[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Rules and Regulations]
[Pages 67263-67267]
[FR Doc No: 2012-26892]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0428; Directorate Identifier 2011-NM-078-AD;
Amendment 39-17248; AD 2012-22-12]
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 adopting a new airworthiness directive (AD) for all
Airbus Model A330-243, -243F, -341, -342, and -343 airplanes. This AD
was prompted by reports of cracking of air intake cowls on Rolls-Royce
Trent engines, worn and detached attachment

links, and fractured thermal anti-ice (TAI) piccolo tubes. This AD
requires inspecting piccolo tubes, piccolo tube mount links, the aft
side of the forward bulkhead, and outer boundary angles (OBA) for
cracks, fractures, and broken links, and corrective actions if
necessary. We are issuing this AD to prevent degraded structural
integrity of the engine nose cowl in case of forward bulkhead damage in
conjunction with a broken piccolo tube, and damage to the engine due to
operation in icing conditions with reduced TAI performance.

DATES: This AD becomes effective December 14, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 14,
2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, 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 include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on May 8, 2012 (77 FR
26998). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    During shop visit, several primary assembly structures of A330
aeroplanes Trent 700 [engine] air intake cowl have been found with
cracks in the forward bulkhead web, web stiffeners and outer
boundary angles. Several attachment links have been found severely
worn, and some had become detached. In 2 cases, the Thermal Anti Ice
(TAI) Piccolo tube was found fractured. Investigations are still
ongoing to determine the root cause(s).
    If not detected and corrected, a broken Piccolo tube in
conjunction with forward bulkhead damage could ultimately lead to in
flight detachment of the outer barrel, which would constitute an
unsafe condition.
    For the reasons described above, this [European Aviation Safety
Agency (EASA)] AD requires to perform inspections of RR [Rolls-
Royce] Trent 700 [engine] nose cowls and, depending on findings, to
do the applicable corrective action(s). These inspections include
internal inspection of Piccolo tube, detailed inspection of Piccolo
tube mount links, [boroscope] inspection of aft side of forward
bulkhead and outer boundary angle [for cracks, fractures, and broken
links].

We are issuing this AD to prevent degraded structural integrity of the
engine nose cowl in case of forward bulkhead damage in conjunction with
a broken piccolo tube and damage to the engine due to operation in
icing conditions with reduced TAI performance. The corrective action is
replacing the affected engine air intake cowl with a new or serviceable
cowl. You may obtain further information by examining the MCAI in the
AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Request To Delete Completion of Reporting Form

    US Airways requested that we delete the requirement to complete
Appendix 01 of Airbus Mandatory Service Bulletin A330-71-3025, dated
January 10, 2011, which is the form for reporting inspection results to
Airbus. US Airways stated that accomplishing this reporting is
burdensome and does not improve the safety aspects of the inlet cowl
inspections.
    We agree because reporting is voluntary. Airbus has concurred that
EASA AD 2011-0062, dated April 4, 2011, does not require reporting of
the inspection findings and that it is Airbus's intent that reporting
should be done on a voluntary basis. We have changed the final rule
throughout to exclude Appendix 01 when referring to Airbus Mandatory
Service Bulletin A330-71-3025, dated January 10, 2011.

