered open-end investment
companies or (ii) other registered closed-end investment companies that
comply with rule 23c-3 under the Act and continuously offer their
shares at net asset value, that are in the Fund's group of investment
companies (collectively, ``Other Funds''). Shares of a Fund operating
pursuant to rule 23c-3 that are exchanged for shares of Other Funds
will be included as part of the amount of the repurchase offer amount
for such Fund as specified in rule 23c-3 under the Act. Any exchange
option will comply with rule 11a-3 under the Act, as if the Fund were
an open-end investment company subject to rule 11a-3. In complying with
rule 11a-3, each Fund will treat an EWC as if it were a contingent
deferred sales load (``CDSL'').

Applicants' Legal Analysis

Multiple Classes of Shares

    1. Section 18(c) of the Act provides, in relevant part, that a
closed-end investment company may not issue or sell any senior security
if, immediately thereafter, the company has outstanding more than one
class of senior security. Applicants state that the creation of
multiple classes of shares of the Funds may be prohibited by section
18(c), as a class may have priority over another class as to payment of
dividends because shareholders of different classes would pay different
fees and expenses.
    2. Section 18(i) of the Act provides that each share of stock
issued by a registered management investment company will be a voting
stock and have equal voting rights with every other outstanding voting
stock. Applicants state that multiple classes of shares of the Funds
may violate section 18(i) of the Act because each class would be
entitled to exclusive voting rights with respect to matters solely
related to that class.
    3. 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 provision of the Act, or from any
rule thereunder, if and to the extent 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 request an exemption under section
6(c) from sections 18(c) and 18(i) to permit the Funds to issue
multiple classes of shares.
    4. Applicants submit that the proposed allocation of expenses and
voting rights among multiple classes is equitable and will not
discriminate against any group or class of shareholders. Applicants
submit that the proposed arrangements would permit a Fund to facilitate
the distribution of its shares and provide investors with a broader
choice of shareholder services. Applicants assert that the proposed
closed-end investment company multiple class structure does not raise
the concerns underlying section 18 of the Act to any greater degree
than open-end investment companies' multiple class structures that are
permitted by rule 18f-3 under the Act. Applicants state that each Fund
will comply with the provisions of rule 18f-3 as if it were an open-end
investment company.

Early Withdrawal Charges

    1. Section 23(c) of the Act provides, in relevant part, that no
registered closed-end investment company will purchase securities of
which it is the issuer, except: (a) On a securities exchange or other
open market; (b) pursuant to tenders, after reasonable opportunity to
submit tenders given to all holders of securities of the class to be
purchased; or (c) under other circumstances as the Commission may
permit by rules and regulations or orders for the protection of
investors.
    2. Rule 23c-3 under the Act permits a registered closed-end
investment company (an ``interval fund'') to make repurchase offers of
between five and twenty-five percent of its outstanding shares at net
asset value at periodic intervals pursuant to a fundamental policy of
the interval fund. Rule 23c-3(b)(1) under the Act provides that an
interval fund may deduct from repurchase proceeds only a repurchase
fee, not to exceed two percent of the proceeds, that is paid to the
interval fund and is reasonably intended to compensate the fund for
expenses directly related to the repurchase.
    3. Section 23(c)(3) provides that the Commission may issue an order
that would permit a closed-end investment company to repurchase its
shares in circumstances in which the repurchase is made in a manner or
on a basis that does not unfairly discriminate against any holders of
the class or classes of securities to be purchased.
    4. Applicants request relief under sections 6(c), discussed above,
and 23(c)(3) from rule 23c-3 to the extent necessary for the Funds to
impose EWCs on shares of the Funds submitted for repurchase that have
been held for less than a specified period.
    5. Applicants state that the EWCs they intend to impose are
functionally similar to CDSLs imposed by open-end investment companies
under rule 6c-10 under the Act. Rule 6c-10 permits open-end investment
companies to impose CDSLs, subject to certain conditions. Applicants
note that rule 6c-10 is grounded in policy considerations supporting
the employment of CDSLs where there are adequate safeguards for the
investor and state that the same policy considerations support
imposition of EWCs in the interval fund context. In addition,
applicants state that EWCs may be necessary for the distributor to
recover distribution costs. Applicants represent that any EWC imposed
by the Funds will comply with rule 6c-10 under the Act as if the rule
were applicable to closed-end investment companies. The Funds will
disclose EWCs in accordance with the requirements of Form N-1A
concerning CDSLs. Applicants further state that the Funds will apply
the EWC (and any waivers or scheduled variations of the EWC) uniformly
to all shareholders in a given class and consistently with the
requirements of rule 22d-1 under the Act.

