scale sites may also support other monitoring objectives of the
SO2 monitoring network such as identifying trends, and
when monitors are sited upwind of local sources, background
concentrations.
    4.4.5 NCore Monitoring. (a) SO2 measurements are
included within the NCore multipollutant site requirements as
described in paragraph (3)(b) of this appendix. NCore-based
SO2 measurements are primarily used to characterize
SO2 trends and assist in understanding SO2
transport across representative areas in urban or rural locations
and are also used for comparison with the SO2 NAAQS.
SO2 monitors at NCore sites that exist in CBSAs with
minimum monitoring requirements per section 4.4.2 above shall be
allowed to count towards those minimum monitoring requirements.
* * * * *

0
25. Appendix G to Part 58 is amended as by revising Table 2 to read as
follows:

Appendix G to Part 58--Uniform Air Quality Index (AQI) and Daily
Reporting

* * * * *

                                                            Table 2--Breakpoints for the AQI
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              These breakpoints                                                            Equal these AQI's
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            PM2.5      PM10
      O3 (ppm)  8-hour        O3 (ppm)    ([mu]g/m   ([mu]g/  CO (ppm)  SO2 (ppm)  1-hour  NO2 (ppm)  1-hour    AQI                 Category
                             1-hour \1\     \3\)      m \3\)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.000-0.059................  ..........    0.0-15.4     0-54   0.0-4.4            0-0.035            0-0.053     0-50  Good.
0.060-0.075................  ..........   15.5-40.4   55-154   4.5-9.4        0.036-0.075        0.054-0.100   51-100  Moderate.
0.076-0.095................  0.125-0.16   40.5-65.4  155-254  9.5-12.4        0.076-0.185        0.101-0.360  101-150  Unhealthy for Sensitive Groups.
                                      4
0.096-0.115................  0.165-0.20   \3\ 65.5-  255-354  12.5-15.    \4\ 0.186-0.304         0.361-0.64  151-200  Unhealthy.
                                      4       150.4                  4
0.116-0.374................  0.205-0.40  \3\ 150.5-  355-424  15.5-30.    \4\ 0.305-0.604          0.65-1.24  201-300  Very Unhealthy.
                                      4       250.4                  4
(\2\)......................  0.405-0.50  \3\ 250.5-  425-504  30.5-40.    \4\ 0.605-0.804          1.25-1.64  301-400  .................................
                                      4       350.4                  4
(\2\)......................  0.505-0.60  \3\ 350.5-  505-604  40.5-50.    \4\ 0.805-1.004          1.65-2.04  401-500  Hazardous.
                                      4       500.4                  4
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Areas are generally required to report the AQI based on 8-hour ozone values. However, there are a small number of areas where an AQI based on 1-hour
  ozone values would be more precautionary. In these cases, in addition to calculating the 8-hour ozone index value, the 1-hour ozone index value may be
  calculated, and the maximum of the two values reported.
\2\ 8-hour O3 values do not define higher AQI values (>=301). AQI values of 301 or greater are calculated with 1-hour O3 concentrations.
\3\ If a different SHL for PM2.5 is promulgated, these numbers will change accordingly.
\4\ 1-hr SO2 values do not define higher AQI values (>=200). AQI values of 200 or greater are calculated with 24-hour SO2 concentrations.

* * * * *

[FR Doc. 2010-13947 Filed 6-21-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 17, 2005 (Volume 70, Number 199)]
[Notices]
[Page 60312-60313]
[DOCID:fr17oc05-46]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EG06-1-000]

Covanta Fairfax, Inc.; Notice of Application for Commission
Determination of Exempt Wholesale Generator Status

October 6, 2005.
    Take notice that on October 3, 2005, Covanta Fairfax, Inc., a
Virginia corporation hereby submits an application for exempt wholesale
generator status pursuant to 18 CFR 365.3 of the Commission's
regulations.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing an intervention or protest on or before the intervention
or protest date need not serve motions to intervene or protests on
persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on October 24, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5687 Filed 10-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 31 (Tuesday, February 15, 2022)]
[Rules and Regulations]
[Pages 8402-8406]
[FR Doc No: 2022-03039]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0259; Project Identifier AD-2020-01128-E;
Amendment 39-21900; AD 2022-02-03]
RIN 2120-AA64

Airworthiness Directives; CFM International, S.A. Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2013-26-01
for all CFM International, S.A. (CFM) CFM56-3 and CFM56-7B model
turbofan engines with a certain accessory gearbox assembly (AGB) not
equipped with a dynamic oil seal assembly in the handcranking pad. AD
2013-26-01 required an independent inspection to verify re-installation
of the handcranking pad cover after removal of the pad cover for
maintenance. This AD was prompted by a dual engine loss of oil event
and 42 prior events of total loss of engine oil during flight. This AD
requires independent inspection to verify re-installation of the AGB
handcranking pad cover after maintenance. This AD also requires the
replacement of the affected AGB as a terminating action to the
inspection requirement. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective March 22, 2022.

ADDRESSES: For service information identified in this final rule,
contact CFM International, S.A., Aviation Operations Center, 1 Neumann
Way, M/D Room 285, Cincinnati, OH 45125; phone:<PHONE_NUMBER>; email:
[email protected]. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0259.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0259; 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 final rule, any
comments received, and other information. The address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kevin Clark, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
(781) 238-7088; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2013-26-01, Amendment 39-17710 (78 FR
79295, December 30, 2013), (AD 2013-26-01). AD 2013-26-01 applied to
all CFM CFM56-3 and CFM56-7B series turbofan engines with certain AGBs
not equipped with a dynamic oil seal in the handcranking pad assembly.
The NPRM published in the Federal Register on May 3, 2021 (86 FR
23301). The NPRM was prompted by a dual engine loss of oil event and 42
prior events of total loss of engine oil during flight. In the NPRM,
the FAA proposed to retain certain requirements of AD 2013-26-01. The
NPRM proposed to require the performance of an independent inspection
to verify re-installation of the AGB handcranking pad cover after
maintenance. Alternatively, the NPRM proposed to require the insertion
of an independent inspection as a required inspection item in the
approved continuous airworthiness maintenance program for the aircraft
not later than the next time the AGB handcranking pad cover is removed
for maintenance.
    The NPRM also proposed to remove the optional terminating action in
AD 2013-26-01 and add a mandatory terminating action for certain model
turbofan engines, requiring the removal and replacement of an affected
AGB with an AGB that incorporates the dynamic oil seal in the
handcranking pad cover assembly. For all CFM56-3 and the majority of
CFM56-7B turbofan engine models, the NPRM proposed to require
replacement of the AGB as a mandatory terminating action to the
inspection requirement. The NPRM does not require this terminating
action for CFM56-7B27A, CFM56-7B27A/3 and CFM56-7B27AE model turbofan
engines because these model engines, which are installed only in
military airplanes, do not have a replacement AGB eligible for
installation. The FAA is issuing this AD to address the unsafe
condition on these products.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from seven commenters. The commenters
were Alaska Airlines, Inc. (Alaska), American Airlines (American), Air
Line Pilot Association, International (ALPA), CFM, Delta Air Lines,
Inc. (Delta), Jet Engine Technology Corporation (Jet Engine
Technology), and United Airlines (United). The following presents the
comments received on the NPRM and the FAA's response to each comment.

