[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18828-18829]
[FR Doc No: 2012-7418]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0577]

Guidance for Industry and Food and Drug Administration Staff;
Factors To Consider When Making Benefit-Risk Determinations in Medical
Device Premarket Approval and de Novo Classifications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance document entitled ``Factors to Consider
When Making Benefit-Risk Determinations in Medical Device Premarket
Approval and De Novo Classifications.'' This guidance is intended to
provide greater clarity on FDA's decisionmaking process with regard to
benefit-risk determinations in the premarket review of medical devices
in the premarket approval and de novo pathways.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Factors to Consider When Making Benefit-Risk
Determinations in Medical Device Premarket Approval and De Novo
Classifications'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002; or to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist in processing your request, or
fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For devices regulated by CDRH: Ruth Fischer, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4424, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    There are many factors that go into assessing the probable benefit
of a device versus its probable risk. This guidance sets out the
principal factors FDA considers when making this determination and
explains them in detail. This guidance also gives examples of how the
factors interrelate and how they may affect FDA's decisions. By
clarifying FDA's decisionmaking process in this way, we hope to improve
the predictability, consistency, and transparency of the review process
for applicable devices. The factors described in this guidance apply to
devices submitted under premarket approval applications and de novo
petitions.
    This guidance also includes a worksheet that reviewers will use in
making benefit-risk determinations for applicable devices. The
worksheet is attached as Appendix B to the guidance, and examples of
how reviewers might use the worksheet are attached as Appendix C to the
guidance. This level of documentation is very helpful to maintaining
the consistency of review across the different review divisions and
better assuring that an appropriate decision is reached.
    In the Federal Register of August 15, 2011 (76 FR 50483), FDA
announced the availability of the draft guidance. Interested persons
were invited to comment by November 14, 2011. FDA considered the
comments and revised the guidance, as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on factors to consider when making benefit-
risk determinations in medical device premarket approval and de novo
classifications. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability is available for all CDRH
guidance documents at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at either http://www.regulations.gov or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Factors to Consider When Making Benefit-Risk Determinations in
Medical Device Premarket Approval and De Novo Classifications'' from
CDRH, you may either send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1772 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    FDA concludes that this guidance contains no new collections of
information. The guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of

Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
807, subpart E, have been approved under OMB control number 0910-0120;
and the collections of information in 21 CFR part 814 have been
approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 22, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7418 Filed 3-27-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 93 (Monday, May 15, 2023)]
[Proposed Rules]
[Pages 30911-30914]
[FR Doc No: 2023-10251]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1043; Project Identifier MCAI-2022-01295-E]
RIN 2120-AA64

Airworthiness Directives; Safran Helicopter Engines, S.A. Engines

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 Safran Helicopter Engines, S.A. (Safran) Model Arrius 2B2
engines. This proposed AD was prompted by the manufacturer revising the
airworthiness limitations section (ALS) of the existing engine
maintenance manual (EMM), introducing new and more restrictive tasks
and limitations for certain life-limited parts. This proposed AD would
require revising the ALS of the existing EMM or instructions for
continued airworthiness (ICA) and the existing approved maintenance or
inspection program, as applicable, by incorporating the actions and
associated thresholds and intervals, including life limits, 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 NPRM by June 29, 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-2023-1043; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For service information that is proposed for IBR in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
phone: +49 221 8999 000; email: [email protected]. You may find this
material on the EASA website at ad.easa.europa.eu. It is also available
at regulations.gov under Docket No. FAA-2023-1043.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kevin Clark, Aviation Safety Engineer,
International Validation Branch, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; 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-2023-1043; Project Identifier
MCAI-2022-01295-E'' 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 Kevin
Clark, Aviation Safety Engineer, International Validation Branch, FAA,
1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that
the FAA receives which 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 2022-0203, dated September 30, 2022
(EASA AD 2022-0203) (referred to after this as the MCAI), to address an
unsafe condition for all Safran Model Arrius 2B2 engines. The MCAI
states that the manufacturer published a revised ALS introducing new
and more restrictive tasks and limitations for certain life-limited
parts. The more restrictive tasks and limitations include replacing
life-limited parts before exceeding the applicable life limit,
performing applicable maintenance tasks, and revising the approved
aircraft maintenance program.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-1043.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2022-0203, which specifies instructions
for accomplishing the actions specified in the applicable ALS,
including replacing life-limited parts, performing maintenance tasks,
and revising the existing approved aircraft maintenance program by
incorporating the limitations, tasks, and associated thresholds and
intervals described in the ALS.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI. The FAA is issuing this NPRM after determining that the
unsafe condition described previously is likely to exist or develop in
other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in the MCAI described previously, except for any differences as
discussed under ``Differences Between this Proposed AD and the MCAI.''
The owner/operator (pilot) holding at least a private pilot certificate
may revise the ALS of the existing EMM or ICA and the existing approved
maintenance or inspection program, as applicable for the engine, and
must enter compliance with the applicable paragraphs of the AD into the
engine maintenance records in accordance with 14 CFR 43.9(a) and
91.417(a)(2)(v). The record must be maintained as required by 14 CFR
91.417, 121.380, or 135.439. This action could be performed equally
well by a pilot or a mechanic. This is an exception to the FAA's
standard maintenance regulations.