Request To Change Piccolo Tube Link Inspection

    US Airways requested that the piccolo tube link inspection be
completely independent for each inlet cowl, and that a conservative
approach could be incorporated in the NPRM (77 FR 26998, May 8, 2012)
to allow only one broken piccolo tube link on an inlet cowl if the cowl
remains in service on an airplane. US Airways stated that more than one
broken piccolo tube link would mandate removal of the cowl prior to
further flight. US Airways explained that the inspection results tie
the serviceability of cowl being inspected to the condition of the
inlet cowl installed on the other engine of the airplane. US Airways
asserted that this will require a difficult and unnecessarily
complicated management plan by an operator. US Airways reasoned that
the serviceability of the inlet cowl being inspected should be
determined independently of the inlet cowl installed on the other
engine, and that Table 3 ``Detailed Inspection of the Broken Piccolo
Tubes Links'' of Paragraph 1.E., ``Compliance,'' of Airbus Mandatory
Service Bulletin A330-71-3025, dated January 10, 2011, contains 20
different scenarios related to the number of broken piccolo tube links
in both the left and right inlet cowls and flight cycles achieved on
each inlet cowl. US Airways stated that the left and right engines and
nacelles are completely separate and designed to individually provide
continued propulsion to the airplane in the event of failure of one
engine; and that this is the basis of the FAA extended operations
(ETOPS) rules.
    We disagree with changing the piccolo tube link inspection
requirements, and allowing one piccolo tube link broken on each inlet
cowl. The criteria and corrective actions specified in Airbus Mandatory
Service Bulletin A330-71-3025, dated January 10, 2011, represent the
conditions for the safe operation of the airplane. Only one piccolo
tube link broken on the airplane is allowed. The commenter did not
provide sufficient data to substantiate that its request would provide
an acceptable level of safety. Once we issue this AD, any person may
request approval of an alternate methods of compliance (AMOC) under the
provisions of paragraph (k) of this AD. We have not changed the AD in
this regard.

Request To Change OBA and Forward Bulkhead Inspection Criteria

    US Airways recommended a change in the OBA and forward bulkhead
inspection criteria, as follows.
     Cracks up to 9 inches in length on the OBA would be
acceptable.
     Cracks up to 2 inches in length on the forward bulkhead
would be acceptable.
     Re-inspection of the OBA and forward bulkhead would be
required at subsequent intervals not to exceed 2,500 flight cycles.
     Replace the inlet cowl for any OBA crack of 22 inches or
greater or any forward bulkhead crack of 13 inches or greater, would be
required prior to further flight.
     Replace the inlet cowl for an OBA crack greater than 15
inches, but less than 22 inches, or any forward bulkhead crack greater
than 9 inches, but less than 13 inches, within 100 flight cycles.

    We disagree because Airbus Mandatory Service Bulletin A330-71-3025,
dated January 10, 2011, which references Rolls-Royce Service Bulletin
RB.211-71-AG416, dated September 3, 2010, provides the inspection
criteria and allowable conditions for the safe operation of the
airplane. The commenter did not present sufficient data to substantiate
that the crack lengths in its first and second recommendations would
provide an acceptable level of safety. Actions suggested by the
commenter in its third, fourth, and fifth recommendations are already
reflected in paragraphs (i)(1)(ii), (i)(2)(i), and (i)(2)(ii) of this
AD. However, operators may request approval of an AMOC under the
provisions of paragraph (k) of this AD if sufficient data are submitted
to substantiate that the change would provide a acceptable level of
safety. We have not changed the AD in this regard.

Request To Change Engine Inlet Cowl Inspection

    US Airways recommended a simpler re-inspection management plan of
inspecting any engine inlet cowl that has achieved more than 5,000
flight cycles since new at repeat intervals not to exceed 2,500 flight
cycles. US Airways stated that the engine inlet cowl inspection should
follow Airbus Mandatory Service Bulletin A330-71-3025, dated January
10, 2011; and Rolls-Royce Service Bulletin RB.211-71-AG416, dated
September 3, 2010; regarding the inspection schedule of the piccolo
tube, the piccolo tube links, the OBA, and the forward bulkhead.
    We disagree because Airbus Mandatory Service Bulletin A330-71-3025,
dated January 10, 2011, which references Rolls-Royce Service Bulletin
RB.211-71-AG416, dated September 3, 2010, specifies the repetitive
inspection intervals for the safe operation of the airplane, which
depend on the crack size. If the crack is within allowable limits, the
inspection interval may be greater or less than 2,500 flight cycles as
recommended by the commenter. Insufficient justification was submitted
to substantiate a 2,500-flight-cycle inspection interval. However,
under the provisions of paragraph (k) of this AD we will consider
requests for an AMOC if sufficient data is submitted to justify an
extended inspection interval for certain limits. We have not changed
the AD in this regard.

