[Federal Register: July 25, 2006 (Volume 71, Number 142)]
[Notices]
[Page 42140-42141]
[DOCID:fr25jy06-114]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 17a-11; SEC File No. 270-94; OMB Control No. 3235-
0085.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    In response to an operational crisis in the securities industry
between 1967 and 1970, the Securities and Exchange Commission
(``Commission'') adopted Rule 17a-11 (17 CFR 240.17a-11) under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange
Act'') on July 11, 1971. The Rule requires broker-dealers that are
experiencing financial or operational difficulties to provide notice to
the Commission, the broker-dealer's designated examining authority
(``DEA''), and the Commodity Futures Trading Commission (``CFTC'') if
the broker-dealer is registered with the CFTC as a futures commission
merchant. Rule 17a-11 is an integral part of the Commission's financial
responsibility program which enables the Commission, a broker-dealer's
DEA, and the CFTC to increase surveillance of a broker-dealer
experiencing difficulties and to obtain any additional information
necessary to gauge the broker-dealer's financial or operational
condition.
    Rule 17a-11 also requires over-the-counter (``OTC'') derivatives
dealers and broker-dealers that are permitted to compute net capital
pursuant to Appendix E to Exchange Act Rule 15c3-1 to notify the
Commission when their tentative net capital drops below certain levels.
OTC derivatives dealers must also provide notice to the Commission of
backtesting exceptions identified pursuant to Appendix F of Rule 15c3-1
(17 CFR 240.15c3-1f).
    Compliance with the Rule is mandatory. The Commission will
generally not publish or make available to any person notice or reports
received pursuant to Rule 17a-11. The Commission believes that
information obtained under Rule 17a-11 relates to a condition report
prepared for the use of the Commission, other federal governmental
authorities, and securities industry self-regulatory organizations
responsible for the regulation or supervision of financial
institutions.
    Only broker-dealers whose capital declines below certain specified
levels or who are otherwise experiencing financial or operational
problems have a reporting burden under Rule 17a-11. In 2005, the
Commission received approximately 600 notices under this Rule. The
Commission did not receive any Rule 17a-11 notices from OTC derivatives
dealers or broker-dealers that are permitted to compute net capital
pursuant to Appendix E to Exchange Act Rule 15c3-1.
    Each broker-dealer reporting pursuant to Rule 17a-11 will spend
approximately one hour preparing and transmitting the notice required
by the rule. Accordingly, the total estimated annualized burden under
Rule 17a-11 is 600 hours.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information has
practical utility; (b) the accuracy of the agency's estimate of the
burden of the proposed collection of information; (c) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Comments should be directed to: R. Corey Booth, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312, or by e-mail
to<EMAIL_ADDRESS>Comments must be submitted to the Office of
Management and Budget within 60 days of this notice.

    Dated: July 17, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-11791 Filed 7-24-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: February 24, 2010 (Volume 75, Number 36)]
[Proposed Rules]
[Page 8279-8285]
[DOCID:fr24fe10-15]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0981; Directorate Identifier 2008-NM-073-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 747 Airplanes

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

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

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SUMMARY: The FAA is revising an earlier NPRM for an airworthiness
directive (AD) that applies to certain Model 747 airplanes. The
original NPRM would have superseded an existing AD that currently
requires repetitive inspections of the body station (BS) 2598 bulkhead,
and corrective actions if necessary. The existing AD also currently
requires a terminating modification for the repetitive inspections and
a post-modification inspection of the modified area. The original NPRM
proposed to continue to require those actions using revised service
information. For certain airplanes, the original NPRM proposed to
require new repetitive inspections, an interim modification, and post-
interim modification inspections. For certain airplanes, the original
NPRM also proposed to require replacing any previously repaired aft
inner chord and reinstalling the terminating modification. The original
NPRM resulted from reports of cracked aft inner chords on airplanes
after certain requirements of the existing AD were done. This new
action revises the original NPRM for airplanes that are converted to
the Model 747-400 large cargo freighter (LCF) configuration by reducing
the threshold and repeat intervals of certain post-modification
inspections. This new action also revises the original NPRM for all
airplanes by proposing that certain inspections of the upper aft outer
chords and diagonal brace attachment fittings, flanges, and rods
continue after the terminating modification. We are proposing this
supplemental NPRM to prevent fatigue cracking of the BS 2598 bulkhead
structure, which could result in inability of the structure to carry
horizontal stabilizer flight loads, and loss of controllability of the
airplane.

DATES: We must receive comments on this supplemental NPRM by March 22,
2010.

ADDRESSES: You may send comments 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 proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER> or
425-227-1152.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Ivan Li, Aerospace Engineer, Airframe
Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0981;
Directorate Identifier 2008-NM-073-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We proposed to amend part 39 of the Federal Aviation Regulations
(14 CFR part 39) with a notice of proposed rulemaking (NPRM) for an AD
(the ``original NPRM'') to supersede AD 2006-05-06, amendment 39-14503
(71 FR 12125, March 9, 2006). The original NPRM applied to certain
Model 747 airplanes. The original NPRM was published in the Federal
Register on September 23, 2008 (73 FR 54751). The original NPRM
proposed to require repetitive inspections of the body station (BS)
2598 bulkhead, and corrective actions if necessary; and a terminating
modification for the repetitive inspections and a post-modification
inspection of the modified area. The original NPRM proposed to require
those actions using revised service information. For certain airplanes,
the original NPRM proposed to require new repetitive inspections, an
interim modification, and post-interim modification inspections. For
certain airplanes, the original NPRM also proposed to require replacing
any previously repaired aft inner chord and reinstalling the
terminating modification.

Actions Since Original NPRM was Issued

    Since we issued the original NPRM, Boeing informed us that the
compliance times of certain post-modification inspections need to be
revised for Model 747-400 series airplanes that have been modified to
operate in a freighter configuration. These airplanes are referred to
as large cargo freighters, or LCF. Boeing states that higher operating

stresses for the subject structure on the Model 747-400 LCF airplanes
mean that these airplanes need a lower inspection threshold and shorter
repeat intervals than those specified in the original NPRM. We agree,
and we have revised paragraphs (m), (q), and (r) of the original NPRM
to reduce the threshold and repetitive intervals.
    In addition, Boeing informed us that for all airplanes certain
inspections of the upper aft outer chords and diagonal brace attachment
fittings, flanges, and rods need to be continued after the terminating
modification is accomplished. Adding the reinforcing modification and
replacing the aft inner chord as specified in the NPRM does not alter
the upper aft outer chord and diagonal brace attachment fittings,
flanges, and rods. Therefore, we have revised paragraph (q) of the
original NPRM to specify that certain inspections must continue after
the terminating modification.

Comments

    We have considered the following comments on the original NPRM.

Request To Revise Costs of Compliance

    Northwest Airlines requests that we revise the ``Costs of
Compliance'' section of the original NPRM to include Boeing's current
cost of the modification kit. Northwest Airlines states that the
current cost is $52,218 rather than the $33,716 quoted in the original
NPRM.
    We agree that the cost of the modification kit has changed. We have
revised the ``Costs of Compliance'' section of this supplemental NPRM
to include the new cost of the kit.