Request To Revise Service Bulletin (SB) References To Allow On-Wing
Procedure

    Alaska requested that the FAA revise the definition in paragraph
(i)(3)(ii) of this AD to include an affected AGB that has been reworked
and reidentified to a part number (P/N) eligible for installation, as
applicable to the removed P/N, in accordance with an FAA approved CFM
International SB.

Alaska also commented that CFM expects to release CFM56-7B S/B 72-1023
in September 2021 and this SB would allow for introduction of AGB part
number 340-046-528-0. Alaska also noted that CFM plans to release
Revision 9 of CFM International CFM56-7B S/B 72-0564 to allow on-wing
installation of the dynamic oil seal in the handcranking pad cover
assembly.
    American also requested that the FAA revise the definition in
paragraph (i)(3)(ii) of this AD to include procedures from future FAA
approved revisions of CFM SBs. American noted that CFM plans to release
Revision 9 of CFM International CFM56-7B S/B 72-0564 to allow on-wing
installation of the dynamic oil seal in the handcranking pad cover
assembly. American also requested that the FAA incorporate the
maintenance procedures from Revision 9 of CFM International SB CFM56-7B
S/B 72-0564 and CFM International SB CFM56-7B S/B 72-1071 into the
proposed AD. American noted the advantage that Revision 9 of CFM
International SB CFM56-7B S/B 72-0564 would allow the AGBs to be
modified on-wing.
    Delta requested that the FAA urge CFM to make an on-wing procedure
available to operators. Delta further requested that the FAA modify the
definition of an affected AGB that has been re-worked and re-identified
to a part number eligible for installation in paragraph (i)(3)(ii) of
the NPRM by removing the specific revision numbers and effective dates
from the SBs in this paragraph. Delta commented that Revision 7 is the
current revision for CFM International SB CFM56-7B S/B 72-0879,
however, AD 2013-26-01 does not list a revision number for an AGB that
is eligible for installation in the terminating action. Further, Delta
stated that European Union Aviation Safety Agency (EASA) AD 2020-0261
allows for the modification and re-identification of an affected AGB
using future revisions of CFM International SB CFM56-7B S/B 72-0564.
    In response to the comments from Alaska, American, and Delta, the
FAA changed the definition of a part eligible for installation in
paragraph (i)(3)(ii) of this AD to ``An affected AGB that, using an
FAA-approved procedure, has been re-worked with a dynamic oil seal in
the starter drive pad and re-identified with a new part number not
listed in paragraph (i)(3)(i) of this AD.'' This change allows
operators to use procedures in service bulletins that contain an FAA-
approved method for installing the dynamic oil seal in the handcranking
pad cover assembly.

Request To Update the Definition of an Engine Shop Visit

    American requested that the FAA update the definition of an engine
shop visit by adding the following additional exceptions to the
definition in paragraph (i)(1) of this AD:
    ``(iii) The removal of the fan disk or the fan disk and booster
spool as an assembly.
    (iv) Accomplishment of a top/bottom case by removal of the HPC
forward and aft stator cases.''
    The FAA disagrees with revising the definition as proposed by
American. The removal of the fan, which includes the fan disk and
booster major module, is excluded from the definition of an engine shop
visit in paragraph (i)(1)(ii) of this AD. Regarding the addition of an
exception to the definition of an engine shop visit to include
accomplishment of a top/bottom case by removal of the high-pressure
compressor (HPC) forward and aft stator cases, American did not provide
rationale for this requested change. The FAA finds that incorporating
this requested exception by the commenter would unnecessarily delay the
accomplishment of the required actions of this AD.

Request To Update the Definition of a Part Eligible for Installation

    Delta requested that the FAA remove the term ``using'' from the
following sentence in paragraph (i)(3)(ii): ``An affected AGB that has
been reworked and reidentified to a part number eligible for
installation using, as applicable, CFM SB 72-0879, Revision 6, dated
March 1, 2018, or SB 72-0564 Revision 8, dated May 6, 2020.'' Delta
reasoned that the cited service information does not specify which
steps or paragraphs are required for compliance.
    The FAA has changed the definition in paragraph (i)(3)(ii) of this
AD to allow the use of FAA-approved methods for installing the dynamic
oil seal in the handcranking pad cover assembly rather than mandating
specific procedures.

Request To Incorporate FAA Advisory Circular (AC) Into CFM SBs

    American requested that CFM incorporate FAA AC 20-176A into its SBs
to distinguish which steps in an SB will have a direct effect on
detecting, preventing, resolving, or eliminating the unsafe condition
identified in an AD. American commented further that the application of
AC 20-176A to previous CFM SBs was successful in reducing global
requests for alternative methods of compliance (AMOCs) and streamlining
the accomplishment of key tasks while meeting strict regulatory
compliance.
    Delta requested that the FAA urge CFM to incorporate FAA AC 20-176A
into its SBs. Delta commented that paragraph (i)(3)(ii) defines an
affected AGB that has been reworked and reidentified to a part number
eligible for installation using, as applicable, CFM International SB
CFM56-7B S/B 72-0879, Revision 6, dated March 1, 2018, or CFM
International SB CFM56-7B S/B 72-0564, Revision 8, dated May 6, 2020.
This definition does not specify which steps or paragraphs are required
for compliance. Delta requested the FAA urge CFM to revise these SBs to
incorporate AC 20-176A to distinguish which steps in an SB will have a
direct effect on detecting, preventing, resolving, or eliminating the
unsafe condition identified in an AD.
    In response to these comments from Delta and American, the FAA has
changed the definition of an AGB eligible for installation in paragraph
(i)(3)(ii) of this AD to allow the use of FAA-approved methods for
installing the dynamic oil seal in the handcranking pad cover assembly
rather than mandating specific procedures. Since the SBs noted by the
commenters are not required for compliance within this AD, the FAA does
not find it necessary to recommend that the manufacturer incorporate
sections from the guidance contained in AC 20-176A in the referenced
SBs.

Request To Revise SB References

    CFM requested that the FAA revise the specified service information
in paragraph (i)(3)(ii) of the NPRM by referencing Revision 7 of CFM
International SB CFM56-7B S/B 72-0879, dated February 10, 2021. CFM
also requested that the FAA change the date of CFM International SB
CFM56-7B S/B 72-1129 from May 5, 2020 to May 6, 2020.
    In response to this comment, the FAA has revised paragraph
(i)(3)(ii) by adding a Note, which refers to Revision 7 of CFM
International SB CFM 56-7B S/B 72-0879, dated February 10, 2021. The
FAA is not requiring use of CFM International SB CFM 56-7B S/B 72-0879
to rework the dynamic oil seal in the handcranking pad cover assembly.
The addition of Note 2 to paragraph (i)(3)(ii) of this AD includes
reference to procedures to install a dynamic oil seal in the
handcranking pad cover assembly, which can be found in CFM
International SB CFM56-3 S/B 72-1129, Revision 7, dated May 6, 2020.
The FAA also updated the publication date of CFM International CFM56-7B
S/B 72-1129 to May 6, 2020.

