[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Proposed Rules]
[Pages 52015-52021]
[FR Doc No: 2017-21223]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9067; Product Identifier 2016-NM-043-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM); reopening
of comment period.

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SUMMARY: We are revising an earlier notice of proposed rulemaking
(NPRM), which applies to all The Boeing Company Model 747-100, 747-
100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400,
747-400D, 747-400F, 747SR, and 747SP series airplanes. This action
revises the NPRM by adding a reporting requirement. We are proposing
this airworthiness directive (AD) to address the unsafe condition on
these products. Since these actions impose an additional burden over
that proposed in the NPRM, we are reopening the comment period to allow
the public the chance to comment on these changes.

DATES: The comment period for the NPRM published in the Federal
Register on September 8, 2016 (81 FR 62031), is reopened.
    We must receive comments on this SNPRM by December 26, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this SNPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may
view this service information at the FAA, Transport Standards Branch,
1601 Lind Avenue SW., Renton, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9067; 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 SNPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Bill Ashforth, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW.,
Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-9067;
Product Identifier 2016-NM-043-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this SNPRM. We will consider all
comments received by the closing date and may amend this SNPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this SNPRM.

Discussion

    We issued an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to all The Boeing Company Model 747-100, 747-100B, 747-100B
SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-
400F, 747SR, and 747SP series airplanes. The NPRM published in the
Federal Register on September 8, 2016 (81 FR 62031). The NPRM was
prompted by a report of fatigue cracking in airplanes that are
approaching or have exceeded their design service objective and a
structural reevaluation that identified additional structural elements
that qualify as structural significant items (SSIs). The NPRM proposed
to require revising the maintenance or inspection program to include
inspections that will give no less than the required damage tolerance
rating (DTR) for certain SSIs, inspecting for cracks of all SSI
structure, and repairing any cracked structure.

Actions Since the NPRM Was Issued

    Since we issued the NPRM, we have determined that reporting must be
required in order to ensure the continuing structural airworthiness of
The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B,
747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and
747SP series airplanes with a high number of flight cycles. All cracks
involving an SSI or related structure in close vicinity to the SSI must
be reported to Boeing in order to evaluate the effectiveness of the
supplemental structural inspections. We have revised paragraph (h) of
this proposed AD to include reporting as part of the inspection
program.

Comments

    We gave the public the opportunity to comment on the NPRM. The
following presents the comments received on the NPRM and the FAA's
response to each comment.

Support for the NPRM

    United Airlines stated that it concurs with the NPRM and has no
further comments.

Requests To Revise Certain Compliance Times

    Boeing and United Parcel Service (UPS) requested that we include a
compliance time of ``1,000 flight cycles measured from 12 months after
the effective date of the AD'' instead of a compliance time of ``within
1,000 flight cycles or 12 months after the effective date of this AD,
whichever occurs later'' as specified in paragraphs (i)(1)(ii),
(i)(2)(ii), (j)(1)(ii), and (j)(2)(ii) of the proposed AD (in the
NPRM). Boeing stated that it is not realistic to incorporate the
proposed inspections within 12 months, as specified in paragraph (h) of
the proposed AD (in the NPRM), while simultaneously performing
inspections as specified in paragraphs (i) and (j) of the proposed AD
(in the NPRM). Boeing noted that the related AD, AD 2004-07-22 R1,
Amendment 39-15326 (73 FR 1052, January 7, 2008; corrected February 14,
2008 (73 FR 8589)) (``AD 2004-07-22 R1''), increases the compliance
time up to 1,000 flight cycles, after allowing 12 months to implement
the new program. UPS stated that the proposed AD (in the NPRM) should
include a 1,000-flight-cycle grace period similar to that provided in
paragraphs (i)(1)(ii) and (i)(2)(ii) of AD 2004-07-22 R1. UPS stated
that the proposed AD (in the NPRM) creates a situation for airplanes
that are already over a threshold to have inspections due almost
immediately upon the revision of the maintenance or inspection program.
    In addition, KLM Royal Dutch Airlines requested that we provide a
grace period for SSI items for which the inspection interval has to be
lowered due to a flight-hour/flight-cycle ratio of 7.0 or more. British
Airways stated that a suitable grace period should be introduced given
that certain inspection intervals could be reduced from 6 years to 2
years.
    We agree with the requests to revise the compliance time. The
revised compliance time proposed by Boeing and UPS is consistent with
the compliance time in AD 2004-07-22 R1, and will not adversely affect
safety. This revised compliance time provides an adequate grace period
for reduced intervals. We have revised paragraphs (i)(1)(ii),
(i)(2)(ii), (j)(1)(ii), and (j)(2)(ii) of this proposed AD accordingly.