Request To Delay the AD Pending Revised Service Information

    All Nippon Airways and Japan Airlines request that we delay issuing
the AD until Boeing revises Alert Service Bulletin 747-53A2427 to
Revision 5 (we referred to Boeing Alert Service Bulletin 747-53A2427,
Revision 4, dated March 6, 2008, in the original NPRM). All Nippon
Airways explains that it has discussed several discrepancies in
Revision 4 with Boeing, and that Boeing clarified those discrepancies
in an information notice (IN). All Nippon Airways states that, since
INs are not approved by the FAA, it will be a burden to operators to
request alternative methods of compliance (AMOCs) once the proposed
rule is mandated. As an alternative, All Nippon Airways proposes that
we include the additional information from the IN in the final rule.
    In addition, Boeing has informed us that there is a discrepancy in
the modification drawing specified in Boeing Alert Service Bulletin
747-53A2427, Revision 4, dated March 6, 2008. The drawing does not
include a step to ``zero-time'' certain existing fastener holes in the
affected areas. The zero-timing is intended to remove any undetectable
cracks in the affected fastener holes.
    We agree that we should refer to the most recent service
information possible. We have reviewed Boeing Service Bulletin 747-
53A2427, Revision 5, dated October 1, 2009. The revised service
information includes the information in the IN referred to by the
commenter (the IN clarifies fastener codes and repair instructions) and
does not require any additional work on airplanes on which the
inspections, interim modification, and repair specified in earlier
revisions of the service bulletin were done. Therefore, we have revised
paragraphs (i), (j), (o), (s), (t), (u), and (v) of this supplemental
NPRM to refer to Boeing Service Bulletin 747-53A2427, Revision 5, dated
October 1, 2009. We have also added new paragraph (w) to the
supplemental NPRM to give credit for doing certain actions in
accordance with Boeing Alert Service Bulletin 747-53A2427, Revision 4,
dated March 6, 2008.
    We have also reviewed Boeing Service Bulletin 747-53-2473, Revision
1, dated February 20, 2007; and Boeing Alert Service Bulletin 747-
53A2473, Revision 2, dated August 28, 2009. We referred to Boeing
Service Bulletin 747-53-2473, dated March 24, 2005, as the appropriate
source of service information for accomplishing the required actions
specified in paragraph (m) of the NPRM.
    Boeing Service Bulletin 747-53-2473, Revision 1, dated February 20,
2007, retains and clarifies the same procedures as in Boeing Service
Bulletin 747-53-2473, dated March 24, 2005, and adds procedures to
replace repaired aft inner chords on certain airplanes on which the
actions specified in Boeing Service Bulletin 747-53-2473, dated March
24, 2005, were done.
    Boeing Alert Service Bulletin 747-53A2473, Revision 2, dated August
28, 2009, adds procedures to inspect to determine if certain fasteners
were installed, and to do related investigative and corrective actions
if necessary, for airplanes on which the support frame modification
specified in Boeing Service Bulletin 747-53-2473, dated March 24, 2005;
or Revision 1, dated February 20, 2007; was done. The related
investigative actions include an open-hole high frequency eddy current
(HFEC) inspection of the fastener holes of a certain type of fastener
for cracks, and a review of maintenance records to verify that an open-
hole HFEC inspection was performed at certain other fastener holes and
the holes were zero-timed. For airplanes on which the holes were not
zero-timed, the service bulletin specifies an HFEC inspection of the
holes for cracks, and corrective actions if necessary. Boeing Alert
Service Bulletin 747-53A2473, Revision 2, dated August 28, 2009, also
adds procedures to do post-modification inspections.
    We have revised paragraph (m) of this supplemental NPRM to refer to
Boeing Service Bulletin 747-53-2473, Revision 1, dated February 20,
2007; and Boeing Alert Service Bulletin 747-53A2473, Revision 2, dated
August 28, 2009. We have revised paragraph (q) of this supplemental
NPRM to refer to Boeing Alert Service Bulletin 747-53A2473, Revision 2,
dated August 28, 2009.
    We have also revised paragraphs (n) and (r) of this supplemental
NPRM to refer to Boeing Alert Service Bulletin 747-53A2473, Revision 2,
dated August 28, 2009, for the post-modification inspections.

Explanation of Change to Paragraph (r) of This Supplemental NPRM

    Boeing Alert Service Bulletin 747-53A2473, Revision 2, dated August
28, 2009, also adds procedures for post-modification inspections. In
paragraph (r) of the NPRM, we specified doing a post-modification
inspection for cracking and repair of any crack, in accordance with a
method approved by the FAA. Because Boeing Service Bulletin 747-
53A2473, Revision 2, dated August 28, 2009, specifies doing support
frame post-modification inspections, we have revised paragraph (r) of
this supplemental NPRM to refer to that service bulletin. The support
frame post-modification inspections consist of the following
inspections specified in Parts 1, 2, and 3 of the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-53A2473, Revision 2,
dated August 28, 2009.
    The ``Part 1--Support Frame Inspections'' include the following
inspections:
     A detailed inspection for cracking of the support frame
and access cut-out forward and aft sides at station 2598.
     A surface HFEC inspection for cracking of the lower floor
support chord at station 2598.
     A low frequency eddy current (LFEC) inspection for
cracking of the support frame outer chord at station 2598.
     A surface and open-hole HFEC inspection for cracking of
the support

frame outer chord and fitting at station 2598.
     An ultrasonic or surface HFEC inspection for cracking of
the support frame outer chord at station 2598.
    The ``Part 2--Hinge Support Inspection'' is an open-hole HFEC
inspection for cracking in the back-up fittings, frame support fitting
and hinge fitting at station 2598.
    The ``Part 3--Support Frame Inspections'' include the following
inspections:
     Detailed inspections for cracking of the frame web around
the periphery of the aft inner chord and the entire modified support
frame.
     Surface HFEC inspections for cracking in the upper forward
inner chord, aft inner chord, upper splice fitting, lower forward inner
chord, and frame support fitting, lower splice fitting, hinge frame
support fitting.
     An LFEC or open-hole HFEC for cracking in the upper aft
inner chord.
     Ultrasonic inspections for cracking in the upper and lower
forward inner chord and frame support fitting.
     A surface HFEC inspection for cracking of the frame web.
     An LFEC for cracking in the aft outer chord.

If any cracking is found, the service bulletin specifies the corrective
action as contacting Boeing for repair data and doing the repair.
    Boeing Alert Service Bulletin 747-53A2473, Revision 2, dated August
28, 2009, specifies that the initial compliance times for doing support
frame post-modification inspections ranges between within 1,500 flight
cycles after doing the modification to within 20,000 flight cycles
after doing the modification, depending on the inspection and airplane
configuration. The service bulletin specifies that the repetitive
interval for the support frame post-modification inspections ranges
between 1,000 flight cycles and 6,000 flight cycles, depending on the
inspection.

Explanation of New Compliance Time for Certain Airplanes in Paragraph
(m) of This Supplemental NPRM

    For airplanes that are modified as specified in paragraph (m) of
the supplemental NPRM and are converted to the Model 747-400 Large
Cargo Freighter (LCF) configuration, the repetitive inspection
specified in paragraph (k)(2) of this AD must be done thereafter at
intervals not to exceed 1,800 flight cycles. We have revised paragraph
(m) of this AD accordingly.

