[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Rules and Regulations]
[Pages 5911-5915]
[FR Doc No: 2015-01188]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0138; Directorate Identifier 2013-NM-020-AD;
Amendment 39-18086; AD 2015-02-19]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 95-24-04 for
all Airbus Model A300 series airplanes; Model A300 B4-600, B4-600R, and
F4-600R series airplanes; and Model A300 C4-605R Variant F airplanes.
AD 95-24-04 required inspections to detect cracks at the aft spar web
of the wings, and repair if necessary. This new AD reduces certain
compliance times, and expands the applicability. This AD was prompted
by a determination that the inspection threshold and interval must be
reduced to allow timely detection of cracks and accomplishment of
applicable repairs, because of cracking in the rear spar web of the
wings between certain ribs due to fatigue-related high shear stress. We
are issuing this AD to detect and correct fatigue-related cracking,
which could result in reduced structural integrity of the wing.

DATES: This AD becomes effective March 11, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 11,
2015.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of
December 27, 1995 (60 FR 58213, November 27, 1995).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0138; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Airbus SAS,
Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51;
email<EMAIL_ADDRESS>Internet http://www.airbus.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>.

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

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 95-24-04, Amendment 39-9436 (60 FR 58213,
November 27, 1995). AD 95-24-04 applied to all Airbus Model A300 series
airplanes; Model A300 B4-600, B4-600R, and F4-600R series airplanes;
and Model A300 C4-605R Variant F airplanes (collectively called Model
A300-600 series airplanes). The NPRM

published in the Federal Register on March 12, 2014 (79 FR 13944).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2013-0013R1, dated February 20, 2013 (referred
to after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition on all Model A300 series
airplanes; Model A300 B4-600, B4-600R, and F4-600R series airplanes;
and Model A300 C4-605R Variant F airplanes. The MCAI states:

    Wing fatigue tests carried out by Airbus revealed cracks on the
vertical web of the rear spar between Ribs 1 and 2. Similar cracks
in the same area were reportedly found by A300 aeroplane operators.
In all cases, the cracks ran from the tip of the build slot to the
nearest adjacent bolt hole.
    This condition, if not detected and corrected, could affect the
structural integrity of the aeroplane.
    To address this unsafe condition, DGAC [Direction
G[eacute]n[eacute]rale de l'Aviation Civile] France issued * * * [an
AD] to require an eddy current inspection of the aft face of the
wing rear spar in the area adjacent to the build slot on Left Hand
(LH) and Right Hand (RH) wings.
    Since that [French] AD was issued, a fleet survey and updated
fatigue and damage tolerance analysis were performed in order to
substantiate the second A300-600 Extended Service Goal (ESG2)
exercise. The results of the survey and analysis showed that the
inspection threshold and interval must be reduced to allow timely
detection of cracks and accomplishment of an applicable corrective
action.
    Prompted by these findings, Airbus issued Airbus Service
Bulletin (SB) A300-57-6059 Revision 04.
    For the reasons described above, this [EASA] AD retains the
requirements of DGAC France AD 1997-375-239(B)R3, which is
superseded, but redefines the thresholds and intervals. This [EASA]
AD also expands the applicability to aeroplanes on which Airbus
modification (mod) 12102 has been embodied in production and to
aeroplanes on which Airbus SB A300-57-6063 (Airbus mod 11130) has
been embodied in service.
* * * * *
    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0138-0003.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM (79
FR 13944, March 12, 2014) and the FAA's response to each comment.

Request To Clarify Applicability

    UPS requested confirmation that Model A300 F4-622R airplanes, which
have Airbus Modification 12102 embodied, do not require inspection per
the NPRM (79 FR 13944, March 12, 2014).
    We agree to clarify the applicability. Model A300 F4-622R airplanes
are not included in the applicability of this AD. No change is
necessary to this AD in this regard.

Requests To Clarify Inspection Threshold

    UPS and FedEx requested clarification of the inspection threshold
for post-modification 11130 (Airbus Service Bulletin A300-57-6063)
airplanes. The commenters asked if the inspection threshold is from
time of modification embodiment or if it is based on total flight
cycles.
    We agree that clarification is necessary. The inspection threshold
for post-modification 11130 (Airbus Service Bulletin A300-57-6063)
airplanes is determined from point of embodiment of Modification 11130,
and is not based on total flight cycles. We have added this
clarification to paragraph (l)(1) of this AD.

Request To Revise Certain Compliance Times

    UPS requested that we revise the compliance times in paragraph (l)
of the NPRM (79 FR 13944, March 12, 2014) to use the same methodology
and consistency used in the compliance time intervals specified in
paragraphs (g) through (j) of the proposed AD. UPS stated that it
disagrees with using the average flight time compliance methodology and
it believes that, in this case, thresholds and repetitive intervals
should be based on wing loading differences between passenger-
configuration and freighter-configuration airplanes.
    We disagree with the commenter's request to revise the specified
compliance times. The commenter did not provide data to substantiate
different airplane utilization and the effect on the identified unsafe
condition. The specific values suggested by the commenter are not
supported by the fatigue and damage tolerance analysis accomplished by
Airbus. The average flight time methodology was supported by EASA. The
FAA has confidence that the unsafe condition will be addressed in an
appropriate time frame. Under the provisions of paragraph (p)(1) of
this AD, we will consider requests for approval of an alternative
method of compliance (AMOC) if sufficient data are submitted to
substantiate different airplane utilization. We have not changed this
AD in this regard.