Request To Change Wording in Paragraphs (h)(2) and (h)(3) of the NPRM
(77 FR 26998, May 8, 2012)

    Airbus requested that we change the word ``engine'' to ``aircraft''
in paragraph (h)(2) of the NPRM (77 FR 26998, May 8, 2012).
    US Airways requested that we clarify the instructions in paragraph
(h)(3) of the NPRM (77 FR 26998, May 8, 2012) by revising ``* * * and
the opposite intake cowl of the same engine has * * *,'' to state ``* *
* and the intake cowl of the opposite engine has * * *.''
    We agree to clarify paragraphs (h)(2) and (h)(3) of this AD. We
changed the word ``engine'' to ``airplane'' in paragraphs (h)(2) and
(h)(3) of the AD, since each engine has one inlet cowl.

Request To Change Unsafe Condition Statement

    Airbus requested that we remove the information that a broken
piccolo tube could lead to in-flight damage of the engine and reduced
TAI performance from the unsafe condition statement in the NPRM (77 FR
26998, May 8, 2012).
    We agree with the commenter's requested wording change of the
unsafe condition statement in this AD. In addition, we have revised the
unsafe condition statement in this AD to match the unsafe condition
statement defined in Airbus Mandatory Service Bulletin A330-71-3025,
dated January 10, 2011. We have changed the Summary and Discussion
sections, and paragraph (e) of the AD.

Request To Change Repetitive Inspection Interval

    Airbus requested that we lower the repetitive inspection interval
for the OBA and forward bulkhead inspections from 450 flight cycles to
250 flight cycles, and from 400 flight cycles to 200 flight cycles
respectively. The commenter stated that these lower inspection
intervals will be introduced in the forthcoming revisions of the Airbus
and Rolls-Royce service information.
    We disagree to change the repetitive inspection intervals in this
AD. We have determined that the compliance times required by this AD
adequately address the identified unsafe condition. However, if
additional data are presented that would justify a shorter compliance
time, we might consider further rulemaking on this issue. New revisions
of the service information referenced in this AD have not been
released. We have not changed the AD in this regard.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously, except for minor
editorial changes. We have determined that these changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 26998, May 8, 2012) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 26998, May 8, 2012).

Costs of Compliance

    Based on the service information, we estimate that this AD affects
about 14 products of U.S. registry. We also estimate that it takes
about 10 work-hours per engine to comply with the basic requirements of
this AD. The average labor rate is $85 per work-hour. Based on these
figures, we estimate the cost of the AD on U.S. operators to be $11,900
per engine, or $850 per engine.
    In addition, we estimate that any necessary follow-on actions would
take about 16 work-hours per engine for a cost of $1,360 per engine. We
have received no definitive data that would enable us to provide
material cost estimates for the on-condition actions specified in this
AD. We have no way of determining the number of products that might
need these actions.

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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

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 the NPRM (77 FR 26998, May 8, 2012),
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.

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 adding the following new AD:

2012-22-12 Airbus: Amendment 39-17248. Docket No. FAA-2012-0428;
Directorate Identifier 2011-NM-078-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective December 14,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A330-243, -243F, -341, -342, and
-343 airplanes, certificated in any category, all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 71, Powerplant.

(e) Reason

    This AD was prompted by reports of cracking of air intake cowls
on Rolls-Royce Trent engines, worn and detached attachment links,
and fractured thermal anti-ice (TAI) piccolo tubes. We are issuing
this AD to prevent degraded structural integrity of the engine nose
cowl in case of forward bulkhead damage in conjunction with a broken
piccolo tube, and damage to the engine due to operation in icing
conditions with reduced TAI performance.

 (f) Compliance

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

(g) Piccolo Tube Inspection

    At the applicable time specified in paragraph (g)(1) or (g)(2)
of this AD, do a boroscope inspection of each air intake cowl
assembly of each engine to detect cracked or fractured piccolo
tubes, in accordance with the Accomplishment Instructions of Airbus
Mandatory Service Bulletin A330-71-3025, excluding Appendices 01 and
02, dated January 10, 2011. If any cracked or fractured piccolo tube
is found: Before further flight, replace the affected engine air
intake cowl with a new or serviceable engine air intake cowl, in
accordance with the Accomplishment Instructions of Airbus Mandatory
Service Bulletin A330-71-3025, excluding Appendices 01 and 02, dated
January 10, 2011.
    (1) For any engine air intake cowl that has accumulated fewer
than 5,000 flight cycles since its first installation on an airplane
as of the effective date of this AD: Inspect within 24 months after
the engine air intake cowl has accumulated 5,000 total flight
cycles.
    (2) For any engine air intake cowl that has accumulated 5,000 or
more flight cycles since its first installation on an airplane as of
the effective date of this AD: Inspect within 24 months after the
effective date of this AD.