Asset-based Distribution Fees

    1. Section 17(d) of the Act and rule 17d-1 under the Act prohibit
an affiliated person of a registered investment company or an
affiliated person of such person, acting as principal, from
participating in or effecting any transaction in connection with any
joint enterprise or joint arrangement in which the investment company
participates unless the Commission issues an order permitting the
transaction. In reviewing applications submitted under section 17(d)
and rule 17d-1, the Commission considers whether the participation of
the investment company in a joint enterprise or joint arrangement is
consistent with the provisions, policies and purposes of the Act, and
the extent to which the participation is on a basis different from or
less advantageous than that of other participants.
    2. Rule 17d-3 under the Act provides an exemption from section
17(d) and rule 17d-1 to permit open-end investment companies to enter
into distribution arrangements pursuant to rule 12b-1 under the Act.
Applicants request an order under section 17(d) and rule 17d-1 under
the Act to the extent necessary to permit the Fund to impose asset-
based distribution fees. Applicants have agreed to comply with rules
12b-1 and 17d-3 as if those rules applied to closed-end investment
companies, which they believe will resolve any concerns that might
arise in connection with a Fund financing the distribution of its
shares through asset-based distribution fees.
    For the reasons stated above, applicants submit that the exemptions
requested under section 6(c) are necessary and appropriate in the
public interest and are consistent with the protection of investors and
the purposes fairly intended by the policy and provisions of the Act.
Applicants further submit that the relief requested pursuant to section
23(c)(3) will be consistent with the protection of investors and will
insure that applicants do not unfairly discriminate against any holders
of the class of securities to be purchased. Finally, applicants state
that the Funds' institution of asset-based distribution fees is
consistent with the provisions, policies and purposes of the Act and
does not involve participation on a basis different from or less
advantageous than that of other participants.

Applicants' Condition

    Applicants agree that any order granting the requested relief will
be subject to the following condition:
    Each Fund relying on the order will comply with the provisions of
rules 6c-10, 12b-1, 17d-3, 18f-3, 22d-1, and, where applicable, 11a-3
under the Act, as amended from time to time, as if those rules applied
to closed-end management investment companies, and will comply with the
NASD Sales Charge Rule, as amended from time to time, as if that rule
applied to all closed-end management investment companies.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-15059 Filed 6-19-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10428-10429]
[FR Doc No: 2020-03571]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP20-521-000]

Betelgeuse Energy, LLC v. Paso Natural Gas Company, L.L.C.;
Notice of Complaint

    Take notice that on February 13, 2020, pursuant to Rule 206 of the
Rules of Practice and Procedures of the Federal Energy Regulatory
Commission (Commission), 18 CFR 385.206, Betelgeuse Energy, LLC
(Betelgeuse or Complainant) filed a complaint against El Paso Natural
Gas Company, L.L.C. (El Paso or Respondent), alleging that El Paso
unlawfully rejected bids submitted by Betelgeuse in two open seasons
held by El Paso pursuant to the right of first refusal provisions in
its FERC Gas Tariff, Third Revised Volume No. 1A. In so doing,
Betelgeuse alleges that El Paso violated those provisions of its
tariff, as well as section 4(c) of the Natural Gas Act, 15 U.S.C.
717c(c), and section 282.221(d)(2) of the Commission's regulations, 18
CFR 282.221(d)(2) (2019), as more fully explained in the complaint.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. All interventions,
or protests must be filed on or before the comment date.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on March 4, 2020.