Requests To Clarify Compliance Times for Components

    Boeing and KLM Royal Dutch Airlines requested that we clarify the
compliance times for removable structural components. The commenters
noted that for inspections of removable structural components, the
accumulated flight cycles and flight hours on the component should be
used instead of flight cycles and flight hours on the airframe. Boeing
noted that some SSI details are replaced, such as when installing
removable structural components or installing used structural parts in
a repair. The commenters recommended we add a note to paragraphs (i)
and (j) of the proposed AD (in the NPRM) to address this issue.
    We agree because an SSI can be removed from the airframe and
replaced, and have different flight cycles and flight hours than the
airframe. Boeing Document D6-35022, ``Supplemental Structural
Inspection Document for Model 747 Airplanes,'' Revision H, dated
September 2013; and Boeing Document D6-35022-1, ``747-400 LCF
Supplemental Structural Inspection Document--Appendix A,'' dated
November 2015; state the following:

    The initial inspection (threshold) and intervals are measured in
flight cycles or flight hours that a particular SSI detail has
accumulated regardless of what the airframe as a whole has
accumulated. Most SSI details have never been replaced and therefore
have accumulated the same flight cycles and flight hours as the
airframe. Some SSI details are replaced, such as when installing
removable structural components (repairable/rotable/expendables) or
installing used structural parts as a repair. In these cases the SSI
details have accumulated flight cycles and flight hours that may be
different than the airframe. The operator must account for this in
determining when inspections must be done.

    We have added new content to paragraph (l) to this proposed AD
(replacing the content in paragraph (l) of the proposed AD (in the
NPRM)) to state that for compliance times that specify total flight
cycles and total flight hours, and the SSI is a removable structural
component, those compliance times must be measured on the SSI since its
installation, regardless of what the airframe as a whole has
accumulated. If the total flight cycles and total flight hours on the
SSI are not available or cannot be determined, the airframe total
flight cycles and total flight hours are to be used for the compliance
times identified in paragraphs (i) and (j) of this proposed AD. We have
also added a reference to ``paragraph (l) of this AD'' to paragraphs
(i) and (j) of this proposed AD.

Request To Add Explanation To Continue Inspections

    Boeing requested that we add an explanation to the NPRM regarding
the continuation of the inspections in AD 2004-07-22 R1 until the start
of the new inspections specified in the NPRM. Boeing recommended that
we add the following text to the ``Proposed AD Requirements'' section
in the preamble of the NPRM:

    Note it is required to start and continue inspections per D6-
35022 Rev G, as required by AD 2004-07-22 R1; until inspections per
D6-35022 Rev H, dated Sept. 2013, and if required also D6-35022-1
Appendix A, dated Nov. 2015, are accomplished as required by the new
AD.

    We agree with the statement that Boeing provided. Inspections
required by AD 2004-07-22 R1 are terminated only after accomplishment
of the corresponding inspections required by this AD, as specified in
paragraphs (i) and (j) of this proposed AD. However, the ``Proposed AD
Requirements'' section is not restated in this proposed AD. Therefore,
we have not changed this proposed AD in this regard.

Request To Clarify Affected Airplanes in Paragraph (i) of the Proposed
AD (in the NPRM)

    Boeing requested that we revise the header and first sentence of
paragraph (i) of the proposed AD (in the NPRM) to clarify the affected
airplanes. Boeing stated that the text ``all Model 747 airplanes''
should be revised so that the paragraph excludes Model 747-8 and 747-8F
airplanes. Boeing noted those models are not included in the
applicability specified in paragraph (c) of the proposed AD (in the
NPRM).
    We agree to clarify the language for the affected airplanes for
paragraph (i) of this proposed AD. When we use the term ``all
airplanes'' in the regulatory text of an AD, we mean all airplanes
identified in paragraph (c) of the AD. Model 747-8 and 747-8F airplanes
are not identified in paragraph (c) of this proposed AD. We have
revised the header and first sentence of paragraph (i) of this proposed
AD by specifying ``all airplanes except . . .'' instead of ``all Model
747 airplanes except . . . .''

Request To Clarify Alternative Methods of Compliance (AMOCs) for AD
2004-07-22 R1

    Boeing requested that we revise paragraph (m)(3) of the proposed AD
(in the NPRM) to clarify that AMOCs are no longer needed for AD 2004-
07-22 R1 after the requirements of the proposed AD (in the NPRM) are
implemented. Boeing stated that both ADs should not be required to be
reported on FAA Form 8100-9.
    We agree to clarify the AMOC requirements, but we do not agree to
revise paragraph (p)(3) of this proposed AD (paragraph (m)(3) of the
proposed AD (in the NPRM)). Paragraphs (i) and (j) of this proposed AD
state that doing

the actions in paragraph (i) or (j) of this proposed AD terminates the
corresponding action required by AD 2004-07-22 R1. Thus, an AMOC for AD
2004-07-22 R1 is no longer needed for a given SSI once the inspection
for that SSI is done as required by this proposed AD. We have not
changed this proposed AD in this regard.

