[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Proposed Rules]
[Pages 6795-6798]
[FR Doc No: 2022-02320]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0089; Project Identifier MCAI-2021-01027-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2021-14-17, which applies to certain Airbus SAS Model A350-941 and -
1041 airplanes. AD 2021-14-17 requires revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations. Since the FAA issued AD
2021-14-17, the FAA has determined that new or more restrictive
airworthiness limitations are necessary. This proposed AD would require
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by March 24,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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 material that will be incorporated by reference (IBR) in this
AD, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0089.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0089; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or

arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0089; Project Identifier
MCAI-2021-01027-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
Rodina, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Discussion

    The FAA issued AD 2021-14-17, Amendment 39-21644 (86 FR 37891, July
19, 2021) (AD 2021-14-17) for certain Airbus SAS Model A350-941 and -
1041 airplanes. AD 2021-14-17 requires revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations. The FAA issued AD 2021-14-
17 to address reduced structural integrity of the airplane.

Actions Since AD 2021-14-17 Was Issued

    Since the FAA issued AD 2021-14-17, the FAA has determined that new
or more restrictive airworthiness limitations are necessary.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0207, dated September 15, 2021
(EASA AD 2021-0207) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus SAS Model A350-941 and -1041 airplanes.
    Airplanes with an original airworthiness certificate or original
export certificate of airworthiness issued after June 30, 2021, must
comply with the airworthiness limitations specified as part of the
approved type design and referenced on the type certificate data sheet;
this proposed AD therefore does not include those airplanes in the
applicability.
    This proposed AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
proposing this AD to address reduced structural integrity of the
airplane. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0207 describes new or more restrictive airworthiness
limitations for airplane structures and safe life limits.
    This AD would also require EASA AD 2020-0210, dated October 5,
2020, which the Director of the Federal Register approved for
incorporation by reference as of August 23, 2021 (86 FR 37891, July 19,
2021).
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA has
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.

Proposed AD Requirements

    This proposed AD would retain the requirements of AD 2021-14-17.
This proposed AD would also require revising the existing maintenance
or inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations, which are specified in EASA AD
2021-0207 described previously, as incorporated by reference. Any
differences with EASA AD 2021-0207 are identified as exceptions in the
regulatory text of this AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(m)(1) of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0207 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0207 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0207 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0207. Service information required by EASA AD 2021-0207 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No.

FAA-2022-0089 after the FAA final rule is published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections) or intervals may be used unless the actions and intervals
are approved as an alternative method of compliance (AMOC) in
accordance with the procedures specified in the AMOCs paragraph under
``Other FAA Provisions.'' This new format includes a ``New Provisions
for Alternative Actions and Intervals'' paragraph that does not
specifically refer to AMOCs, but operators may still request an AMOC to
use an alternative action or interval.

Costs of Compliance

    The FAA estimates that this proposed AD affects 15 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2021-14-17 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the new proposed
actions to be $7,650 (90 work-hours x $85 per work-hour).

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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by:
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a. Removing Airworthiness Directive (AD) 2021-14-17, Amendment 39-21644
(86 FR 37891, July 19, 2021); and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2022-0089; Project Identifier MCAI-2021-
01027-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by March 24, 2022.

(b) Affected ADs

    This AD replaces AD 2021-14-17, Amendment 39-21644 (86 FR 37891,
July 19, 2021) (AD 2021-14-17).

(c) Applicability

    This AD applies to Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category, with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before June 30, 2021.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address reduced structural integrity of the
airplane.

(f) Compliance

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

(g) Retained Maintenance or Inspection Program Revision, With No
Changes

    This paragraph restates the requirements of paragraph (g) of AD
2021-14-17, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before May 29, 2020: Except as specified
in paragraph (h) of this AD, comply with all required actions and
compliance times specified in, and in accordance with, European
Union Aviation Safety Agency (EASA) AD 2020-0210, dated October 5,
2020 (EASA AD 2020-0210). Accomplishing the revision of the existing
maintenance or inspection program required by paragraph (j) of this
AD terminates the requirements of this paragraph.