Request To Revise Reference to Engine Models

    CFM requested that the FAA update the AD to replace references to
``CFM56-3B'' model turbofan engines with ``CFM56-3'' when referring to
all CFM56-3, CFM56-3B and CFM56-3C model turbofan engines.
    The FAA notes the reference to ``CFM56-3B'' that existed in the
preamble of the NPRM has been updated to ``CFM56-3'' in the preamble of
this final rule.

Request To Clarify the Mandatory Terminating Action

    CFM and United requested that the FAA clarify if paragraph (h),
Mandatory Terminating Action, requires removal and replacement of the
AGB or if the AGB can be re-worked and re-identified. The commenters
indicated that there is an on-wing re-work procedure that is being
developed to install the dynamic oil seal in the handcranking pad cover
assembly, and using only the term ``replace'' may prevent the use of
this re-work for compliance. United also requested that the FAA clarify
whether compliance with the mandatory terminating action can be
achieved only by removing and replacing the AGB, or if re-working and
re-identifying the AGB, per the instructions in CFM International
CFM56-7B S/B 72-0564 and CFM International SB CFM56-7B S/B 72-0879 for
the CFM56-7B engine fleet is acceptable.
    The FAA agrees that re-working and re-identifying the AGB on-wing
to install a dynamic oil seal in the handcranking pad cover assembly
resolves the unsafe condition. The FAA has revised paragraph (i)(2)(ii)
in this final rule to allow re-work and re-identification of the
affected AGB to a part eligible for installation.

Request To Modify Compliance Time for Mandatory Terminating Action

    Delta requested that the FAA modify the compliance time for AGB
replacement in Mandatory Terminating Action, paragraph (h)(2), of the
proposed AD for affected CFM56-7B model turbofan engines to be
consistent with the requirement for CFM56-3 model turbofan engines.
Delta noted that both engine models are subject to the same unsafe
condition.
    The FAA disagrees with modifying the mandatory terminating action
compliance time in paragraph (h)(2) for CFM56-7B model turbofan engines
to be consistent with the mandatory terminating action compliance time
for CFM56-3 model turbofan engines. The fleets using these engine
models have differences in utilization and logistics that require
different compliance end dates to address the unsafe condition.

Request for Alternative Procedure for Compliance

    Jet Engine Technology commented that it has attempted to purchase
the dynamic oil seal, part number 333-089-185-000, listed in CFM
International SB CFM56-7B S/B 72-1129, Revision 7, but was informed it
was out of stock as of May 26, 2021. According to Jet Engine
Technology, there was a 360-day lead time to obtain this part. Jet
Engine Technology indicated that due to the unavailability of the parts
and because the AD is mandating the terminating action at next shop
visit after the effective date of the AD, it will not be possible for
an FAA-certified repair station to return the engine back to service.
Jet Engine Technology requested information pertaining to other types
of procedures that can be done to return the engine to service after a
shop visit.
    CFM has confirmed to the FAA that parts will be available to
suppliers, operators, and repair stations to install an AGB with the
dynamic oil seal in the handcranking cover pad assembly.

Request To Delay Publication of This AD

    United and CFM requested that the FAA delay publication of this AD.
United requested that the FAA wait until after CFM has made on-wing
instructions available for accomplishing the AGB re-work and re-
identification because CFM International CFM56-7B SB 72-0564, Revision
8, dated May 6, 2020, and CFM International CFM56-7B S/B 72-0879,
Revision 6, dated March 1, 2018 do not contain instructions for on-wing
accomplishment. CFM requested that the FAA delay publication until
Revision 9 of CFM International CFM56-7B S/B 72-0564 and the initial
version of CFM International CFM56-7B S/B 72-1071 are published as
these SBs will provide instructions for the on-wing modification to
install the dynamic oil seal in the handcranking pad cover assembly.
    The FAA disagrees with delaying publication of this AD based on the
anticipated issuance of CFM service information. Publication of this AD
at this time is necessary to address the unsafe condition. However, the
FAA has updated this AD, in response to similar comments, to allow for
any FAA approved method, including an on-wing procedure, to install an
AGB with a dynamic oil seal in the handcranking pad cover assembly.

Request for Clarification on Compliant AGB Part Numbers

    United requested that the FAA clarify whether CFM engines that have
compliant AGB part numbers installed (whether by removal and
replacement or by re-working and re-identifying the AGB) are required
to have the independent inspection of the AGB handcranking pad cover
performed to verify re-installation after maintenance.
    As set forth in paragraph (h), Mandatory Terminating Action, the
requirements of paragraph (g) of this AD are terminated after the
accomplishment of the mandatory terminating action. Further, paragraph
(f) of this AD mandates compliance with the required actions, unless
already done.

Support for the NPRM

    ALPA supported the NPRM without change.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting the AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes, and
any other changes described previously, this AD is adopted as proposed
in the NPRM. None of the changes will increase the economic burden on
any operator.

Related Service Information

    The FAA reviewed CFM International Service Bulletin (SB) CFM56-7B
S/B 72-0879, Revision 7, dated February 10, 2021 (CFM SB 72-0879); CFM
International SB CFM56-3 S/B 72-1129, Revision 7, dated May 6, 2020
(CFM SB 72-1129); CFM International SB CFM56-7B S/B 72-0564 Revision 9,
dated December 3, 2021 (CFM SB 72-0564); and CFM56-7B S/B 72-1071,
initial issue, dated December 3, 2021 (CFM SB 72-1071). CFM SB 72-1129
describes procedures for the introduction of a new starter drive pad,
new handcranking cover assembly, and re-working and re-identifying an
AGB installed on CFM56-3 model turbofan engines. CFM SB 72-0879, CFM SB
72-0564 and CFM SB 72-1071 describe procedures for the introduction of
a new starter drive pad, new handcranking cover, and re-working and re-
identifying an AGB installed on CFM56-7B model turbofan engines. 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 ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 700 engines installed on
airplanes of U.S. registry. The FAA estimates that the majority of
operators will perform the repair and re-identification of the AGB
rather than replace the AGB with a zero hour part. For the purpose of
this cost estimate, the FAA estimates that 95% of AGBs will be repaired
and re-identified while 5% of AGBs will be replaced with a zero hour
AGB.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Independent Inspection................  1 work-hour x $85 per                 $0             $85         $59,500
                                         hour = $85.
Insert inspection item into aircraft    1 work-hour x $85 per                  0              85          59,500
 maintenance program.                    hour = $85.
Re-work and re-identify AGB...........  4 work-hours x $85 per            12,000          12,340       8,206,100
                                         hour = $340.
Replace AGB with zero hour AGB........  4 work-hours x $85 per           526,700         527,040      18,446,400
                                         hour = $340.
----------------------------------------------------------------------------------------------------------------

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 has determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) 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 Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing airworthiness directive 2013-26-01, Amendment 39-17710 (78
FR 79295, December 30, 2013); and
0
b. Adding the following new airworthiness directive:

2022-02-03 CFM International, S.A.: Amendment 39-21900; Docket No.
FAA-2021-0259; Project Identifier AD-2020-01128-E.