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 since
coordinated with other manufacturers and CAAs to

use this process. As a result, the FAA proposes to incorporate by
reference EASA AD 2022-0203 in the FAA final rule. Service information
required by the EASA AD for compliance will be available at
regulations.gov by searching for and locating Docket No. FAA-2023-1043
after the FAA final rule is published.

Differences Between This Proposed AD and the MCAI

    Paragraph (1) of EASA AD 2022-0203 requires replacing each
component before exceeding the applicable life limit and, within the
thresholds and intervals, accomplishing all applicable maintenance
tasks after its effective date, this proposed AD would require revising
the ALS of the existing EMM or ICA and the existing approved
maintenance or inspection program, as applicable, by incorporating the
actions specified in paragraph (1) of EASA AD 2022-0203, within 90 days
after the effective date of this AD. This proposed AD would not require
compliance with paragraphs (2) through (5) of EASA AD 2022-0203.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 185 engines installed on helicopters of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Revise the ALS......................  1 work-hour x $85 per                $0              $85          $15,725
                                       hour = $85.
----------------------------------------------------------------------------------------------------------------

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:

Safran Helicopter Engines, S.A.: Docket No. FAA-2023-1043; Project
Identifier MCAI-2022-01295-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by June 29, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Safran Helicopter Engines, S.A. Model
Arrius 2B2 engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7200, Engine
(Turbine/Turboprop).

(e) Unsafe Condition

    This AD was prompted by the manufacturer revising the
airworthiness limitations section (ALS) of the existing engine
maintenance manual (EMM), introducing new and more restrictive tasks
and limitations for certain life-limited parts. The FAA is issuing
this AD to prevent failure of life-limited parts. The unsafe
condition, if not addressed, could result in failure of one or more
engines, loss of thrust control, and loss of the helicopter.

(f) Compliance

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

(g) Required Actions

    (1) Within 90 days after the effective date of this AD, revise
the ALS of the existing EMM or instructions for continued
airworthiness and the existing approved maintenance or inspection
program, as applicable, by incorporating the actions specified in
paragraph (1) of European Union Aviation Safety Agency (EASA) AD
2022-0203, dated September 30, 2022 (EASA AD 2022-0203).
    (2) The action required by paragraph (g)(1) of this AD may be
performed by the owner/operator (pilot) holding at least a private
pilot certificate and must be entered into the aircraft records
showing compliance with this AD in accordance with 14 CFR 43.9(a)
and 91.417(a)(2)(v). The record must be maintained as required by 14
CFR 91.417, 121.380, or 135.439.

(h) Provisions for Alternative Actions and Intervals

    After the actions required by paragraph (g) of this AD have been
done, no alternative actions and associated thresholds and
intervals, including life limits, are allowed unless they are
approved as specified in the provisions of the ``Ref. Publication''
section of EASA AD 2022-0203.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, nternational 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 certification office, send it to the attention of
the person identified in paragraph (j) of this AD and email 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.

(j) Additional Information

    For more information about this AD, contact Kevin Clark,
Aviation Safety Engineer, International Validation Branch, FAA, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (781) 238-
7088; email: [email protected].