(h) Piccolo Link Inspection

    If the inspection findings of paragraph (g) of this AD indicate
no cracked or fractured piccolo tube: Before further flight, do a
boroscope inspection of the piccolo tube links to detect broken
links, in accordance with the Accomplishment Instructions of Airbus
Mandatory Service Bulletin A330-71-3025, excluding Appendices 01 and
02, dated January 10, 2011. If no broken links are found: Before
further flight, do the actions required by paragraph (i) of this AD.
    (1) If four or more broken piccolo tube links are found: Before
further flight, replace the affected engine air intake cowl with a
new or serviceable engine air intake cowl, in accordance with the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A330-71-3025, excluding Appendices 01 and 02, dated January 10,
2011.
    (2) If three or fewer broken piccolo tube links are found, and
the opposite engine air intake cowl of the same airplane has
accumulated 5,000 flight cycles or less since the engine air intake
cowl was first installed on an airplane: Before further flight, do
the actions in Figure A-FBBAA-Sheet 03, Flow Chart, of Airbus
Mandatory Service Bulletin A330-71-3025, excluding Appendices 01 and
02, dated January 10, 2011, as required by paragraph (i) of this AD.
    (3) If three or fewer broken piccolo tube links are found, and
the opposite engine air intake cowl of the same airplane has
accumulated more than 5,000 flight cycles since the engine air
intake cowl was first installed on an airplane: Before further
flight, do a boroscope inspection of the piccolo tube links of the
opposite engine air intake cowl side to detect broken links, in
accordance with the Accomplishment Instructions of Airbus Mandatory
Service Bulletin A330-71-3025, excluding Appendices 01 and 02, dated
January 10, 2011.
    (i) If the inspection findings of the piccolo tube links of the
opposite engine air intake cowl side indicate no broken piccolo tube
links: Before further flight, do the actions required by paragraph
(i) of this AD.
    (ii) If the inspection findings of the piccolo tube links of the
opposite engine air intake cowl side indicate one or more broken
piccolo tube links: Before further flight, do the actions specified
in Note 01 of Figure A-FBBAA-Sheet 02, Flow Chart, of Airbus
Mandatory Service Bulletin A330-71-3025, excluding Appendices 01 and
02, dated January 10, 2011, at the time specified in Note 01 of
Figure A-FBBAA-Sheet 02, Flow Chart, of Airbus Mandatory Service
Bulletin A330-71-3025, excluding Appendices 01 and 02, dated January
10, 2011, except for the instructions to ``See Sheet 03.'' Where
Note 01 of Figure A-FBBAA-Sheet 02, Flow Chart, of Airbus Mandatory
Service Bulletin A330-71-3025, excluding Appendices 01 and 02, dated
January 10, 2011, specifies to ``See Sheet 03'' to do a detailed
inspection of the OBA and bulkhead, as specified in Rolls-Royce
Service Bulletin RB.211-71-AG416, excluding Appendix 1, dated
September 3, 2010: This AD requires the detailed inspection
specified in Figure A-FBBAA-Sheet 03, Flow Chart, of Airbus
Mandatory Service Bulletin A330-71-3025, excluding Appendices 01 and
02, dated January 10, 2011, to be done in accordance with paragraph
(i) of this AD.

(i) Repetitive Outer Boundary Angle and Forward Bulkhead Inspection

    If the results of the inspection required by paragraph (h) of
this AD indicate no broken piccolo tube links, or if the
requirements in paragraph (h)(2) or (h)(3)(ii) of this AD specify to
do the actions in Figure A-FBBAA-Sheet 03, Flow Chart, of Airbus
Mandatory Service Bulletin A330-71-3025, excluding Appendices 01 and
02, dated January 10, 2011: Before further flight, do a boroscope
inspection of the OBA and forward bulkhead to detect cracks or
fractures, in accordance with the Accomplishment Instructions of
Airbus