(a) Effective Date

    This airworthiness directive (AD) is effective March 22, 2022.

(b) Affected ADs

    This AD replaces AD 2013-26-01, Amendment 39-17710 (78 FR 79295,
December 30, 2013).

(c) Applicability

    This AD applies to CFM International, S.A. CFM56-3 and CFM56-7B
model turbofan engines equipped with an accessory gearbox (AGB)
assembly with the following part numbers (P/Ns):
    (1) For CFM56-3, CFM56-3B, and CFM56-3C model turbofan engines,
AGB P/N: 335-300-103-0, 335-300-105-0, 335-300-106-0, 335-300-107-0,
335-300-108-0, 335-300-109-0, or 335-300-110-0, installed.
    (2) For CFM56-7B20, CFM56-7B20/2, CFM56-7B20/3, CFM56-7B22,
CFM56-7B22/2, CFM56-7B22/3, CFM56-7B22/3B1, CFM56-7B22/B1, CFM56-
7B24, CFM56-7B24/2, CFM56-7B24/3, CFM56-7B24/3B1, CFM56-7B24/B1,
CFM56-7B26, CFM56-7B26/2, CFM56-7B26/3, CFM56-7B26/3B1, CFM56-7B26/
3B2, CFM56-7B26/3B2F, CFM56-7B26/3F, CFM56-7B26/B1, CFM56-7B26/B2,
CFM56-7B27, CFM56-7B27/2, CFM56-7B27/3, CFM56-7B27/3B1, CFM56-7B27/
3B1F, CFM56-7B27/3B3, CFM56-7B27/3F, CFM56-7B27/B1, and CFM56-7B27/
B3 model turbofan engines, AGB P/N: 340-046-503-0, 340-046-504-0, or
340-046-505-0, installed.
    (3) For CFM56-7B27A, CFM56-7B27A/3, or CFM56-7B27AE model
turbofan engines, AGB P/N: 340-188-601-0, 340-188-603-0, or 340-188-
605-0, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7260, Turbine Engine
Accessory Drive.

(e) Unsafe Condition

    This AD was prompted by a dual engine loss of oil event and 42
prior events of total loss of engine oil during flight. The FAA is
issuing this AD to prevent loss of engine oil while in flight. The
unsafe condition, if not addressed, could result in engine failure,
loss of thrust control, reduced control of the aircraft, and damage
to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) After the effective date of this AD, after any maintenance
that involves removal and re-installation of the AGB handcranking
pad cover, perform an independent inspection to verify re-
installation of the AGB handcranking pad cover; or
    (2) Prior to the next removal of the AGB handcranking pad cover
from the engine, insert the independent inspection required by
paragraph (g)(1) of this AD as a required inspection item in the
existing approved continuous airworthiness maintenance program for
the aircraft.

(h) Mandatory Terminating Action

    As a mandatory terminating action to the requirements of
paragraph (g) of this AD:
    (1) For affected CFM56-3, CFM56-3B, and CFM56-3C model turbofan
engines, at the next engine shop visit, or before December 31, 2026,
whichever occurs first after the effective date of this AD, replace
the affected AGB with a part eligible for installation.
    (2) For affected CFM56-7B model turbofan engines, except for
CFM56-7B27A, CFM56-

7B27A/3 and CFM56-7B27AE model turbofan engines, at the next engine
shop visit, or before December 31, 2024, whichever occurs first
after the effective date of this AD, replace the affected AGB with a
part eligible for installation.

(i) Definition

    (1) For the purpose of this AD, an ``engine shop visit'' is the
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine case flanges, except for
the following situations, which do not constitute an engine shop
visit:
    (i) Separation of engine flanges solely for the purposes of
transportation of the engine without subsequent maintenance; or
    (ii) Separation of engine flanges solely for the purpose of
replacing the fan or propulsor without subsequent maintenance.
    (2) For the purpose of this AD, for affected CFM56-3, CFM56-3B,
and CFM56-3C model turbofan engines, a part eligible for
installation is:
    (i) An AGB with a P/N other than 340-046-503-0, 340-046-504-0,
or 340-046-505-0; or
    (ii) An AGB that, using an FAA-approved procedure, has been re-
worked with a dynamic oil seal in the handcranking pad cover
assembly and re-identified with a new P/N not listed in paragraph
(i)(2)(i) of this AD.
    Note 1 to paragraph (i)(2)(ii): Procedures to install a dynamic
oil seal in the handcranking pad cover assembly can be found in CFM
International SB CFM56-3 S/B 72-1129, Revision 7, dated May 6, 2020.
    (3) For the purpose of this AD, for affected CFM56-7B model
turbofan engines, except for CFM56-7B27A, CFM56-7B27A/3 and CFM56-
7B27AE model turbofan engines, a part eligible for installation is:
    (i) An AGB with a P/N other than 340-046-503-0, 340-046-504-0,
or 340-046-505-0; or
    (ii) An affected AGB that, using an FAA-approved procedure, has
been re-worked with a dynamic oil seal in the handcranking pad cover
assembly and re-identified with a new P/N not listed in paragraph
(i)(3)(i) of this AD.
    Note 2 to paragraph (i)(3)(ii): Procedures to install a dynamic
oil seal in the handcranking pad cover assembly can be found in CFM
International SB CFM56-7B S/B 72-0879, Revision 7, dated February
10, 2021, CFM56-7B S/B 72-0564, Revision 9, dated December 3, 2021,
or CFM56-7B S/B 72-1071, initial issue, dated December 3, 2021.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (k) of this AD. You may email your request
to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Kevin Clark,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].

(l) Material Incorporated by Reference

    None.

    Issued on January 6, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-03039 Filed 2-14-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Rules and Regulations]
[Pages 16199-16200]
[FR Doc No: 2014-06447]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0228]
RIN 1625-AA00

Safety Zone, Brandon Road Lock and Dam to Lake Michigan including
Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River, and
Calumet-Saganashkee Channel, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce a segment of the Safety Zone;
Brandon Road Lock and Dam to Lake Michigan including Des Plaines River,
Chicago Sanitary and Ship Canal, Chicago River, Calumet-Saganashkee
Channel on all waters of the Chicago Sanitary and Ship Canal from Mile
Marker 296.1 to Mile Marker 296.7 at specified times from March 21 to
March 30, 2014. This action is necessary to protect the waterway,
waterway users, and vessels from the hazards associated with the U.S.
Army Corps of Engineers' Fish Suppression and Dispersal Barriers
testing operations.
    During any of the enforcement periods listed below, entry into,
transiting, mooring, laying-up or anchoring within the enforced area of
this safety zone by any person or vessel is prohibited unless
authorized by the Captain of the Port, Lake Michigan, or his designated
representative.