(k) 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 the AD specifies otherwise.
    (i) European Union Aviation Safety Agency AD 2022-0203, dated
September 30, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0203, contact EASA, Konrad Adenauer-Ufer 3,
50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]. You may find this material on the EASA website
at ad.easa.europa.eu.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information 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 May 9, 2023.
Gaetano A. Sciortino,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-10251 Filed 5-12-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Rules and Regulations]
[Pages 39072-39073]
[FR Doc No: 2020-14141]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2020-0388]

Safety Zones; Recurring Safety Zones in Captain of the Port Sault
Sainte Marie Zone for Events in July

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will establish safety zones for the St. Ignace
Festivals of Fireworks Celebration fireworks starting in July, 2020 to
provide for the safety of life on navigable waterways. Our regulation
for safety zones within the Captain of the Port Sault Sainte Marie Zone
identifies the regulated area for these safety zones. During the
enforcement periods, vessels must stay out of the established safety
zone and may only enter with permission from the designated
representative of the Captain of the Port Sault Sainte Marie.

DATES: The regulations in 33 CFR 165.918 will be enforced on Saturday
nights from July 4, 2020, through September 6, 2020, from thirty
minutes before sunset to thirty minutes after the end of the fireworks
display.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email BOSN4 Robert Gruschow, Waterways
Management, U.S. Coast Guard Sector

Sault Sainte Marie; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones in 33 CFR 165.918 as per the time, dates, and locations in Table
1.

                                 Table 1
                            [Datum NAD 1983]
------------------------------------------------------------------------
             Event                     Location            Event date
------------------------------------------------------------------------
(4) Festivals of Fireworks      All U.S. navigable      Beginning July
 Celebration Fireworks; St.      waters of East Moran    4th and
 Ignace, MI.                     Bay within an           following
                                 approximate 1000-foot   Saturdays to
                                 radius from the         September 6,
                                 fireworks launch site   2020; 30
                                 at the end of the       minutes before
                                 Starline Mill Slip,     sunset and 30
                                 centered in position    minutes after
                                 45[deg]52'24.62'' N,    the end of the
                                 084[deg]43'18.13'' W.   fireworks
                                                         display.
------------------------------------------------------------------------

    This action is being taken to protect the safety of life and
property on navigable waters prior to, during, and immediately after
firework displays. During the enforcement period, no vessel may transit
this regulated area without approval from the Captain of the Port Sault
Sainte Marie or a designated representative. Vessels and persons
granted permission to enter the safety zone shall obey all lawful
orders or directions of the Captain of the Port Sault Sainte Marie, or
an on-scene representative.
    This notice of enforcement is issued under authority of 33 CFR
165.930 and 5 U.S.C. 552(a). In addition to this document in the
Federal Register, the Coast Guard will also provide notice through
other means, which will include Broadcast Notice to Mariners, Local
Notice to Mariners, distribution in leaflet form, and on-scene oral
notice. The Captain of the Port Sault Sainte Marie or a designated on-
scene representative may be contacted via Channel 16, VHF-FM or at
(906) 635-3319.

    Dated: June 25, 2020.
P.S. Nelson,
Captain, U.S. Coast Guard, Captain of the Port Sault Sainte Marie.
[FR Doc. 2020-14141 Filed 6-29-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: July 19, 2010 (Volume 75, Number 137)]
[Notices]
[Page 41922]
[DOCID:fr19jy10-133]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at Fort Smith Regional Airport, Fort Smith, AR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release airport property.

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

SUMMARY: The FAA proposes to rule and invites public comment on the
release of land at Fort Smith Regional Airport under the provisions of
Title 49, U.S.C. Section 47153(c).

DATES: Comments must be received on or before August 18, 2010.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Mr. Edward N. Agnew, Manager, Federal
Aviation Administration, Southwest Region, Airports Division, Arkansas/
Oklahoma Airports Development Office, ASW-630, 2601 Meacham Boulevard,
Fort Worth, Texas 76137.
    In addition, one copy of any comments submitted to the FM must be
mailed or delivered to Mr. John Parker, Airport Director, Fort Smith
Regional Airport, at the following address: Fort Smith Regional
Airport, 6700 McKennon Blvd., Suite 200, Fort Smith, AR 72903.