Mandatory Service Bulletin A330-71-3025, excluding Appendices 01 and
02, dated January 10, 2011; and the Accomplishment Instructions of
Rolls-Royce Service Bulletin RB.211-71-AG416, excluding Appendix 1,
dated September 3, 2010.
    (1) If the findings of the inspection are within the allowable
damage limits, as specified in the Accomplishment Instructions of
Rolls-Royce Service Bulletin RB.211-71-AG416, excluding Appendix 1,
dated September 3, 2010: Do the actions in paragraphs (i)(1)(i) and
(i)(1)(ii) of this AD.
    (i) Repeat the inspection of the OBA and forward bulkhead
thereafter at the repeat interval specified in Part 3.B. of the
Accomplishment Instructions of Rolls-Royce Service Bulletin RB.211-
71-AG416, excluding Appendix 1, dated September 3, 2010.
    (ii) Repeat the inspections specified in paragraphs (g) and (h)
of this AD thereafter at intervals not to exceed 2,500 flight
cycles.
    (2) If the findings of the inspection are not within the
allowable damage limits, as specified in the Accomplishment
Instructions of Rolls-Royce Service Bulletin RB.211-71-AG416,
excluding Appendix 1, dated September 3, 2010: Do the actions in
paragraphs (i)(2)(i) or (i)(2)(ii) of this AD, as applicable.
    (i) If any OBA crack is 22 inches or greater, or any forward
bulkhead crack is 13 inches or greater: Before further flight,
replace the affected engine air intake cowl with a new or
serviceable engine air intake cowl, in accordance with the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A330-71-3025, excluding Appendices 01 and 02, dated January 10,
2011.
    (ii) If any OBA crack is 15 inches or greater, but less than 22
inches, or any forward bulkhead crack is 9 inches or greater, but
less than 13 inches: Within 100 flight cycles, replace the affected
engine air intake cowl with a new or serviceable engine air intake
cowl, in accordance with the Accomplishment Instructions of Airbus
Mandatory Service Bulletin A330-71-3025, excluding Appendices 01 and
02, dated January 10, 2011.

(j) Repetitive Inspections for Replaced Engine Air Intake Cowls

    If any engine air intake cowl is replaced in accordance with the
requirements of this AD with an engine air intake cowl that has less
than 5,000 flight cycles since the engine air intake cowl was first
installed on an airplane: Repeat the inspection required by
paragraph (g) of this AD thereafter at the compliance time specified
in paragraph (g)(1) of this AD.
    (1) If any engine air intake cowl is replaced in accordance with
the requirements of this AD with an engine air intake cowl with
5,000 flight cycles or more since the engine air intake cowl was
first installed on an airplane: Repeat the inspections required by
paragraphs (g) and (h) of this AD thereafter at intervals not to
exceed 2,500 flight cycles.
    (2) If any engine air intake cowl is replaced in accordance with
the requirements of this AD with an engine air intake cowl with
5,000 flight cycles or more since the engine air intake cowl was
first installed on an airplane: Repeat the inspections required by
paragraph (i) of this AD thereafter at the intervals specified in
the Accomplishment Instructions of Rolls-Royce Service Bulletin
RB.211-71-AG416, excluding Appendix 1, dated September 3, 2010.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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: Vladimir
Ulyanov, 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) 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.

(l) Related Information

    Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2011-0062, dated April 4, 2011, and the service
information specified in paragraphs (l)(1) and (l)(2) of this AD,
for related information.
    (1) Airbus Mandatory Service Bulletin A330-71-3025, excluding
Appendices 01 and 02, dated January 10, 2011.
    (2) Rolls-Royce Service Bulletin RB.211-71-AG416, excluding
Appendix 1, dated September 3, 2010.

