[Federal Register: October 17, 2007 (Volume 72, Number 200)]
[Proposed Rules]
[Page 58770-58773]
[DOCID:fr17oc07-14]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0048; Directorate Identifier 2007-NM-181-AD]
RIN 2120-AA64

Airworthiness Directives; Construcciones Aeronauticas, S.A.
(CASA), Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, * * * Special Federal Aviation
Regulation 88 (SFAR88) * * * required a safety review of the
aircraft Fuel Tank System * * *.
* * * * *
    Fuel Airworthiness Limitations are items arising from a systems
safety analysis that have been shown to have failure mode(s)
associated with an `unsafe condition' * * *. These are identified in
Failure Conditions for which an unacceptable probability of ignition
risk could exist if specific tasks and/or practices are not
performed in accordance with the manufacturers' requirements.

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by November 16,
2007.

ADDRESSES: You may send comments by any of the following methods:
     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: Room W12-140 on the ground floor of the
West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

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

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-0048;
Directorate Identifier 2007-NM-181-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 based on those comments.
    We will post all comments we receive, without change, to http://dms.dot.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

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2007-0007, dated January 9, 2007 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, the FAA published Special Federal
Aviation Regulation 88 (SFAR 88) in June 2001. SFAR 88 required a
safety review of the aircraft Fuel Tank System to determine that the
design meets the requirements of FAR (Federal Aviation Regulation)
Sec.  25.901 and Sec.  25.981(a) and (b).
    A similar regulation has been recommended by the JAA (Joint
Aviation

Authorities) to the European National Aviation Authorities in JAA
letter 04/00/02/07/03-L024 of 3 February 2003. The review was
requested to be mandated by NAA's (National Aviation Authorities)
using JAR (Joint Aviation Regulation) Sec.  25.901(c), Sec.
25.1309.
    In August 2005 EASA published a policy statement on the process
for developing instructions for maintenance and inspection of Fuel
Tank System ignition source prevention (EASA D 2005/CPRO,
http://www.easa.eu.int/home/cert_policy_statements_en.html) that also

included the EASA expectations with regard to compliance times of
the corrective actions on the unsafe and the not unsafe part of the
harmonised design review results. On a global scale the TC (type
certificate) holders committed themselves to the EASA published
compliance dates (see EASA policy statement). The EASA policy
statement has been revised in March 2006: The date of 31-12-2005 for
the unsafe related actions was set at 01-07-2006.
    Fuel Airworthiness Limitations are items arising from a systems
safety analysis that have been shown to have failure mode(s)
associated with an `unsafe condition' as defined in FAA's memo 2003-
112-15 `SFAR 88--Mandatory Action Decision Criteria'. These are
identified in Failure Conditions for which an unacceptable
probability of ignition risk could exist if specific tasks and/or
practices are not performed in accordance with the manufacturers'
requirements.
    This EASA Airworthiness Directive mandates the Fuel System
Airworthiness Limitations (comprising maintenance/inspection tasks
and Critical Design Configuration Control Limitations (CDCCL)) for
the type of aircraft, that resulted from the design reviews and the
JAA recommendation and EASA policy statement mentioned above.

    The corrective action is revising the Airworthiness Limitations
Section of the Instructions for Continued Airworthiness to incorporate
new limitations for fuel tank systems. You may obtain further
information by examining the MCAI in the AD docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to SFAR 88. (The JAA is an associated body of the European
Civil Aviation Conference (ECAC) representing the civil aviation
regulatory authorities of a number of European States who have agreed
to co-operate in developing and implementing common safety regulatory
standards and procedures.) Under this regulation, the JAA stated that
all members of the ECAC that hold type certificates for transport
category airplanes are required to conduct a design review against
explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    European Aeronautic Defense and Space Company (EADS) CASA has
issued CN-235/C-295 Technical Document DT-0-C00-05001, Issue C, dated
October 2006. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect 8 products of U.S. registry. We also estimate that it
would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $640, or $80 per product.