Request To Clarify Approval of Previous AMOCs

    Qantas Airways requested that we clarify paragraph (m)(4) of the
proposed AD (in the NPRM), which approves previous AMOCs for the
actions specified in paragraphs (h), (i), and (j) of the proposed AD
(in the NPRM), except for any SSI that has an expanded inspection area
identified in Boeing Document D6-35022, ``Supplemental Structural
Inspection Document for Model 747 Airplanes,'' Revision H, dated
September 2013; or Boeing Document D6-35022-1, ``747-400 LCF
Supplemental Structural Inspection Document--Appendix A,'' dated
November 2015. Qantas Airways requested that previous AMOCs also be
approved for the actions required by paragraph (k) of the proposed AD
(in the NPRM), which specifies repairing any cracked structure.
    We agree and have added a reference to paragraph (k) in paragraph
(p)(4) of this proposed AD (paragraph (m)(4) of the proposed AD (in the
NPRM)).

Request for Relief From Certain Requirements

    UPS requested that we revise paragraph (k) of the proposed AD (in
the NPRM) to match the wording in paragraph (j) of AD 2004-07-22 R1 in
order to avoid an unnecessary burden for Boeing, operators, and the
FAA. UPS stated that paragraph (k) of the proposed AD (in the NPRM)
specifies repairs to be done in accordance with AMOC-approved methods.
UPS noted that previous repairs have been approved as AMOCs to
paragraph (j) of AD 2004-07-22 R1, which corresponds to paragraph (k)
of the proposed AD (in the NPRM). UPS further stated that paragraph
(m)(4) of the proposed AD (in the NPRM) states that AMOCs approved for
AD 2004-07-22 R1 are approved as AMOCs for the corresponding provisions
of paragraphs (h), (i), and (j) of the proposed AD (in the NPRM). UPS
noted that paragraph (j) of AD 2004-07-22 R1 requires repairs to be
done in accordance with FAA-approved methods. UPS concluded that a
requirement to have all repairs be AMOC-approved creates an unnecessary
burden.
    We agree to revise paragraph (k) of this proposed AD. Paragraph (j)
of AD 2004-07-22 R1 allows repairs to be performed using an FAA-
approved method. This is because the original intent of the
supplemental structural inspection document (SSID) program was to
perform damage-tolerant-type inspections of SSIs that had no
significant prior fatigue crack history on pre-14 CFR 25.571 amendment
45 airplanes. In accordance with the SSID program, when cracking was
found, Boeing would remove the SSI from the SSID, produce a separate
service bulletin to address the cracking, and the FAA would then
mandate the inspections specified in that service bulletin. These
repairs would then need an AMOC to the corresponding AD when
inspections were due. Since AD 2004-07-22 R1 was issued, the FAA and
Boeing have determined that in many cases it is not necessary to create
a separate service bulletin and AD, provided the cracks are found in an
SSI and the existing inspections in the SSID are sufficient to maintain
airworthiness and detect cracks in a timely manner. This is similar to
how airworthiness limitations programs are managed on post-14 CFR
25.571 amendment 45 airplanes. We have revised paragraph (k) of this
proposed AD to state that repairs are to be performed using an FAA-
approved method.
    We also acknowledge that AMOCs to AD 2004-07-22 R1 have been
issued, but these were issued to paragraph (l)(3) of that AD, rather
than to paragraph (j) of that AD as discussed by UPS. These AMOCs were
issued because operators could not inspect the SSI in accordance with
the SSID and required alternate inspections or inspection intervals. We
have determined that the guidance on when AMOCs are needed relative to
the SSID program is not clear. Therefore, we have discussed this in the
``Proposed Requirements of this SNPRM'' section in this document and
added new content to paragraph (m) to this proposed AD to clarify when
operators must request an AMOC.