(h) Retained Exceptions to EASA AD 2020-0210, With No Changes

    This paragraph restates the requirements of paragraph (h) of AD
2021-14-17, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before May 29, 2020:
    (1) Where EASA AD 2020-0210 refers to its effective date, this
AD requires using August 23, 2021 (the effective date of AD 2021-14-
17).

    (2) The requirements specified in paragraphs (1) and (2) of EASA
AD 2020-0210 do not apply to this AD.
    (3) Paragraph (3) of EASA AD 2020-0210 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after August 23, 2021 (the effective
date of AD 2021-14-17).
    (4) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA 2020-0210 is at the ``applicable thresholds''
as incorporated by the requirements of paragraph (3) of EASA AD
2020-0210, or within 90 days after August 23, 2021 (the effective
date of AD 2021-14-17), whichever occurs later.
    (5) The provisions specified in paragraphs (4) and (5) of EASA
AD 2020-0210 do not apply to this AD.
    (6) The ``Remarks'' section of EASA AD 2020-0210 does not apply
to this AD.

(i) Retained Provisions for Alternative Actions or Intervals, With a
New Exception

    This paragraph restates the requirements of paragraph (i) of AD
2021-14-17, with a new exception. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before May 29, 2020: Except as required
by paragraph (j) of this AD, after the existing maintenance or
inspection program has been revised as required by paragraph (g) of
this AD, no alternative actions (e.g., inspections) or intervals are
allowed unless they are approved as specified in the provisions of
the ``Ref. Publications'' section of EASA AD 2020-0210.

(j) New Maintenance or Inspection Program Revision

    Except as specified in paragraph (k) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2021-0207, dated September 15, 2021 (EASA
AD 2021-0207). Accomplishing the revision of the existing
maintenance or inspection program required by this paragraph
terminates the requirements of paragraph (g) of this AD.

(k) Exceptions to EASA AD 2021-0207

    (1) Where EASA AD 2021-0207 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The requirements specified in paragraphs (1) and (2) of EASA
AD 2021-0207 do not apply to this AD.
    (3) Paragraph (3) of EASA AD 2021-0207 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (4) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2021-0207 is at the applicable
``thresholds'' as incorporated by the requirements of paragraph (3)
of EASA AD 2021-0207, or within 90 days after the effective date of
this AD, whichever occurs later.
    (5) The provisions specified in paragraphs (4) and (5) of EASA
AD 2021-0207 do not apply to this AD.
    (6) The ``Remarks'' section of EASA AD 2021-0207 does not apply
to this AD.

(l) New Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (j) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2021-0207.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (n)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.

(n) Related Information

    (1) For information about EASA AD 2020-0210 and AD 2021-0207,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this EASA AD on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2022-0089.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email [email protected].

    Issued on January 31, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-02320 Filed 2-4-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 92 (Thursday, May 12, 2016)]
[Proposed Rules]
[Pages 29508-29511]
[FR Doc No: 2016-11168]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-6669; Directorate Identifier 2015-NM-191-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede Airworthiness Directive (AD) 2006-20-
11, which applies to certain The Boeing Company Model 757-200, -200CB,
and -200PF series airplanes. AD 2006-20-11 currently requires initial
and repetitive detailed or high frequency eddy current (HFEC)
inspections for cracks around the rivets at the upper fastener row of
the skin lap splice of the fuselage, and repairing any crack found.
Since we issued AD 2006-20-11, an evaluation done by the design
approval holder (DAH) indicated that the fuselage skin lap splice is
subject to widespread fatigue damage (WFD). This proposed AD would no
longer allow the detailed inspections and would instead require
repetitive external HFEC inspections for cracking of the skin lap
splices of the fuselage, and repair if necessary. We are proposing this
AD to detect and correct fatigue cracking at certain skin lap splice
locations of the fuselage, which could result in reduced structural
integrity and rapid decompression of the airplane.