    Dated: February 18, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-03571 Filed 2-21-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47334-47335]
[FR Doc No: 2013-18793]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4020-DR; Docket ID FEMA-2013-0001]

New York; Amendment No. 10 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New York (FEMA-4020-DR), dated August 31, 2011, and
related determinations.

DATES: Effective Date: July 25, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New York is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 31, 2011.

    Fulton County for Public Assistance.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,

Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-18793 Filed 8-2-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Rules and Regulations]
[Pages 75465-75466]
[FR Doc No: 2022-26646]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0571; Airspace Docket No. 22-ANM-46]
RIN 2120-AA66

Establishment of Class E Airspace; Christmas Valley Airport, OR

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: This action establishes Class E airspace extending upward from
700 feet above the surface at Christmas Valley Airport, OR. These
actions will support the airport's transition from visual flight rules
(VFR) to instrument flight rules (IFR) at the airport.

DATES: Effective 0901 UTC, February 23, 2023. The Director of the
Federal Register approves this incorporation by reference under 1 CFR
part 51, subject to the annual revision of FAA Order JO 7400.11,
Airspace Designations and Reporting Points, and publication of
conforming amendments.

ADDRESSES: FAA Order JO 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Nathan A. Chaffman, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
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 would establish Class E airspace at Christmas Valley Airport, OR
to support IFR operations at the airport.

History

    The FAA published a notice of proposed rulemaking (NPRM) in the
Federal Register for FAA-2022-0571 (87 FR 38309; June 28, 2022) to
establish Class E airspace beginning at 700 feet above the surface at
Christmas Valley Airport, OR. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. Two comments were received. One comment was
received in favor of the proposal, and one comment was against the
proposal. The comment against argues that, ``A 14 mile radius 700'
[sic] transition area is grossly excessive for one proposed standard
instrument approach procedure. This proposed transition area should be
no larger than required for flight below 1,200 feet, above ground
level.'' The above comment does not make a valid argument against the
FAA's actions, as the airspace is appropriately sized. Class E5
airspace areas with a base of 700 feet

above the surface must be designated to accommodate departing IFR
operations until they reach 1,200 feet above the surface. Additionally,
a climb gradient of 200 feet per nautical mile (NM) must be applied to
determine the size of all Class E airspace for departures. Christmas
Valley Airport allows for diverse departures, as it does not have a
published departure procedure. Due to rising terrain south and west of
the airport, a Class E5 airspace area encircling the airport with a 14-
mile radius is necessary to accommodate IFR departures until reaching
1,200 feet above the surface.
    Class E5 airspace designations is published in paragraph 6005 of
FAA Order JO 7400.11G, dated August 19, 2022, and effective September
15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designation listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11G, Airspace Designations
and Reporting Points, dated August 19, 2022, and effective September
15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11G lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending 14 CFR part 71 by establishing Class E airspace
beginning at 700 feet above the surface at Christmas Valley Airport to
contain departing aircraft until reaching 1,200 feet above the surface,
and arriving aircraft below 1,500 feet above the surface. The airspace
is centered on the Christmas Valley Airport reference point, with a 14-
mile radius to account for rising terrain in the vicinity of the
airport.
    The Class E5 airspace designation is published in paragraph 6005 of
FAA Order JO 7400.11G, dated August 19, 2022, and became effective
September 15, 2022, which is incorporated by reference in 14 CFR 71.1.
The Class E airspace designation listed in this document will be
published subsequently in FAA Order JO 7400.11.
    FAA Order JO 7400.11 is published annually and becomes effective on
September 15.