DATES: The regulations in 33 CFR 165.930 will be enforced from 7 a.m.
to 11 a.m. and from 1 p.m. to 5 p.m. on March 21, 2014, and during
those hours each day from March 24 to March 30, 2014.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email MST1 Joseph McCollum, Prevention Department, Coast Guard
Sector Lake Michigan, telephone<PHONE_NUMBER>, email address
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a segment of
the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including
Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River,
Calumet-Saganashkee Channel, Chicago, IL, listed in 33 CFR 165.930.
Specifically, the Coast Guard will enforce this safety zone between
Mile Marker 296.1 to Mile Marker 296.7 on all waters of the Chicago
Sanitary and Ship Canal. Enforcement will occur from 7 a.m. to 11 a.m.
and from 1 p.m. to 5 p.m. on March 21, 2014, and during those hours
each day from March 24 to March 30, 2014. This enforcement action is
necessary because the Captain of the Port, Lake Michigan, has
determined that the U.S. Army Corps of Engineers' Fish Suppression and
Dispersal Barriers testing operations pose risks to life and property.
Because of these risks, it is necessary to control vessel movement
during the operations to prevent injury and property loss.
    In accordance with the general regulations in Sec.  165.23 of this
part, entry into, transiting, mooring, laying up, or anchoring within
the enforced area of this safety zone by any person or vessel is
prohibited unless authorized by the Captain of the Port, Lake Michigan,
or his or her designated representative.
    Vessels that wish to transit through the safety zone may request
permission from the Captain of the Port, Lake Michigan. Requests must
be made in advance and approved by the Captain of the Port before
transits will be authorized. Approvals will be granted on a case by
case basis. The Captain of the Port may be contacted via U.S. Coast
Guard Sector Lake Michigan on VHF channel 16.
    This notice is issued under authority of 33 CFR 165.930 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Captain of the Port, Lake Michigan, will also provide notice through
other means, which may include, but are not limited to, Broadcast
Notice to Mariners, Local Notice to Mariners, local news media,
distribution in leaflet form, and on-scene oral notice. Additionally,
the Captain of the Port, Lake Michigan, may notify representatives from
the maritime industry through telephonic and email notifications.

    Dated: March 4, 2014.
M.W. Sibley,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2014-06447 Filed 3-24-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Notices]
[Pages 52393-52395]
[FR Doc No: 2012-21266]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Vehicle Theft Prevention
Standard; BMW of North America, LLC

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition for exemption.

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

SUMMARY: This document grants in full the BMW of North America, LLC
(BMW) petition for exemption of the Carline 4 vehicle line in
accordance with 49 CFR Part 543, Exemption from the Theft Prevention
Standard. This petition is granted because the agency has determined
that the antitheft device to be placed on the line as standard
equipment is likely to be as effective in reducing and deterring motor
vehicle theft as compliance with the parts-marking requirements of the
Theft Prevention Standard (49 CFR part 541). BMW requested confidential
treatment for specific information in its petition that the agency will
address by separate letter.

DATES: The exemption granted by this notice is effective beginning with
the 2014 model year (MY).

FOR FURTHER INFORMATION CONTACT: Ms. Carlita Ballard, Office of
International Policy, Fuel Economy and Consumer Programs, National
Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., West
Building, Room W43-439, Washington, DC 20590. Ms. Ballard's telephone
number is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated June 4, 2012, BMW
requested an exemption from the parts-marking requirements of the Theft
Prevention Standard (49 CFR Part 541) for the Carline 4 vehicle line
beginning with MY 2014. The petition requested exemption from parts-
marking pursuant to 49 CFR Part 543, Exemption from Vehicle Theft
Prevention Standard, based on the installation of an antitheft device
as standard equipment for an entire vehicle line.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant an
exemption for one vehicle line per model year. In its petition, BMW
provided a detailed description and diagram of the identity, design,
and location of the components of the antitheft device for its Carline
4 vehicle line. BMW stated that all Carline 4 vehicles will be equipped
with a passive antitheft device as standard equipment beginning with MY
2014.

The immobilizer device is automatically activated when the engine is
shut off and the vehicle key is removed from the ignition lock
cylinder. Key features of the antitheft device will include a key with
a transponder, loop antenna (coil), engine control unit (DME/DDE) with
encoded start release input, an electronically-coded vehicle
immobilizer/car access system (EWS/CAS) control unit and a passive
immobilizer. BMW's submission is considered a complete petition as
required by 49 CFR 543.7, in that it meets the general requirements
contained in Sec.  543.5 and the specific content requirements of Sec.
543.6.
    BMW stated that the EWS immobilizer device prevents the vehicle
from being driven away under its own engine power. Its transponder
contains a chip which is integrated in the key, powered by a battery
and consists of a transmitter/receiver which communicates with the EWS
control unit. The EWS control unit provides the interface to the loop
antenna (coil), engine control unit and starter. The ignition and fuel
supply are only released when a correct coded release signal has been
sent by the EWS control unit to allow the vehicle to start. When the
EWS control unit has sent a correct release signal, and after the
initial starting value, the release signal becomes a rolling, ever-
changing, random code that is stored in the DME/DDE and EWS (CAS
control modules). The DME/DDE must identify the release signal and only
then will the ignition signal and fuel supply be released. Deactivation
of the device cannot be carried out with the mechanical key, but must
occur electronically. The vehicle is also equipped with a central-
locking system that can be operated to lock and unlock all doors or to
unlock only the driver's door, preventing forced entry into the vehicle
through the passenger doors. The vehicle can be further secured by
locking the doors and hood using either the key lock cylinder on the
driver's door or the remote frequency remote control. BMW stated that
the frequency for the remote control constantly changes to prevent an
unauthorized person from opening the vehicle by intercepting the
signals of its remote control. BMW also stated that the proposed
antitheft device does not provide any visible or audible indication of
unauthorized entry.
    BMW compared the effectiveness of its antitheft device with devices
which NHTSA has previously determined to be as effective in reducing
and deterring motor vehicle theft as would compliance with the parts-
marking requirements of Part 541. The antitheft device that BMW intends
to install on its Carline 4 vehicle line for MY 2014 is the same device
that BMW has installed on its X1, X3 and X5 vehicle lines, as well as
its Carline 1, 3, 5, 6, 7, Z4, and MINI vehicle lines. BMW asserts that
theft data have indicated a decline in theft rates for vehicle lines
that have been equipped with antitheft devices similar to that which it
proposes to install on the Carline 4 vehicle line. Specifically, BMW
stated that for MY/CY 2009, the agency's data show that theft rates for
its lines are: 0.3926 (1-series), 0.5216 (3-series), 0.4098 (5-series),
1.6529 (6-series), 0.6617 (7-series), 0.3671 (X3), 0.2750 (Z4/M)), and
0.1155 (MINI Cooper). Using an average of 3 MYs data (2007-2009), theft
rates for those lines are: 0.2383, 0.7029, 0.7988, 2.3463, 2.0683,
0.5146, 0.5309 and 0.2386 respectively.
    In addressing the specific content requirements of 543.6, BMW
provided information on the reliability and durability of its device.
To ensure reliability and durability of the device, BMW conducted tests
based on its own specified standards and believes that the device is
reliable and durable since the device complied with its specified
requirements for each test. BMW provided a detailed list of the tests
conducted in its June 2012 request for exemption from the parts-marking
requirements. Further assuring the reliability and durability of the
Carline 4 antitheft device, BMW notes that the mechanical keys for the
Carline 4 are unique. A special key blank, a special key cutting
machine and the vehicle's unique code are needed to duplicate a key.
BMW stated that new keys will only be issued to authorized persons.
    Based on the supporting evidence submitted by BMW, the agency
believes that the antitheft device for the BMW Carline 4 vehicle line
is likely to be as effective in reducing and deterring motor vehicle
theft as compliance with the parts-marking requirements of the Theft
Prevention Standard (49 CFR Part 541). The agency concludes that the
device will provide four of the five types of performance listed in
Sec.  543.6(a)(3): Promoting activation; preventing defeat or
circumvention of the device by unauthorized persons; preventing
operation of the vehicle by unauthorized entrants; and ensuring the
reliability and durability of the device.
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7(b), the agency grants
a petition for exemption from the parts-marking requirements of Part
541, either in whole or in part, if it determines that, based upon
supporting evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of Part 541. The agency
finds that BMW has provided adequate reasons for its belief that the
antitheft device for the Carline 4 vehicle line is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of the Theft Prevention Standard
(49 CFR Part 541). This conclusion is based on the information BMW
provided about its device.
    For the foregoing reasons, the agency hereby grants in full BMW's
petition for exemption for the MY 2014 Carline 4 vehicle line from the
parts-marking requirements of 49 CFR Part 541. The agency notes that 49
CFR Part 541, Appendix A-1, identifies those lines that are exempted
from the Theft Prevention Standard for a given MY. 49 CFR Part 543.7(f)
contains publication requirements incident to the disposition of all
Part 543 petitions. Advanced listing, including the release of future
product nameplates, the beginning model year for which the petition is
granted and a general description of the antitheft device is necessary
in order to notify law enforcement agencies of new vehicle lines
exempted from the parts-marking requirements of the Theft Prevention
Standard.
    If BMW decides not to use the exemption for this line, it must
formally notify the agency. If such a decision is made, the line must
be fully marked as required by 49 CFR Parts 541.5 and 541.6 (marking of
major component parts and replacement parts).
    NHTSA notes that if BMW wishes in the future to modify the device
on which this exemption is based, the company may have to submit a
petition to modify the exemption. Part 543.7(d) states that a Part 543
exemption applies only to vehicles that belong to a line exempted under
this part and equipped with the anti-theft device on which the line's
exemption is based. Further, Sec.  543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.''
    The agency wishes to minimize the administrative burden that Part
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend Part 543 to require the submission of a
modification petition for every change to the components or design of
an antitheft device. The significance of many such changes could be de
minimis. Therefore, NHTSA suggests that if the manufacturer
contemplates making any changes the effects of which might be

