[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25303-25304]
[FR Doc No: 2015-10336]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0476 and FDA-2013-E-0654]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TUDORZA PRESSAIR

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TUDORZA PRESSAIR and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of applications 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.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 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 TUDORZA
PRESSAIR (aclidinium bromide). TUDORZA PRESSAIR is indicated for the
long-term maintenance treatment of bronchospasm associated with chronic
obstructive pulmonary disease, including chronic bronchitis and
emphysema. Subsequent to this approval, the USPTO received patent term
restoration applications for TUDORZA PRESSAIR (U.S. Patent Nos.
6,750,226 and 7,078,412) from Almiral, S.A., and the USPTO requested
FDA's assistance in determining the patents eligibilities for patent
term restoration. In a letter dated July 16, 2013, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of TUDORZA PRESSAIR represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO

requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
TUDORZA PRESSAIR is 3,136 days. Of this time, 2,739 days occurred
during the testing phase of the regulatory review period, while 397
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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: December 24, 2003. FDA has verified the applicant's claim
that the date the investigational new drug application became effective
was on December 24, 2003.
    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,
2011. FDA has verified the applicant's claim that the new drug
application (NDA) for TUDORZA PRESSAIR (NDA 202-450) was submitted on
June 23, 2011.
    3. The date the application was approved: July 23, 2012. FDA has
verified the applicant's claim that NDA 202-450 was approved on July
23, 2012.
    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 applications for patent extension,
this applicant seeks 1,679 or 1,298 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 6, 2015. 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 November 2, 2015. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (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.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10336 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 4, 2008 (Volume 73, Number 66)]
[Notices]
[Page 18525-18526]
[DOCID:fr04ap08-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

March 31, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP96-200-186.
    Applicants: CenterPoint Energy Gas Transmission Company.
    Description: CenterPoint Energy Gas Transmission Company submits an
amended negotiated rate agreement with Constellation Energy Commodities
Group, Inc.
    Filed Date: 03/27/2008.
    Accession Number: 20080328-0076.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 08, 2008.

    Docket Numbers: RP03-36-030.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits its Thirty-
Sixth Revised Sheet 9 et al. to FERC Gas Tariff, First Revised Volume
1.
    Filed Date: 03/26/2008.
    Accession Number: 20080328-0082.
    Comment Date: 5 p.m. Eastern Time on Monday, April 07, 2008.

    Docket Numbers: RP08-123-001, RP07-499-003, RP07-498-003 (Not
Consolidated).
    Applicants: Central Kentucky Transmission Company.
    Description: Central Kentucky Transmission Company submits their
request that FERC approve a change in the effective date to June 1,
2008 for certain tariff sheets.
    Filed Date: 03/26/2008.
    Accession Number: 20080328-0078.
    Comment Date: 5 p.m. Eastern Time on Monday, April 07, 2008.

    Docket Numbers: RP08-124-001, RP07-508-003, RP07-500-004, RP07-478-
004, RP07-415-001, RP07-412-004, RP07-174-004 (Not Consolidated).
    Applicants: Columbia Gulf Transmission Company.

    Description: Columbia Gulf Transmission Company's request that the
FERC approve a change in the effective date to June 1, 2008 for certain
tariff sheets.
    Filed Date: 03/26/2008.
    Accession Number: 20080328-0081.
    Comment Date: 5 p.m. Eastern Time on Monday, April 07, 2008.

    Docket Numbers: RP08-125-001, RP07-515-003, RP07-497-003, (Not
Consolidated).
    Applicants: Crossroads Pipeline Company.
    Description: Crossroad Pipeline Company's request that the FERC
approve a change in the effective date to June 1, 2008 for certain
tariff sheets.
    Filed Date: 03/26/2008.
    Accession Number: 20080328-0080.
    Comment Date: 5 p.m. Eastern Time on Monday, April 07, 2008.