Clarification of Compliance Time

    We have revised paragraph (q)(2) of this supplemental NPRM to
specify that the applicable related investigative and corrective
actions must be done before further flight, as specified in Boeing
Alert Service Bulletin 747-53A2473, Revision 2, dated August 28, 2009.

Explanation of Change Made to Paragraph (x)(3) of This Supplemental
NPRM

    Boeing Commercial Airplanes has received an Organization
Designation Authorization (ODA), which replaces their previous
designation as a Delegation Option Authorization (DOA) holder. We have
revised paragraph (x)(3) of this AD to delegate the authority to
approve an alternative method of compliance for any repair required by
this AD to the Boeing Commercial Airplanes ODA.

Explanation of Added/Removed Paragraphs in the Supplemental NPRM

    We have added a new paragraph (d) to this supplemental NPRM to
provide the Air Transport Association (ATA) of America subject code for
this proposed AD. This code is added to make this supplemental NPRM
parallel with other new AD actions. We have re-identified subsequent
paragraphs accordingly.
    Paragraph (n) of the original NPRM indicates that, after the
effective date of the AD, Boeing Alert Service Bulletin 747-53A2427,
Revision 4, dated March 6, 2008, must be used to accomplish the
requirements of paragraphs (h) and (i) of the original NPRM (i.e.,
paragraphs (i) and (j) of this supplemental NPRM). We have removed
paragraph (n) of the original NPRM, and have referred to Boeing Service
Bulletin 747-53A2427, Revision 5, dated October 1, 2009, in paragraphs
(i) and (j) of this supplemental NPRM.

Explanation of Additional Change to ``Costs of Compliance'' Paragraph

    We have revised the ``Costs of Compliance'' section to clarify
which costs are retained from AD 2006-05-06 and which costs are new in
this supplemental NPRM.

Explanation of Changes Made to the Manufacturer Name

    We have revised this supplemental NPRM to identify the legal name
of the manufacturer as published in the most recent type certificate
data sheet for the affected airplane models.

FAA's Determination and Proposed Requirements of the Supplemental NPRM

    We are proposing this supplemental NPRM because we evaluated all
pertinent information and determined an unsafe condition exists and is
likely to exist or develop on other products of the same type design.
Certain changes described above expand the scope of the original 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 supplemental NPRM.

Costs of Compliance

    There are about 998 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this proposed AD. The average labor rate
is $80 per work hour.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                     Work                                         U.S.-
              Action                 hours     Parts       Cost per airplane    registered       Fleet cost
                                                                                airplanes
----------------------------------------------------------------------------------------------------------------
Surface HFEC inspections (required       2         None  $160, per inspection          162  $25,920, per
 by AD 2006[dash]05[dash]06) and                          cycle.                             inspection cycle.
 open-hole HFEC inspections (new
 proposed action).
Detailed inspections (required by        2         None  $160, per inspection          162  $25,920, per
 AD 2006[dash]05[dash]06).                                cycle.                             inspection cycle.
Terminating modification               126      $52,218  $62,298.............          162  $10,092,276.
 (partially required by AD
 2006[dash]05[dash]06; additional
 modification actions in this new
 proposed action).

Interim modification (new proposed       4        4,000  $4,320..............          162  $699,840.
 action).
Replacement of previously repaired       2         None  $160................          162  $25,920.
 aft inner chords (new proposed
 action).
Support Frame upper Corner               8         None  $640................          162  $103,680.
 Fastener Inspection (new proposed
 action).
Post-modification inspection (new        4         None  $320................          162  $51,840.
 proposed action).
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this supplemental NPRM and placed it in the AD docket. See
the ADDRESSES section for a location to examine the regulatory
evaluation.

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

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

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

Sec.  39.13  [Amended]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-14503 (71 FR 12125, March 9, 2006) and adding the
following new airworthiness directive (AD):

The Boeing Company: Docket No. FAA-2008-0981; Directorate Identifier
2008-NM-073-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by March 22,
2010.

Affected ADs

    (b) This AD supersedes AD 2006-05-06, Amendment 39-14503.

Applicability

    (c) This AD applies to 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, line numbers 1 though 1307 inclusive.

Subject

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

Unsafe Condition

    (e) This AD results from reports of cracked aft inner chords on
airplanes after certain requirements of the existing AD were done.
We are issuing this AD to prevent fatigue cracking of the body
station (BS) 2598 bulkhead structure, which could result in
inability of the structure to carry horizontal stabilizer flight
loads, and loss of controllability of the airplane.

Compliance

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

Restatement of Requirements of AD 2006-05-06

Repetitive High Frequency Eddy Current (HFEC) Inspections of the
Bulkhead Frame Supports

    (g) Before the accumulation of 10,000 total flight cycles, or
within 1,000 flight cycles after August 16, 2001 (the effective date
of AD 2001-14-07, amendment 39-12318, which was superseded by AD
2006-05-06), whichever occurs later: Do an open-hole HFEC inspection
to find cracking of the bulkhead frame support under the hinge
support fittings of the horizontal stabilizer on the left and right
sides at BS 2598, in accordance with Figure 2 of the Accomplishment
Instructions of Boeing Service Bulletin 747-53A2449, Revision 1,
dated May 24, 2001; or Revision 2, dated March 14, 2002. Repeat the
inspection after that at intervals not to exceed 3,000 flight
cycles. Inspections accomplished before August 16, 2001, per Boeing
Alert Service Bulletin 747-53A2449, dated June 8, 2000, are
considered acceptable for compliance with the applicable inspection
specified in this paragraph.

Repair of Any Cracked Bulkhead Frame Support

    (h) If any cracking is found during any inspection required by
paragraph (g) of this AD, before further flight, repair using a
method approved in accordance with the procedures specified in
paragraph (x) of this AD.

Repetitive Inspections of Inner Chords, Frame Support Fitting, and
Splice Fitting

    (i) Do a surface HFEC inspection of the forward and aft inner
chords, the frame support, and the splice fitting of the forward
inner chord of the upper corners of the station 2598 bulkhead to
find cracking, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 747-53A2427, Revision 2, dated October
5, 2000; Revision 3, dated September 27, 2001; or Boeing Service
Bulletin 747-53A2427, Revision 5, dated October 1, 2009; at the
latest of the times specified in paragraphs (i)(1) and (i)(2) of
this AD, as applicable. Repeat the inspection after that at
intervals not to exceed 1,500 flight cycles. After the effective
date of this AD, Boeing Service Bulletin 747-53A2427, Revision 5,
dated October 1, 2009, must be used.
    (1) For airplanes having line numbers 1 through 1241 inclusive:
    (i) Before the accumulation of 6,000 total flight cycles.
    (ii) Within 500 flight cycles after August 28, 2001 (the
effective date of AD 2001-15-03, amendment 39-12337, which was
superseded by AD 2006-05-06).
    (iii) For airplanes inspected before August 28, 2001, in
accordance with Boeing Alert Service Bulletin 747-53A2427, dated
December 17, 1998 (including inspections of the splice fitting); or
Revision 1, dated October 28, 1999: Within 1,500 flight cycles after
accomplishment of the last inspection done in accordance with the
original service bulletin or Revision 1, as applicable.
    (2) For airplanes having line numbers 1242 through 1307
inclusive:
    (i) Before the accumulation of 16,000 total flight cycles.
    (ii) Within 500 flight cycles after August 28, 2001.
    (iii) For airplanes inspected before August 28, 2001, in
accordance with Boeing Alert Service Bulletin 747-53A2427, dated
December 17, 1998 (including inspections of the splice fitting), or
Revision 1, dated October 28, 1999: Within 1,500 flight cycles after
accomplishment of the last inspection done in accordance with Boeing
Alert Service Bulletin 747-53A2427, dated December 17, 1998; or
Revision 1, dated October 28, 1999, as applicable.