characterized as de minimis, it should consult the agency before
preparing and submitting a petition to modify.

    Authority:  49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Issued on: August 21, 2012.
Mary L. Versailles,
Senior Policy Advisor for International Policy, Fuel Economy and
Consumer Programs.
[FR Doc. 2012-21266 Filed 8-28-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 85, Number 77 (Tuesday, April 21, 2020)]
[Notices]
[Page 22212]
[FR Doc No: 2020-08384]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88647; File No. SR-CboeBYX-2019-012]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Withdrawal of a Proposed Rule Change To Introduce a Small Retail Broker
Distribution Program

April 15, 2020.
    On August 1, 2019, Cboe BYX Exchange, Inc. (``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend the BYX fee schedule to introduce a Small
Retail Broker Distribution Program. The proposed rule change was
immediately effective upon filing with the Commission pursuant to
Section 19(b)(3)(A) of the Act.\3\ The proposed rule change was
published for comment in the Federal Register on August 20, 2019.\4\
The Commission received no comment letters regarding the proposed rule
change. On September 30, 2019, the Commission issued an order
temporarily suspending the proposed rule change pursuant to Section
19(b)(3)(C) of the Act \5\ and simultaneously instituting proceedings
under Section 19(b)(2)(B) of the Act \6\ to determine whether to
approve or disapprove the proposed rule change (``OIP'').\7\ The
Commission received no comment letters in response to the OIP. On
February 12, 2020, pursuant to Section 19(b)(2) of the Act,\8\ the
Commission designated a longer period within which to approve or
disapprove the proposed rule change.\9\ On April 9, 2020, the Exchange
withdrew the proposed rule change (SR-CboeBYX-2019-012).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ See Securities Exchange Act Release No. 86670 (August 14,
2019), 84 FR 43207 (August 20, 2019).
    \5\ 15 U.S.C. 78s(b)(3)(C).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 87166 (September 30,
2019), 84 FR 53197 (October 4, 2019).
    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See Securities Exchange Act Release No. 88179 (February 12,
2020), 85 FR 9505 (February 19, 2020).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(57) and (58).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-08384 Filed 4-20-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 223 (Tuesday, November 21, 2023)]
[Notices]
[Pages 81150-81154]
[FR Doc No: 2023-25657]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98941; File No. SR-Phlx-2023-47]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Its
Pricing Schedule at Options 7, Sections 4 and 7 Regarding Multiply
Listed Options Fees and Routing Fees

November 15, 2023.
    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 November 1, 2023, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, 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's Pricing Schedule at Options
7, Section 4, Multiply Listed Options Fees, and Options 7, Section 7,
Routing Fees.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, 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 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
    Phlx proposes to amend its Pricing Schedule at Options 7, Section
4, Multiply Listed Options Fees, and Options 7, Section 7, Routing
Fees. Each pricing change will be described below.
Options 7, Section 4
    Phlx proposes to amend its Pricing Schedule at Options 7, Section
4, ``Multiply Listed Options Fees (Includes options overlying equities,
ETFs, ETNs and indexes which are Multiply Listed) (Excludes SPY and
broad-based index options symbols listed within Options 7, Section
5.A).'' Specifically, Phlx proposes to amend its Qualified Contingent
Cross (``QCC'') Rebates.
    Today, the Exchange assesses a $.20 per contract QCC Transaction
Fee for a Lead Market Maker,\3\ Market Maker,\4\ Firm \5\ and Broker-
Dealer.\6\ Customers \7\ and Professionals \8\ are not assessed a QCC
Transaction Fee. QCC Transaction Fees apply to electronic QCC Orders
\9\ and Floor QCC Orders.\10\ Additionally, today, Phlx pays QCC
rebates. Specifically, Phlx pays a QCC Rebate of $0.12 per contract on
electronic QCC Orders, as defined in Options 3, Section 12, and Floor
QCC Orders, as defined in Options 8, Section 30(e), when a QCC Order is
comprised of a Customer or Professional order on one side and a Lead
Market Maker, Market Maker, Broker-Dealer, or Firm order on the other
side. This rebate is $0.17 per contract in the event that a member or
member organization executes greater than 1,000,000 qualifying QCC
contracts in a given month. Further, this rebate is $0.22 per contract
in the event that a member or member organization executes: (1) greater
than 1,000,000 qualifying QCC contracts in a given month, (2) Floor
Originated Strategy Executions in excess of 3,500,000 contracts in a
given month, and (3) at least 40% of the member or member
organization's QCC executed contracts in that month are comprised of a
Lead Market Maker, Market Maker, Broker-Dealer, or Firm order on one
side and Lead Market Maker, Market Maker, Broker-Dealer, or Firm order
on the other side.
---------------------------------------------------------------------------