Request To Remove Repair Approval Requirement

    FedEx acknowledged that repair approvals must specifically ``refer
to this AD,'' but made no specific request.
    UPS requested that we remove the statement ``For a repair method to
be approved, the repair approval must specifically refer to this AD''
from paragraphs (k)(2) and (n) of the NPRM (79 FR 13944, March 12,
2014). UPS stated that the NPRM indicates that this requirement is due
to the potential for doing inadequate repairs. UPS asserted that no
examples are included in the NPRM to demonstrate where inadequate
repairs were made, and that the proposed wording, being specific to
repairs, eliminates the interpretation that Airbus messages or other
approved EASA documents are acceptable for approving minor deviations
(corrective actions) needed during accomplishment of a mandated Airbus
service bulletin. UPS also stated that this repair requirement will
result in an increase in AMOC requests to the FAA, and will likely
result in delays to other FAA services and activities.
    We concur with UPS's request to remove from this AD the requirement
that repair approvals must specifically refer to this AD.
    Since late 2006, we have included a standard paragraph titled
``Airworthy Product'' in all MCAI ADs in which the FAA develops an AD
based on a foreign authority's AD. The MCAI or referenced service
information in an FAA AD often directs the owner/operator to contact
the manufacturer for corrective actions, such as a repair. Briefly, the
Airworthy Product paragraph allowed owners/operators to use corrective
actions provided by the manufacturer if those actions were FAA-
approved. In addition, the paragraph stated that any actions approved
by the State of Design Authority (or its delegated agent) are
considered to be FAA-approved.
    In the NPRM (79 FR 13944, March 12, 2014), we proposed to prevent
the use of repairs that were not specifically developed to correct the
unsafe condition, by requiring that the repair approval provided by the
State of Design Authority or its delegated agent specifically refer to
this FAA AD. This change was intended to clarify the method of
compliance and to provide operators with better visibility of repairs
that are specifically developed and approved to correct the unsafe
condition. In addition, we proposed to change the phrase ``its
delegated agent'' to include a design approval holder (DAH) with State
of Design Authority design organization approval (DOA), as

applicable, to refer to a DAH authorized to approve required repairs
for the proposed AD.
    UPS specifically stated the following in its comments to the NPRM
(79 FR 13944, March 12, 2014): ``The proposed wording, being specific
to repairs, eliminates the interpretation that Airbus messages are
acceptable for approving minor deviations (corrective actions) needed
during accomplishment of an AD mandated Airbus service bulletin.''
    This comment has made the FAA aware that some operators have
misunderstood or misinterpreted the Airworthy Product paragraph to
allow the owner/operator to use messages provided by the manufacturer
as approval of deviations during the accomplishment of an AD-mandated
action. The Airworthy Product paragraph does not approve messages or
other information provided by the manufacturer for deviations to the
requirements of the AD-mandated actions. The Airworthy Product
paragraph only addresses the requirement to contact the manufacturer
for corrective actions for the identified unsafe condition and does not
cover deviations from other AD requirements. However, deviations to AD-
required actions are addressed in 14 CFR 39.17, and anyone may request
the approval for an alternative method of compliance to the AD-required
actions using the procedures found in 14 CFR 39.19.
    To address this misunderstanding and misinterpretation of the
Airworthy Product paragraph, we have changed that paragraph and
retitled it ``Contacting the Manufacturer.'' This paragraph now
clarifies that for any requirement in this AD to obtain corrective
actions from a manufacturer, the actions must be accomplished using a
method approved by the FAA, EASA, or Airbus's EASA DOA.
    The Contacting the Manufacturer paragraph also clarifies that, if
approved by the DOA, the approval must include the DOA-authorized
signature. The DOA signature indicates that the data and information
contained in the document are EASA-approved, which is also FAA-
approved. Messages and other information provided by the manufacturer
that do not contain the DOA-authorized signature approval are not EASA-
approved, unless EASA directly approves the manufacturer's message or
other information.
    This clarification does not remove flexibility afforded previously
by the Airworthy Product paragraph. Consistent with long-standing FAA
policy, such flexibility was never intended for required actions. This
is also consistent with the recommendation of the Airworthiness
Directive Implementation Aviation Rulemaking Committee to increase
flexibility in complying with ADs by identifying those actions in
manufacturers' service instructions that are ``Required for
Compliance'' with ADs. We continue to work with manufacturers to
implement this recommendation. But once we determine that an action is
required, any deviation from the requirement must be approved as an
alternative method of compliance.
    Commenters to an NPRM having Directorate Identifier 2012-NM-101-AD
(78 FR 78285, December 26, 2013) pointed out that in many cases the
foreign manufacturer's service bulletin and the foreign authority's
MCAI may have been issued some time before the FAA AD. Therefore, the
DOA may have provided U.S. operators with an approved repair, developed
with full awareness of the unsafe condition, before the FAA AD is
issued. Under these circumstances, to comply with the FAA AD, the
operator would be required to go back to the manufacturer's DOA and
obtain a new approval document, adding time and expense to the
compliance process with no safety benefit.
    Based on these comments, we removed the requirement that the DAH-
provided repair specifically refer to this AD from paragraphs (k)(2)
and (n) of this AD. Before adopting such a requirement, the FAA will
coordinate with affected DAHs and verify they are prepared to implement
means to ensure that their repair approvals consider the unsafe
condition addressed in the AD. Any such requirements will be adopted
through the normal AD rulemaking process, including notice-and-comment
procedures, when appropriate.
    We have also decided not to include a generic reference to either
the ``delegated agent'' or the ``DAH with State of Design Authority
design organization approval,'' but instead we will provide the
specific delegation approval granted by the State of Design Authority
for the DAH.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 13944, March 12, 2014) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 13944, March 12, 2014).