(m) 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 the AD specifies otherwise.
    (i) Airbus Mandatory Service Bulletin A330-71-3025, excluding
Appendices 01 and 02, dated January 10, 2011.
    (ii) Rolls-Royce Service Bulletin RB.211-71-AG416, excluding
Appendix 1, dated September 3, 2010.
    (3) For Airbus service information identified in this AD,
contact Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) For Rolls-Royce service information identified in this AD,
contact Rolls-Royce Plc, Technical Publications, P.O. Box 31, Derby,
DE24 8BJ, United Kingdom; telephone 44 (0) 1332 245882; fax 44 (0)
1332 249936; Internet http://www.Rolls-Royce.com.
    (5) You may review copies of the 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>.
    (6) 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 October 26, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-26892 Filed 11-8-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Notices]
[Page 28042-28043]
[DOCID:fr12jn09-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

June 8, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP09-679-000.
    Applicants: Wyckoff Gas Storage Company, LLC.
    Description: Wyckoff Gas Storage Company, LLC submits First Revised
Sheet No. 30 et al. to its FERC Gas Tariff, Original Volume No. 1.
    Filed Date: 06/01/2009.
    Accession Number: 20090604-0283.
    Comment Date: 5 p.m. Eastern Time on Monday, June 15, 2009.

    Docket Numbers: RP09-680-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Florida Gas Transmission Company submits Second
Revised Sheet No. 203 to its FERC Gas Tariff, Fourth Revised Volume No.
1.
    Filed Date: 06/01/2009.
    Accession Number: 20090604-0284.
    Comment Date: 5 p.m. Eastern Time on Monday, June 15, 2009.
    Docket Numbers: RP09-681-000.
    Applicants: Transwestern Pipeline Company, LLC.
    Description: Transwestern Pipeline Company, LLC submit Second
Revised Sheet No. 96 to its FERC Gas Tariff, Third Revised Volume No.
1.
    Filed Date: 06/01/2009.
    Accession Number: 20090604-0285.
    Comment Date: 5 p.m. Eastern Time on Monday, June 15, 2009.

    Docket Numbers: RP09-682-000.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits Fifth Revised
Sheet No. 205 et al. to FERC Gas Tariff, Fifth Revised Volume 1, to be
effective 7/2/09.
    Filed Date: 06/01/2009.
    Accession Number: 20090604-0286.
    Comment Date: 5 p.m. Eastern Time on Monday, June 15, 2009.

    Docket Numbers: RP09-754-000.
    Applicants: Rendezvous Pipeline Company, LLC.
    Description: Rendezvous Pipeline Company, LLC submits First Revised
Sheet No. 24 et al. to it FERC Gas Tariff, Original Volume No. 1.
    Filed Date: 06/05/2009.
    Accession Number: 20090605-0302.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 17, 2009.

    Docket Numbers: RP09-755-000.
    Applicants: El Paso Natural Gas Company.
    Description: El Paso Natural Gas Company submits Thirty-Ninth
Revised Sheet No. 1 et al. to its FERC Gas Tariff, Second Revised
Volume No. 1A.
    Filed Date: 06/04/2009.
    Accession Number: 20090605-0301.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 16, 2009.

    Docket Numbers: RP09-756-000.
    Applicants: Texas Eastern Transmission LP.
    Description: Texas Eastern Transmission, LP submits Petition for
Temporary Waiver of Tariffs Provisions and Request for Expedited
Action.
    Filed Date: 06/05/2009.
    Accession Number: 20090608-0141.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 17, 2009.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission,

888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-13793 Filed 6-11-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73604-73605]
[FR Doc No: 2014-29025]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2014-0034; OMB No. 1660-0040]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Standard Flood Hazard Determination Form

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the renewal of the Standard Flood
Hazard Determination Form which is used by federally regulated lending
institutions to determine if a structure is located within an
identified Special Flood Hazard Area (SFHA) and whether flood insurance
is available.