    \3\ The term ``Lead Market Maker'' applies to transactions for
the account of a Lead Market Maker (as defined in Options 2, Section
12(a)). A Lead Market Maker is an Exchange member who is registered
as an options Lead Market Maker pursuant to Options 2, Section
12(a). An options Lead Market Maker includes a Remote Lead Market
Maker which is defined as an options Lead Market Maker in one or
more classes that does not have a physical presence on an Exchange
floor and is approved by the Exchange pursuant to Options 2, Section
11. See Options 7, Section 1(c). The term ``Floor Lead Market
Maker'' is a member who is registered as an options Lead Market
Maker pursuant to Options 2, Section 12(a) and has a physical
presence on the Exchange's trading floor. See Options 8, Section
2(a)(3).
    \4\ The term ``Market Maker'' is defined in Options 1, Section
1(b)(28) as a member of the Exchange who is registered as an options
Market Maker pursuant to Options 2, Section 12(a). A Market Maker
includes SQTs and RSQTs as well as Floor Market Makers. See Options
7, Section 1(c). The term ``Floor Market Maker'' is a Market Maker
who is neither an SQT or an RSQT. A Floor Market Maker may provide a
quote in open outcry. See Options 8, Section 2(a)(4).
    \5\ The term ``Firm'' applies to any transaction that is
identified by a member or member organization for clearing in the
Firm range at The Options Clearing Corporation. See Options 7,
Section 1(c).
    \6\ The term ``Broker-Dealer'' applies to any transaction which
is not subject to any of the other transaction fees applicable
within a particular category. See Options 7, Section 1(c).
    \7\ The term ``Customer'' applies to any transaction that is
identified by a member or member organization for clearing in the
Customer range at The Options Clearing Corporation (``OCC'') which
is not for the account of a broker or dealer or for the account of a
``Professional'' (as that term is defined in Options 1, Section
1(b)(45)). See Options 7, Section 1(c).
    \8\ The term ``Professional'' applies to transactions for the
accounts of Professionals, as defined in Options 1, Section 1(b)(45)
means any person or entity that (i) is not a broker or dealer in
securities, and (ii) places more than 390 orders in listed options
per day on average during a calendar month for its own beneficial
account(s). See Options 7, Section 1(c).
    \9\ Electronic QCC Orders are described in Options 3, Section
12.
    \10\ Floor QCC Orders are described in Options 8, Section 30(e).
---------------------------------------------------------------------------

    Also, the Exchange pays a QCC Rebate of $0.14 per contract on
electronic QCC Orders, as defined in Options 3, Section 12, and Floor
QCC Orders, as defined in Options 8, Section 30(e), when a QCC Order is
comprised of a Lead Market Maker, Market Maker, Broker-Dealer, or Firm
order on one side and a Lead Market Maker, Market Maker, Broker-Dealer,
or Firm order on the other side. This rebate is $0.19 per contract in
the event that a member or member organization executes greater than
1,000,000 qualifying QCC contracts in a given month. Further, this
rebate is $0.27 per contract in the event that a member or member
organization executes: (1) greater than 1,000,000 qualifying QCC
contracts in a given month, (2) Floor Originated Strategy Executions in
excess of 3,500,000 contracts in a given month, and (3) at least 40% of
the member or member organization's QCC executed contracts in that
month are comprised of a Lead Market Maker, Market Maker, Broker-
Dealer, or Firm order on one side and Lead Market Maker, Market Maker,
Broker-Dealer, or Firm order on the other side.
    At this time, the Exchange proposes to amend the number of
qualifying QCC contracts that must be executed in a given month with
respect to these aforementioned rebates. The Exchange proposes to amend
the current 1,000,000 qualifying QCC contracts to 750,000 qualifying
QCC contracts in. With this proposed changed, the rule text would
provide:
     A QCC Rebate of $0.12 per contract will be paid on
electronic QCC Orders, as defined in Options 3, Section 12, and Floor
QCC Orders, as defined in Options 8, Section 30(e), when a QCC Order is
comprised of a Customer or Professional order on one side and a Lead
Market Maker, Market Maker, Broker-Dealer, or Firm order on the other
side. This rebate will be $0.17 per contract in the event that a member
or member organization executes greater than 750,000 qualifying QCC
contracts in a given month. This rebate will be $0.22 per contract in
the event that a member or member organization executes: (1) greater
than 750,000 qualifying QCC contracts in a given month, (2) Floor
Originated Strategy Executions in excess of 3,500,000 contracts in a
given month, and (3) at least 40% of the member or member
organization's QCC executed contracts in that month are comprised of a
Lead Market Maker, Market Maker, Broker-Dealer, or Firm order on one
side and Lead Market Maker, Market Maker, Broker-Dealer, or Firm order
on the other side.
     A QCC Rebate of $0.14 per contract will be paid on
electronic QCC Orders, as defined in Options 3, Section 12, and Floor
QCC Orders, as defined in Options 8, Section 30(e), when a QCC Order is
comprised of a Lead Market Maker, Market Maker, Broker-Dealer, or Firm
order on one side and a Lead Market Maker, Market Maker, Broker-Dealer,
or Firm order on the other side. This rebate will be $0.19 per contract
in the event