Related Service Information

    We reviewed Airbus Service Bulletin A300-57-6059, Revision 04,
dated February 22, 2011. The service information describes procedures
for repetitive inspections and repair of the wing rear spar. You can
find this information at http://www.regulations.gov by searching for
and locating Docket No. FAA-2014-0138.

Costs of Compliance

    We estimate that this AD affects 71 airplanes of U.S. registry.
    The actions that were required by AD 95-24-04, Amendment 39-9436
(60 FR 58213, November 27, 1995), and are retained in this AD take
about 3 work-hours per inspection cycle, at an average labor rate of
$85 per work-hour. Based on these figures, the estimated cost of the
actions that were required by AD 95-24-04 is $255 per product for each
inspection cycle.
    We also estimate that it will take about 3 work-hours per product
to comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $18,105 per inspection cycle, or
$255 per product for each inspection cycle.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this 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 determined that 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. 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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0138; 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 AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of 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 removing Airworthiness Directive (AD)
95-24-04, Amendment 39-9436 (60 FR 58213, November 27, 1995), and
adding the following new AD:

2015-02-19 Airbus: Amendment 39-18086. Docket No. FAA-2014-0138;
Directorate Identifier 2013-NM-020-AD.

(a) Effective Date

    This AD becomes effective March 11, 2015.

(b) Affected ADs

    This AD replaces AD 95-24-04, Amendment 39-9436 (60 FR 58213,
November 27, 1995).

(c) Applicability

    This AD applies to the Airbus airplanes specified in paragraphs
(c)(1) through (c)(5) of this AD, certificated in any category, all
manufacturer serial numbers.
    (1) Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and
B4-203 airplanes.
    (2) Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes.
    (3) Model A300 B4-605R and B4-622R airplanes.
    (4) Model A300 F4-605R airplanes.
    (5) Model A300 C4-605R Variant F airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by a determination that the inspection
compliance time and interval must be reduced to allow timely
detection of cracks and accomplishment of applicable repairs if
necessary because of cracking in the rear spar web of the wings
between certain ribs due to fatigue-related high shear stress. We
are issuing this AD to detect and correct fatigue-related cracking,
which could result in reduced structural integrity of the wing.

(f) Compliance

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

(g) Retained Inspection of Model A300 B2 Series Airplanes

    This paragraph restates the requirements of paragraph (a) of AD
95-24-04, Amendment 39-9436 (60 FR 58213, November 27, 1995), with
no changes. For Model A300 B2 series airplanes: Prior to the
accumulation of 18,000 total flight cycles, or within 1,400 flight
cycles after December 27, 1995 (the effective date of AD 95-24-04),
whichever occurs later, perform a high frequency eddy current (HFEC)
inspection to detect cracks at the aft spar web of the wings, in
accordance with Airbus Service Bulletin A300-57-0213, dated August
12, 1994. Repeat the inspection thereafter at intervals not to
exceed 5,000 flight cycles.

(h) Retained Inspection of Model A300 B4-103 and B4-2C Airplanes

    This paragraph restates the requirements of paragraph (b) of AD
95-24-04, Amendment 39-9436 (60 FR 58213, November 27, 1995), with
no changes. For Model A300 B4-103 and B4-2C airplanes: Prior to the
accumulation of 19,000 total flight cycles, or within 1,400 flight
cycles after December 27, 1995 (the effective date of AD 95-24-04),
whichever occurs later, perform an HFEC inspection to detect cracks
at the aft spar web of the wings, in accordance with Airbus Service
Bulletin A300-57-0213, dated August 12, 1994. Repeat the inspection
thereafter at intervals not to exceed 6,000 flight cycles.

(i) Retained Inspection of Model A300 B4-200 Airplanes

    This paragraph restates the requirements of paragraph (c) of AD
95-24-04, Amendment 39-9436 (60 FR 58213, November 27, 1995), with
no changes. For Model A300 B4-200 airplanes: Prior to the
accumulation of 17,000 total flight cycles, or within 1,400 flight
cycles after December 27, 1995 (the effective date of AD 95-24-04),
whichever occurs later, perform an HFEC inspection to detect cracks
at the aft spar web of the wings, in accordance with Airbus Service
Bulletin A300-57-0213, dated August 12, 1994. Repeat the inspection
thereafter at intervals not to exceed 5,000 flight cycles.