DATES: Comments must be submitted on or before February 9, 2015.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2013-0034. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., Room 8NE, Washington, DC
20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Susan Bernstein, Program Specialist,
FEMA, Federal Insurance and Mitigation Administration (FIMA), 202-212-
2113 for additional information. You may contact the Records Management
Division for copies of the proposed collection of information at
facsimile number<PHONE_NUMBER> or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On September 23, 1994, Section 303(a) of the
Riegle Community Development and Regulatory Improvement Act of 1994 was
signed into law. Section 303(a) of this Act requires the Federal bank
and thrift regulatory agencies to conduct a systematic review of their
regulation and written policies in order to improve efficiency, reduce
unnecessary costs, and eliminate inconsistencies and outmoded and
duplicative requirements. Title V of this Act is the National Flood
Insurance Reform Act (NFIRA). Section 528 of the NFIRA requires that
FEMA develop a standard hazard determination form for recording the
determination of whether a structure is located within an identified
Special Flood Hazard Area (SFHA) and whether flood insurance is
available. Section 528 of the NFIRA also requires the use of this form
by regulated lending institutions, federal agency lenders, the Federal
National Mortgage Association, the Federal Home Loan Mortgage
Corporation, and the Government National Mortgage Association for any
loan made, increased, extended, renewed or purchased by these entities.
    The requirement for federally regulated lending institutions to
determine whether a building or mobile home securing a loan is located
in an area having special flood hazards and whether flood insurance is
available has been in effect since the enactment of the Flood Disaster
Protection Act of 1973, although the use of a standard form was not
required until the enactment of the Riegle Community Development and
Regulatory Improvement Act of 1994. The establishment of the Standard
Flood Hazard Determination form has enabled lenders to provide
consistent information.

Collection of Information

    Title: Standard Flood Hazard Determination Form.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0040.
    FEMA Form: FEMA Form 086-0-32, Standard Flood Hazard Determination
Form (SFHDF).
    Abstract: FEMA Form 086-0-32, SFHDF is used by regulated lending
institutions, federal agency lenders, related lenders/regulators, and
the Government. Federally regulated lending institutions complete this
form when making, increasing, extending, renewing or purchasing each
loan for the purpose is of determining whether flood insurance is
required and available. The form may also be used by property owner,
insurance agents, realtors, community officials for flood insurance
related documentation.
    Affected Public: Business or other for-profit.
    Number of Respondents: 46,456,460.
    Number of Responses: 46,456,460.
    Estimated Total Annual Burden Hours: 15,330,632 hours.

                                                       Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of                                     Total
                                                       Number of    responses     Total       Average burden      annual      Average     Total annual
       Type of  respondent        Form name/form No.  respondents      per      number of   per response  (in  burden  (in    hourly     respondent cost
                                                                   respondent   responses         hours)          hours)     wage rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Business or other for-profit....  Standard Flood       46,456,460           1   46,456,460  0.33 (20 minutes)   15,330,632      $62.05   $951,265,715.60
                                   Hazard
                                   Determination
                                   Form (SFHDF)/FEMA
                                   Form 086-0-32.
                                                     --------------------------------------                   ------------------------------------------
    Total.......................  ..................   46,456,460  ..........   46,456,460  .................   15,330,632  ..........    951,265,715.60
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Note: The ``Avg. Hourly Wage Rate'' for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate.

    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $951,265,715.60. There are no annual costs to
respondents' operations and maintenance costs for technical services.
There are no annual start-up or capital costs. The cost to the Federal
Government is $4,309.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: December 3, 2014.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2014-29025 Filed 12-10-14; 8:45 am]
BILLING CODE 9110-11-P


[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12621-12623]
[FR Doc No: 2019-06390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2032]

Limited Population Pathway for Antibacterial and Antifungal
Drugs; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Limited Population
Pathway for Antibacterial and Antifungal Drugs.'' The purpose of the
meeting is to provide a public forum for FDA to listen to comments on
the draft guidance for industry, ``Limited Population Pathway for
Antibacterial and Antifungal Drugs,'' that was published in the Federal
Register on June 13, 2018. FDA is also reopening the comment period on
this draft guidance for comments to be submitted for consideration
before we finish work on the final version of the guidance.

DATES: The public meeting will be held on July 12, 2019, from 9 a.m. to
3 p.m. Eastern Time. Submit either electronic or written comments by
August 12, 2019, to ensure that the Agency considers your comments on
the draft guidance before it finishes work on the final version of the
guidance. See the SUPPLEMENTARY INFORMATION section for registration
date and information.

ADDRESSES: The public meeting will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503A (the Great Room), Silver
Spring, MD 20993. Entrance for the public meeting participants (non-FDA
employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2032 for ``Limited Population Pathway for Antibacterial and
Antifungal Drugs.'' 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 Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).