Request for Approval of Alternative Determination of Utilization

    British Airways and UPS requested that we approve an alternative
determination of airplane utilization (i.e., an airplane's average
flight hours/flight cycles). The commenters stated that section 5.1.3.
of Boeing Document D6-35022, ``Supplemental Structural Inspection
Document for Model 747 Airplanes,'' Revision H, dated September 2013,
specifies that the utilization is an average of flight hours per flight
for each airplane and that the utilization should be determined since
the last D-check. British Airways recommended that utilization be
considered from the delivery of the airplane. British Airways stated
the proposed change is a more realistic average over the life of the
airplane, makes it easier for operators to determine future
utilization, and reduces the possibility of missing inspections due to
minor changes in utilization between D-checks.
    UPS recommended that an option be included to allow operators to
use projected utilizations. UPS stated that the following terminology
in Boeing Document D6-35022, ``Supplemental Structural Inspection
Document for Model 747 Airplanes,'' Revision H, dated September 2013,
can be contradictory and cannot be complied with: ``for determining
utilization, use flight hours and cycles accumulated since the last D
check or its equivalent. If future utilization is known, use the new
average flight hours.'' UPS stated that the option would allow the
operator to determine utilization from its maintenance program.
    We disagree that future airplane utilization (unless known through
scheduled maintenance) or airplane utilization based on the delivery
date of the airplane is acceptable. The terminology used in Boeing
Document D6-35022, ``Supplemental Structural Inspection Document for
Model 747 Airplanes,'' Revision H, dated September 2013, is:

    After implementing the FLS [Flight Length Sensitive] inspections
and to account for utilization changes over time, it is recommended
the operator re-assess the airplane's utilization at least every D
check or its equivalent. As a result of a re-assessment, SSIs which
require inspection more frequently should be inspected within the
new interval since the last inspection or at the next C check,
whichever is later.

    Future airplane utilization or airplane utilization from the
delivery date would not, in general, be conservative in assessing the
aircraft structure and is not equivalent. We have not changed this
proposed AD in this regard.
    We also disagree that the terminology that UPS cited in Boeing
Document D6-35022, ``Supplemental Structural Inspection Document for
Model 747 Airplanes,'' Revision H, dated September 2013, is
contradictory. If the utilization that is used to set up the
maintenance program changes over time, then the maintenance program
schedule should be updated based on the new utilization. For example,
if the average flight hours increase over the assessment period, then
that operator should revise its maintenance program in consideration of
the new average

flight hours. We have not changed this proposed AD in this regard.

Requests To Allow a Tolerance for Selecting Forms

    UPS and British Airways requested that we provide a tolerance for
selecting the appropriate DTR forms. UPS recommended a tolerance of +/-
0.1 hour be allowed for selecting DTR forms. UPS stated that the
historic utilization of its fleet is slightly less than 7 flight hours
per flight cycle since delivery of the airplane and over the most
recent D-check interval. UPS stated that current utilization
projections show an average over 7 flight hours per flight cycle. UPS
concluded that since it would have no knowledge ahead of time which
airplane will be under or over 7, a tolerance in selecting the
appropriate DTR form would provide a significant benefit to
incorporating the program change without affecting the level of safety.
British Airways recommended a tolerance of +/-0.2 hour for the 7-hour
utilization threshold and +/-0.25 hour for 9- or 11-hour utilization
thresholds. British Airways noted that if the utilization increases
during the next interval, then the interval is significantly reduced,
causing difficulty in providing the correct maintenance. The commenters
noted that no tolerance is provided in Boeing Document D6-35022,
``Supplemental Structural Inspection Document for Model 747
Airplanes,'' Revision H, dated September 2013.
    We do not find it necessary to include the requested tolerance in
this AD, because section 5.1.3 of Boeing Document D6-35022,
``Supplemental Structural Inspection Document for Model 747
Airplanes,'' Revision H, dated September 2013, states, ``DTR values can
be read to the nearest two significant figures (0.1),'' and section 7.3
of that document provides the following example on how to determine
what the average flight hours per flight cycle without the use of
additional tolerances:

    For Wing SSIs, the initial step is to check to see if the SSI if
Flight Length Sensitive (FLS). If so, the operator uses the average
flight length to select the DTR Check Form that the airplane's
average flight length fits under. For example, at the SSID
threshold, the airplane's average flight length is 8.6 hours. For
this SSID item, there may be forms for <7 hours and >7 hours. In
this case, the operator is to use the >7 hour DTR check form.

Therefore, an operator will be able to determine if its average flight
hours are either <7 hours or >=7 hours without needing the aid of an
additional tolerance. We have not changed this proposed AD in this
regard.

Request To Clarify if a Reassessment Is Required

    UPS requested that we clarify whether a reassessment of utilization
is required. UPS stated that Boeing Document D6-35022, ``Supplemental
Structural Inspection Document for Model 747 Airplanes,'' Revision H,
dated September 2013, states, ``it is recommended the operator re-
assess the airplane's utilization at least every D check or
equivalent,'' but it is not clear if this recommendation is a
requirement of the proposed AD (in the NPRM) or an option.
    We agree to clarify. Boeing Document D6-35022, ``Supplemental
Structural Inspection Document for Model 747 Airplanes,'' Revision H,
dated September 2013, is for an exploratory program. When that document
calls out recommendations on re-assessing the airplane's utilization,
this should be done at the operator's own discretion. The reassessment
is not a requirement of this proposed AD. We have not changed this
proposed AD in this regard.