(j) Retained Inspection of Model A300 B4-601, B4-603, B4-620, B4-622,
B4-605R, B4-622R, and F4-605R Airplanes

    This paragraph restates the requirements of paragraph (d) of AD
95-24-04, Amendment 39-9436 (60 FR 58213, November 27, 1995), with
no changes. For Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R,
B4-622R, and F4-605R airplanes: Prior to the accumulation of 21,600
flight cycles, perform an HFEC inspection to detect cracks at the
aft spar web of the wings, in accordance with Airbus Service
Bulletin A300-57-6059, dated August 12, 1994. Repeat the inspection
thereafter at intervals not to exceed 5,700 flight cycles.
Accomplishment of the initial inspection required by paragraph (l)
of this AD terminates the requirements of this paragraph.

(k) Retained Repairs

    This paragraph restates the requirements of paragraph (e) of AD
95-24-04, Amendment 39-9436 (60 FR 58213, November 27, 1995), with
new actions and with specific delegation approval language in
paragraph (k)(2) of this AD.
    (1) Before the effective date of this AD, if any crack is
detected during any inspection required by paragraphs (g) through
(j) of this AD: Prior to further flight, repair the crack, in
accordance with Airbus Service Bulletin A300-57-0213, dated August
12, 1994; or Airbus Service Bulletin A300-57-6059, dated August 12,
1994; as applicable; or in accordance with a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA.
    (2) As of the effective date of this AD, if any crack is
detected during any inspection required by paragraphs (g) through
(j) of this AD: Before further flight, repair the crack, in
accordance with Airbus Service Bulletin A300-57-0213, dated August
12, 1994; or Airbus Service Bulletin A300-57-6059, Revision 04,
dated February 22, 2011; as applicable; except if Airbus Service
Bulletin A300-57-0213, dated August 12, 1994; or Airbus Service
Bulletin A300-57-6059, Revision 04, dated February 22, 2011;
specifies to contact Airbus for an approved repair, before further
flight, repair the crack using a method approved by either the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; the European Aviation Safety Agency (EASA); or

Airbus's EASA design organization approval (DOA).

(l) New Repetitive Inspections

    For airplanes identified in paragraphs (c)(2) through (c)(5) of
this AD: At the later of the times specified in paragraphs (l)(1)
and (l)(2) of this AD, perform an HFEC inspection to detect cracks
of the aft face of the wing rear spar web in the area adjacent to
the build slot, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A300-57-6059, Revision 04, dated February
22, 2011. Repeat the inspection thereafter at the applicable time
specified in Airbus Service Bulletin A300-57-6059, Revision 04,
dated February 22, 2011, except as specified in paragraph (m) of
this AD. Accomplishment of the initial inspection required by this
paragraph terminates the requirements of paragraph (j) of this AD.
    (1) At the earlier of the applicable times specified in the
``Threshold Inspection'' column in table 1 through table 4 of
paragraph 1.E., ``Compliance,'' of Airbus Service Bulletin A300-57-
6059, Revision 04, dated February 22, 2011. Where Airbus Service
Bulletin A300-57-6059, Revision 04, dated February 22, 2011,
specifies ``(FH)'' and ``(FC)'' in the ``Threshold Inspection''
columns, this AD specifies ``total flight hours'' and ``total flight
cycles.'' The inspection threshold for airplanes on which Airbus
Modification 11130 (Airbus Service Bulletin A300-57-6063) has been
done is determined from the point of embodiment of Airbus
Modification 11130, and is not based on total flight cycles.
    (2) At the earlier of the applicable times specified in the
``Grace Period'' column in table 1 through table 4 of paragraph
1.E., ``Compliance,'' of Airbus Service Bulletin A300-57-6059,
Revision 04, dated February 22, 2011. Where Airbus Service Bulletin
A300-57-6059, Revision 04, dated February 22, 2011, specifies
``(FH)'' and ``(FC)'' in the ``Grace Period'' columns, this AD
specifies ``flight hours'' and ``flight cycles.'' Where Airbus
Service Bulletin A300-57-6059, Revision 04, dated February 22, 2011,
specifies a grace period, this AD requires compliance within the
specified time after the effective date of this AD.

(m) Compliance Time Exceptions

    The repetitive inspection required by paragraph (l) of this AD
must be accomplished at the earlier of the applicable times
specified in the ``Repeat Interval'' column of table 1 through table
4 of Airbus Service Bulletin A300-57-6059, Revision 04, dated
February 22, 2011. Where Airbus Service Bulletin A300-57-6059,
Revision 04, dated February 22, 2011, specifies ``(FC)'' and
``(FH)'' in the ``Repeat Interval'' columns, this AD specifies
``flight hours'' and ``flight cycles.''

(n) New Repair

    If any crack is detected during any inspection required by
paragraph (l) of this AD: Before further flight, repair the crack,
in accordance with the Accomplishment Instructions of Airbus Service
Bulletin A300-57-6059, Revision 04, dated February 22, 2011. Where
Airbus Service Bulletin A300-57-6059, Revision 04, dated February
22, 2011, specifies to contact Airbus for an approved repair: Before
further flight, repair the crack using a method approved by either
the Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; the EASA; or Airbus's EASA DOA. Repair of any
cracking, as required by this paragraph, does not terminate the
repetitive inspections required by paragraph (l) of this AD.

(o) Credit for Previous Actions

    (1) This paragraph provides credit for the actions required by
paragraphs (j) and (k) of this AD, if those actions were performed
before the effective date of this AD using Airbus Service Bulletin
A300-57-6059, dated August 12, 1994.
    (2) This paragraph provides credit for the actions required by
paragraphs (j), (k), (l), and (n) of this AD, if those actions were
performed before the effective date of this AD using Airbus Service
Bulletin A300-57-6059, Revision 03, dated October 25, 1999, which is
not incorporated by reference in this AD.