FOR FURTHER INFORMATION CONTACT: Mr. Jimmy Pierre, Federal Aviation
Administration, Airports Development Office, ASW-630, 2601 Meacham
Boulevard, Fort Worth, Texas 76137.
    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the Fort Smith Regional Airport.
    On June 24, 2010, the FAA determined that the request to release
property at Fort Smith Regional Airport submitted by the City of Fort
Smith met the procedural requirements of the Federal Aviation
Regulations, Part 155. The FAA may approve the request, in whole or in
part, no later than August 1, 2010.
    The following is a brief overview of the request:
    The Fort Smith Regional Airport requests the release of 2.11 acres
of airport property. The release of property will allow the Arkansas
Highway Department to make improvements to Highway 255 and Century
Drive. The release will also allow the airport to receive, in exchange
for the 2.11 acres, a cash payment in the amount of $257,400.00, which
the Airport will use toward AlP eligible taxiway improvements in the
general aviation area at Fort Smith Regional Airport.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the application,
notice and other documents germane to the application in person at the
Fort Smith Regional Airport.

    Issued in Fort Worth, Texas, on June 24, 2010.
Kelvin L. Solco,
Manager, Airports Division.
[FR Doc. 2010-17292 Filed 7-16-10; 8:45 am]
BILLING CODE 4910-13-M


[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Page 47058]
[FR Doc No: 2012-19278]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[P-2079-069--CA]

Middle Fork American River Hydroelectric Project Placer County
Water Agency; Notice of Draft Environmental Impact Statement; Public
Meetings

    a. Date and Time of Meetings: Tuesday, August 28, 2012, from 9:00
a.m. to 11:00 a.m. and from 7:00 p.m. to 9:00 p.m. (Pacific Time).
    b. Location: The Holiday Inn Auburn, 120 Grass Valley Highway,
Auburn, California 95603, Telephone:<PHONE_NUMBER>.
    c. FERC Contact: Carolyn Templeton,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    d. Purpose of the Meeting: Commission staff will hold two public
meetings for the purpose of receiving verbal and/or written comments on
the draft environmental impact statement for the Middle Fork American
River Project No. 2079. The daytime meeting will focus on resource
agency, Indian tribes, and non-governmental organization comments,
while the evening meeting is primarily for receiving input from the
public. All interested individuals and entities are invited to attend
one or both of the public meetings. The meetings will be recorded by a
court reporter, and all statements will become part of the Commission's
public record for the project. This meeting is posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.
    e. All local, state, and federal agencies, tribes, and interested
parties, are hereby invited to participate in the meeting.

    Dated: July 31, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-19278 Filed 8-6-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Notices]
[Pages 3694-3696]
[FR Doc No: 2020-00936]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-E-3053 and FDA-2018-E-4226]

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

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 MAVYRET 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 patents which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by March 23, 2020.
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 July 20, 2020. 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 March 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 23, 2020. 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 Nos.
FDA-2018-E-3053 and FDA-2018-E-4226 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; MAVYRET.'' 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 MAVYRET (a
fixed dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A
protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor). MAVYRET
is indicated for treatment of patients with chronic HCV genotype 1, 2,
3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis
(Child-Pugh A). MAVYRET is also indicated for the treatment of adult
patients with HCV genotype 1 infection, who previously have been
treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A
protease inhibitor, but not both. Subsequent to this approval, the
USPTO received patent term restoration applications for MAVYRET (U.S.
Patent Nos. 8,937,150 and 9,586,978) from AbbVie, Inc., and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated May 13, 2019, FDA advised
the USPTO that this human drug product had undergone a regulatory
review period and that the

approval of MAVYRET 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
MAVYRET is 1,725 days. Of this time, 1,492 days occurred during the
testing phase of the regulatory review period, while 233 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:
November 14, 2012. FDA has verified the applicant's claim that the date
the investigational new drug applications became effective was on
November 12, 2012.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
14, 2016. FDA has verified the applicant's claim that the new drug
application (NDA) for MAVYRET (NDA 209394) was initially submitted on
December 14, 2016.
    3. The date the application was approved: August 3, 2017. FDA has
verified the applicant's claim that NDA 209394 was approved on August
3, 2017.
    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 0 days or 150 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: January 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00936 Filed 1-21-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Page 92813]
[FR Doc No: 2016-30544]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-527-000]

InterGen Energy Solutions, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
InterGen Energy Solutions, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 3, 2017.
    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
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
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>.