Request To Provide Guidelines for Adjusting Certain Intervals

    KLM Royal Dutch Airlines (KLM) requested that we provide guidance
for adjusting certain intervals. KLM stated that no information is
given on how to adjust repeat flight length sensitive (FLS) tasks for
airplanes with a flight-hour/flight-cycle ratio of 7.0 or more once the
initial inspection is performed. KLM stated that chapter 5.0 of Boeing
Document D6-35022, ``Supplemental Structural Inspection Document for
Model 747 Airplanes,'' Revision H, dated September 2013, does not give
clear guidelines. KLM stated that FLS tasks in Boeing Document D6-
35022, ``Supplemental Structural Inspection Document for Model 747
Airplanes,'' Revision H, dated September 2013, will result in a
significant decrease of the repetitive interval of complex inspections
for a flight-hour/flight-cycle ratio of 7.0 or more.
    In reviewing Boeing Document D6-35022, ``Supplemental Structural
Inspection Document for Model 747 Airplanes,'' Revision H, dated
September 2013, we have determined that it adequately addresses
adjustment of the repetitive FLS tasks in sections 5.1.3 and 7.3. In
addition, under the provisions of paragraph (p) of this AD, we will
consider requests for alternate approaches to compliance time changes
if sufficient data are submitted to substantiate that the approach and
compliance time changes would provide an acceptable level of safety. We
have not changed this proposed AD in this regard.

Request To Fix Typographical Error

    Boeing and KLM requested that we revise a typographical error in
paragraph (j)(2) of the proposed AD (in the NPRM), which refers to
paragraph (i)(2)(ii) of the proposed AD (in the NPRM). The commenters
stated that the correct reference is paragraph (j)(2)(ii) of the
proposed AD (in the NPRM).
    We agree with the request. We have revised paragraph (j)(2) of this
proposed AD accordingly.

Removal of Inspection Program for Transferred Airplanes

    We have determined that the requirements specified in paragraph (l)
of the proposed AD (in the NPRM) are not necessary. The inspection
program for transferred airplanes was included in early SSID programs
that involved a ``candidate fleet'' (a specific group of airplanes that
was inspected instead of all airplanes). Therefore, we have removed
those requirements from this proposed AD.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Document D6-35022, ``Supplemental Structural
Inspection Document for Model 747 Airplanes,'' Revision H, dated
September 2013. This service information describes procedures for
inspections to detect cracks of all structure identified as SSIs, and
includes six new SSIs since the last revision.
    We also reviewed Boeing Document D6-35022-1, ``747-400 LCF
Supplemental Structural Inspection Document--Appendix A,'' dated
November 2015. This service information describes procedures for
inspections of the wings, fuselage, and empennage SSIs for Model 747-
400 LCF airplanes.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type design.
Certain changes described above expand the scope of the NPRM. As a
result, we have determined that it is necessary to reopen the comment

period to provide additional opportunity for the public to comment on
this SNPRM.

Proposed Requirements of This SNPRM

    This SNPRM would require revising the maintenance or inspection
program to include inspections that will give no less than the required
damage tolerance rating (DTR) for certain SSIs, inspecting for cracks
of all SSI structure, and repairing any cracked structure. This
proposed AD also would require reporting all cracks involving an SSI or
related structure in close vicinity to the SSI to Boeing.
    This SNPRM would require revisions to certain operator maintenance
documents to include new inspections. Compliance with these inspections
is required by 14 CFR 91.403(c). For airplanes that have been
previously modified, altered, or repaired in the areas addressed by
these inspections, the operator may not be able to accomplish the
actions described in the revisions. In this situation, to comply with
14 CFR 91.403(c), the operator must request approval for an alternative
method of compliance according to paragraph (p) of this proposed AD.
The request should include a description of changes to the required
inspections that will ensure the continued damage tolerance of the
affected airplane.

Costs of Compliance

    We estimate that this proposed AD affects 118 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revision of maintenance or inspection   1 work-hour x $85 per                 $0             $85         $10,030
 program.                                hour = $85.
----------------------------------------------------------------------------------------------------------------