(p) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International 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 International Branch, send it
to ATTN: Dan Rodina, Aerospace Engineer, International Branch, ANM-
116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW.,
Renton, WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
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. The AMOC approval letter must specifically reference this
AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA. If
approved by the DOA, the approval must include the DOA-authorized
signature.

(q) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2013-0013R1, dated February 20,
2013, for related information. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0138-0003.
    (2) Service information identified in this AD that is not
incorporated by reference in this AD is available at the addresses
specified in paragraphs (r)(5) and (r)(6) of this AD.

(r) 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.
    (3) The following service information was approved for IBR on
effective March 11, 2015.
    (i) Airbus Service Bulletin A300-57-6059, Revision 04, dated
February 22, 2011.
    (ii) Reserved.
    (4) The following service information was approved for IBR on
December 27, 1995 (60 FR 58213, November 27, 1995).
    (i) Airbus Service Bulletin A300-57-0213, dated August 12, 1994.
    (ii) Airbus Service Bulletin A300-57-6059, dated August 12,
1994.
    (5) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (6) You may view this 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
425-227-1221.
    (7) 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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on January 15, 2015.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-01188 Filed 2-3-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Notices]
[Pages 36178-36179]
[FR Doc No: 2013-14276]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-485-000]

Texas Gas Transmission, LLC; Notice Of Application

    Take notice that on May 29, 2013, Texas Gas Transmission, LLC
(Texas Gas), 9 Greenway Plaza, Suite 2800, Houston, Texas 77046, filed
in Docket No. CP13-485-000, pursuant to section 7(b) of the Natural Gas
Act (NGA) this abbreviated application for authorization to abandon
certain mainline facilities. Texas Gas requests authority to abandon
approximately 623 miles of pipeline segments and associated facilities
from Eunice, Louisiana to Hardinsburg, Kentucky. The facilities to be
abandoned consist primarily of one of three ``looped'' parallel
pipelines that comprise a portion of Texas Gas' mainline facilities.
All of Texas Gas' installed facilities south of Eunice and north of
Hardinsburg will remain in interstate natural gas transportation
service. Following abandonment, Texas Gas will continue to provide
natural gas transportation service on its remaining pipeline facilities
as more fully set forth in the application which is on file with the
Commission and open to public inspection. The filing may also be viewed
on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter
the docket number excluding the last three digits in the docket number
field to access the document. For assistance, please contact FERC
Online Support at<EMAIL_ADDRESS>or toll free at (866) 208-
3676, or TTY, contact<PHONE_NUMBER>.
    Any questions regarding this application may be directed to J. Kyle
Stephens, Vice President of Regulatory Affairs, Boardwalk Pipeline
Partners, LP, 9 Greenway Plaza, Houston, Texas, 77046; by fax to (713)
479-1846; or by email to<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit an original plus five copies of filings made with the Commission
and must mail a copy to the applicant and to every other party in the
proceeding. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and five copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for 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>.
    Comment Date: July 2, 2013.

    Dated: June 11, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-14276 Filed 6-14-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 89 (Tuesday, May 8, 2018)]
[Notices]
[Pages 20829-20830]
[FR Doc No: 2018-09791]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4360-DR; Docket ID FEMA-2018-0001]

Ohio; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Ohio (FEMA-4360-DR), dated April 17, 2018,
and related determinations.

DATE:  The declaration was issued April 17, 2018.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 17, 2018, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Ohio resulting from severe storms, flooding, and landslides
during the period of February 14-25, 2018, is of sufficient severity
and magnitude to warrant a major disaster declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists in the State of Ohio.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Steven Johnson, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Ohio have been designated as
adversely affected by this major disaster:

    Adams, Athens, Belmont, Brown, Columbiana, Gallia, Hamilton,
Jackson, Lawrence, Meigs, Monroe, Muskingum, Noble, Perry, Pike,
Scioto, Vinton, and Washington Counties for Public Assistance.
    All areas within the State of Ohio are eligible for assistance
under the Hazard Mitigation Grant Program.

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

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-09791 Filed 5-7-18; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Page 8709]
[FR Doc No: 2019-04316]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2388-000]

Notice of Authorization for Continued Project Operation: City of
Holyoke Gas and Electric Department

    On August 31, 2016, City of Holyoke Gas and Electric Department,
licensee for the Holyoke No. 3 Hydroelectric Project, filed an
Application for a New License pursuant to the Federal Power Act (FPA)
and the Commission's regulations thereunder. The Holyoke No. 3
Hydroelectric Project is located between the first and second canals
adjacent to the Connecticut River, in the City of Holyoke in Hampton
County, Massachusetts.
    The license for Project No. 2388 was issued for a period ending
February 20, 2019. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2388 is issued to
the licensee for a period effective February 21, 2019 through February
20, 2020, or until the issuance of a new license for the project or
other disposition under the FPA, whichever comes first. If issuance of
a new license (or other disposition) does not take place on or before
February 20, 2020, notice is hereby given that, pursuant to 18 CFR
16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the licensee, City of Holyoke Gas and Electric
Department, Inc., is authorized to continue operation of the Holyoke
No. 3 Hydroelectric Project until such time as the Commission acts on
its application for a subsequent license.