    Docket Numbers: RP08-127-001, RP08-110-001, RP07-509-004, RP07-479-
004, RP07-414-003, RP07-413-004, RP07-340-005, (Not Consolidated).
    Applicants: Columbia Gas Transmission Corporation.
    Description: Columbia Gas Transmission Corporation's request that
the FERC approve a change in the effective date to June 1, 2008 for
certain tariff sheets.
    Filed Date: 03/26/2008.
    Accession Number: 20080328-0079.
    Comment Date: 5 p.m. Eastern Time on Monday, April 07, 2008.

    Docket Numbers: RP08-218-001.
    Applicants: Gulfstream Natural Gas System, L.L.C.
    Description: Gulfstream Natural Gas System LLC submits Original
Sheet 8.02i and 8.02j to FERC Gas Tariff, Original Volume 1, to become
effective March 26, 2008.
    Filed Date: 03/27/2008.
    Accession Number: 20080328-0132.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 08, 2008.

    Docket Numbers: RP08-283-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Maritimes & Northeast Pipeline, LLC submits Second
Revised Sheet 400 et al. to FERC Gas Tariff, First Revised Volume 1, to
become effective April 27, 2008.
    Filed Date: 03/27/2008.
    Accession Number: 20080328-0077.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 08, 2008.
    Docket Numbers: RP08-284-000.
    Applicants: Pine Needle LNG Company, LLC.
    Description: Pine Needle LNG Company LLC submits Fifteenth Revised
Sheet 4 to its FERC Gas Tariff, Original Volume 1, to become effective
May 1, 2008.
    Filed Date: 03/27/2008.
    Accession Number: 20080328-0113.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 08, 2008.

    Docket Numbers: RP08-287-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Annual Incidental Purchases and Sales Report of
Rockies Express Pipeline LLC.
    Filed Date: 03/28/2008.
    Accession Number: 20080328-5093.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 09, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-7017 Filed 4-3-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Rules and Regulations]
[Pages 40071-40081]
[FR Doc No: 2023-13154]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0163; Project Identifier AD-2022-01380-T;
Amendment 39-22468; AD 2023-12-10]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2022-02-
16, which applied to all The Boeing Company Model 787-8, 787-9, and
787-10 airplanes. AD 2022-02-16 required revising the limitations and
operating procedures sections of the existing airplane flight manual
(AFM) to incorporate limitations prohibiting certain landings and the
use of certain minimum equipment list (MEL) items, and to incorporate
operating procedures for calculating landing distances, when in the
presence of interference from wireless broadband operations in the 3.7-
3.98 GHz frequency band (5G C-Band) as identified by Notices to Air
Missions (NOTAMs). Since the FAA issued AD 2022-02-16, the FAA
determined that additional limitations are needed due to the continued
deployment of new 5G C-Band stations whose signals are expected to
cover most of the contiguous United States at transmission frequencies
between 3.7-3.98 GHz. This AD requires revising the limitations section
of the existing AFM to incorporate limitations prohibiting certain
landings and the use of certain MEL items, and retains the operating
procedures from AD 2022-02-16 for calculating landing distances, due to
the presence of 5G C-Band interference. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective June 21, 2023.