DATES: We must receive comments on this proposed AD by June 27, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, 3855
Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone:
206-544-5000, extension 2; fax:<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6669.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6669; 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 (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Eric Schrieber, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5348; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-6669;
Directorate Identifier 2015-NM-191-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

    On September 22, 2006, we issued AD 2006-20-11, Amendment 39-14781
(71 FR 58485, October 4, 2006) (``AD 2006-20-11''), for certain The
Boeing Company Model 757-200, -200CB, and -200PF series airplanes. AD
2006-20-11 requires initial and repetitive detailed or HFEC inspections
for cracks around the rivets at the upper fastener row of the skin lap
splice of the fuselage, and repairing any crack found. AD 2006-20-11
resulted from reports of cracking in the fuselage skin of the crown
skin panel. We issued AD 2006-20-11 to detect and correct premature
fatigue cracking at certain skin lap splice locations of the fuselage,
and consequent rapid decompression of the airplane.
    Structural fatigue damage is progressive. It begins as minute
cracks, and those cracks grow under the action of repeated stresses.
This can happen because of normal operational conditions and design
attributes, or

because of isolated situations or incidents such as material defects,
poor fabrication quality, or corrosion pits, dings, or scratches.
Fatigue damage can occur locally, in small areas or structural design
details, or globally. Global fatigue damage is general degradation of
large areas of structure with similar structural details and stress
levels. Multiple-site damage is global damage that occurs in a large
structural element such as a single rivet line of a lap splice joining
two large skin panels. Global damage can also occur in multiple
elements such as adjacent frames or stringers. Multiple-site-damage and
multiple-element-damage cracks are typically too small initially to be
reliably detected with normal inspection methods. Without intervention,
these cracks will grow, and eventually compromise the structural
integrity of the airplane, in a condition known as WFD. As an airplane
ages, WFD will likely occur, and will certainly occur if the airplane
is operated long enough without any intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the LOV. Many LOVs, however, do depend on accomplishment of
future maintenance actions. As stated in the WFD rule, any maintenance
actions necessary to reach the LOV will be mandated by airworthiness
directives through separate rulemaking actions.
    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.
    We are proposing this AD to detect and correct fatigue cracking at
certain skin lap splice locations of the fuselage, which could result
in reduced structural integrity and rapid decompression of the
airplane.

Actions Since AD 2006-20-11 Was Issued

    Since issuance of AD 2006-20-11, an evaluation done by the DAH
indicated that the fuselage skin lap splice is subject to WFD.
    We have determined that the detailed inspection that is allowed as
an option in AD 2006-20-11, does not adequately address the identified
unsafe condition. Only HFEC inspections are adequate to address the
identified unsafe condition.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Special Attention Service Bulletin 757-53-0090,
Revision 1, dated November 19, 2015. The service information describes
procedures for repetitive external HFEC inspections for cracking of the
skin lap splices of the fuselage. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously. For information on the
procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6669.

Costs of Compliance

    We estimate that this proposed AD affects 572 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspections [retained actions    Up to 20 work-hours x                $0  Up to $1,700 per    Up to $972,400 per
 from AD 2006-20-11].             $85 per hour = up to                     inspection cycle.   inspection cycle.
                                  $1,700 per inspection
                                  cycle.
New proposed inspections.......  Up to 20 work-hours x                 0  Up to $1,700 per    Up to $972,400 per
                                  $85 per hour = up to                     inspection cycle.   inspection cycle.
                                  $1,700 per inspection
                                  cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
a cost estimate for the on-condition repairs specified in this proposed
AD.

Authority for This Rulemaking

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

Regulatory Findings

    We 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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2006-20-11, Amendment 39-14781 (71 FR 58485, October 4, 2006), and
adding the following new AD:

The Boeing Company: Docket No. FAA-2016-6669; Directorate Identifier
2015-NM-191-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by June 27,
2016.

(b) Affected ADs

    This AD replaces AD 2006-20-11, Amendment 39-14781 (71 FR 58485,
October 4, 2006) (``AD 2006-20-11''). This AD affects AD 2006-11-11,
Amendment 39-14615 (71 FR 30278, May 26, 2006) (``AD 2006-11-11'').