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 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Construcciones Aeronauticas, S.A. (CASA): Docket No. FAA-2007-0048;
Directorate Identifier 2007-NM-181-AD.

Comments Due Date

    (a) We must receive comments by November 16, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all CASA Model CN-235, CN-235-100, CN-
235-200, CN-235-300, and C-295 airplanes; certificated in any
category.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (g) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, the FAA published Special Federal
Aviation Regulation 88 (SFAR 88) in June 2001. SFAR 88 required a
safety review of the aircraft Fuel Tank System to determine that the
design meets the requirements of FAR (Federal Aviation Regulation)
Sec.  25.901 and Sec.  25.981(a) and (b).
    A similar regulation has been recommended by the JAA (Joint
Aviation Authorities) to the European National Aviation Authorities
in JAA letter 04/00/02/07/03-L024 of 3 February 2003. The review was
requested to be mandated by NAA's (National Aviation Authorities)
using JAR (Joint Aviation Regulation) Sec.  25.901(c), Sec.
25.1309.
    In August 2005 EASA published a policy statement on the process
for developing instructions for maintenance and inspection of Fuel
Tank System ignition source prevention (EASA D 2005/CPRO,
http://www.easa.eu.int/home/cert_policy_statements_en.html) that also

included the EASA expectations with regard to compliance times of
the corrective actions on the unsafe and the not unsafe part of the
harmonised design review results. On a global scale the TC (type
certificate) holders committed themselves to the EASA published
compliance dates (see EASA policy statement). The EASA policy
statement has been revised in March 2006: the date of 31-12-2005 for
the unsafe related actions was set at 01-07-2006.
    Fuel Airworthiness Limitations are items arising from a systems
safety analysis that have been shown to have failure mode(s)
associated with an `unsafe condition' as defined in FAA's memo 2003-
112-15 `SFAR 88--Mandatory Action Decision Criteria'. These are
identified in Failure Conditions for which an unacceptable
probability of ignition risk could exist if specific tasks and/or
practices are not performed in accordance with the manufacturers'
requirements.
    This EASA Airworthiness Directive mandates the Fuel System
Airworthiness Limitations (comprising maintenance/inspection tasks
and Critical Design Configuration Control Limitations (CDCCL)) for
the type of aircraft, that resulted from the design reviews and the
JAA recommendation and EASA policy statement mentioned above.

    The corrective action is revising the Airworthiness Limitations
Section of the Instructions for Continued Airworthiness to
incorporate new limitations for fuel tank systems.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 3 months after the effective date of this AD, or
before December 16, 2008, whichever occurs first, revise the
Airworthiness Limitations section of the Instructions for Continued
Airworthiness to incorporate the Fuel Airworthiness Limitation
maintenance and inspection tasks as defined in European Aeronautic
Defense and Space Company (EADS) CASA CN-235/C295 Technical Document
DT-0-C00-05001, Issue C, dated October 2006. For all tasks
identified in Technical Document DT-0-C00-05001, the initial
compliance times start from the later of the times specified in
paragraphs (f)(1)(i) and (f)(1)(ii) of this AD, and the repetitive
inspections must be accomplished thereafter at the interval
specified in Technical Document DT-0-C00-05001, except as provided
by paragraph (f)(3) of this AD.
    (i) The effective date of this AD.
    (ii) The date of issuance of the original Spanish standard
airworthiness certificate or the date of issuance of the original
Spanish export certificate of airworthiness.
    (2) Within 6 months after the effective date of this AD, or
before December 16, 2008, whichever occurs first, revise the
Airworthiness Limitations section of the Instructions for Continued
Airworthiness to include the CDCCL data contained in EADS CASA CN-
235/C-295 Technical Document DT-0-C00-05001, Issue C, dated October
2006.
    (3) Except as provided by paragraph (g) of this AD: After
accomplishing the actions specified in paragraphs (f)(1) and (f)(2)
of this AD, no alternative inspection, inspection intervals, or
CDCCLs may be used.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, ANM-
116, International Branch, Transport Airplane Directorate, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Shahram
Daneshmandi, Aerospace Engineer, International Branch, ANM-116, FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2007-0007, dated January 9, 2007; and EADS
CASA CN-235/C-295 Technical Document DT-0-C00-05001, Issue C, dated
October 2006, for related information.