Repair of Any Cracked Inner Chord, Frame Support, or Splice Fitting

    (j) If any cracking is found during the inspections required by
paragraph (i) of this AD, before further flight, repair in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 747-53A2427, Revision 2, dated October 5, 2000;
Revision 3, dated September 27, 2001; or Boeing Service Bulletin
747-53A2427, Revision 5, dated October 1, 2009. After the effective
date of this AD, Boeing Service Bulletin 747-53A2427, Revision 5,
dated October 1, 2009, must be used. Where Boeing Alert Service
Bulletin 747-53A2427, Revision 2, dated October 5, 2000; Revision 3,
dated September 27, 2001; or Boeing Service Bulletin 747-53A2427,
Revision 5, dated October 1, 2009; specifies that the manufacturer
may be contacted for disposition of certain repair conditions,
before further flight, repair using a method approved in accordance
with the procedures specified in paragraph (x) of this AD.

Repetitive Detailed Inspections of BS 2598 Bulkhead

    (k) Before the accumulation of 10,000 total flight cycles, or
within 1,000 flight cycles after October 27, 2003 (the effective
date of AD 2003-19-08, amendment 39-13311, which was superseded by
AD 2006-05-06), whichever is later: Do a detailed inspection of the
BS 2598 bulkhead for discrepancies (cracking, elongated fastener
holes) of the areas specified in paragraphs (k)(1) and (k)(2) of
this AD, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 747-53A2467, dated July 26, 2001; or
Revision 1, dated April 28, 2005. Repeat the inspections after that
at intervals not to exceed 3,000 flight cycles, except as required
by paragraph (m) of this AD. Doing the modification specified in
paragraph (m) or (q) of this AD terminates the inspection of the
area specified in paragraph (k)(1) of this AD.
    (1) The lower aft inner chords.
    (2) The upper aft outer chords, and the diagonal brace
attachment fittings, flanges, and rods.

    Note 1: For the purposes of this AD, a detailed inspection is
``an intensive examination of a specific item, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at an intensity deemed appropriate. Inspection aids such as
mirrors magnifying lenses, etc. may be necessary. Surface cleaning
and elaborate procedures may be required.''

Repair of Any Cracked BS 2598 Bulkhead

    (l) If any discrepancy is found during any inspection required
by paragraph (k) of this AD: Before further flight, repair in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 747-53A2467, dated July 26, 2001; or Revision 1,
dated April 28, 2005. If the service bulletin specifies to contact
Boeing for appropriate action: Before further flight, repair using a
method approved in accordance with the procedures specified in
paragraph (x) of this AD.

Terminating Modification With New Compliance Time for Certain
Airplanes for the Inspection Specified in Paragraph (k)(2) of This
AD

    (m) Except as provided by paragraph (q) of this AD: Before the
accumulation of 20,000 total flight cycles, or within 48 months
after April 13, 2006 (the effective date of AD 2006-05-06),
whichever occurs later, modify the bulkhead by doing all applicable
actions including surface and open-hole HFEC inspections for
cracking of the upper forward inner chords, aft inner chords, upper
splice fittings, and frame support fittings, as specified in the
Accomplishment Instructions of Boeing Service Bulletin 747-53-2473,
dated March 24, 2005; Revision 1, dated February 20, 2007; or Boeing
Alert Service Bulletin 747-53A2473, Revision 2, dated August 28,
2009. Repair any cracks before further flight, in accordance with
Boeing Service Bulletin 747-53-2473, dated March 24, 2005; Revision
1, dated February 20, 2007; or Boeing Alert Service Bulletin 747-
53A2473, Revision 2, dated August 28, 2009. Where Boeing Service
Bulletin 747-53-2473, dated March 24, 2005; Revision 1, dated
February 20, 2007; or Boeing Alert Service Bulletin 747-53A2473,
Revision 2, dated August 28, 2009 specifies that the manufacturer
may be contacted for disposition of certain repair conditions:
Before further flight, repair the cracks using a method approved in
accordance with the procedures specified in paragraph (x) of this
AD. Accomplishment of the modification terminates the requirements
of paragraphs (g), (i), and (k)(1) of this AD. After the effective
date of this AD, Boeing Alert Service Bulletin 747-53A2473, Revision
2, dated August 28, 2009 must be used for the actions specified in
this paragraph. For airplanes that are converted to the Model 747-
400 Large Cargo Freighter (LCF) configuration, repeat the inspection
specified in paragraph (k)(2) of this AD thereafter at intervals not
to exceed 1,800 flight cycles.

Post-Modification Inspection and Repair

    (n) Except as provided by paragraphs (q) and (r) of this AD:
Within 20,000 flight cycles after doing the modification required by
paragraph (m) of this AD, inspect the BS 2598 bulkhead for cracks,
and repair any cracks before further flight, in accordance with a
method approved by the Manager, Seattle Aircraft Certification
Office (ACO).

New Requirements of This AD

Terminating Repair for Repetitive Surface HFEC Inspections

    (o) As of the effective date of this AD, accomplishing the aft
inner chord repair required by paragraph (j) of this AD in
accordance with the applicable structural repair manual (SRM)
specified in the Accomplishment Instructions of Boeing Service
Bulletin 747-53A2427, Revision 5, dated October 1, 2009, ends the
repetitive surface HFEC inspections required by paragraph (i) of
this AD for that side of the bulkhead only.

Replacement of Previously Repaired Aft Inner Chord and
Reinstallation of Terminating Modification

    (p) For airplanes on which the terminating modification required
by paragraph (m) of this AD has been done in accordance with Boeing
Service Bulletin 747-53-2473, dated March 24, 2005: Within 1,500
flight cycles after doing the modification, or within 1,000 flight
cycles after the effective date of this AD, whichever occurs later,
do a one-time general visual inspection for repairs installed
previously on the left and right side aft inner chords. For
airplanes with previously installed repairs, before further flight,
do rework (i.e., replace any previously repaired aft inner chord
with a new aft inner chord and reinstall the terminating
modification), using a method approved in accordance with the
procedures specified in paragraph (x) of this AD.