Regulatory Notices and Analyses

    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, is
non-controversial, and unlikely to result in adverse or negative
comments. 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. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant the 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 FAA 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 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 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 FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM OR E Christmas Valley, OR [New]

Christmas Valley Airport, OR
    (Lat. 43[deg]14'11'' N, long. 120[deg]39'53'' W)

    That airspace extending upward from 700 feet above the surface
within a 14-mile radius of the Christmas Valley Airport.

    Issued in Des Moines, Washington, on November 14, 2022.
B.G. Chew,
Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2022-26646 Filed 12-8-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Notices]
[Page 55385]
[FR Doc No: 2018-24073]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3405-EM; Docket ID FEMA-2018-0001]

Florida; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the State of Florida (FEMA-3405-EM), dated October 9, 2018, and related
determinations.

DATES: This amendment was issued October 22, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective October 19, 2018.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-24073 Filed 11-2-18; 8:45 am]
 BILLING CODE 9111-11-P


[Federal Register: April 8, 2008 (Volume 73, Number 68)]
[Proposed Rules]
[Page 19015-19017]
[DOCID:fr08ap08-16]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28160; Directorate Identifier 2007-NM-006-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 757-200 and 757-300 Series
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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

SUMMARY: The FAA is revising an earlier proposed airworthiness
directive (AD) for certain Boeing Model 757-200 and 757-300 series
airplanes. The original NPRM would have required installing a bonding
jumper between a ground and the clamp on the tube of the forward and
aft gray water composite drain masts. The original NPRM resulted from a
report of charred insulation blankets and burned wires around the
forward gray water composite drain mast found during an inspection of
the forward cargo compartment on a Model 767-300F airplane. For certain
airplanes, this action revises the original NPRM by adding a new
inspection of existing aft bonding jumper assemblies that might be too
short, repair if necessary, and replacement of the bonding jumper
assembly with a new, longer bonding jumper assembly if necessary. We
are proposing this supplemental NPRM to prevent a fire near a composite
drain mast and possible disruption of the electrical power system due
to a lightning strike on a composite drain mast, which could result in
the loss of several functions essential for safe flight.

DATES: We must receive comments on this supplemental NPRM by May 5,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Nicholas Wilson, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-
28160; Directorate Identifier 2007-NM-006-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued a notice of proposed rulemaking (NPRM) (the ``original
NPRM'') to amend 14 CFR part 39 to include an airworthiness directive
(AD) that would apply to certain Boeing Model 757-200 and 757-300
series airplanes. The original NPRM was published in the Federal
Register on May 16, 2007 (72 FR 27497). The original NPRM proposed to
require installing a bonding jumper between a ground and the clamp on
the tube of the forward and aft gray water composite drain masts.

Actions Since Original NPRM Was Issued

    Since we issued the original NPRM, Boeing has advised us of reports
of the bonding jumper being too short to reach the bracket in the aft
drain installation, as described in Boeing Special Attention Service
Bulletin 757-30-0024, dated July 24, 2006. Boeing has issued Special
Attention Service Bulletin 757-30-0024, Revision 1, dated October 25,
2007. The procedures in this service bulletin are essentially the same
as those in the original service bulletin. The service bulletin also
includes procedures to correct bonding jumper assemblies that are too
short on airplanes that changed the aft drain mast in accordance with
the original issue of the service bulletin, and procedures that should
be followed if the proper resistance values of the bonding jumper
cannot be met. We have added a new paragraph to this supplemental NPRM
to require inspection, repair, and replacement of the aft bonding
jumper assemblies installed according to the original service bulletin
that have been determined to be too short. We have also revised
paragraph (f) of the supplemental NPRM to refer to Revision 1 of the
service bulletin as the appropriate source of service information for
the proposed requirements.