    We have not specified cost estimates for the inspection and repair
specified in this proposed AD. Compliance with this proposed AD
constitutes a method of compliance with the FAA aging airplane safety
final rule (AASFR) (70 FR 5518, February 2, 2005) for certain baseline
structure of Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C,
747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and 747SP series
airplanes. The AASFR requires certain operators to incorporate damage
tolerance inspections into their maintenance inspection programs. These
requirements are described in 14 CFR 121.1109(c)(1) and 14 CFR
129.109(b)(1). Accomplishment of the actions specified in this proposed
AD will meet the requirements of these regulations for certain baseline
structure. The costs for accomplishing the inspection portion of this
proposed AD were accounted for in the regulatory evaluation of the
AASFR for airplanes affected by that rule. For airplanes not affected
by the AASFR, we have received no definitive data that would enable us
to provide cost estimates for the inspection portion of this proposed
AD.
    We estimate the following costs to do any necessary reporting that
would be required based on the results of the proposed inspections in
the maintenance inspection program. We have no way of determining the
number of aircraft that might need this action:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                 Action                           Labor cost            Parts cost         Cost per product
----------------------------------------------------------------------------------------------------------------
Reporting...............................  1 work-hour x $85 per hour              $0  $85 per inspection cycle.
                                           = $85.
----------------------------------------------------------------------------------------------------------------

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this proposed AD
is 2120-0056. The paperwork cost associated with this proposed AD has
been detailed in the Costs of Compliance section of this document and
includes time for reviewing instructions, as well as completing and
reviewing the collection of information. Therefore, all reporting
associated with this proposed AD is mandatory. Comments concerning the
accuracy of this burden and suggestions for reducing the burden should
be directed to the FAA at 800 Independence Ave. SW., Washington, DC
20591, ATTN: Information Collection Clearance Officer, AES-200.

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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on

the relationship between the national Government and the States, or on
the distribution of power and responsibilities among the various levels
of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2016-9067; Product Identifier
2016-NM-043-AD.

(a) Comments Due Date

    We must receive comments by December 26, 2017.

(b) Affected ADs

    This AD affects AD 2004-07-22 R1, Amendment 39-15326 (73 FR
1052, January 7, 2008; corrected February 14, 2008 (73 FR 8589))
(``AD 2004-07-22 R1'').

(c) Applicability

    This AD applies to all The Boeing Company Model 747-100, 747-
100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400,
747-400D, 747-400F, 747SR, and 747SP series airplanes, certificated
in any category.

    Note 1 to paragraph (c) of this AD: A Model 747-400 LCF airplane
is a Model 747-400 series airplane that has been modified from a
passenger airplane to a freighter configuration, as specified in
Boeing Service Bulletin 747-00-2084.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage;
54, Nacelles/Pylons; 55, Stabilizers; 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report of incidents involving fatigue
cracking in transport category airplanes that are approaching or
have exceeded their design service objective, and a structural
reevaluation by the manufacturer that identified additional
structural elements that qualify as structural significant items
(SSIs). We are issuing this AD to ensure the continued structural
integrity of all The Boeing Company Model 747-100, 747-100B, 747-
100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D,
747-400F, 747SR, and 747SP series airplanes.

(f) Compliance

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

(g) Definition of SSI

    For the purposes of this AD, an SSI is defined as a principal
structural element (PSE). A PSE is a structural element that
contributes significantly to the carrying of flight, ground, or
pressurization loads, and whose integrity is essential in
maintaining the overall structural integrity of the airplane.

(h) Maintenance or Inspection Program Revision for All Airplanes

    Prior to reaching the compliance times specified in paragraph
(i)(1)(i), (i)(2)(i), (j)(1)(i), or (j)(2)(i) of this AD, as
applicable, or within 12 months after the effective date of this AD,
whichever occurs later: Incorporate a revision into the maintenance
or inspection program, as applicable, that provides no less than the
required damage tolerance rating (DTR) for each SSI listed in the
applicable service information specified in paragraph (h)(1) or
(h)(2) of this AD. The revision to the maintenance or inspection
program must include, and must be implemented in accordance with,
the procedures in Section 5.0, ``Damage Tolerance Rating (DTR)
System Application,'' and Section 6.0, ``SSI Discrepancy Reporting''
of Boeing Document D6-35022, ``Supplemental Structural Inspection
Document for Model 747 Airplanes,'' Revision H, dated September
2013; and Boeing Document D6-35022-1, ``747-400 LCF Supplemental
Structural Inspection Document--Appendix A,'' dated November 2015;
as applicable. Accomplishing the revision required by this paragraph
terminates the actions required by paragraphs (f), (g), and (h) of
AD 2004-07-22 R1.
    (1) For all airplanes except Model 747-400 LCF airplanes: SSIs
listed in Boeing Document D6-35022, ``Supplemental Structural
Inspection Document for Model 747 Airplanes,'' Revision H, dated
September 2013.
    (2) For Model 747-400 LCF airplanes: SSIs listed in Boeing
Document D6-35022, ``Supplemental Structural Inspection Document for
Model 747 Airplanes,'' Revision H, dated September 2013; and SSIs
listed in Boeing Document D6-35022-1, ``747-400 LCF Supplemental
Structural Inspection Document--Appendix A,'' dated November 2015.
For SSIs listed in both Boeing Document D6-35022-1, ``747-400 LCF
Supplemental Structural Inspection Document--Appendix A,'' dated
November 2015; and Boeing Document D6-35022, ``Supplemental
Structural Inspection Document for Model 747 Airplanes,'' Revision
H, dated September 2013: Incorporate the SSIs listed in Boeing
Document D6-35022-1, ``747-400 LCF Supplemental Structural
Inspection Document--Appendix A,'' dated November 2015.