    Issued in Renton, Washington, on October 9, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E7-20470 Filed 10-16-07; 8:45 am]

BILLING CODE 4910-13-P


Note to Docket
Docket EPA-HQ-OW-2011-0188
Proposed National Pollutant Discharge Elimination System (NPDES) Concentrated Animal Feeding Operation (CAFO) Reporting Rule

(EPA-HQ-OW-2011-0188; RIN 2040-AF22)

Examples of CAFO Site-Specific Information Publicly Available on the Internet

The proposed National Pollutant Discharge Elimination System (NPDES) Concentrated Animal Feeding Operation (CAFO) Reporting Rule would require CAFOs to submit information to EPA.  EPA also proposes to allow states with authorized NPDES programs to submit the information that would be required by the proposed rule to EPA on behalf of a CAFO.

Provided in this document are examples that illustrate publicly accessible site-specific information for CAFOs.  EPA recognizes that some of the examples provided are more comprehensive than others.  EPA's inclusion of these examples in this document does not constitute a determination that these states should submit the information that would be required by the proposed rule or that the information displayed by the examples would fulfill the requirements of the proposed rule.  EPA used examples of publicly accessible site-specific information for CAFOs in developing the voluntarily state submission process in the proposed NPDES CAFO Reporting Rule.

Publicly Available Data on Livestock Operations: Ad hoc examples of CAFO site-specific data available on-line

Compiled by:
U.S. Environmental Protection Agency
Office of Water, Office of Wastewater Management
Water Permits Division, Rural Branch

Example:  	MARYLAND Department of Environment
Available at:  http://www.mde.state.md.us/programs/Land/SolidWaste/CAFOMAFO/Pages/Programs/LandPrograms/Solid_Waste/cafo_search/CAFO.aspx

Example:  	NEW YORK Department of Environmental Conservation
Available at:
http://www.dec.ny.gov/permits/36895.html

Example:  	MICHIGAN Department of Natural Resources and Environment
Available at:
http://www.michigan.gov/deq/0,1607,7-135-3313_3682_3713-96774--,00.html

Example:	DELAWARE Department of Agriculture
Available at: http://dda.delaware.gov/nutrients/forms/2009/122009_Current%20CAFO%20List.pdf and
http://dda.delaware.gov/nutrients/forms/2008/052108_CAFOList.pdf.

Example:	PENNSYLVANIA Chesapeake Watershed Implementation Plan (WIP), November 29, 2010
Available at:  http://www.portal.state.pa.us/portal/server.pt/document/1010622/chesapeake_bay_wip_november_29%2C_2010_pdf?qid=36945254&rank=1, page 33.

Example: 	VIRGINIA Department of Recreation and Conservation
Available at:
http://webdat.dcr.virginia.gov/cfprog/dswc/afoprm.cfm.

Example:	WEST VIRGINIA
Available at:
http://www.aegis.jsu.edu/ and http://www.aegis.jsu.edu/WV/WVdownload.html and http://www.aegis.jsu.edu/AEGISDownloads/WVDownloads/WV_AFOpointGeo.zip and http://www.aegis.jsu.edu/AEGISDownloads/WVDownloads/WV_AFOpolyGeo.zip.