Additional Changes to This Supplemental NPRM

    We have also updated the Costs of Compliance section of this
supplemental NPRM to reflect the new inspection, the current number of
U.S.-registered airplanes, and the cost of parts necessary to
accomplish the proposed actions.
    We have confirmed with the airplane manufacturer that the composite
and aluminum drain mast can be interchangeable. Therefore, we have
added a new paragraph (h), ``Parts Installation,'' to this supplemental
NPRM to prohibit installation of a composite gray water drain mast,
unless a bonding jumper is also installed, as specified in paragraph
(f) of this AD. We have also re-identified subsequent paragraphs
accordingly.

FAA's Determination and Proposed Requirements of the Supplemental NPRM

    We are proposing this supplemental NPRM because we evaluated all
pertinent information and determined an unsafe condition exists and is
likely to exist or develop on other products of the same type design.
Certain changes described above expand the scope of the original NPRM.
As a result, we have determined that it is necessary to reopen the
comment period to provide additional opportunity for the public to
comment on this supplemental NPRM.

Costs of Compliance

    There are about 83 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this supplemental NPRM.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Average labor                           Cost per        Number of U.S.-
              Action                 Work hours     rate per hour          Parts            airplane     registered  airplanes         Fleet cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bonding jumper installation......               2             $80  $392, per kit (1 kit            $944  70...................  $66,080.
                                                                    per drain mast).
Inspection of existing bonding                  1              80  $392................             472  Up to 70.............  Up to $33,040.
 jumper installation in bulk
 cargo compartment.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this supplemental NPRM and placed it in the AD docket. See
the ADDRESSES section for a location to examine the regulatory
evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Boeing: Docket No. FAA-2007-28160; Directorate Identifier 2007-NM-
006-AD.

Comments Due Date

    (a) We must receive comments by May 5, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 757-200 and 757-300 series
airplanes, certificated in any category; as identified in Boeing
Special Attention Service Bulletin 757-30-0024, Revision 1, dated
October 25, 2007.

Unsafe Condition

    (d) This AD results from a report of charred insulation blankets
and burned wires around the forward gray water composite drain mast
found during an inspection of the forward cargo compartment on a
Model 767-300F airplane. We are issuing this AD to prevent a fire
near a composite drain mast and possible disruption of the
electrical power system due to a lightning strike on a composite
drain mast, which could result in the loss of several functions
essential for safe flight.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Bonding Jumper Installation

    (f) Except as provided by paragraph (g) of this AD: Within 60
months after the effective date of this AD, install a bonding jumper
between a ground and the clamp on the tube of the forward and aft
gray water composite drain mast, in accordance with Parts 1 and 2 of
the Accomplishment Instructions of Boeing Special Attention Service
Bulletin 757-30-0024, Revision 1, dated October 25, 2007.

Existing Bonding Jumper Inspection

    (g) For airplanes on which the bonding jumper was installed on
the aft drain mast in

accordance with Boeing Special Attention Service Bulletin 757-30-
0024, dated July 24, 2006: Within 60 months after the effective date
of this AD, do a general visual inspection of the aft bonding jumper
assembly for signs of riding (chafing) in accordance with Part 3 of
the Accomplishment Instructions of Boeing Special Attention Service
Bulletin 757-30-0024, Revision 1, dated October 25, 2007. If no
riding damage is found, no further action is required by this AD for
the aft drain mast. If riding damage is found, before further flight
do the actions specified in paragraphs (g)(1) and (g)(2) of this AD.
Doing the actions specified in this paragraph terminates the
requirement to install the bonding jumper on the aft drain mast
specified in paragraph (f) of this AD.
    (1) Repair any riding damage found in accordance with the
service bulletin.
    (2) Remove the existing bonding jumper assembly and install a
new, longer bonding jumper assembly in accordance with Part 3 of the
Accomplishment Instructions of the service bulletin. As an option to
the longer bonding jumper assembly, operators may remove the
bracket, fill the holes in the stringer, and restore the finish in
accordance with Part 3 of the Accomplishment Instructions of the
service bulletin; and install the ground bracket and jumper assembly
in accordance with Part 2 of the Accomplishment Instructions of the
service bulletin.