    Dated: December 13, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-30544 Filed 12-19-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Proposed Rules]
[Pages 60303-60307]
[FR Doc No: 2015-25272]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3983; Directorate Identifier 2015-NM-141-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-
200B, 747-300, 747SR, and 747SP series airplanes. This proposed AD was
prompted by an evaluation by the design approval holder (DAH)
indicating that the upper chords of the upper deck floor beams are
subject to widespread fatigue damage (WFD). This proposed AD would
require repetitive inspections for cracks at the floor panel attachment
fastener holes; repetitive inspections for cracks in the upper and
lower chords of the upper deck floor beams at permanent fastener
locations; repetitive inspections for cracks in certain repaired and
modified areas; and related investigative and corrective actions if
necessary. This proposed AD would also require repetitive replacement
of the upper chords of the upper deck floor beams, including pre-
replacement inspections and corrective action if necessary; and post-
replacement repetitive inspections and repair if necessary. We are
proposing this AD to detect and correct fatigue cracking of the upper
chords of the upper deck floor beams. Undetected cracking could result
in large deflection or deformation of the upper deck floor beams,
resulting in damage to wire bundles and control cables for the flight
control system, and reduced controllability of the airplane. Multiple
adjacent severed floor beams could result in rapid decompression of the
airplane.

DATES: We must receive comments on this proposed AD by November 20,
2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3983.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3983; 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

(phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Roger Caldwell, Aerospace Engineer,
Technical Operations Center, ANM-100D, FAA, Denver Aircraft
Certification Office, 26805 East 68th Avenue, Room 214, Denver, CO
80249; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
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-2015-3983;
Directorate Identifier 2015-NM-141-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

    Structural fatigue damage is progressive. It begins as minute
cracks, and those cracks grow under the action of repeated stresses.
This can happen because of normal operational conditions and design
attributes, or because of isolated situations or incidents such as
material defects, poor fabrication quality, or corrosion pits, dings,
or scratches. Fatigue damage can occur locally, in small areas or
structural design details, or globally. Global fatigue damage is
general degradation of large areas of structure with similar structural
details and stress levels. Multiple-site damage is global damage that
occurs in a large structural element such as a single rivet line of a
lap splice joining two large skin panels. Global damage can also occur
in multiple elements such as adjacent frames or stringers. Multiple-
site-damage and multiple-element-damage cracks are typically too small
initially to be reliably detected with normal inspection methods.
Without intervention, these cracks will grow, and eventually compromise
the structural integrity of the airplane, in a condition known as
widespread fatigue damage (WFD). As an airplane ages, WFD will likely
occur, and will certainly occur if the airplane is operated long enough
without any intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the LOV. Many LOVs, however, do depend on accomplishment of
future maintenance actions. As stated in the WFD rule, any maintenance
actions necessary to reach the LOV will be mandated by airworthiness
directives through separate rulemaking actions.
    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.
    An evaluation by the DAH indicated that the upper chords of the
upper deck floor beams are subject to WFD. The inspections and
replacement in this proposed AD were developed to support the
airplane's LOV of the engineering data that support the established
structural maintenance program. We are proposing this AD to detect and
correct fatigue cracking of the upper chords of the upper deck floor
beams. Undetected cracking could result in large deflection or
deformation of the upper deck floor beams, resulting in damage to wire
bundles and control cables for the flight control system, and reduced
controllability of the airplane. Multiple adjacent severed floor beams
could result in rapid decompression of the airplane.

Other Relevant Rulemaking

    On September 28, 2005, we issued AD 2005-20-29, Amendment 39-14326
(70 FR 59246, October 12, 2005), for certain Boeing Model 747-100, 747-
100B, 747-100B SUD, 747-200B, 747-300, 747SP, and 747SR series
airplanes. AD 2005-20-29 requires repetitive inspections to detect
cracks in various areas of the upper deck floor beams, and repair if
necessary. AD 2005-20-29 resulted from fatigue testing that revealed
severed upper chords of the upper deck floor beams due to fatigue
cracking. We issued AD 2005-20-29, to detect and correct cracking in
the upper chords of the upper deck floor beams. Undetected cracking
could result in large deflection or deformation of the upper deck floor
beams, resulting in damage to wire bundles and control cables for the
flight control system, and reduced controllability of the airplane.
Multiple adjacent severed floor beams could result in rapid
decompression of the airplane.
    AD 2005-20-29, Amendment 39-14326 (70 FR 59246, October 12, 2005),
refers to Boeing Alert Service Bulletin 747-53A2452, dated April 3,
2003, as the appropriate source of service information for certain
inspections. This proposed AD would require new inspections at reduced
compliance times, which would end the inspections done using Boeing
Alert Service Bulletin 747-53A2452, dated April 3, 2003.