(c) Applicability

    (c) This AD applies to The Boeing Company Model 757-200, -200CB,
and -200PF series airplanes, certificated in any category, as
identified in Boeing Special Attention Service Bulletin 757-53-0090,
Revision 1, dated November 19, 2015.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by an evaluation done by the design
approval holder which indicated that the fuselage skin lap splice is
subject to widespread fatigue damage. We are issuing this AD to
detect and correct fatigue cracking at certain skin lap splice
locations of the fuselage, which could result in reduced structural
integrity and rapid decompression of the airplane.

(f) Compliance

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

(g) Retained Initial and Repetitive Inspections With Terminating Action

    This paragraph restates the requirements of paragraph (f) of AD
2006-20-11, with terminating action. Do initial and repetitive
detailed or high frequency eddy current (HFEC) inspections for
cracking around the rivets at the upper fastener row of the skin lap
splice of the fuselage by doing all the actions in accordance with
the Accomplishment Instructions of Boeing Special Attention Service
Bulletin 757-53-0090, dated June 2, 2005, except as provided by
paragraphs (h) and (i) of this AD. Do the inspections at the
applicable times specified in Paragraph 1.E., ``Compliance,'' of
Boeing Special Attention Service Bulletin 757-53-0090, dated June 2,
2005; except where Boeing Special Attention Service Bulletin 757-53-
0090, dated June 2, 2005, specifies a compliance time ``after the
original release date of this service bulletin,'' this AD requires
compliance after November 8, 2006 (the effective date of AD 2006-20-
11). Accomplishing an inspection required by paragraph (j) of this
AD terminates the inspections required by this paragraph.

(h) Retained Repair With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2006-20-11, with no changes. If any crack is found during any
inspection required by paragraph (g) of this AD: Before further
flight, repair the crack using a method approved in accordance with
the procedures specified in paragraph (m) of this AD.

(i) Retained No Reporting Required With No Changes

    This paragraph restates the provision specified in paragraph (h)
of AD 2006-20-11, with no changes. Although Boeing Special Attention
Service Bulletin 757-53-0090, dated June 2, 2005, recommends that
inspection results be reported to the manufacturer, this AD does not
include that requirement.

(j) New Repetitive Inspections

    At the applicable time specified in table 1 of paragraph 1.E.,
``Compliance,'' of Boeing Special Attention Service Bulletin 757-53-
0090, Revision 1, dated November 19, 2015, except as provided by
paragraph (l)(1) of this AD: Do an external high frequency eddy
current (HFEC) inspection for cracking of the skin lap splices of
the fuselage, in accordance with the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 757-53-0090, Revision 1,
dated November 19, 2015. Repeat the inspection thereafter at the
applicable times specified in table 1 of paragraph 1.E.,
``Compliance,'' of Boeing Special Attention Service Bulletin 757-53-
0090, Revision 1, dated November 19, 2015. Doing an inspection
required by this paragraph terminates the inspections required by
paragraph (g) of this AD.

(k) Repair for Cracking Found During Inspections Required by Paragraph
(j) of This AD

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

(l) Exceptions to Service Information

    (1) Where Boeing Special Attention Service Bulletin 757-53-0090,
Revision 1, dated November 19, 2015, specifies a compliance time
``after the Revision 1 date of this service bulletin,'' this AD
requires compliance within the specified compliance time after the
effective date of this AD.
    (2) Although Boeing Special Attention Service Bulletin 757-53-
0090, Revision 1, dated November 19, 2015, specifies to contact
Boeing for repair instructions, and specifies that action as ``RC''
(Required for Compliance), paragraph (k) of this AD requires repair
before further flight using a method approved in accordance with the
procedures specified in paragraph (m) of this AD.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (n)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO, to make those findings. To be approved the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane and the approval must
specifically refer to this AD.
    (4) AMOCs approved for AD 2006-20-11, are approved as AMOCs for
the corresponding provisions of paragraphs (g) and (j) of this AD.
    (5) Except as required by paragraph (l)(2) of this AD: For
service information that contains steps that are labeled as Required
for Compliance (RC), the provisions of paragraphs (m)(5)(i) and
(m)(5)(ii) apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures

identified in an RC step, must be done to comply with the AD. An
AMOC is required for any deviations to RC steps, including substeps
and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.
    (6) The inspections specified in paragraph (g) of this AD are
approved as an AMOC to paragraph (h) of AD 2006-11-11 for the
inspections of Significant Structural Items (SSI) 53-30-07 and 53-
60-07 (fuselage lap splices, left and right upper fastener row)
listed in the May 2003 or June 2005 revision of the Boeing 757
Maintenance Planning Data (MPD) Document D622N001-9. This AMOC
applies only to the common areas identified in paragraphs (m)(6)(i)
and (m)(6)(ii) of this AD. All provisions of AD 2006-11-11 that are
not specifically referenced in the above statements remain fully
applicable and must be complied with as specified in AD 2006-11-11.
Operators may revise their FAA-approved maintenance or inspection
program with these alternative inspections for common areas.
    (i) Common areas inspected before the effective date of this AD
in accordance with the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 757-53-0090, dated June 2, 2005.
    (ii) Common areas inspected in accordance with the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 757-53-0090, Revision 1, dated November 19, 2015.

(n) Related Information

    (1) For more information about this AD, contact Eric Schrieber,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles
Aircraft Certification Office (ACO), 3960 Paramount Boulevard,
Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone:<PHONE_NUMBER>, extension 2; fax:<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on May 5, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-11168 Filed 5-11-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: March 7, 2006 (Volume 71, Number 44)]
[Notices]
[Page 11458-11459]
[DOCID:fr07mr06-98]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53388; File No. SR-Phlx-2006-13]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Extension of a Pilot Program Concerning Option Position
Limits

February 28, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 28, 2006, the Philadelphia Stock Exchange, Inc. (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Phlx. The Exchange has
filed the proposal as a ``non-controversial'' rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders it effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Phlx proposes to extend, for a period of approximately six
months, through September 1, 2006, a pilot program applicable to
Exchange Rule 1001, Position Limits, which increases the standard
position and exercise limits for equity option contracts and options on
the Nasdaq-100 Index Tracking Stock \5\ (``QQQQ'') (``Pilot Program'').
The text of the proposed rule change is available on the Phlx's Web
site (http://www.phlx.com), at the Phlx's principal office, and at the

Commission's Public Reference Room.
---------------------------------------------------------------------------

    \5\ The Nasdaq-100[reg], Nasdaq-100 Index[reg], Nasdaq[reg], The
Nasdaq Stock Market[reg], Nasdaq-100 SharesSM, Nasdaq-100
TrustSM, Nasdaq-100 Index Tracking StockSM,
and QQQSM are trademarks or service marks of The Nasdaq
Stock Market, Inc. (``Nasdaq'') and have been licensed for use for
certain purposes by the Phlx pursuant to a License Agreement
(``License'') with Nasdaq. The Nasdaq-100 Index[reg] (``Index'') is
determined, composed, and calculated by Nasdaq without regard to the
Licensee, the Nasdaq-100 TrustSM, or the beneficial
owners of Nasdaq-100 SharesSM. Nasdaq has complete
control and sole discretion in determining, comprising, or
calculating the Index or in modifying in any way its method for
determining, comprising, or calculating the Index in the future.
---------------------------------------------------------------------------

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 Phlx 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 these 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 aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to extend the Pilot
Program, which is scheduled to expire March 3, 2006,\6\ for
approximately an additional six-month period, through September 1,
2006.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 51322 (March 4,
2005), 70 FR 12260 (March 11, 2005) (notice of filing and immediate
effectiveness of File No. SR-Phlx-2005-17). See also Securities
Exchange Act Release No. 52261 (August 15, 2005), 70 FR 49004
(August 22, 2005) (notice of filing and immediate effectiveness of
File No. SR-Phlx-2005-51, which extended the Pilot Program).
---------------------------------------------------------------------------

    Position limits impose a ceiling on the number of option contracts
in each class on the same side of the market relating to the same
underlying security that can be held or written by an investor or group
of investors acting in concert. Exchange Rule 1002 (not proposed to be
amended herein) establishes corresponding exercise limits. Exercise
limits prohibit an investor or group of investors acting in concert
from exercising more than a specified number of puts or calls in a
particular class within five consecutive business days.
    Exchange Rule 1001 subjects equity options to one of five different
position limits depending on the trading volume and outstanding shares
of the underlying security. Exchange Rule 1002 establishes exercise
limits for the corresponding options at the same levels as the
corresponding security's position limits.\7\
---------------------------------------------------------------------------