    Dated: March 5, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-04316 Filed 3-8-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Pages 9242-9243]
[FR Doc No: 2016-03807]

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

Federal Aviation Administration

Noise Exposure Map Notice for Los Angeles International Airport,
Los Angeles, California

AGENCY: Federal Aviation Administration, (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise exposure maps submitted by Los Angeles
World Airports, for Los Angeles International Airport under the
provisions of 49 U.S.C. 47501 et. seq (Aviation Safety and Noise
Abatement Act) and 14 CFR part 150 are in compliance with applicable
requirements.

DATES: The effective date of the FAA's determination on the noise
exposure maps is February 24, 2016 and applicable February 12, 2016.

FOR FURTHER INFORMATION CONTACT: Victor Globa, Environmental Protection
Specialist, Federal Aviation Administration, Los Angeles Airports
District Office, Mailing Address: P.O. Box 92007, Los Angeles,
California 90009-2007. Street Address: 15000 Aviation Boulevard,
Hawthorne, California 90261. Telephone: 310/725-3637.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the noise exposure maps submitted for Los Angeles International
Airport are in compliance with applicable requirements of Title14, Code
of Federal Regulations (CFR) Part 150 (hereinafter referred to as
``Part 150''), effective February 12, 2016. Under 49 U.S.C. Section
47503 of the Aviation Safety and Noise Abatement Act (hereinafter
referred to as ``the Act''), an airport operator may submit to the FAA
noise exposure maps which meet applicable regulations and which depict
non-compatible land uses as of the date of submission of such maps, a
description of projected aircraft operations, and the ways in which
such operations will affect such maps. The Act requires such maps to be
developed in consultation with interested and affected parties in the
local community, government

agencies, and persons using the airport. An airport operator who has
submitted noise exposure maps that are found by FAA to be in compliance
with the requirements of Part 150, promulgated pursuant to the Act, may
submit a noise compatibility program for FAA approval which sets forth
the measures the operator has taken or proposes to take to reduce
existing non-compatible uses and prevent the introduction of additional
non-compatible uses.
    The FAA has completed its review of the noise exposure maps and
accompanying documentation submitted by Los Angeles World Airports. The
documentation that constitutes the ``Noise Exposure Maps'' as defined
in Section 150.7 of Part 150 includes: Exhibit 5-1, 2015 Noise Exposure
Map (Existing Conditions)--Los Angeles International Airport; Exhibit
5-2, 2020 Noise Exposure Map (Future Conditions)--Los Angeles
International Airport. The Noise Exposure Maps contain current and
forecast information including the depiction of the airport and its
boundary; the runway configurations, land uses such as residential,
commercial, industrial, and open space/recreational land use; locations
of noise sensitive public buildings (such as schools, hospitals, and
historic properties on or eligible for the National Register of
Historic Places); and the Community Noise Equivalent Level (CNEL) 65,
70, and 75 decibel airport noise contours resulting from existing and
forecast airport operations. The frequency of airport operations is
described in Section 4.6.1 of the Noise Exposure Map Update report.
Flight tracks associated with Los Angeles International Airport are
depicted in Exhibits 4-3 thru 4-10a. The Los Angeles International
Airport noise monitoring system is described in Section 4.7 and
monitoring locations are shown on Exhibit 4-12 of the Noise Exposure
Map Update report. Estimates of the number of people residing within
the CNEL contours is located in Section 5.5 of the Noise Exposure Map
Update report. The FAA has determined that these noise exposure maps
and accompanying documentation are in compliance with applicable
requirements. This determination is effective on February 12, 2016.
    FAA's determination on an airport operator's noise exposure maps is
limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of Part 150. Such determination
does not constitute approval of the applicant's data, information or
plans, or a commitment to approve a noise compatibility program or to
fund the implementation of that program. If questions arise concerning
the precise relationship of specific properties to noise exposure
contours depicted on a noise exposure map submitted under Section 47503
of the Act, it should be noted that the FAA is not involved in any way
in determining the relative locations of specific properties with
regard to the depicted noise contours, or in interpreting the noise
exposure maps to resolve questions concerning, for example, which
properties should be covered by the provisions of Section 47506 of the
Act. These functions are inseparable from the ultimate land use control
and planning responsibilities of local government. These local
responsibilities are not changed in any way under Part 150 or through
FAA's review of noise exposure maps. Therefore, the responsibility for
the detailed overlaying of noise exposure contours onto the map
depicting properties on the surface rests exclusively with the airport
operator that submitted those maps, or with those public agencies and
planning agencies with which consultation is required under Section
47503 of the Act. The FAA has relied on the certification by the
airport operator, under Section 150.21 of Part 150, that the
statutorily required consultation has been accomplished.
    Copies of the full noise exposure map documentation and of the
FAA's evaluation of the maps are available for examination at the
following locations:
Federal Aviation Administration, Western-Pacific Region Office,
Airports Division, Room 3012, 15000 Aviation Boulevard, Hawthorne,
California 90261.
Federal Aviation Administration, Los Angeles Airports District Office,
Room 3000, 15000 Aviation Boulevard, Hawthorne, California 90261.
Los Angeles International Airport, Los Angeles World Airports,
Attention: Mr. Scott Tatro, Airport Environmental Manager II, 1 World
Way, Los Angeles, California 90045.
    Questions may be directed to the individual named above under the
heading FOR FURTHER INFORMATION CONTACT.