ADDRESSES: AD Docket: You may examine the AD docket at regulations.gov
under Docket No. FAA-2023-0163; 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 final rule, any comments
received, and other information. The address for Docket Operations is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Brett Portwood, Continued Operational
Safety Technical Advisor, COS Program Management Section, Operational
Safety Branch, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712-4137;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2022-02-16, Amendment 39-21913 (87 FR 2692,
January 19, 2022) (AD 2022-02-16). AD 2022-02-16 applied to all The
Boeing Company (Boeing) Model 787-8, 787-9, and 787-10 airplanes. The
NPRM published in the Federal Register on May 3, 2023 (88 FR 27716).
    The NPRM was prompted by a determination that radio altimeters
cannot be relied upon to perform their intended function if they
experience 5G C-Band interference, and a determination that, during
landings, as a result of this interference, certain airplane systems
may not properly transition from AIR to GROUND mode when landing on
certain runways, resulting in a longer landing distance than normal due
to the effect on thrust reverser deployment, speedbrake deployment, and
increased idle thrust.
    In the NPRM, the FAA proposed to retain the AFM revisions required
by AD 2022-02-16 until June 30, 2023. On or before June 30, 2023, the
FAA proposed to require replacing those AFM revisions with limitations
prohibiting the same landings and use of certain MEL items at all
airports for non-radio altimeter tolerant airplanes. For radio
altimeter tolerant airplanes, the FAA proposed to allow the prohibited
operations at 5G C-Band mitigated airports (5G CMAs) as identified in
an FAA Domestic Notice. Lastly, the FAA proposed to retain the
operating procedures from AD 2022-02-16 for calculating landing
distances. The FAA proposed this AD to address degraded deceleration
performance and longer landing distance, which could lead to a runway
excursion.

Discussion of Final Airworthiness Directive

Comments

    The FAA provided the public with an opportunity to comment on the
proposed AD and received comments from five commenters. The following
presents the comments received on the NPRM and the FAA's response to
each comment.

Support for NPRM

    Boeing and the Air Line Pilots Association, International (ALPA),
supported the NPRM without change.
    The supportive comments from ALPA included additional viewpoints
without a suggestion specific to the AD or a request the FAA can act
on. These comments are outside the scope of this final rule.

Request To Revise AFM Limitations

    Comment summary: All Nippon Airways Co., Ltd. (All Nippon),
requested the FAA revise paragraph (h)(2) of the proposed AD to refer
to the new landing distances instead of HYD PRESS L+R failure
distances, based on the new landing distance tables established by
Boeing.
    FAA response: The FAA has not received or reviewed a new landing
distance table as described by the commenter. Anyone may propose
alternative data to address the unsafe condition under the AMOC
procedures referenced in paragraph (k) of this AD.

Request for Additional AMOC Relief

    Comment summary: All Nippon requested that the FAA revise the
proposed AD to allow AMOCs approved for AD 2023-10-02, Amendment 39-
22438 (88 FR 34065, May 26, 2023) (AD 2023-10-02) as AMOCs for the new
AFM revisions for radio altimeter tolerant airplanes specified in
paragraph (j) of the proposed AD.
    FAA response: The FAA does not agree. An airplane that is a radio
altimeter tolerant airplane for purposes of AD 2023-10-02 will also be
a radio altimeter tolerant airplane for purposes of this AD. However,
because the hazards mitigated by AD 2023-10-02 are separate and
distinct from the hazards mitigated by this AD, the FAA has determined
that AMOCs approved for compliance with AD 2023-10-02 may not always be
appropriate to address the unsafe condition specified in this AD. For
this reason, operators with an approved AMOC for AD 2023-10-02 will
need to request approval of

it as an AMOC for compliance with this AD.

Request To Extend Compliance Time

    Comment summary: All Nippon and American Airlines expressed concern
regarding the compliance time for the proposed actions and requested
the FAA revise the AD to provide a minimum of 3 to 4 weeks from the
effective date of the AD.
    FAA response: The FAA understands the commenters' concerns and made
every effort to publish this AD as soon as possible. After refraining
from operating at their FCC-authorized levels for a year and a half,
wireless companies are now able to operate at higher levels, yet still
not at the levels authorized. Specifically, wireless companies expect
to operate their networks in urban areas with minimal restrictions due
to the completion of retrofits. Additionally, the FAA anticipates 19
additional telecommunication companies will begin transmitting in the
C-Band after June 30, 2023. Although the FAA continues to work with the
companies that intend to transmit in the 3.7-3.98-GHz band near 5G
CMAs, the FAA has no agreement with those companies to provide the FAA
with tower locations and other information necessary to support the
current NOTAM/AMOC process. Therefore, the FAA will not be able to
extend the compliance date beyond June 30, 2023.