    \7\ Exchange Rule 1002 states, in relevant part, ``* * * no
member or member organization shall exercise, for any account in
which such member or member organization has an interest or for the
account of any partner, officer, director or employee thereof or for
the account of any customer, a long position in any option contract
of a class of options dealt in on the Exchange (or, respecting an
option not dealt in on the Exchange, another exchange if the member
or member organization is not a member of that exchange) if as a
result thereof such member or member organization, or partner,
officer, director or employee thereof or customer, acting alone or
in concert with others, directly or indirectly, has or will have
exercised within any five (5) consecutive business days aggregate
long positions in that class (put or call) as set forth as the
position limit in Rule 1001, in the case of options on a stock or on
an Exchange-Traded Fund Share.* * *''
---------------------------------------------------------------------------

Standard Position and Exercise Limit

    The Pilot Program increases the standard position and exercise
limits for equity options traded on the Exchange and for options
overlying QQQQ to the following levels:
---------------------------------------------------------------------------

    \8\ Except when the Pilot Program is in effect.

------------------------------------------------------------------------
  Standard equity option contract        Pilot program equity option
             limit \8\                          contract limit
------------------------------------------------------------------------
                         13,500                               25,000
                         22,500                               50,000
                         31,500                               75,000
                         60,000                              200,000
                         75,000                              250,000
------------------------------------------------------------------------
Standard QQQQ option contract limit  Pilot program QQQQ option contract
                                                               limit
------------------------------------------------------------------------
                        300,000                              900,000
------------------------------------------------------------------------

    To date the Exchange believes that there have been no adverse
effects on the market as a result of these increases in the limits for
equity option contracts and options overlying QQQQ.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \9\ in general, and furthers the objective of Section
6(b)(5) of the Act \10\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanisms of a free and open market and the
national market system, and, in general to protect investors and the
public interest, by extending the Pilot Program for approximately an
additional six months.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 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 either solicited or received.

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

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\13\
However, Rule 19b-4(f)(6)(iii)\14\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange provided the Commission
with written notice of its intent to file this proposed rule change at
least five business days prior to the date of filing the proposed rule
change. In addition, the Exchange has requested that the Commission
waive the 30-day pre-operative delay. The Commission believes that
waiving the 30-day pre-operative delay is consistent with the
protection of investors and in the public interest because it will
allow the Pilot Program to continue uninterrupted.\15\
---------------------------------------------------------------------------

    \13\ 17 CFR 240.19-4(f)(6)(iii).
    \14\ Id.
    \15\ For the purposes only of waiving the pre-operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the 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 Act.

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 No. SR-Phlx-2006-13 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File No. SR-Phlx-2006-13. 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. Copies of such filing will also be available for
inspection and copying at the principal office of the Phlx. 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 No. SR-Phlx-2006-13 and should be
submitted on or before March 28, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-3163 Filed 3-6-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 119 (Thursday, June 22, 2017)]
[Notices]
[Pages 28523-28524]
[FR Doc No: 2017-12998]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4316-DR: Docket ID FEMA-2017-0001]

New Hampshire; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New Hampshire (FEMA-4316-DR), dated June 1,
2017, and related determinations.

DATES: Effective June 1, 2017.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated June 1, 2017, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of New Hampshire resulting from a severe winter storm during the
period of March 14-15, 2017, is of sufficient severity and magnitude
to warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of New Hampshire.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

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

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

Robert J. Fenton,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-12998 Filed 6-21-17; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Pages 83418-83419]
[FR Doc No: 2023-26255]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-2199; FDA-2022-E-2200; and FDA-2022-E-2201]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Empaveli and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by January 29, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 28, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