(i) Inspections for All Airplanes Except Model 747-400 LCF Airplanes

    For all airplanes except Model 747-400 LCF airplanes: Perform
inspections to detect cracks of all structure identified in Boeing
Document D6-35022, ``Supplemental Structural Inspection Document for
Model 747 Airplanes,'' Revision H, dated September 2013, at the
times specified in paragraph (i)(1), (i)(2), or (i)(3) of this AD,
as applicable, except as required by paragraph (l) of this AD. Once
the initial inspection has been performed, in order to remain in
compliance with the maintenance or inspection program, as required
by paragraph (h) of this AD, repetitive inspections are required at
the intervals specified in Boeing Document D6-35022, ``Supplemental
Structural Inspection Document for Model 747 Airplanes,'' Revision
H, dated September 2013. Doing an inspection required by this
paragraph terminates the corresponding inspection required by
paragraph (i) of AD 2004-07-22 R1.
    (1) For wing structure, except as provided by paragraph (i)(3)
of this AD: Inspect at the times specified in paragraph (i)(1)(i) or
(i)(1)(ii) of this AD, whichever occurs later.
    (i) Within the applicable compliance time specified in paragraph
(i)(1)(i)(A) or (i)(1)(i)(B) of this AD.
    (A) For all Model 747-100, 747-100B, 747-100B SUD, 747-200B,
747-200C, 747-200F, 747-300, 747SR, and 747SP series airplanes:
Prior to the accumulation of 20,000 total flight cycles or 100,000
total flight hours, whichever occurs first.
    (B) For all Model 747-400, 747-400D, and 747-400F series
airplanes: Prior to the accumulation of 20,000 total flight cycles
or 115,000 total flight hours, whichever occurs first.
    (ii) Within 1,000 flight cycles measured from 12 months after
the effective date of this AD.
    (2) For all structure other than wing structure, except as
provided by paragraph (i)(3) of this AD: At the time specified in
paragraph (i)(2)(i) or (i)(2)(ii) of this AD, whichever occurs
later.
    (i) Prior to the accumulation of 20,000 total flight cycles.
    (ii) Within 1,000 flight cycles measured from 12 months after
the effective date of this AD.
    (3) For any portion of an SSI that has been replaced with new
structure: Inspect at the later of the times specified in paragraphs
(i)(3)(i) and (i)(3)(ii) of this AD.

    (i) At the time specified in paragraph (i)(1) or (i)(2) of this
AD, as applicable.
    (ii) Within 10,000 flight cycles after the replacement of the
part with a new part.

(j) Inspections for Model 747-400 LCF Airplanes

    For Model 747-400 LCF airplanes: Perform inspections to detect
cracks of all structure identified in Boeing Document D6-35022,
``Supplemental Structural Inspection Document for Model 747
Airplanes,'' Revision H, dated September 2013; and Boeing Document
D6-35022-1, ``747-400 LCF Supplemental Structural Inspection
Document--Appendix A,'' dated November 2015; at the times specified
in paragraph (j)(1) or (j)(2) of this AD, as applicable, except as
required by paragraph (l) of this AD. Once the initial inspection
has been performed, in order to remain in compliance with the
maintenance or inspection program, as required by paragraph (h) of
this AD, repetitive inspections are required at the intervals
specified in Boeing Document D6-35022, ``Supplemental Structural
Inspection Document for Model 747 Airplanes,'' Revision H, dated
September 2013; and Boeing Document D6-35022-1, ``747-400 LCF
Supplemental Structural Inspection Document--Appendix A,'' dated
November 2015. For SSIs listed in both Boeing Document D6-35022,
``Supplemental Structural Inspection Document for Model 747
Airplanes,'' Revision H, dated September 2013; and Boeing Document
D6-35022-1, ``747-400 LCF Supplemental Structural Inspection
Document--Appendix A,'' dated November 2015; the SSIs listed in
Boeing Document D6-35022-1, ``747-400 LCF Supplemental Structural
Inspection Document--Appendix A,'' dated November 2015, take
precedence (i.e., the SSIs in the latter document prevail). Doing an
inspection required by this paragraph terminates the corresponding
inspection required by paragraph (i) of AD 2004-07-22 R1.
    (1) For wing structure: Inspect at the times specified in
paragraph (j)(1)(i) or (j)(1)(ii) of this AD, whichever occurs
later.
    (i) Prior to the accumulation of 20,000 total flight cycles or
115,000 total flight hours, whichever occurs first.
    (ii) Within 1,000 flight cycles measured from 12 months after
the effective date of this AD.
    (2) For all structure other than wing structure: At the time
specified in paragraph (j)(2)(i) or (j)(2)(ii) of this AD, whichever
occurs later.
    (i) At the earlier of the times specified in paragraphs
(j)(2)(i)(A) and (j)(2)(i)(B) of this AD.
    (A) Prior to the accumulation of 20,000 total flight cycles.
    (B) Within the applicable initial compliance time specified in
Boeing Document D6-35022, ``Supplemental Structural Inspection
Document for Model 747 Airplanes,'' Revision H, dated September
2013; and Boeing Document D6-35022-1, ``747-400 LCF Supplemental
Structural Inspection Document--Appendix A,'' dated November 2015.
For SSIs are listed in both Boeing Document D6-35022, ``Supplemental
Structural Inspection Document for Model 747 Airplanes,'' Revision
H, dated September 2013; and Boeing Document D6-35022-1, ``747-400
LCF Supplemental Structural Inspection Document--Appendix A,'' dated
November 2015; the SSIs listed in Boeing Document D6-35022-1, ``747-
400 LCF Supplemental Structural Inspection Document--Appendix A,''
dated November 2015, take precedence (i.e., the SSIs in the latter
document prevail).
    (ii) Within 1,000 flight cycles measured from 12 months after
the effective date of this AD.