Revised Terminating Modification

    (q) Doing the applicable modification required by paragraph
(q)(1) or (q)(2) of this AD at the applicable time terminates the
requirements of paragraph (m) of this AD and the repetitive
inspections required by paragraphs (g), (i), and (k)(1) of this AD.
For airplanes that are converted to the Model 747-400 LCF
configuration, the inspection specified in paragraph (k)(2) of this
AD must be repeated thereafter at intervals not to exceed 1,800
flight cycles.
    (1) For airplanes on which the terminating modification required
by paragraph (m) of this AD has not been done as of the effective
date of this AD: Before the accumulation of 20,000 total flight
cycles, or within 18 months after the effective date of this AD,
whichever occurs later, modify the bulkhead, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
53A2473, Revision 2, dated August 28, 2009; except that where Boeing
Alert Service Bulletin 747-53A2473, Revision 2, dated August 28,
2009, specifies to contact Boeing for modification data, the
modification data must be approved in accordance with the procedures
specified in paragraph (x) of this AD and the modification must be
done within the times specified in this paragraph.
    (2) For airplanes on which the terminating modification required
by paragraph (m) of this AD has been done in accordance with Boeing
Service Bulletin 747-53-2473, dated March 24, 2005; or Revision 1,
dated February 20, 2007; as of the effective date of this AD: Within
1,000 flight cycles after the effective date of this AD, or within
1,500 flight cycles after doing the modification, whichever occurs
later, do a general visual inspection of the applicable areas
specified in paragraphs (q)(2)(i) and (q)(2)(ii) of this AD to
determine if certain fasteners are installed, and, before further
flight, do all applicable related investigative and corrective
actions, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 747-53A2473, Revision 2, dated August
28, 2009; except where Boeing Alert Service Bulletin 747-53A2473,
Revision 2, dated August 28, 2009, specifies to contact Boeing for
repair or rework data, the data must be approved in accordance with
the procedures specified in paragraph (x) of this AD and the repair
or rework must be done before further flight.
    (i) For airplanes modified in accordance with Boeing Service
Bulletin 747-53-2473, dated March 24, 2005: Inspect the upper
forward inner chord, frame support fitting, and splice fitting.
    (ii) For airplanes modified in accordance with Boeing Service
Bulletin 747-53-2473, Revision 1, dated February 20, 2007: Inspect
the frame web and upper shear deck aft side; and the upper forward
inner chord, frame support fitting, and splice fitting.

Post-Modification Inspection and Repair

    (r) For airplanes on which the terminating modification has been
done in accordance with paragraph (m) or (q) of this AD: Perform
post-modification inspections of the BS 2598 bulkhead for cracking,
in accordance with Parts 1, 2, and 3 of the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-53A2473, Revision
2, dated August 28, 2009. Do the inspections at the applicable times
specified in Tables 6 through 9 of paragraph 1.E., ``Compliance,''
of Boeing Service Bulletin 747-53A2473, Revision 2, dated August 28,
2009; except where the service bulletin specifies a compliance time
after the date of the service bulletin, this AD requires compliance
within the specified compliance time after the effective date of
this AD. If any cracking is found during any inspection required by
this paragraph, before further flight, repair using a method
approved in accordance with the procedures specified in paragraph
(x) of this AD. Repeat the inspections thereafter at the applicable
times specified in Tables 6 through 9 of paragraph 1.E.,
``Compliance,'' of Boeing Service Bulletin 747-53A2473, Revision 2,
dated August 28, 2009. Accomplishing the applicable inspections
required by this paragraph terminates the requirements of paragraph
(n) of this AD.

Open-Hole HFEC Inspection(s) and Terminating Repair

    (s) For airplanes on which the terminating modification required
by paragraph (m) or (q) of this AD has not been done: Do an initial
open-hole HFEC inspection to detect cracks in the bulkhead splice
fitting, frame support fitting, and forward and aft inner chords on
the left and right sides of the BS 2598 bulkhead, in accordance with
the Accomplishment Instructions of Boeing Service Bulletin 747-
53A2427, Revision 5, dated October 1, 2009. Do the initial
inspection at the applicable time specified in Table 1 or 3 of
paragraph 1.E., ``Compliance,'' of Boeing Service Bulletin 747-
53A2427, Revision 5, dated October 1, 2009; except where Boeing
Service Bulletin 747-53A2427, Revision 5, dated October 1, 2009,
specifies a compliance time after the date on the service bulletin,
this AD requires compliance within the specified compliance time
after the effective date of this AD.
    (1) If no crack is detected, repeat the open-hole HFEC
inspection thereafter at intervals not to exceed 1,500 flight
cycles.
    (2) If any crack is detected, before further flight, repair it
in accordance with the Accomplishment Instructions of Boeing Service
Bulletin 747-53A2427, Revision 5, dated October 1, 2009; except
where Boeing Service Bulletin 747-53A2427, Revision 5, dated October
1, 2009, specifies to contact Boeing for appropriate action, before
further flight, repair the crack using a method approved in
accordance with the procedures specified in paragraph (x) of this
AD. Accomplishing the aft inner chord repair in accordance with the
applicable structural repair manual (SRM) specified in the
Accomplishment Instructions of Boeing Service Bulletin 747-53A2427,
Revision 5, dated October 1, 2009, ends the repetitive surface and
open-hole HFEC inspections required by paragraphs (i) and (s)(1),
respectively, of this AD for that side of the bulkhead only.

Interim Modification

    (t) For Group 1 airplanes, as identified in Boeing Service
Bulletin 747-53A2427, Revision 5, dated October 1, 2009, on which
the SRM repair required by paragraph (j) or (s)(2) of this AD has
not been done; and on which the terminating modification required by
paragraph (m) or (q) of this AD has not been done: Before the
accumulation of 12,000 total flight cycles, or within 1,500 flight
cycles after the effective date of this AD, whichever occurs later,
install the interim modification for the aft inner chords, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 747-53A2427, Revision 5, dated October 1, 2009.
Accomplishing the interim modification ends the repetitive surface
and open-hole HFEC inspections required by paragraphs (i) and
(s)(1), respectively, of this AD.

Post-Interim Modification/Repair Repetitive Surface and Open-Hole
HFEC Inspections

    (u) For airplanes on which the interim modification required by
paragraph (t) of this AD has been done or the SRM repair required by
paragraph (j) or (s)(2) of this AD has been done; and on which the
terminating modification required by paragraph (m) or (q) of this AD
has not been done: At the applicable times specified in Table 1, 2,
or 3 of paragraph 1.E., ``Compliance,'' of Boeing Service Bulletin
747-53A2427, Revision 5, dated October 1, 2009, do a surface HFEC
inspection to detect cracks on the forward side (unmodified area) of
the bulkhead, and open-hole and surface HFEC inspections to detect
cracks in the modified or repaired area, in accordance with the
Accomplishment Instructions of Boeing Service Bulletin 747-53A2427,
Revision 5, dated October 1, 2009. Repeat the open-hole and surface
HFEC inspections thereafter at intervals not to exceed 1,500 flight
cycles, until the modification required by paragraph (q) of this AD
is done, as applicable; except that for airplanes on which the
repair of any cracked aft inner chord has been done on only one side
of the bulkhead in accordance with the applicable SRM as required by
paragraph (j) or (s)(2) of this AD, the repetitive surface and open-
hole HFEC inspections required by paragraphs (i) and (s)(1),
respectively, of this AD must continue to be done for the other side
of the bulkhead.

Repair of Any Cracked Inner Chord, Splice Fitting, or Frame Support
Fitting

    (v) If any crack is detected during any surface or open-hole
HFEC inspection required by paragraph (u) of this AD, before further
flight, repair any cracked inner chord, splice fitting, or frame
support fitting, in accordance with the Accomplishment Instructions
of Boeing Service Bulletin 747-53A2427, Revision 5, dated October 1,
2009; except where Boeing Service Bulletin 747-53A2427, Revision 5,
dated October 1, 2009, specifies to contact Boeing for appropriate
action, before further flight, repair the crack using a method
approved in accordance with the procedures specified in paragraph
(x) of this AD.