Parts Installation

    (h) As of the effective date of this AD, no person may install,
on any airplane, a composite gray water drain mast, unless a bonding
jumper is also installed, as specified in paragraph (f) of this AD.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Seattle Aircraft Certification Office, FAA,
has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

    Issued in Renton, Washington, on March 31, 2008.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-7302 Filed 4-7-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17056-17057]
[FR Doc No: 2015-07300]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Ear, Nose, and Throat Devices Panel of the Medical Devices
Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Ear, Nose, and Throat Devices
Panel of the Medical Devices Advisory Committee. This meeting was
announced in the Federal Register of March 13, 2015. The amendment is
being made to reflect a change in the April 30th Agenda portion of the
document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring MD 20993-0002,
<EMAIL_ADDRESS>301-796-6875, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington DC
area), code EN. Please call the Information Line for up-to-date
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 13, 2015
(80 FR 13392), FDA announced that a meeting of the Ear, Nose, and
Throat Devices Panel of the Medical Devices Advisory Committee would be
held on April 30 and May 1, 2015. On page 13393, in the first and
second columns, the Agenda portion of the document is changed to read
as follows:
    On April 30, 2015, the Agency is adding three Agenda items to the
original five agenda items posted in the March 13, 2015, Federal
Register document. The three additional items are: Speech Training Aids
for the Hearing Impaired (Battery Powered or Non-Patient), Speech
Training Aids for the Hearing Impaired (AC-powered and Patient-
Contact), and Nasal Septal Button Devices. The committee will discuss
and make recommendations regarding the classification of Hearing
Protectors, Circumaural Hearing Protectors, Tactile Hearing Aids,
Speech Training Aids for the Hearing Impaired (Battery Powered or Non-
Patient), Speech Training Aids for the Hearing Impaired (AC-powered and
Patient-Contact), Vestibular Analysis, Middle Ear Inflation Devices,
and Nasal Septal Button Devices. These devices are considered
preamendments devices since they were in commercial distribution prior
to May 28, 1976, when the Medical Devices Amendments became effective.
Hearing Protectors are currently regulated under the heading,
``Protector, Hearing (Insert),'' Product Code EWD, as unclassified
under the 510(k) premarket notification authority. Circumaural Hearing
Protectors are currently regulated under the heading, ``Protector,
Hearing (Circumaural),'' Product Code EWE, as unclassified under the
510(k) premarket notification authority. Tactile Hearing Aid Devices
are currently regulated under the heading, ``Hearing Aid, Tactile,''
Product Code LRA, as unclassified under the 510(k) premarket
notification authority. Speech Training Aids for the Hearing Impaired
(Battery Powered or Non-Patient) are currently regulated under the
heading, ``Aids, Speech Training For The Hearing Impaired (Battery-
Operated or Non-Patient),'' Product Code LFA, as unclassified under the
510(k) premarket notification authority. Speech Training Aids for the
Hearing Impaired (AC-Powered and Patient-Contact) are currently
regulated under the heading, ``Aids, Speech Training For The Hearing
Impaired (AC-Powered and Patient-Contact),'' Product Code LEZ, as
unclassified under the 510(k) premarket notification authority.
Vestibular Analysis Apparatuses are currently regulated under the
heading, ``Apparatus, Vestibular Analysis,'' Product Code LXV, as
unclassified under the 510(k) premarket notification authority. Middle
Ear Inflation Devices are currently regulated under the heading,
``Device, Inflation, Middle Ear,'' Product Code MJV, as unclassified
under the 510(k) premarket notification authority. Nasal Septal Button
Devices are currently regulated under the heading, ``Button, Nasal
Septal,'' Product Code LFB, as unclassified under the 510(k) premarket
notification authority. FDA is seeking committee input on the risks,
safety and effectiveness, and the regulatory classification of Hearing
Protectors, Circumaural Hearing Protectors, Tactile Hearing Aids,
Speech Training Aids for the Hearing Impaired (Battery Powered or Non-
Patient), Speech Training Aids for the Hearing Impaired (AC-Powered and
Patient-Contact), Vestibular Analysis, Middle Ear Inflation Devices,
and Nasal Septal Button Devices.