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 Nos.
FDA-2022-E-2199; FDA-2022-E-2200; and FDA-2022-E-2201 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; EMPAVELI.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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 Sec.  10.20 (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>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the

actual amount of extension that the Director of USPTO may award (for
example, half the testing phase must be subtracted as well as any time
that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, Empaveli
(pegcetacoplan) indicated for the treatment of adult patients with
paroxysmal nocturnal hemoglobinuria. Subsequent to this approval, the
USPTO received patent term restoration applications for Empaveli (U.S.
Patent Nos. 10,035,822; 10,125,171; and 10,875,893) from Apellis
Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated September 21, 2022, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of Empaveli represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Empaveli is 2,501 days. Of this time, 2,258 days occurred during the
testing phase of the regulatory review period, while 243 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
July 11, 2014. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 11,
2014.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: September 14,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for Empaveli (NDA 215014) was initially submitted on
September 14, 2020.
    3. The date the application was approved: May 14, 2021. FDA has
verified the applicant's claim that NDA 215014 was approved on May 14,
2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 137 days, 545 days, or 579 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26255 Filed 11-28-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Rules and Regulations]
[Page 21694]
[FR Doc No: 2017-09365]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Withdrawal of Approval of a New Animal Drug
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new animal drug application (NADA). This action is being taken at
the sponsors' request because these products are no longer manufactured
or marketed.

DATES: Withdrawal of approval is effective May 22, 2017.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Sioux Biochemical, Inc., 204 Third St. NW.,
Sioux Center, IA 51250 has requested that FDA withdraw approval of NADA
009-505 for F.S.H.-P (follicle stimulating hormone) Powder for
Injection because the product is no longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec.  514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADA
009-505, and all supplements and amendments thereto, is hereby
withdrawn, effective May 22, 2017.
    Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of this application.

    Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09365 Filed 5-9-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Notices]
[Page 63225-63227]
[DOCID:fr14oc10-123]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63050; File No. SR-Phlx-2010-137]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Regarding
Anti-Internalization Functionality for NASDAQ OMX PSX

October 6, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on September 30, 2010, NASDAQ OMX PHLX LLC (``Phlx'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Phlx Rule 3307 to provide an
optional anti-internalization functionality on NASDAQ OMX PSX
(``PSX''). The text of the proposed rule change is available from the
Exchange's Web site at http://nasdaqomxphlx.cchwallstreet.com, at the
Exchange's principal office, and at 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 Exchange included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below, and is set forth in Sections A, B, and C below.

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

1. Purpose
    The Exchange is proposing to provide a voluntary anti-
internalization function for the PSX System. Under the proposal, market
participants entering orders under a specific market participant
identifier (``MPID'') may voluntarily direct that they not execute
against other orders entered into the System under the same MPID.
    Under the proposal, the System, if requested, will not execute
orders entered under the same MPID against each other. Instead, the
System will execute against all eligible trading interest of other
market participants, in accordance with PSX's price-size execution
priority, up to the point where an incoming order would interact with a
resting order having the same MPID. In such a case, share amounts equal
to the size of the portion of an incoming order that is designated by
the order execution algorithm to interact with an order already in the
System with the same MPID will be decremented from each order.
    For example, if market participant ABCD had an order to sell 1,000
shares at $10 on the book, entered an order to buy 1,000 shares at $10,
and the System allocated 100 shares of the incoming order to the
resting ABCD order and 900 shares to other market participants' orders,
the System would execute the 900 shares allocated to other market
participants and would decrement, without execution, the remaining 100
shares of the incoming order as well as 100 shares from ABCD's resting
order. Similarly, if ABCD had a resting order to sell 2,000 shares at
$10, entered an order to buy 500 shares at $10, and the System
allocated all 500 shares to the resting ABCD order, the System would
cancel the incoming order and

decrement the resting order by 500 shares.
    Anti-internalization functionality is designed to assist market
participants in complying with certain rules and regulations of the
Employee Retirement Income Security Act (``ERISA'') that preclude and/
or limit managing broker-dealers of such accounts from trading as
principal with orders generated for those accounts. It can also assist
market participants in reducing execution fees potentially resulting
from the interaction of executable buy and sell trading interest from
the same firm. The Exchange notes that use of the functionality does
not relieve or otherwise modify the duty of best execution owed to
orders received from public customers. As such, market participants
using anti-internalization functionality will need to take appropriate
steps to ensure that public customer orders that do not execute because
of the use of anti-internalization functionality ultimately receive the
same execution price (or better) that they would have originally
obtained if execution of the order was not inhibited by the
functionality.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\3\ in general, and with
Sections 6(b)(5) of the Act,\4\ in particular, in that the proposal is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. The Exchange
notes that similar functionality has previously been approved for The
NASDAQ Stock Market LLC (the ``NASDAQ Exchange'').\5\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f.
    \4\ 15 U.S.C. 78f(b)(5).
    \5\ NASDAQ Exchange Rule 4757(a)(4).
---------------------------------------------------------------------------