Actions Accomplished According to Previous Issue of Service
Bulletin

    (w) Inspections, interim modification, and repairs accomplished
before the effective date of this AD in accordance with Boeing Alert
Service Bulletin 747-53A2427, Revision 4, dated March 6, 2008, are

considered acceptable for compliance with the corresponding action
specified paragraphs (i), (j), (s), (t), (u), and (v) of this AD.

Alternative Methods of Compliance (AMOCs)

    (x)(1) The Manager, Seattle ACO, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Ivan Li, Aerospace
Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; telephone (425) 917-
6437; fax<PHONE_NUMBER>. Or, e-mail information to 9-ANM-Seattle-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by Boeing
Commercial Airplanes Organization Designation Authorization (ODA)
that has been authorized by the Manager, Seattle ACO, to make those
findings. For a repair method to be approved, the repair must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) AMOCs approved previously in accordance with AD 2006-05-06
are approved as AMOCs for the corresponding provisions of this AD.

    Issued in Renton, Washington, on February 11, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-3542 Filed 2-23-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 5, 2009 (Volume 74, Number 23)]
[Notices]
[Page 6188-6189]
[DOCID:fr05fe09-65]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59327; File No. SR-NYSE-2009-09]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Implementing an Equity Transaction Fee for Shares Executed on or
Through the New York Block Exchange Effective Upon Filing With the
Commission

January 30, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on January 28, 2009, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to implement an equity transaction fee
effective January 29, 2009, for shares executed on the New York Block
Exchange SM (``NYBX'' or the ``Facility'').\4\ The Exchange
will charge each Member Organization $.0025 per share executed on the
NYBX.
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    \4\ See Securities Exchange Act Release No. 59281 (January 22,
2008) 74 FR 5014 (January 28, 2009) (SR-NYSE-2008-120) and
Securities Exchange Act Release No. 59282 (January 22, 2009), 74 FR
5009 (January 28, 2009) (SR-NYSE-2008-119).
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    The text of the proposed rule change is available at http://
www.nyse.com, the Exchange, and the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to implement an equity transaction fee for
executions on or through the New York Block Exchange system with effect
from the scheduled launch date of January 29, 2009. The NYBX will be an
electronic facility of the Exchange to provide for the continuous
matching and execution of securities listed on the NYSE of all non-
displayed orders with the aggregate of all displayed and non-displayed
orders of the NYSE Display Book[supreg] (``Display Book'' or ``DBK'')
while also considering protected quotations of all automated trading
centers (``away markets''). The proposed transactional fee of $.0025
per executed share will be charged to both the buyer(s) and seller(s)
of the executed shares. The fee will be charged for all executions of
NYBX orders, including those NYBX executions that take place in the DBK
or

in away markets. Only NYSE members, member organizations and sponsoring
member organizations will be charged this transaction fee. Transaction
fees for executions of orders entered by sponsored participants will be
charged to the sponsoring member organization.
    The following example will demonstrate how the proposed NYBX
transactional fee will be charged:
    Example No 1:
    User A enters a buy order into NYBX for 10,000 shares of XYZ
security. User B enters a sell order into NYBX for 10,000 shares of XYZ
security. User A's buy order for 10,000 shares of XYZ security and User
B's sell order for 10,000 shares of XYZ security execute in or through
NYBX. User A is charged $.0025 per executed share (10,000 shares x
$.0025 = $25.00). User B is also charged $.0025 per executed share
(10,000 shares x $.0025 = $25.00).
    NYBX Executions in the DBK or in Away Markets:
    The NYBX transactional fee will be charged for all executions of
all orders entered into the NYBX facility, whether such executions take
place in the NYBX facility, the DBK or in away markets. Therefore, in
the example above, if the execution of 10,000 shares of XYZ security
takes place within the NYBX facility, Users A and B would each be
charged $.0025 per executed share (10,000 shares x $.0025 = $25.00).
However, if Users A and B's NYBX orders are routed to the DBK for
execution, and the execution of the orders take place in the DBK, Users
A and B would each be charged $.0025 per executed share (10,000 shares
x $.0025 = $25.00). Similarly, if Users A and B's NYBX orders are
routed to away markets pursuant to Rule 611 of Regulation NMS, and the
execution of the orders take place on the away markets, Users A and B
would each be charged $.0025 per executed share (10,000 shares x $.0025
= $25.00). Therefore, Users A and B will not pay any additional
transactional fee for the execution of NYBX orders to the extent that
an NYBX order or a portion thereof may be executed in the DBK or in the
away markets.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 \5\ of the Securities Exchange Act of
1934 (the ``Act'') \6\ in general and Section 6(b)(4) of the Act \7\ in
particular, in that it provides for the equitable allocation of
reasonable dues, fees and other charges among its members and other
persons using its facilities. Specifically, the proposed transaction
fee is reasonable in light of the costs incurred by the Exchange for
the operation of the NYBX system. Further, the NYBX fee is consistent
with some exchanges' fees and lower than other exchanges' fees for
removal of liquidity. For example, the BATS Exchange, Inc. fee for
removal of liquidity is $.0025 per execution,\8\ while the Nasdaq \9\
and International Securities Exchange (``ISE'') \10\ fee is $.0030,
NYSE Arca is $.0029 \11\ and Direct Edge is $.0026.\12\ Additionally,
the transaction fee is equitable as the fee is applied to all users of
the NYBX system equally.
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    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78a.
    \7\ 15 U.S.C. 78f(b)(4).
    \8\ See the BATS Exchange, Inc. Price List for 2009.
    \9\ See the Nasdaq Price List for 2009.
    \10\ See the International Securities Exchange Price List for
2009.
    \11\ See the NYSE Arca Price List for 2009.
    \12\ See the Direct Edge Price List for 2009.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \13\ of the Act and subparagraph (f)(2) of Rule
19b-4 \14\ thereunder, because it establishes a due, fee, or other
charge imposed by NYSE. At any time within 60 days of the filing of
such proposed rule change, the Commission may summarily abrogate such
rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2009-09 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2009-09. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2009-09 and should be
submitted on or before February 26, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-2429 Filed 2-4-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Proposed Rules]
[Page 62523]
[FR Doc No: 2013-24124]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0499; FRL- 9901-36-Region3]

Approval and Promulgation of Air Quality Implementation Plans;
District of Columbia; Infrastructure Requirements for the 2008 Lead
National Ambient Air Quality Standards and State Board Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the District of Columbia (hereafter ``the
District'') pursuant to the Clean Air Act (CAA). Whenever new or
revised national ambient air quality standards (NAAQS) are promulgated,
the CAA requires states to submit a plan for the implementation,
maintenance, and enforcement of such NAAQS. The plan is required to
address basic program elements including, but not limited to,
regulatory structure, monitoring, modeling, legal authority, and
adequate resources necessary to assure attainment and maintenance of
the NAAQS. These elements are referred to as infrastructure
requirements. The District has made a submittal addressing the
infrastructure requirements for the 2008 lead (Pb) NAAQS (``the
infrastructure submittal'') and a separate submittal addressing
requirements in relation to State Boards. This action is being taken
under the CAA. In the Final Rules section of this Federal Register, EPA
is approving the District's SIP submittals as a direct final rule
without prior proposal because the Agency views these as
noncontroversial submittals and anticipates no adverse comments. A more
detailed description of the District's submittals and EPA's evaluation
are included in a Technical Support Document (TSD) prepared in support
of this rulemaking action. A copy of the TSD is available, upon
request, from the EPA Regional Office listed in the ADDRESSES section
of this document. If no adverse comments are received in response to
this action, no further activity is contemplated. If EPA receives
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time.