    On May 1, 2015, the committee will discuss key issues related to a
potential pre- to postmarket shift in clinical data requirements for
modifications to cochlear implants in pediatric patients. These issues
are categorized into three broad areas for discussion:
    1. Cochlear implant changes (e.g. sound processing features,
patient characteristics) that may be suitable for this pre- to
postmarket shift in clinical data requirements.
    2. Appropriate premarket clinical data requirements to support pre-
to postmarket shift (e.g. leveraging clinical data from adults and/or
older children.)
    3. Clinical study design considerations (e.g. study endpoints and
test metrics, subject characteristics) for postmarket studies to
confirm safety and effectiveness and inform future labeling.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: March 24, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-07300 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36573-36574]
[FR Doc No: 2022-13082]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2021-0080; Notice 1]

FCA US LLC Receipt of Petition for Decision of Inconsequential
Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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

SUMMARY: FCA US LLC f/k/a Chrysler Group LLC (collectively referred to
as ``FCA US'') has determined that certain model year (MY) 2018-2022
Alfa Romeo Stelvio motor vehicles do not fully comply with Federal
Motor Vehicle Safety Standard (FMVSS) No. 111, Rear Visibility. FCA US
filed a noncompliance report dated September 21, 2021. FCA US
subsequently petitioned NHTSA on October 14, 2021, for a decision that
the subject noncompliance is inconsequential as it relates to motor
vehicle safety. This notice announces receipt of FCA US' petition.

DATES: Send comments on or before July 18, 2022.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the docket. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000 (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:

I. Overview

    FCA US has determined that certain MY 2018-2022 Alfa Romeo Stelvio
motor vehicles do not fully comply with the requirements of paragraphs
S2 and S.5.5.1 of FMVSS No. 111, Rear Visibility (49 CFR 571.111). FCA
US filed a noncompliance report dated September 21, 2021, pursuant to
49 CFR part 573, Defect and Noncompliance Responsibility and Reports.
FCA US subsequently petitioned NHTSA on October 14, 2021, for an
exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential as
it relates to motor vehicle safety, pursuant to 49 U.S.C. 30118(d) and
30120(h) and 49 CFR part 556, Exemption for Inconsequential Defect or
Noncompliance.
    This notice of receipt of FCA US' petition is published under 49
U.S.C. 30118 and 30120 and does not represent any Agency decision or
other exercise of judgment concerning the merits of the petition.

II. Vehicles Involved

    Approximately 43,701 MY 2018-2022 Alfa Romeo Stelvio motor vehicles
manufactured between April 12, 2017, and August 27, 2021, are
potentially involved.

III. Noncompliance

    FCA US explains that the noncompliance is that the subject vehicles
are equipped with rearview camera displays that when tested to FMVSS
No. 111, covers a required portion of a test object and therefore, do
not fully meet the field of view requirements outlined in paragraphs S2
and S5.5.1 of FMVSS No. 111. Specifically, the rearview camera display
includes ``dynamic guidelines'' that project the vehicle to be wider
than it is. As a result, the ``dynamic gridlines'' partially cover the
lower inside edges of the front test object when the steering wheel is
straight.