Example:	NEBRASKA Department of Agriculture
Available at:
http://www.agr.state.ne.us/publications/promotion/cattle_feeders.html


[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Rules and Regulations]
[Pages 72840-72842]
[FR Doc No: 2021-27628]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0364; Project Identifier MCAI-2019-00119-E;
Amendment 39-21872; AD 2021-26-13]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
(Type Certificate Previously Held by Rolls-Royce plc) Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Rolls-Royce Deutschland Ltd & Co KG (RRD) Trent 1000-A2, Trent 1000-
AE2, Trent 1000-C2, Trent 1000-CE2, Trent 1000-D2, Trent 1000-E2, Trent
1000-G2, Trent 1000-H2, Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2
model turbofan engines. This AD was prompted by the manufacturer
revising the engine Time Limits Manual (TLM) life limits of certain
critical rotating parts, updating direct accumulation counting (DAC)
data files, and updating certain maintenance tasks. This AD requires
revision of the engine TLM life limits of certain critical rotating
parts and DAC data files, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is incorporated by reference. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective January 27, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 27,
2022.

ADDRESSES: For material incorporated by reference in this AD, contact
the 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 https://ad.easa.europa.eu. You may view this
material 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>. It
is also available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-0364.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-0364; 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, the
EASA AD, 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: Kevin M. Clark, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a supplemental notice of proposed rulemaking (SNPRM)
to amend 14 CFR part 39 by adding an AD that would apply to RRD Trent
1000-A2, Trent 1000-AE2, Trent 1000-C2, Trent 1000-CE2, Trent 1000-D2,
Trent 1000-E2, Trent 1000-G2, Trent 1000-H2, Trent 1000-J2, Trent 1000-
K2, and Trent 1000-L2 model turbofan engines. The SNPRM published in
the Federal Register on September 20, 2021 (86 FR 52111). The SNPRM was
prompted by the manufacturer revising the engine TLM life limits of
certain critical rotating parts, updating DAC data files, and updating
certain maintenance tasks. The SNPRM proposed to require operators to
revise the ALS of their approved maintenance program by incorporating
the revised tasks of the applicable TLM for each affected model
turbofan engine. The SNPRM proposed to require accomplishing the
actions specified in EASA AD 2020-0241, dated November 5, 2020 (also
referred to as the Mandatory Continuing Airworthiness Information, or
the MCAI), as incorporated by reference, except for any differences
identified as exceptions in the regulatory text of the proposed AD and
except as discussed under ``Differences Between this Proposed AD and
the EASA AD.'' The FAA is issuing this AD to address the unsafe
condition on these products. See the MCAI for additional background
information.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0241 to correct an unsafe
condition for all RRD Trent 1000-A2, Trent 1000-AE2, Trent 1000-C2,
Trent 1000-CE2, Trent 1000-D2, Trent 1000-E2, Trent 1000-G2, Trent
1000-H2, Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2 model turbofan
engines.

Discussion of Final Airworthiness Directive

Comments

    The FAA received one comment from an individual commenter. The
commenter expressed support for the SNPRM without change, but
incorrectly referenced automotive engines within the rationale for the
support.

Conclusion

    The FAA reviewed the relevant data, considered the comment
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. Except for minor editorial changes, this
AD is adopted as proposed in the SNPRM. None of the changes will
increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2020-0241. EASA AD 2020-0241 requires
accomplishment of the actions specified in RRD's updated TLM for
affected engines as specified in Rolls-Royce Trent 1000 TLM T-Trent-
10RRC, Chapters 05-10 and 05-20, Revision 20, dated August 1, 2020.
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.

Costs of Compliance

    The FAA estimates that this AD affects 20 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revise the continuous airworthiness     1 work-hour x $85 per                 $0             $85          $1,700
 maintenance program.                    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.[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES][RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/
PREAMB][SUPLINF][HED]*[/HED]
    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 adding the following new airworthiness
directive:

2021-26-13 Rolls-Royce Deutschland Ltd & Co KG (Type Certificate
previously held by Rolls-Royce plc): Amendment 39-21872; Docket No.
FAA-2020-0364; Project Identifier MCAI-2019-00119-E.