DATES: Comments must be received in writing by November 21, 2013.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2013-0499 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2013-0499, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2013-0499. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the District of Columbia Department of the
Environment, Air Quality Division, 1200 1st Street NE., 5th floor,
Washington, DC 20002.

FOR FURTHER INFORMATION CONTACT: Emlyn V[eacute]lez-Rosa, (215) 814-
2038, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, with the same title,
that is located in the ``Rules and Regulations'' section of this
Federal Register publication.

    Dated: September 13, 2013.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2013-24124 Filed 10-21-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29198-29199]
[FR Doc No: 2019-13130]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC19-101-000.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act of Dominion Energy South Carolina, Inc.
    Filed Date: 6/13/19.
    Accession Number: 20190613-5177.
    Comments Due: 5 p.m. ET 7/5/19.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG19-127-000.
    Applicants: West Columbia Storage LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of West Columbia Storage LLC.
    Filed Date: 6/13/19.
    Accession Number: 20190613-5176.
    Comments Due: 5 p.m. ET 7/5/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2721-008.
    Applicants: El Paso Electric Company.
    Description: Supplement to December 28, 2018 Updated Market Power
Analysis of El Paso Electric Company.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5033.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER17-2575-003.
    Applicants: Allegheny Energy Supply Company, LLC.
    Description: Compliance filing: Allegheny Energy Supply Company
Compliance Filing to be effective 1/3/2018.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5053.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-81-001.
    Applicants: Athens Energy, LLC.
    Description: Compliance filing: Offer of Settlement (ER19-81) to be
effective N/A.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5083.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-1738-002.
    Applicants: PSEG Fossil Sewaren Urban Renewal LLC.
    Description: Tariff Amendment: Amendment to Application for MBR to
be effective 6/30/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5102.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2129-000.
    Applicants: Southern California Edison Company.
    Description: Tariff Cancellation: Cancel LGIA AltasGas Sonoran
Energy LLC SA No. 158 to be effective 6/24/2019.
    Filed Date: 6/13/19.
    Accession Number: 20190613-5171.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2130-000.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Sec.  205(d) Rate Filing: DOE_SRS 2015 Task Order Agr
to be effective 8/13/2019.
    Filed Date: 6/13/19.
    Accession Number: 20190613-5172.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2131-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Attachment AF Revisions to
Clarify Mitigated Transition State Offers to be effective 8/14/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5028.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2132-000.
    Applicants: The Empire District Electric Company.
    Description: Sec.  205(d) Rate Filing: Revised Agreement for
Wholesale Distribution Service to be effective 6/15/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5041.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2133-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-06-14_SA 3321 METC-
Isabella Renewables I & II E&P (J717 J728) to be effective 6/5/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5051.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2134-000.
    Applicants: Wheelabrator Shasta Energy Company Inc.
    Description: Sec.  205(d) Rate Filing: Request for Category 1
Seller Status in SW Region & Revised MBR Tariff to be effective 6/15/
2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5052.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2135-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: amended LGIA, Blythe Mesa
Solar Project, SA 172 to be effective 6/15/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5054.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2136-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 205 filing of tariff
revisions re: Changes to Cash Collateral Requirements to be effective
8/14/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5056.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2137-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.

    Description: Sec.  205(d) Rate Filing: ISO-NE & NEPOOL; Rev. to
Offer Cap Req. in Day-Ahead Energy Mkt. & Eff. Date Chg to be effective
10/1/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5057.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2138-000.
    Applicants: Cabrillo Power II LLC.
    Description: Tariff Cancellation: Notice of Cancellation to be
effective 6/15/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5097.
    Comments Due: 5 p.m. ET 7/5/19.
    Docket Numbers: ER19-2139-000.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Baseline eTariff Filing: Baseline OATT Filing to be
effective 6/15/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5108.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2140-000.
    Applicants: Shawville Power, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession Filing
to be effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5109.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2141-000.
    Applicants: New Castle Power, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession Filing
to be effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5110.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2142-000.
    Applicants: Brunot Island Power, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession to be
effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5112.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2143-000.
    Applicants: Gilbert Power, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession Filing
to be effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5114.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2144-000.
    Applicants: Sayreville Power, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession Filing
to be effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5117.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2145-000.
    Applicants: Portland Power, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession Filing
to be effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5126.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2146-000.
    Applicants: Warren Generation, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession to be
effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5130.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2147-000.
    Applicants: Mountain Power, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession Filing
to be effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5136.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2148-000.
    Applicants: Heritage Power Marketing, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession to be
effective 5/17/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5137.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2149-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-06-14_Attachment X
revisions relating to Shared Interconnection Facilities to be effective
8/14/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5146.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2150-000.
    Applicants: Shawville Power, LLC.
    Description: Baseline eTariff Filing: New Baseline Reactive Tariff
Filing to be effective 9/1/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5154.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2151-000.
    Applicants: New Castle Power, LLC.
    Description: Baseline eTariff Filing: New Baseline Reactive Tariff
Filing to be effective 9/1/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5157.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2152-000.
    Applicants: Brunot Island Power, LLC.
    Description: Baseline eTariff Filing: New Baseline Reactive Tariff
Filing to be effective 9/1/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5159.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: ER19-2153-000.
    Applicants: Gilbert Power, LLC.
    Description: Baseline eTariff Filing: New Baseline Reactive Tariff
Filing to be effective 9/1/2019.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5160.
    Comments Due: 5 p.m. ET 7/5/19.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES19-31-000.
    Applicants: Duquesne Light Company.
    Description: Duquesne Light Co. submits the application re section
204 of the Federal Power Act for an Order Authorizing the Issuance of
short-term indebtedness.
    Filed Date: 6/11/19.
    Accession Number: 20190614-0020.
    Comments Due: 5 p.m. ET 7/2/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 14, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-13130 Filed 6-20-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10523-10525]
[FR Doc No: 2023-03517]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0044]

Product-Specific Guidance Meetings Between the Food and Drug
Administration and Abbreviated New Drug Applicants Under the Generic
Drug User Fee Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Product-
Specific Guidance Meetings Between FDA and ANDA Applicants Under
GDUFA.'' This draft guidance provides recommendations to industry on
product-specific guidance (PSG) meetings between FDA and a prospective
applicant preparing to submit to FDA or an applicant that has submitted
to FDA an abbreviated new drug application (ANDA) under the Federal
Food, Drug and Cosmetic Act (FD&C Act). Specifically, this draft
guidance provides information on requesting and conducting PSG meetings
with FDA (PSG teleconferences, pre-submission PSG meetings, and post-
submission PSG meetings), as contemplated in the Generic Drug User Fee
Amendments (GDUFA) Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This
draft guidance is intended to provide procedures that will promote
well-managed PSG meetings and help ensure that such meetings are
scheduled and conducted in accordance with the time frames set forth in
the GDUFA III commitment letter.