IV. Rule Requirements

    Paragraphs S2 and S5.5.1 of FMVSS No. 111 include the requirements
relevant to this petition. Paragraph S2 of FMVSS No. 111 specifies that
the purpose of this standard is to reduce the number of deaths and
injuries that occur when the driver of a motor vehicle does not have a
clear and reasonably unobstructed view to the rear. Paragraph S5.5.1 of
FMVSS No. 111 requires the rearview image to include: (a) A minimum of
a 150-mm wide portion along the circumference of each test object
located at positions F and G; and (b) the full width and height of each
test object located at positions A through E, when tested in accordance
with the procedures in S14.1 of FMVSS 111.

V. Summary of FCA US' Petition

    The following views and arguments presented in this section, V.
Summary of FCA US' Petition, are the views and arguments provided by
FCA US. They have not been evaluated by the Agency and do not reflect
the views of the Agency.
    In its petition, FCA US describes the subject noncompliance and
explains that it is caused by an incorrect calibration in the subject
vehicles. According to FCA US the subject noncompliance is
inconsequential to motor vehicle safety because the subject
noncompliance ``does not create an unclear or unreasonably obstructed
view to the rear.'' FCA US specifies that although the subject
noncompliance exists, the obstruction caused by the gridlines while
performing the FMVSS No. 111 test is ``transitory'' and does not
``significantly obstruct the view to the rear.'' \1\ Further, the
gridlines will move rearward as the vehicle does, resulting in the test
objects to be ``displayed in full.''
---------------------------------------------------------------------------

    \1\ FCA US provided photos of the noncompliance in its petition
which can be viewed in full at https://www.regulations.gov/docket/NHTSA-2021-0080.
---------------------------------------------------------------------------

    FCA US quoted an excerpt from the notice of final rule for FMVSS
No. 111 in which FCA US says that NHTSA ``acknowledged that over lays,
such as gridlines, could provide safety-related benefits.''
    FCA US concludes that the subject noncompliance is inconsequential
as it relates to motor vehicle safety, and that its petition to be
exempted from providing notification of the noncompliance, as required
by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by
49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles that FCA US no
longer controlled at the time it determined that the noncompliance
existed. However, any decision on this petition does not relieve
vehicle distributors and dealers of the prohibitions on the sale, offer
for sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after FCA US
notified them that the subject noncompliance existed.

(Authority: 49 U.S.C. 30118, 30120: delegations of authority at 49
CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2022-13082 Filed 6-16-22; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67290-67292]
[FR Doc No: 2018-28217]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-6002]

Determination of Regulatory Review Period for Purposes of Patent
Extension; RUBRACA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for RUBRACA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 26, 2019. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 26,
2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

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 February 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 26, 2019. 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-2017-E-6002 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; RUBRACA.'' 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 between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, RUBRACA
(rucaparib). RUBRACA is indicated as monotherapy for the treatment of
patients with deleterious BRCA mutation (germline and/or somatic)
associated advanced ovarian cancer who have been treated with two or
more chemotherapies. Select patients for therapy based on an FDA-
approved companion diagnostic for RUBRACA. This indication is approved
under accelerated approval based on objective response rate and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trials. Subsequent to this approval, the USPTO received a
patent term restoration application for RUBRACA (U.S. Patent No.
6,495,541) from Agouron Pharmaceuticals, LLC and the USPTO requested
FDA's assistance in determining the patent's eligibility for patent
term restoration. In a letter dated October 16, 2017, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of RUBRACA represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
RUBRACA is 2,644 days. Of this time, 2,464 days occurred during the
testing phase of the regulatory review period, while 180 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
September 25, 2009. FDA has verified the applicant's claim that the
date the investigational new drug application became effective was on
September 25, 2009.

    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 23,
2016. FDA has verified the applicant's claim that the new drug
application (NDA) for RUBRACA (NDA 209115) was initially submitted on
June 23, 2016.
    3. The date the application was approved: December 19, 2016. FDA
has verified the applicant's claim that NDA 209115 was approved on
December 19, 2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,412 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-28217 Filed 12-27-18; 8:45 am]
 BILLING CODE 4164-01-P