Request for Clarification of Domestic Notices and 5G CMA List

    Comment summary: Virgin Atlantic requested clarification on how to
access Domestic Notices, as well as the mechanism to know when an
airport is no longer on the 5G CMA list.
    FAA response: The Domestic Notice referenced in this AD can be
found at https://www.faa.gov/air_traffic/publications/domesticnotices/domestic_gen.html. The FAA considers this 5G CMA list permanent based
upon the voluntary agreements in place with the telecommunication
companies. In the event an airport from the 5G CMA list needs to be
removed, the FAA will issue a NOTAM until a more permanent solution is
put in place.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. This AD is adopted as proposed in the
NPRM.

Interim Action

    The FAA considers this AD to be an interim action. Once the
Technical Standard Order (TSO) standard for radio altimeters is
established, which will follow the existing international technical
consensus on the establishment of the minimum operational performance
standards (MOPS), the FAA anticipates that the MOPS will be
incorporated into the TSO. Once a new radio altimeter TSO is developed,
approved, and available, the FAA might consider additional rulemaking.

Effective Date

    Section 553(d) of the Administrative Procedure Act (APA) (5 U.S.C.
551 et seq.) requires publication of a rule not less than 30 days
before its effective date. However, section 553(d) authorizes agencies
to make rules effective in less than 30 days when the agency finds
``good cause.'' Radio altimeters cannot be relied upon to perform their
intended function if they experience interference from wireless
broadband operations in the 5G C-Band. During landings, as a result of
this interference, certain airplane systems may not properly transition
from AIR to GROUND mode when landing on certain runways, resulting in a
longer landing distance than normal due to the effect on thrust
reverser deployment, speedbrake deployment, and increased idle thrust,
which could lead to a runway excursion. To address this unsafe
condition, the actions required by this AD must be accomplished before
the compliance date of June 30, 2023. The FAA based this date on the
changes to the 5G C-Band environment beginning on July 1, 2023. These
changes include increased wireless broadband deployment and
transmissions closer to the parameters authorized by the FCC. The
earlier operators learn of the requirements in this AD, the earlier
they can take action to ensure compliance. An effective date less than
30 days would ensure the AD is codified earlier, thereby increasing
awareness of its requirements. Therefore, the FAA finds that good cause
exists pursuant to 5 U.S.C. 553(d) for making this amendment
immediately effective.

Costs of Compliance

    The cost information below describes the costs to change the AFM.
Although this AD largely maintains the AFM limitations currently
required by AD 2022-02-16, the FAA acknowledges that this AD may also
impose costs on some aircraft operators from having to change their
conduct to comply with the amended AFM. However, the FAA lacks the data
necessary to quantify the costs associated with aircraft operators
changing their conduct.
    The FAA estimates that this AD affects 145 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
AFM revision (retained action from AD   1 work-hour x $85 \1\                 $0             $85         $12,325
 2022-02-16).                            per hour = $85.
New AFM revision (new required action)  1 work-hour x $85 per                  0              85      \2\ 12,325
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------
\1\ The labor rate of $85 per hour is the average wage rate for an aviation mechanic.
\2\ The estimated cost for this revision would not constitute a significant economic impact (even for small
  entities) because $85 is a minimal cost compared to the regular costs of maintaining and operating a Model 787-
  8, 787-9, or 787-10 transport category airplane.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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:
0
a. Removing Airworthiness Directive (AD) 2022-02-16, Amendment 39-21913
(87 FR 2692, January 19, 2022), and
0
b. Adding the following new AD:

2023-12-10 The Boeing Company: Amendment 39-22468; Docket No. FAA-
2023-0163; Project Identifier AD-2022-01380-T.

(a) Effective Date

    This airworthiness directive (AD) is effective June 21, 2023.

(b) Affected ADs

    This AD replaces AD 2022-02-16, Amendment 39-21913 (87 FR 2692,
January 19, 2022) (AD 2022-02-16).