(a) Effective Date

    This airworthiness directive (AD) is effective January 27, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Rolls-Royce Deutschland Ltd & Co KG (Type
Certificate previously held by Rolls-Royce plc) (RRD) Trent 1000-A2,
Trent 1000-AE2, Trent 1000-C2, Trent 1000-CE2, Trent 1000-D2, Trent
1000-E2, Trent 1000-G2, Trent 1000-H2, Trent 1000-J2, Trent 1000-K2,
and Trent 1000-L2 model turbofan 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 engine
Time Limits Manual life limits of certain critical rotating parts,
updating the direct accumulation counting data files, and updating
certain maintenance tasks. The FAA is issuing this AD to prevent the
failure of critical rotating parts. The unsafe condition, if not
addressed, could result in failure of one or more engines, loss of
thrust control, and loss of the airplane.

(f) Compliance

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

(g) Required Actions

    Except as specified in paragraph (h) of this AD: Perform all
required actions within the compliance times specified in, and in
accordance with, European Union Aviation Safety Agency AD 2020-0241,
dated November 5, 2020 (EASA AD 2020-0241).

(h) Exceptions to EASA AD 2020-0241

    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2020-0241 are not required by this AD.
    (2) Where EASA AD 2020-0241 requires compliance from its
effective date, this AD requires using the effective date of this
AD.
    (3) Paragraph (3) of EASA AD 2020-0241 specifies revising the
approved airworthiness maintenance program within 12 months after
its effective date, but this AD requires revising the existing
approved continuous airworthiness maintenance program within 90 days
after the effective date of this AD.
    (4) This AD does not mandate compliance with the ``Remarks''
section of EASA AD 2020-0241.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2020-0241
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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
ECO Branch, send it to the attention of the person identified in
paragraph (k) of this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Kevin M. Clark,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0241,
dated November 5, 2020.
    (ii) [Reserved]
    (3) For EASA AD 2020-0241, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]. You may find this EASA AD on the EASA website at
https://ad.easa.europa.eu.
    (4) You may view this service information at the 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 material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on December 9, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-27628 Filed 12-22-21; 8:45 am]
BILLING CODE 4910-13-P[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][RULES]


[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Notices]
[Pages 75824-75826]
[FR Doc No: 2016-26322]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1393]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Patent Term Restoration, Due Diligence Petitions,
Filing, Format, and Content of Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on Patent Term Restoration, Due
Diligence Petitions, Filing, Format, and Content of Petitions.

DATES: Submit either electronic or written comments on the collection
of information by January 3, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-1393 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Patent Term Restoration, Due
Diligence Petitions, Filing, Format, and Content of Petitions.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 11601 Landsdown
Street, 10A63, North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Patent Term Restoration, Due Diligence Petitions, Filing, Format, and
Content of Petitions--21 CFR Part 60--OMB Control Number 0910-0233--
Extension

    FDA's patent extension activities are conducted under the authority
of the Drug Price Competition and Patent Term Restoration Act of 1984
(21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term
Restoration Act of 1988 (35 U.S.C. 156). New human drug, animal drug,
human biological, medical device, food additive, or color additive
products regulated by the FDA must undergo FDA safety, or safety and
effectiveness review before marketing is permitted. Where the product
is covered by a patent, part of the patent's term may be consumed
during this review, which diminishes the value of the patent. In
enacting the Drug Price Competition and Patent Term Restoration Act of
1984 and the Generic Animal Drug and Patent Term Restoration Act of
1988, Congress sought to encourage development of new, safer, and more
effective medical and food additive products. It did so by authorizing
the U.S. Patent and Trademark Office (USPTO) to extend the patent term
by a portion of the time during which FDA's safety and effectiveness
review prevented marketing of the product. The length of the patent
term extension is generally limited to a maximum of 5 years, and is
calculated by USPTO based on a statutory formula. When a patent holder
submits an application for patent term extension to USPTO, USPTO
requests information from FDA, including the length of the regulatory
review period for the patented product. If USPTO concludes that the
product is eligible for patent term extension, FDA publishes a notice
that describes the length of the regulatory review period and the dates
used to calculate that period. Interested parties may request, under
Sec.  60.24 (21 CFR 60.24), revision of the length of the regulatory
review period, or may petition under Sec.  60.30 (21 CFR 60.30) to
reduce the regulatory review period by any time where marketing
approval was not pursued with ``due diligence.''
    The statute defines due diligence as ``that degree of attention,
continuous directed effort, and timeliness'' as may