(k) Repair

    If any cracked structure is found during any inspection required
by paragraph (i) or (j) of this AD, repair before further flight
using an FAA-approved method.

(l) Compliance Time Clarification

    For compliance times identified in paragraphs (i) and (j) of
this AD that specify total flight cycles and total flight hours, and
the SSI is a removable structural component, those compliance times
must be measured on the SSI since its first installation on any
airplane, regardless of what the airframe as a whole has
accumulated. If the total flight cycles and total flight hours on
the SSI are not available or cannot be determined, use the airframe
total flight cycles and total flight hours for the compliance times
identified in paragraphs (i) and (j) of this AD.

(m) No Alternative Inspections and Inspection Intervals

    After accomplishing the revision required by paragraph (h) of
this AD, no alternative inspections or inspection intervals may be
used unless the alternative inspection or inspection interval is
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (p) of this AD.

(n) Terminating Action for AD 2004-07-22 R1

    Accomplishing the revision required by paragraph (h) of this AD
and all of the initial inspections required by paragraph (i) or (j)
of this AD, as applicable, terminates all requirements of AD 2004-
07-22 R1.

(o) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(p) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (q)(1) of this AD. Information may be
emailed to: [email protected]
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) AMOCs approved for AD 2004-07-22 R1 are approved as AMOCs
for the corresponding provisions of paragraphs (h), (i), (j), and
(k) of this AD for the SSIs identified in the AMOC, except for any
SSI that has an expanded inspection area identified in Boeing
Document D6-35022, ``Supplemental Structural Inspection Document for
Model 747 Airplanes,'' Revision H, dated September 2013; or Boeing
Document D6-35022-1, ``747-400 LCF Supplemental Structural
Inspection Document--Appendix A,'' dated November 2015, as
applicable.

(q) Related Information

    (1) For more information about this AD, contact Bill Ashforth,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 1601
Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:
425-917-6590; email: [email protected].
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 1601 Lind Avenue
SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on September 25, 2017.
Dionne Palermo,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2017-21223 Filed 11-8-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: April 6, 2010 (Volume 75, Number 65)]
[Notices]
[Page 17415-17416]
[DOCID:fr06ap10-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0400]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for FANAPT and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES:  Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product FANAPT
(iloperidone). FANAPT is indicated for the acute treatment of
schizophrenia in adults. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
FANAPT (U.S. Patent No. RE39,198) from Aventis Holdings Inc., and the
Patent and Trademark Office requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated September 2, 2009, FDA advised the Patent and Trademark Office
that this human drug product had undergone a regulatory review period
and that the approval of FANAPT represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
    FDA has determined that the applicable regulatory review period for
FANAPT is 6,552 days. Of this time, 5,964 days occurred during the
testing phase of the regulatory review period, while 588 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
May 31, 1991. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 31,
1991.

    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: September 27,
2007. FDA has verified the applicant's claim that the new drug
application (NDA) 22-192 was submitted on September 27, 2007.
    3. The date the application was approved: May 6, 2009. FDA has
verified the applicant's claim that NDA 22-192 was approved on May 6,
2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 5 years of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by June 7, 2010. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by October 4,
2010. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-7678 Filed 4-5-10; 8:45 am]
BILLING CODE 4160-01-S