(c) Applicability

    This AD applies to all The Boeing Company Model 787-8, 787-9,
and 787-10 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by a determination that radio altimeters
cannot be relied upon to perform their intended function if they
experience interference from wireless broadband operations in the
3.7-3.98 GHz frequency band (5G C-Band), and a determination that,
during landings, as a result of this interference, certain airplane
systems may not properly transition from AIR to GROUND mode when
landing on certain runways, resulting in a longer landing distance
than normal due to the effect on thrust reverser deployment,
speedbrake deployment, and increased idle thrust. The FAA is issuing
this AD to address degraded deceleration performance and longer
landing distance, which could lead to a runway excursion.

(f) Compliance

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

(g) Definitions

    (1) For purposes of this AD, a ``5G C-Band mitigated airport''
(5G CMA) is an airport at which the telecommunications companies
have agreed to voluntarily limit their 5G deployment at the request
of the FAA, as identified by an FAA Domestic Notice.
    (2) For purposes of this AD, a ``radio altimeter tolerant
airplane'' is one for which the radio altimeter, as installed,
demonstrates the tolerances specified in paragraphs (g)(2)(i) and
(ii) of this AD, using a method approved by the FAA.
    (i) Tolerance to radio altimeter interference, for the
fundamental emissions (3.7-3.98 GHz), at or above the power spectral
density (PSD) curve threshold specified in figure 1 to paragraph
(g)(2)(i) of this AD.

BILLING CODE 4910-13-P

Figure 1 to paragraph (g)(2)(i)--Fundamental Effective Isotropic PSD
at Outside Interface of Aircraft Antenna
[GRAPHIC] [TIFF OMITTED] TR21JN23.092

    (ii) Tolerance to radio altimeter interference, for the spurious
emissions (4.2-4.4 GHz), at or above the PSD curve threshold
specified in figure 2 to paragraph (g)(2)(ii) of this AD.

Figure 2 to paragraph (g)(2)(ii)--Spurious Effective Isotropic PSD
at Outside Interface of Aircraft Antenna
[GRAPHIC] [TIFF OMITTED] TR21JN23.093

    (3) For purposes of this AD, a ``non-radio altimeter tolerant
airplane'' is one for which the radio altimeter, as installed, does
not demonstrate the tolerances specified in paragraphs (g)(2)(i) and
(ii) of this AD.
    (4) Runway condition codes are defined in figure 3 to paragraph
(g)(4) of this AD.

Figure 3 to paragraph (g)(4)--Runway Condition Codes

[GRAPHIC] [TIFF OMITTED] TR21JN23.094

(h) Retained Airplane Flight Manual (AFM) Revision

    This paragraph restates the requirements of paragraph (h) of AD
2022-02-16.
    (1) Within 2 days after January 19, 2022 (the effective date of
AD 2022-02-16): Revise the Limitations Section of the existing AFM
to include the information specified in figure 4 to paragraph (h)(1)
of this AD. This may be done by inserting a copy of figure 4 to
paragraph (h)(1) of this AD into the existing AFM.

Figure 4 to paragraph (h)(1)--AFM Limitations Revisions
[GRAPHIC] [TIFF OMITTED] TR21JN23.095

    (2) Within 2 days after January 19, 2022 (the effective date of
AD 2022-02-16): Revise the Operating Procedures Section of the
existing AFM to include the information specified in figure 5 to
paragraph (h)(2) of this AD. This may be done by inserting a copy of
figure 5 to paragraph (h)(2) of this AD into the existing AFM.