reasonably be expected from, and are ordinarily exercised by, a person
during a regulatory review period. As provided in Sec.  60.30(c), a due
diligence petition ``shall set forth sufficient facts, including dates
if possible, to merit an investigation by FDA of whether the applicant
acted with due diligence.'' Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates whether any change in the
regulatory review period if necessary. If so, the corrected regulatory
review period is published in the Federal Register. A due diligence
petitioner not satisfied with FDA's decision regarding the petition
may, under Sec.  60.40 (21 CFR 60.40), request an informal hearing for
reconsideration of the due diligence determination. Petitioners are
likely to include persons or organizations having knowledge that FDA's
marketing permission for that product was not actively pursued
throughout the regulatory review period. The information collection for
which an extension of approval is being sought is the use of the
statutorily created due diligence petition.
    Since 1992, 20 requests for revision of the regulatory review
period have been submitted under Sec.  60.24(a). For 2013, 2014 and
2015, a total of 5 requests have been submitted under Sec.  60.24(a).
During that same time period, there have been no requests under
Sec. Sec.  60.30 and 60.40; however, for purposes of this information
collection approval, we are estimating that we may receive one
submission annually.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
60.24(a)........................               3            1.66               5             100             500
60.30...........................               1               1               1              50              50
60.40...........................               1               1               1              10              10
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             560
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26322 Filed 10-31-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 245 (Wednesday, December 21, 2011)]
[Rules and Regulations]
[Pages 79065-79066]
[FR Doc No: 2011-32626]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-1099]

Drawbridge Operation Regulations; Annisquam River and Blynman
Canal, Gloucester, MA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
SR127 Bridge at mile 0.0 across the Annisquam River and Blynman Canal.
The deviation is necessary to facilitate bridge rehabilitation repairs.
This deviation allows the bridge to remain in the closed position for
31 days.

DATES: This deviation is effective from December 19, 2011 through
January 18, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-1099 and are available online
at www.regulations.gov, inserting USCG-2011-1099 in the ``Keyword'' and
then clicking ``Search''. They are also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. John McDonald, Project Officer, First Coast Guard
District<EMAIL_ADDRESS>or telephone<PHONE_NUMBER>. If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The SR127 Bridge, across the Annisquam
River/Blynman Canal, mile 0.0, at Gloucester, Massachusetts, has a
vertical clearance in the closed position of 7 feet at mean high water
and 16 feet at mean low water. The drawbridge operation regulations are
listed at 33 CFR 117.586.
    The owner of the bridge, Massachusetts Department of
Transportation, requested a temporary deviation from the regulations to

facilitate bridge rehabilitation repairs, replacement of deck purlins
on the bascule spans.
    Under this temporary deviation the SR127 Bridge may remain in the
closed position from December 19, 2011 through January 18, 2012.
    A work platform will be located under the bascule spans across the
navigable channel reducing vertical clearance under the bridge by six
feet. The work platform will in place during working hours, 6:30 a.m.
through 4 p.m., Monday through Friday. The platform shall be removed
upon request by calling the bridge at<PHONE_NUMBER> or by marine radio
on VHF FM channel 13 and 16. On weekends and during non-working hours
the platform shall be removed. Vessels that can pass under the draw in
the closed position may do so on weekends and non-working hours.
    The Gloucester Harbor Master and the local marinas were notified
and no objections were received.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: December 12, 2011.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2011-32626 Filed 12-20-11; 8:45 am]
BILLING CODE 9110-04-P