    Issued in Hawthorne, California, February 12, 2016.
Robin K. Hunt,
Acting Manager, Airports Division, AWP-600. Western-Pacific Region.
[FR Doc. 2016-03807 Filed 2-23-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83847-83848]
[FR Doc No: 2016-28048]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3848]

E11(R1) Addendum: Clinical Investigation of Medicinal Products in
the Pediatric Population; International Council for Harmonisation;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``E11(R1) Addendum:
Clinical Investigation of Medicinal Products in the Pediatric
Population'' (E11(R1) addendum). The draft guidance was prepared under
the auspices of the International Council for Harmonisation (ICH),
formerly the International Conference on Harmonisation. The draft
guidance is an addendum to the guidance entitled ``E11 Clinical
Investigation of Medicinal Products in the Pediatric Population'' (ICH
E11 guidance). The draft guidance is intended to update the ICH E11
guidance and provide clarification and current regulatory perspective
on topics in global pediatric drug development.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 21, 2017.

ADDRESSES: You may submit comments as follows:

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): 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-2016-D-3848 for ``E11(R1) Addendum: Clinical Investigation of
Medicinal Products in the Pediatric Population; International Council
for Harmonisation; Draft Guidance for Industry; Availability.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Lynne Yao,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Silver Spring, MD 20993-0002, 301-
796-2141; or CBER's Office of Communication, Outreach and Development;
Center for Biologics Evaluation and Research; Food and Drug
Administration; 10903 New Hampshire Ave., Bldg. 71; Silver Spring, MD
20993-0002<EMAIL_ADDRESS>1-800-835-4709 or<PHONE_NUMBER>.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
301-796-4548.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal
Products in the Pediatric Population; International Council for
Harmonisation; Draft Guidance for Industry; Availability.'' In recent
years, many important initiatives have been undertaken by regulatory
authorities and industry associations to promote international
harmonization of regulatory requirements. FDA has participated in
meetings designed to enhance harmonization and is committed to seeking
scientifically based harmonized technical procedures for pharmaceutical
development. One of the goals of harmonization is to identify and then
reduce differences in clinical and scientific approaches for drug
development among regulatory agencies.
    ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
    In September 2016, the ICH Assembly endorsed the draft guidance
entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal
Products in the Pediatric Population'' and agreed that the guidance
should be made available for public comment. The draft guidance is the
product of the E11 Expert Working Group of the ICH. Comments about this
draft will be considered by FDA and the E11 Expert Working Group.
    The addendum to the ICH E11 guidance complements the guidance and
provides clarification and current regulatory perspective on current
and evolving topics in global pediatric drug development. The E11(R1)
addendum includes sections on ethical considerations; age
classification and pediatric subgroups, including neonates; and
pediatric formulations that supplement the content in the ICH E11
guidance. A new section on Commonality of Scientific Approach for
Pediatric Drug Development Programs addresses issues to aid scientific
discussions at various stages of pediatric drug development in
different regions. The section on Approaches to Optimize Pediatric Drug
Development provides additional information on extrapolation and
introduces modelling and simulation.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``E11(R1)
Addendum: Clinical Investigation of Medicinal Products in the Pediatric
Population.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at https://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: November 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28048 Filed 11-21-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40376-40377]
[FR Doc No: 2011-17140]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0595]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exports: Notification
and Recordkeeping Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August
8, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0482.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance:.

Exports: Notification and Recordkeeping Requirements--21 CFR Part 1
(OMB Control Number 0910-0482--Extension

    The respondents to this information collection are exporters who
have notified FDA of their intent to export unapproved products that
may not be sold or marketed in the United.States as allowed under
section 801(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act (21 U.S.C. 381)). In general, the notification identifies the
product being exported (e.g. name, description, and in some cases,
country of destination) and specifies where the notification should be
sent. These notifications are sent only for an initial export;
subsequent exports of the same product to the same destination (or, in
the case of certain countries identified in section 802(b) of the FD&C
Act (21 U.S.C. 382) would not result in a notification to FDA.
    The recordkeepers to this information collection are exporters who
export human drugs, biologics, devices, animal drugs, foods and
cosmetics that may not be sold in the United States and maintain
records demonstrating their

compliance with the requirements in section 801(e)(1) of the FD&C Act.
    In the Federal Register of December 6, 2010 (75 FR 75677), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                           21 CFR section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101 (d)..........................................................             400                3            1,200               15           18,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                     Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                           21 CFR section                               Number of       frequency of     Total annual      Hours per       Total hours
                                                                      record-keepers   recordkeeping       records        recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101(b), (c), (e).................................................             320                3              960               22           21,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17140 Filed 7-7-11; 8:45 am]
BILLING CODE 4160-01-P


Legal Standards on TSCA Section 4, 8(a), 8(c), 8(d) and Applicability to a Section 21 Petition