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (1)
Significantly affect the protection of investors or the public
interest; (2) impose any significant burden on competition; and (3)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \6\ and Rule 19b-
4(f)(6) thereunder.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Phlx has given the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date on which the
Exchange filed the proposed rule change.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\8\
However, Rule 19b-4(f)(6) \9\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange requests that the
Commission waive the 30-day operative delay so that the benefits of
this functionality to PSX market participants expected from the rule
change can be implemented on or about October 8, 2010, when the
Exchange expects to launch trading on PSX and have the technological
changes in place to support the proposed rule change. The Commission
notes that the proposal is similar to rules adopted by other
exchanges.\10\ For these reasons, the Commission believes it is
consistent with the protection of investors and the public interest to
waive the 30-day operative delay, and hereby grants such waiver.\11\
---------------------------------------------------------------------------

    \8\ 17 CFR 240.19b-4(f)(6)(iii).
    \9\ Id.
    \10\ NASDAQ Exchange Rule 4757(a)(4), BATS Exchange Rule 11.9(f)
and NYSE ArcaEquities Rule 7.31(qq).
    \11\ For the purposes only of waiving the operative date of this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend 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.

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-Phlx-2010-137 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-Phlx-2010-137. 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,\12\ 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 website
viewing and printing 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 the 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-Phlx-2010-137 and should be submitted on
or before November 4, 2010.
---------------------------------------------------------------------------

    \12\ The text of the proposed rule change is available on
Exchange's Web site at http://nasdaqtrader.com/
micro.aspx?id=PHLXfilings, on the Commission's website at http://
www.sec.gov, at Phlx, and at the Commission's Public Reference Room.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-25808 Filed 10-13-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 916-918]
[FR Doc No: 2020-00074]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-6098]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Focus Groups as Used by the Food and Drug
Administration (All Food and Drug Administration-Regulated Products)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collection of information for the
generic collection for focus groups as used by FDA (all FDA-regulated
products).

DATES: Submit either electronic or written comments on the collection
of information by March 9, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 9, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 9, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2019-N-6098 for ``Agency Information Collection Actitivites;
Proposed Collection; Comment Request; Focus Groups as Used by the Food
and Drug Administration (All FDA-Regulated Products).'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Focus Groups as Used by the Food and Drug Administration (All FDA-
Regulated Products)

OMB Control Number 0910-0497--Extension

    FDA conducts focus group interviews on a variety of topics
involving FDA-regulated products, including drugs, biologics, devices,
food, tobacco, and veterinary medicine.
    Focus groups provide an important role in gathering information
because they allow for a more indepth understanding of consumers'
attitudes, beliefs, motivations, and feelings than do quantitative
studies. Focus groups serve the narrowly defined need for direct and
informal opinion on a specific topic and as a qualitative research tool
have three major purposes:
     To obtain consumer information that is useful for
developing variables and measures for quantitative studies,
     To better understand consumers' attitudes and emotions in
response to topics and concepts, and
     To further explore findings obtained from quantitative
studies.
    FDA will use focus group findings to test and refine their ideas
but will generally conduct further research before making important
decisions such as adopting new policies and allocating or redirecting
significant resources to support these policies.
    Respondents to this collection of information will include members
of the general public, healthcare professionals, the industry, and
other stakeholders who are related to a product under FDA's
jurisdiction. Inclusion and exclusion criteria will vary depending on
the research topic.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Interviews.............................................           8,800                1            8,800             1.75           15,400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00074 Filed 1-7-20; 8:45 am]
BILLING CODE 4164-01-P