Related Service Information Under 1 CFR Part 51

    We reviewed the following service information. This service
information 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 of this NPRM.
     Boeing Alert Service Bulletin 747-53A2452, Revision 1,
dated July 16, 2012. This service information describes procedures for
repetitive open hole or surface high frequency eddy current (HFEC)
inspections, as applicable, for cracks at the floor panel attachment
fastener holes in certain areas and stations; repetitive surface HFEC
inspections for cracks in the upper and lower chords of the upper deck
floor beams at permanent fastener locations in certain areas and
stations; and related investigative and corrective actions. This
service information also describes procedures, for airplanes on which
certain repairs or modifications are done, for repetitive open hole or
surface HFEC inspections, as applicable, for

cracks in the repaired and modified areas; and repair.
     Boeing Alert Service Bulletin 747-53A2852, dated June 22,
2012. This service information describes procedures for repetitive
replacement of the upper chords of the upper deck floor beams,
including pre-replacement inspections and corrective action, and post-
replacement repetitive inspections and repair.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between this AD and the Service Information.'' For
information on the procedures and compliance times, see this service
information at http://www.regulations.gov by searching for and locating
Docket No. FAA-2015-3983.
    The phrase ``related investigative actions'' is used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that (1) are related to the primary actions, and (2) further
investigate the nature of any condition found. Related investigative
actions in an AD could include, for example, inspections.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective actions in an AD could include, for
example, repairs.
    For any repair #10 or repair #13 done as specified in Boeing Alert
Service Bulletin 747-53A2452, paragraph (i)(2) of this proposed AD
would require that post-repair inspections be done before further
flight using a method approved in accordance with the procedures
specified in paragraph (o) of this AD. Operators must contact the FAA
or Boeing Commercial Airplanes Organization Designation Authorization
(ODA) before further flight so that the type of actions and intervals
for the post-repair inspections can be determined.

Differences Between This Proposed AD and the Service Information

    Boeing Alert Service Bulletin 747-53A2452, Revision 1, dated July
16, 2012; and Boeing Alert Service Bulletin 747-53A2852, dated June 22,
2012; specify to contact the manufacturer for instructions on how to
repair certain conditions, but this proposed AD would require repairing
those conditions in one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes ODA whom we have authorized to make those findings.

Explanation of Compliance Time

    The compliance time for the installation specified in this proposed
AD for addressing WFD was established to ensure that discrepant
structure is replaced before WFD develops in airplanes. Standard
inspection techniques cannot be relied on to detect WFD before it
becomes a hazard to flight. We will not grant any extensions of the
compliance time to complete any AD-mandated service bulletin related to
WFD without extensive new data that would substantiate and clearly
warrant such an extension.

Costs of Compliance

    We estimate that this proposed AD affects 67 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspections specified in Boeing    Up to 884 work-                  $0  $75,140, per         $5,034,380, per
 Alert Service Bulletin             hours x $85 per                      inspection cycle.    inspection cycle.
 747[dash]53A2452, Revision 1,      hour = $75,140,
 dated July 16, 2012.               per inspection
                                    cycle.
Replacement specified in Boeing    Up to 696 work-               0 [1]  $59,160, per         $3,963,720, per
 Alert Service Bulletin             hours x $85 per                      replacement.         replacement.
 747[dash]53A2852, dated June 22,   hour = $59,160,
 2012.                              per replacement.
Post-replacement inspections       Up to 586 work-                   0  $49,810, per         $3,337,270, per
 specified in Boeing Alert          hours x $85 per                      inspection cycle.    inspection cycle.
 Service Bulletin                   hour = $49,810,
 747[dash]53A2852, dated June 22,   per inspection
 2012.                              cycle.
----------------------------------------------------------------------------------------------------------------
[1] We currently have no specific cost estimates associated with the parts necessary for the proposed
  replacement.