DATES: Submit either electronic or written comments on the draft
guidance by April 24, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: 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-2023-D-0044 for ``Product-Specific Guidance Meetings Between FDA
and ANDA Applicants Under GDUFA.'' 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: David Coppersmith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring MD 20993-0002, 301-
796-9193.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Product-Specific Guidance Meetings Between FDA and ANDA
Applicants Under GDUFA.'' The Generic Drug User Fee Amendments (GDUFA
I) amended the FD&C Act to authorize FDA to assess and collect user
fees to provide the Agency with resources to help ensure patients have
access to quality, affordable, safe, and effective generic drugs. GDUFA
fee resources bring greater predictability and timeliness to the review
of generic drug applications. GDUFA must be reauthorized every 5 years
to continue FDA's ability to assess and collect GDUFA fees and this
user fee program has been reauthorized two times since GDUFA I, most
recently in the Generic Drug User Fee Amendments of 2022 (GDUFA III).
As described in the GDUFA III commitment letter applicable to this
latest reauthorization, FDA has agreed to performance goals and program
enhancements regarding aspects of the generic drug assessment program
that build on previous authorizations of GDUFA. New enhancements to the
program are designed to maximize the efficiency and utility of each
assessment cycle, with the intent of reducing the number of assessment
cycles for ANDAs and facilitating timely access to generic medicines
for American patients.
    To receive approval for an ANDA submitted under section 505(j) of
the FD&C Act, an applicant generally must demonstrate, among other
things, that its proposed drug product is bioequivalent to the
reference listed drug (RLD). As noted in 21 CFR 320.24, in vivo and/or
in vitro methods can be used to establish bioequivalence (BE). FDA
recommends that applicants consult published PSGs when considering an
appropriate BE study and/or other studies for a proposed drug product.
PSGs provide recommendations for developing generic drug products and
describe FDA's current thinking on the evidence needed to demonstrate
that an ANDA is therapeutically equivalent to the specific RLD product.
    As described in the GDUFA III commitment letter, FDA agreed to
certain time frames and procedures for scheduling and conducting: (1)
PSG teleconferences to provide feedback on the potential impact of a
new or revised PSG on the applicant's development program and (2) pre-
submission PSG meetings and post-submission PSG meetings to provide a
forum in which the applicant can discuss the scientific rationale for
an approach other than the approach recommended in the PSG to ensure
that the approach complies with the relevant statutes and regulations.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Product-
Specific Guidance Meetings Between FDA and ANDA Applicants Under
GDUFA.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if

it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collection of
information are subject to review by OMB under the PRA. The collections
of information pertaining to the submissions of controlled
correspondence, GDUFA III commitment letter, and meetings related to
generic drug development have been approved under OMB control number
0910-0797. The collections of information pertaining to the Generic
Drug User Fee Program have been approved under OMB control number 0910-
0727. The collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03517 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Page 11086]
[FR Doc No: 2019-05661]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9991-31-Region 10]

Proposed Reissuance of NPDES General Permit for Offshore Seafood
Processors in Alaska (AKG524000)

AGENCY: Environmental Protection Agency, Region 10.

ACTION: Notice of proposed reissuance of NPDES General Permit and
request for public comment.

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

SUMMARY: The Director, Office of Water and Watersheds, Environmental
Protection Agency (EPA) Region 10, is proposing to reissue a National
Pollutant Discharge Elimination System (NPDES) General Permit to
Offshore Seafood Processors in Alaska. As proposed, the General Permit
will authorize discharges of seafood processing waste from facilities
(also referred to as ``vessels'') that discharge at least 3 nautical
miles (NM) or greater from the Alaska shore as delineated by mean lower
low water (MLLW) or a closure line and which engage in the processing
of fresh, frozen, canned, smoked, salted or pickled seafood, the
processing of mince, or the processing of meal, paste and other
secondary by-products.

DATES: Comments must be received by May 9, 2019.

ADDRESSES: You may send comments by any of the following methods:
    Comments on the draft General Permit should be sent to Director,
Office of Water and Watersheds; USEPA Region 10; 1200 Sixth Avenue,
Suite 155, OWW-191; Seattle, WA 98101 and may also be submitted by fax
to<PHONE_NUMBER> or electronically to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Permit documents may be found on the
EPA Region 10 website at: https://www.epa.gov/npdes-permits/npdes-general-permit-offshore-seafood-processors-alaska. Copies of the draft
general permit and Fact Sheet are also available upon request. Requests
may be made to Audrey Washington at<PHONE_NUMBER> or to Joseph Ziobro
at<PHONE_NUMBER>. Requests may also be electronically mailed to:
<EMAIL_ADDRESS>or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

    There are currently fewer than 100 permitted seafood processors
that discharge effluent and operate more than 3 NM from the Alaskan
shore or closure line. Most of the seafood processed on the vessels are
pollock and Pacific cod. Other species have included sablefish,
arrowtooth flounder, Pacific hake, jack mackerel, Alaska plaice,
Pacific Ocean perch, rockfish, sculpin, lumpsucker, skate, sole,
Greenland turbot, bairdi, opilio, and king crab. The permit authorizes
the discharge of seafood processing wastes that are mostly waste solids
(shell, bones, skin, scales, flesh and organs), blood, body fluids,
slime, oils and fats from cooking and rendering operations;
disinfectants; and miscellaneous wastewaters. This Permit does not
authorize the discharge of pollutants from any shore-based facilities,
nor any pollutants from vessels transporting seafood processing waste
solely for the purpose of dumping materials into ocean waters. The
median annual waste discharged from a vessel in 2014 and 2015 was 7.1
and 6.2 million pounds, respectively.
    A description of the basis for the conditions and requirements of
the draft general permit is given in the Fact Sheet. In addition, the
EPA has completed an Ocean Discharge Criteria Evaluation pursuant to 40
CFR Subpart M which supports the basis for the conditions and
requirements in the draft general permit. Facilities will receive a
written notification from the EPA whether permit coverage and
authorization to discharge under the general permit is approved. Major
changes from the 2009 General Permit include the removal of the metals
monitoring requirement and the removal of the requirement to grind
effluent except in cases when vessels that discharge more than 10
million pounds per annual reporting year are discharging within Steller
Sea Lion critical habitat areas designated by the National Marine
Fisheries Service.
    The EPA is preparing a Biological Evaluation for this Permit
action. Consultations under the Endangered Species Act between the EPA
and the National Marine Fisheries Service and the U.S. Fish and
Wildlife Service are ongoing. Also for review in Section X of the Fact
Sheet are potential mitigation measures provided by National Marine
Fisheries Service for vessels that are exempt from grinding
requirements in Steller sea lion critical habitat.

II. Other Legal Requirements

    This action was submitted to the Office of Management and Budget
(OMB) for review under Executive Orders 12866, Regulatory Planning and
Review, and 13563, Improving Regulation and Regulatory Review, and was
determined to be not significant. Compliance with Endangered Species
Act, Essential Fish Habitat, Paperwork Reduction Act, and other
requirements are discussed in the Fact Sheet to the proposed permit.

    Dated: March 15, 2019.
Daniel D. Opalski,
Director, Office of Water and Watersheds, Region 10.
[FR Doc. 2019-05661 Filed 3-22-19; 8:45 am]
 BILLING CODE 6560-50-P