Figure 5 to paragraph (h)(2)--AFM Operating Procedures Revision
[GRAPHIC] [TIFF OMITTED] TR21JN23.096

[GRAPHIC] [TIFF OMITTED] TR21JN23.097

[GRAPHIC] [TIFF OMITTED] TR21JN23.098

(i) New Requirement: AFM Revision for Non-Radio Altimeter Tolerant
Airplanes

    For non-radio altimeter tolerant airplanes, do the actions
specified in paragraphs (i)(1) and (2) of this AD.
    (1) On or before June 30, 2023, revise the Limitations Section
of the existing AFM to include the information specified in figure 6
to paragraph (i) of this AD. This may be done by inserting a copy of
figure 6 to paragraph (i) of this AD into the existing AFM.
Incorporating the AFM revision required by this paragraph terminates
the AFM revision required by paragraph (h)(1) of this AD.
    (2) Before further flight after incorporating the limitations
specified in figure 6 to paragraph (i) of this AD, remove the AFM
revision required by paragraph (h)(1) of this AD.

Figure 6 to paragraph (i)--AFM Revision for Non-Radio Altimeter
Tolerant Airplanes
[GRAPHIC] [TIFF OMITTED] TR21JN23.099

(j) New Requirement: AFM Revision for Radio Altimeter Tolerant
Airplanes

    For radio altimeter tolerant airplanes, do the actions specified
in paragraphs (j)(1) and (2) of this AD.
    (1) On or before June 30, 2023, revise the Limitations Section
of the existing AFM to include the information specified in figure 7
to paragraph (j) of this AD. This may be done by inserting a copy of
figure 7 to paragraph (j) of this AD into the existing AFM.
Incorporating the AFM revision required by this paragraph terminates
the AFM revision required by paragraph (h)(1) of this AD.
    (2) Before further flight after incorporating the limitations
specified in figure 7 to paragraph (j) of this AD, remove the AFM
revision required by paragraph (h)(1) of this AD.

Figure 7 to paragraph (j)--AFM Revision for Radio Altimeter Tolerant
Airplanes
[GRAPHIC] [TIFF OMITTED] TR21JN23.100

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Operational Safety 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the manager of the Operational Safety 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 responsible Flight Standards Office.
    (3) AMOCs approved for AD 2021-23-12, Amendment 39-21810 (86 FR
69984, December 9, 2021), providing relief for specific radio
altimeter installations are approved as AMOCs for the requirements
specified in paragraph (h) of this AD until June 30, 2023.

(l) Related Information

    For more information about this AD, contact Brett Portwood,
Continued Operational Safety Technical Advisor, COS Program
Management Section, Operational Safety Branch, FAA, 3960 Paramount
Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; email:
[email protected].

(m) Material Incorporated by Reference

    None.

    Issued on June 9, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-13154 Filed 6-16-23; 11:15 am]
BILLING CODE 4910-13-C


[Federal Register: October 30, 2009 (Volume 74, Number 209)]
[Notices]
[Page 56246-56247]
[DOCID:fr30oc09-99]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 12b-1; SEC File No. 270-188; OMB Control No. 3235-0212.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget a request for extension of the previously
approved collection of information discussed below.
    Rule 12b-1 (17 CFR 270.12b-1) permits a registered open-end
investment company (``mutual fund'') to distribute its own shares and
pay the expenses of distribution out of the mutual fund's assets
provided, among other things, that the mutual fund adopts a written
plan (``Rule 12b-1 plan'') and has in writing any agreements relating
to the implementation of the Rule 12b-1 plan. The rule in part requires
that (i) the adoption or material amendment of a Rule 12b-1 plan be
approved by the mutual fund's directors and shareholders; (ii) the
board review quarterly reports of amounts spent under the Rule 12b-1
plan; and (iii) the board consider continuation of the Rule 12b-1 plan
at least annually. Rule 12b-1 also requires funds relying on the rule
to preserve for six years, the first two years in an easily accessible
place, copies of the Rule 12b-1 plan, related agreements and reports,
as well as minutes of board meetings that describe the factors
considered and the basis for adopting or continuing a Rule 12b-1 plan.
    The board and shareholder approval requirements of Rule 12b-1 are
designed to ensure that fund shareholders and directors receive
adequate information to evaluate and approve a Rule 12b-1 plan. The
requirement of quarterly reporting to the board is designed to ensure
that the Rule 12b-1 plan continues to benefit the fund and its
shareholders. The recordkeeping requirements of the rule are necessary
to enable Commission staff to oversee compliance with the rule.
    Based on information filed with the Commission by funds, Commission
staff estimates that there are approximately 6,871 mutual fund
portfolios have at least one share class subject to a Rule 12b-1
plan.\1\ However, many of these portfolios are part of an affiliated
group of funds known as a ``mutual fund family'' that is overseen by a
common board of directors. Although the board must review and approve
the Rule 12b-1 plan for each fund separately, we have allocated the
costs and hourly burden related to Rule 12b-1 based on the number of
fund families that have at least one fund that charges 12b-1 fees,
rather than on the total number of mutual fund portfolios that
individually have a 12b-1 plan.\2\ Based on information filed with the
Commission, the staff estimates that there are approximately 371 fund
families with common boards of directors that have at least one fund
with a 12b-1 plan.
---------------------------------------------------------------------------