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

The Boeing Company: Docket No. FAA-2015-3983; Directorate Identifier
2015-NM-141-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by November 20,
2015.

(b) Affected ADs

    This AD affects AD 2005-20-29, Amendment 39-14326 (70 FR 59246,
October 12, 2005).

(c) Applicability

    This AD applies to The Boeing Company Model 747-100, 747-100B,
747-100B SUD, 747-200B, 747-300, 747SR, and 747SP series airplanes;
certificated in any category; as identified in Boeing Alert Service
Bulletin 747-53A2852, dated June 22, 2012.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder (DAH) indicating that the upper chords of the upper deck
floor beams are subject to widespread fatigue damage (WFD). We are
issuing this AD to detect and correct fatigue cracking of the upper
chords of the upper deck floor beams. Undetected cracking could
result in large deflection or deformation of the upper deck floor
beams, resulting in damage to wire bundles and control cables for
the flight control system, and reduced controllability of the
airplane. Multiple adjacent severed floor beams could result in
rapid decompression of the airplane.

(f) Compliance

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

(g) Repetitive Inspections of the Upper Chords of the Upper Deck Floor
Beams

    At the applicable times specified in Tables 1 through 7 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
747-53A2452, Revision 1, dated July 16, 2012, except as required by
paragraph (l)(1) of this AD: Do the inspections specified in
paragraphs (g)(1) and (g)(2) of this AD, and do all applicable
related investigative and corrective actions, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
53A2452, Revision 1, dated July 16, 2012, except as required by
paragraph (l)(2) of this AD. Repeat the inspections specified in
paragraphs (g)(1) and (g)(2) of this AD thereafter at the applicable
times specified in Tables 1 through 7 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 747-53A2452,
Revision 1, dated July 16, 2012. Do all applicable related
investigative and corrective actions before further flight. Doing
the inspections required by paragraphs (g)(1) and (g)(2) of this AD
terminates the inspections required by paragraphs (m) and (n) of AD
2005-20-29, Amendment 39-14326 (70 FR 59246, October 12, 2005).
    (1) Do an open hole or surface high frequency eddy current
(HFEC) inspection, as applicable, for cracks at the fastener holes
of the floor panel attachment in the applicable areas and stations
identified in Boeing Alert Service Bulletin 747-53A2452, Revision 1,
dated July 16, 2012.
    (2) Do a surface HFEC inspection for cracks in the upper and
lower chords of the upper deck floor beams at permanent fastener
locations in the applicable areas and stations identified in Boeing
Alert Service Bulletin 747-53A2452, Revision 1, dated July 16, 2012.

(h) Terminating Modification and Repair for the Inspection Specified in
Paragraph (g)(1) of This AD

    A fastener hole modification or a fastener hole repair in Area 1
or Area 2 as described in Boeing Alert Service Bulletin 747-53A2452,
Revision 1, dated July 16, 2012, terminates the inspection of the
fastener holes of the floor panel attachment required by paragraph
(g)(1) of this AD for the repaired or modified area only, provided
the modification and repair, including related investigative and
corrective actions, are done in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-53A2452, Revision
1, dated July 16, 2012, except as required by paragraph (l)(2) of
this AD.

(i) Post Mod/Repair Repetitive Inspections

    (1) For airplanes on which any fastener hole modification or any
fastener hole repair was done as specified in Boeing Alert Service
Bulletin 747-53A2452: Except as required by paragraph (i)(2) of this
AD, at the applicable times specified in Tables 8 and 9 of paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 747-53A2452,
Revision 1, dated July 16, 2012, or within 1,000 flight cycles after
the effective date of this AD, whichever occurs later, do an open
hole or surface HFEC inspection, as applicable, for cracks in the
repaired and modified areas, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-53A2452, Revision
1, dated July 16, 2012. If any cracking is found, before further
flight, repair using a method approved in accordance with the
procedures specified in paragraph (o) of this AD. Repeat the
applicable inspections thereafter at the times specified in Tables 8
and 9 of paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 747-53A2452, Revision 1, dated July 16, 2012. Doing an
inspection required by this paragraph terminates the inspections
required by paragraph (p) of AD 2005-20-29, Amendment 39-14326 (70
FR 59246, October 12, 2005).
    (2) For any repair #10 or repair #13 done as specified in Boeing
Alert Service Bulletin 747-53A2452: Before further flight, do post-
repair inspections using a method approved in accordance with the
procedures specified in paragraph (o) of this AD.