FOR FURTHER INFORMATION CONTACT: Sarah Walinsky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002,
[email protected],<PHONE_NUMBER>; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register for June 13, 2018 (83 FR 27616), FDA
announced the availability of a draft guidance for industry entitled
``Limited Population Pathway for Antibacterial and Antifungal Drugs.''
\1\ This draft guidance provides information on the implementation of
section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 356(h), added by section 3042 of the 21st Century Cures Act,
which established the limited population pathway for antibacterial and
antifungal drugs (LPAD pathway). This draft guidance is intended to
assist sponsors in the development of certain new antibacterial and
antifungal drugs for approval under the LPAD pathway. This draft
guidance also is intended to assist sponsors in developing labeling,
including prescribing information, patient labeling, and carton/
container labeling, that incorporates certain statements required by
section 506(h) of the FD&C Act. The LPAD pathway is intended to
encourage the development of certain antibacterial and antifungal drugs
for limited and specific populations of patients to help address the
critical public health and patient care concern that has resulted from
the current decline in antibacterial and antifungal drug research and
development as serious antibacterial and antifungal drug-resistant
infections increase.
---------------------------------------------------------------------------

    \1\<EMAIL_ADDRESS>---------------------------------------------------------------------------

    FDA received numerous comments on the draft guidance from a diverse
group of stakeholders. FDA also received requests for listening
meetings with FDA to provide feedback concerning the draft guidance on
the LPAD pathway. In view of these requests and to promote
transparency, FDA will hold a public meeting at which stakeholders may
present or comment on the draft guidance.
    The format of the meeting involves presentations from the public.
The Agency will not be inviting specific presenters; rather, with this
document, FDA is soliciting presentations from interested stakeholders.
FDA also invites interested persons to submit written comments to the
docket established with the publication of the draft guidance on the
LPAD pathway. FDA is also reopening the comment period on this draft
guidance for comments to be submitted for consideration before it
finishes work on the final version of the guidance. Submit either
electronic or written comments by August 12, 2019, to ensure that the
Agency considers your comments on this draft before it finishes work on
the final version of the guidance.

II. Topics for Discussion at the Public Meeting

    FDA is holding a public meeting to receive information and comments
concerning the draft guidance on the LPAD pathway from a broad group of

stakeholders, including patients, researchers, healthcare providers,
manufacturers, interested industry, professional organizations, and the
public. The Agency has determined that a public meeting is the most
appropriate way to ensure public engagement on the draft guidance. FDA
welcomes any relevant information that stakeholders wish to share.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://fdalimitedpoppathwayantibacterial_antifungal.eventbrite.com by July 1,
2019, at 11:59 p.m. Eastern Time. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone.
    Registration is free and based on space availability. Persons
interested in attending this public meeting must register by July 1,
2019, at 11:59 p.m. Eastern Time. Early registration is recommended
because seating is limited; therefore, FDA may limit the number of
participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting/public workshop
will be provided beginning at 8:15 a.m. We will let registrants know if
registration closes before the day of the public meeting/public
workshop.
    If you need special accommodations due to a disability, please
contact Sarah Walinsky (see FOR FURTHER INFORMATION CONTACT) no later
than July 1, 2019, at 11:59 p.m. Eastern Time.
    Requests for Oral Presentations: During online registration you may
indicate which topic(s) you wish to address, and an approximate desired
length of your presentation, so that FDA can consider this information
in organizing the presentations. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation, or submit
requests for designated representatives to present. Following the close
of registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and we will select and notify participants. All requests to make oral
presentations must be received by the close of registration on July 1,
2019, at 11:59 p.m. Eastern Time. If selected for presentation, any
presentation materials must be emailed to the Sarah Walinsky (see FOR
FURTHER INFORMATION CONTACT) no later than 12 p.m. Eastern Time July 8,
2019. No commercial or promotional material will be permitted to be
presented or distributed at the public meeting. Presenters are
encouraged to submit a copy of their presentation and related written
material to the docket (see ADDRESSES) in advance of the public
meeting.
    Streaming Webcast of the public meeting: This public meeting will
also be webcast via https://collaboration.fda.gov/lppaadpm0719.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm631810.htm.

    Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06390 Filed 4-1-19; 8:45 am]
 BILLING CODE 4164-01-P