1.  Legal standard regarding TSCA section 8(a) rules.
	Section 8(a) of TSCA authorizes the EPA Administrator to promulgate rules under which manufacturers and processors of chemical substances must maintain such records and submit such information as the EPA Administrator may reasonably require. Regarding mixtures, section 8(a) of TSCA authorizes the EPA Administrator to promulgate rules under which manufacturers and processors of mixtures must maintain such records and submit such information to the extent the EPA Administrator determines the maintenance of records or submission or reports, or both, is necessary for the effective enforcement of TSCA. Section 8(a) of TSCA generally excludes small manufacturers and processors of chemical substances or mixtures from the reporting requirements established in TSCA section 8(a). However, EPA is authorized by TSCA section 8(a)(3)(A)(ii) to require TSCA section 8(a) reporting from small manufacturers and processors with respect to any chemical substance or mixture that is the subject of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that is the subject of an order in effect under TSCA section 5(e), or that is the subject of relief granted pursuant to a civil action under TSCA section 5 or 7. The standard for determining whether an entity qualifies as a small manufacturer is found at 40 CFR 704.3.
      Section 21(b)(4)(B) of TSCA provides the standard for judicial review should EPA deny a request for rulemaking under TSCA section 8(a): ``If the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that ...there is a reasonable basis to conclude that the issuance of such a rule ...is necessary to protect health or the environment against an unreasonable risk of injury,'' the court shall order the Administrator to initiate the requested action. 15 U.S.C. 2620(b)(4)(B).

2. Legal standard regarding TSCA section 8(d) rules.
	Section 8(d) of TSCA authorizes EPA to require the submission of unpublished health and safety studies initiated or conducted by, or known to or reasonably ascertainable by, manufacturers, processors, and distributors of chemical substances or mixtures. Studies may be excluded ``if the Administrator finds that submission of lists of such studies are unnecessary to carry out the purposes of [TSCA].'' 15 U.S.C. 2607(d)(1).
      Section 21(b)(4)(B) of TSCA provides the standard for judicial review should EPA deny a request for rulemaking under TSCA section 8(d): ``If the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that ...there is a reasonable basis to conclude that the issuance of such a rule ...is necessary to protect health or the environment against an unreasonable risk of injury,'' the court shall order the Administrator to initiate the requested action. 15 U.S.C. 2620(b)(4)(B).

3. Legal standard regarding TSCA section 8(c) call-in.
      TSCA section 8(c) requires manufacturers, processors, and distributors of chemical substances or mixtures 1) to keep records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the chemical substance or mixture and 2) to permit inspection and submit copies of such records upon request of any duly designated representative of the Administrator. EPA's implementing regulations are at 40 CFR part 717.
	 Among the actions potentially available under TSCA section 8, only rules are proper objects of a TSCA section 21 petition. Pursuant to TSCA section 8(c) and EPA's implementing regulations at 40 CFR 717.17, allegations of adverse reactions are not called in by rule. In contrast, other provisions of TSCA -- including part of TSCA section 8(c) -- require or authorize the Administrator to act by rule. Section 21 of TSCA allows any person to petition ``to initiate a proceeding for the issuance, amendment, or repeal of a rule under section 2603, 2605, or 2607." 15 U.S.C. 2620(a). EPA interprets TSCA section 21 to apply only to the enumerated actions.

4. Legal standard regarding TSCA section 4 rules.
      To issue a TSCA section 4 test rule, EPA must find that data and experience are insufficient to reasonably determine or predict the effects of a chemical substance or mixture on health or the environment and that testing of the chemical substance or mixture is necessary to develop the missing data. 15 U.S.C. 2603(a)(1). In addition, EPA must find either that the chemical substance or mixture may present an unreasonable risk of injury or that the chemical substance or mixture is produced in substantial quantities and may either result in significant or substantial human exposure or result in substantial environmental release. 15 U.S.C. 2603(a)(1).
	In the case of a mixture, EPA must also find that ``the effects which the mixture's manufacture, distribution in commerce, processing, use, or disposal or any combination of such activities may have on health or the environment may not be reasonably and more efficiently determined or predicted by testing the chemical substances which comprise the mixture.'' 15 U.S.C. 2603(a)(2).
	TSCA section 21 omits the finding that ``testing is necessary to develop the data'' from the findings that a petitioner must demonstrate in order for a court to require EPA to initiate TSCA section 4 rulemaking. 15 U.S.C. 2620(b)(4)(B)(i). Nonetheless, EPA believes TSCA section 21(b)(4) is best interpreted as incorporating this finding. The alternative would be to read the statute as empowering a court to require EPA to initiate a rulemaking even where the Agency could not make proposed findings consistent with TSCA section 4 or take final action on the rule. EPA's interpretation is supported by legislative history (Ref. 1).
	TSCA section 21(b)(4)(B)(i) provides for judicial review of a petition to promulgate a TSCA section 4 rule for chemical substances. In contrast, TSCA section 21 does not provide for judicial review of a petition to promulgate a test rule for mixtures. Section 3 of TSCA gives distinct definitions for "chemical substance" and "mixture", and section 21(b)(4)(B)(i) of TSCA specifies that the court's review pertains to application of the TSCA section 4 factors to chemical substances. Moreover, TSCA section 21(b)(4)(B)(i) does not contain the additional finding that TSCA section 4 requires for issuing a test rule for mixtures (that the effect may not be reasonably and more efficiently determined or predicted by testing the chemical components). Congress left the complex issues associated with the testing of mixtures to the Administrator's discretion.