(j) Replacement of the Upper Chords of the Upper Deck Floor Beams
(Includes Pre-Replacement Inspections)

    Replace the upper chords of the upper deck floor beams by doing
the actions required by paragraphs (j)(1) and (j)(2) of this AD at
the times specified in those paragraphs. Accomplishing the
replacement required by this paragraph terminates the inspections
required by paragraphs (g) and (i) of this AD.
    (1) Before the accumulation of 30,000 total flight cycles, or
within 3,000 flight cycles after the effective date of this AD,
whichever occurs later, do an open hole HFEC inspection for cracks
at certain fastener locations in the floor beam webs and side of
body frames, and do a detailed inspection for cracks of any removed
part that will be re-installed, and do all applicable corrective
actions, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 747-53A2852, dated June 22, 2012,
except as required by paragraph (l)(2) of this AD. Do all applicable
corrective actions before further flight.
    (2) Before further flight after accomplishing the inspections
required by paragraph (j)(1) of this AD, install new upper chords of
the upper deck floor beams and reinforcing straps or angles, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 747-53A2852, dated June 22, 2012, except as
required by paragraph (l)(2) of this AD.

(k) Post-Replacement Repetitive Inspections

    For airplanes on which any replacement required by paragraph (j)
or (k)(2)(ii) of this AD is done: At the applicable times specified
in Tables 2 through 4 in paragraph 1.E., ``Compliance,'' of Boeing
Alert Service

Bulletin 747-53A2852, dated June 22, 2012, do HFEC inspections for
cracks at the permanent fastener holes and the upper chords of the
upper deck floor beams, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-53A2452, Revision
1, dated July 16, 2012.
    (1) If any cracking is found during any inspection required by
paragraph (k) or (k)(2)(i) of this AD, before further flight, repair
using a method approved in accordance with the procedures specified
in paragraph (o) of this AD.
    (2) If no cracking is found during any inspection required by
the introductory text of paragraph (k) or (k)(2)(i) of this AD, do
the actions required by paragraphs (k)(2)(i) and (k)(2)(ii) of this
AD.
    (i) Repeat the inspections specified in paragraph (k) of this AD
thereafter at the applicable times specified in Tables 8 and 9 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
747-53A2452, Revision 1, dated July 16, 2012.
    (ii) Within 10,000 flight cycles after accomplishing the initial
HFEC inspections required by paragraph (k) of this AD, replace the
upper chords of the upper deck floor beams by doing the actions
specified in paragraphs (j)(1) and (j)(2) of this AD.

(l) Exceptions to Service Information

    (1) Where Boeing Alert Service Bulletin 747-53A2452, Revision 1,
dated July 16, 2012, specifies a compliance time ``after the
Revision 1 date of this service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) Where Boeing Alert Service Bulletin 747-53A2452, Revision 1,
dated July 16, 2012; or Boeing Alert Service Bulletin 747-53A2852,
dated June 22, 2012; specifies to contact Boeing for appropriate
action: Before further flight, repair using a method approved in
accordance with the procedures specified in paragraph (o) of this
AD.

(m) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraphs (g), (h), and (i) of this AD, if those actions were
performed before the effective date of this AD using Boeing Alert
Service Bulletin 747-53A2452, dated April 3, 2003, which was
incorporated by reference in AD 2005-20-29, Amendment 39-14326 (70
FR 59246, October 12, 2005).

(n) Special Flight Permit

    Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

(o) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
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 ACO, send it to the
attention of the person identified in paragraph (p)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(p) Related Information

    (1) For more information about this AD, contact Roger Caldwell,
Aerospace Engineer, Technical Operations Center, ANM-100D, FAA,
Denver Aircraft Certification Office, 26805 East 68th Avenue, Room
214, Denver, CO 80249; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on September 27, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-25272 Filed 10-5-15; 8:45 am]
BILLING CODE 4910-13-P