    \1\ This estimate is based on information from the Commission's
NSAR database.
    \2\ This allocation is based on conversations with fund
representatives on how fund boards comply with the requirements of
Rule 12b-1. Despite this allocation of hourly burdens and costs, the
number of annual responses each year will continue to depend on the
number of fund portfolios with 12b-1 plans rather than the number of
fund families with 12b-1 plans. The staff estimates that the number
of annual responses per fund portfolio will be four per year
(quarterly, with the annual reviews taking place at one of the
quarterly intervals). Thus, we estimate that funds will make 27,484
responses (6871 fund portfolios x 4 responses per fund portfolio=
27,484 responses) each year.
---------------------------------------------------------------------------

    Based on conversations with fund representatives, Commission staff
estimates that for each of the 371 mutual fund families with a
portfolio that has a Rule 12b-1 plan, the average annual burden of
complying with the rule is 425 hours. This estimate takes into account
the time needed to prepare quarterly reports to the board of directors,
the board's consideration of those reports, and the board's annual
consideration of whether to continue the plan.\3\ We therefore estimate
that the total hourly burden per year for all funds to comply with
current information collection requirements under Rule 12b-1, is
157,675 hours (371 fund families x 425 hours per fund family = 157,675
hours) over the three year period for which we are requesting approval
of the information collection burden).
---------------------------------------------------------------------------

    \3\ We do not estimate any costs or time burden related to the
recordkeeping requirement, as funds are already required to maintain
these records pursuant to other rules, and would keep these records
in any case as a matter of business practice.
---------------------------------------------------------------------------

    If a currently operating fund seeks to (i) adopt a new Rule 12b-1
plan or (ii) materially increase the amount it spends for distribution
under its Rule 12b-1 plan, Rule 12b-1 requires that the fund obtain
shareholder approval. As a consequence, the fund will incur the cost of
a proxy. Based on conversations with fund industry representatives,
Commission staff estimates that approximately three funds per year
prepare a proxy in connection with the adoption or material amendment
of a Rule 12b-1 plan. The staff further estimates that the cost of each
fund's proxy is $30,000. Thus the total annual cost burden of Rule 12b-
1 to the fund industry is $90,000 (3 funds requiring a proxy x $30,000
per proxy).
    The collections of information required by Rule 12b-1 are necessary
to obtain the benefits of the rule. Notices to the Commission will not
be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless
it displays a currently valid control number.
    Please direct general comments regarding the above information to
the following persons: (i) Desk Officer for the Securities and Exchange
Commission, Office of Management and Budget, Room 10102, New Executive
Office Building, Washington, DC 20503 or send an e-mail to Shagufta
Ahmed at<EMAIL_ADDRESS>and (ii) Charles Boucher,
Director/CIO, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: October 26, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-26175 Filed 10-29-09; 8:45 am]

BILLING CODE 8011-01-P