that a member or member organization executes greater than 750,000
qualifying QCC contracts in a given month. This rebate will be $0.27
per contract in the event that a member or member organization
executes: (1) greater than 750,000 qualifying QCC contracts in a given
month, (2) Floor Originated Strategy Executions in excess of 3,500,000
contracts in a given month, and (3) at least 40% of the member or
member organization's QCC executed contracts in that month are
comprised of a Lead Market Maker, Market Maker, Broker-Dealer, or Firm
order on one side and Lead Market Maker, Market Maker, Broker-Dealer,
or Firm order on the other side.
The Exchange believes that lowering the number of qualifying QCC
contracts for purpose of qualifying for these QCC Rebates from
1,000,000 to 750,000 qualifying QCC contracts will incentivize Phlx
members and member organizations to transact a greater amount of QCC
Orders on Phlx.
Options 7, Section 7
    Currently, Phlx assesses a Non-Customer routing fee of $0.99 per
contract and a Customer routing fee of $0.23 per contract, in addition
to the actual transaction fee assessed by the away market, for routing
contracts to markets other than The Nasdaq Options Market LLC (``NOM'')
and Nasdaq BX, Inc. (``BX''). Currently, if the away market pays a
rebate, the Exchange assesses a Customer a Routing Fee of $0.13 per
contract for markets other than NOM and BX. Currently, Phlx assesses a
Customer a $0.13 per contract Fixed Fee in addition to the actual
transaction fee assessed when routing to NOM and BX.
    At this time, the Exchange proposes to assess a Non-Customer an
increased routing fee to route to any options exchange of $1.20 per
contract. The Exchange also proposes to assess a Customer a Fixed Fee
of $0.23 per contract, in addition to the actual transaction fee
assessed by the away market, for routing contracts to any options
exchange. The Exchange would no longer assess the lower routing of
$0.13 per contract, in addition to the actual transaction fee assessed,
when routing to NOM and BX. The Exchange will continue to assess a
$0.13 per contract routing fee if the away market pays a rebate,
including NOM and BX. The purpose of the proposed routing fees is to
recoup costs incurred by the Exchange when routing orders to other
options exchanges on behalf of options members and member
organizations. In determining its proposed routing fees, the Exchange
took into account transaction fees assessed by other options exchanges,
the Exchange's projected clearing costs, and the projected
administrative, regulatory, and technical costs associated with routing
orders to other options exchanges. The Exchange will continue to use
its affiliated broker-dealer, Nasdaq Execution Services, to route
orders to other options exchanges. Routing services offered by the
Exchange are completely optional and market participants can readily
select between various providers of routing services, including other
exchanges and broker-dealers. Also, the Exchange notes that market
participants may elect to mark their orders as ``Do Not Route'' to
avoid any routing fees.\11\ The Exchange believes that the proposed
Routing Fees would enable the Exchange to recover the costs it incurs
to route orders to away markets after taking into account the other
costs associated with routing orders to other options exchanges. Also,
the Exchange's proposal would uniformly assess the same Customer
routing fees, regardless of the away venue, of $0.23 per contract, in
addition to the actual transaction fee assessed, or $0.13 per contract
if the away market pays a rebate.
---------------------------------------------------------------------------

    \11\ See Phlx Options 3, Section 7(d).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\12\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\13\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees, and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The proposed changes to its Pricing Schedule are reasonable in
several respects. As a threshold matter, the Exchange is subject to
significant competitive forces in the market for options transaction
services that constrain its pricing determinations in that market. The
fact that this market is competitive has long been recognized by the
courts. In NetCoalition v. Securities and Exchange Commission \14\
(``NetCoalition''), the D.C. Circuit stated, ``[n]o one disputes that
competition for order flow is `fierce.' . . . As the SEC explained,
`[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers' . . . .'' \15\
---------------------------------------------------------------------------

    \14\ NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).
    \15\ Id. at 539 (quoting Securities Exchange Act Release No.
59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008)
(SR-NYSEArca-2006-21)).
---------------------------------------------------------------------------

    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
options transaction services. The Exchange is only one of seventeen
options exchanges to which market participants may direct their order
flow. Within this environment, market participants can freely and often
do shift their order flow among the Exchange and competing venues in
response to changes in their respective pricing schedules. Within the
foregoing context, the proposal represents a reasonable attempt by the
Exchange to attract additional order flow to the Exchange and increase
its market share relative to its competitors.
Options 7, Section 4
    The Exchange's proposal to amend a qualifier for several QCC
Rebates to lower the number of qualifying QCC contracts that must be
executed in a given month from 1,000,000 to 750,000 qualifying QCC
contracts is reasonable because lowering the number of qualifying QCC
contracts for purpose of these QCC Rebates from 1,000,000 to 750,000
qualifying QCC contracts will incentivize Phlx members and member
organizations to transact a greater number of QCC Orders on Phlx.
    The Exchange's proposal to amend a qualifier for several QCC
Rebates to lower the number of qualifying QCC contracts that must be
executed in a given month from 1,000,000 qualifying QCC contracts to
750,000 qualifying QCC contracts is equitable and not unfairly
discriminatory because all members and member organizations may qualify
for QCC Rebates, provided they transact the requisite volume.
Options 7, Section 7
    The Exchange's proposal to assess a Non-Customer an increased
routing fee of $1.20 to route to another options exchange and a
Customer a Fixed Fee of $0.23 per contract, in addition to the actual
transaction fee assessed by the away market, for routing contracts to
any options exchange \16\ is reasonable

because the proposed Routing Fees would enable the Exchange to recover
the costs it incurs to route orders to away markets after taking into
account the other costs associated with routing orders to other options
exchanges. In determining its proposed routing fees, the Exchange took
into account transaction fees assessed by other options exchanges, the
Exchange's projected clearing costs, and the projected administrative,
regulatory, and technical costs associated with routing orders to other
options exchanges. While the Exchange is no longer offering a
discounted Routing Fee to route to NOM and BX, the Exchange notes that
the Routing Fee will be $0.13 for these markets, similar to other
options markets, if they pay a rebate.\17\ Routing services offered by
the Exchange are completely optional and market participants can
readily select between various providers of routing services, including
other exchanges and broker-dealers. Also, the Exchange notes that
market participants may elect to mark their orders as ``Do Not Route''
to avoid any routing fees.\18\
---------------------------------------------------------------------------

    \16\ The Exchange would no longer assess the lower routing of
$0.13 per contract, in addition to the actual transaction fee
assessed, when routing to NOM and BX.
    \17\ Both NOM and BX offer rebates. See NOM's Pricing Schedule
at Options 7, Section 2 and BX's Pricing Schedule at Options 7,
Section 2.
    \18\ See Phlx Options 3, Section 7(d).
---------------------------------------------------------------------------

    The Exchange's proposal to assess a Non-Customer an increased
routing fee of $1.20 to route to another options exchange and a
Customer a Fixed Fee of $0.23 per contract, in addition to the actual
transaction fee assessed by the away market, for routing contracts to
any options exchange is equitable and not unfairly discriminatory as
all Non-Customers would be assessed a uniform routing fee.
Additionally, Customers will be uniformly assessed the same fee,
regardless of the destination market. Customers will continue to
receive favorable pricing as compared to other market participants
because Customer liquidity enhances market quality on the Exchange by
providing more trading opportunities, which benefits all market
participants. Finally, the Exchange notes that market participants may
elect to market orders as Do Not Route to avoid any routing fees.

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.
Inter-Market Competition
    The proposal does not impose an undue burden on inter-market
competition. The Exchange believes its proposal remains competitive
with other options markets and will offer market participants with
another choice of where to transact options. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited.
Intra-Market Competition
    The proposed amendments do not impose an undue burden on intra-
market competition.
Options 7, Section 4
    The Exchange's proposal to amend a qualifier for several QCC
Rebates to lower the number of qualifying QCC contracts that must be
executed in a given month from 1,000,000 qualifying QCC contracts to
750,000 qualifying QCC contracts does not impose an undue burden on
competition because all members and member organizations may qualify
for QCC Rebates, provided they transact the requisite volume.
Options 7, Section 7
    The Exchange's proposal to assess a Non-Customer an increased
routing fee of $1.20 to route to another options exchange and a
Customer a Fixed Fee of $0.23 per contract, in addition to the actual
transaction fee assessed by the away market, for routing contracts to
any options exchange does not impose an undue burden on competition as
all Non-Customers would be assessed a uniform routing fee.
Additionally, Customers will be uniformly assessed the same fee,
regardless of the destination market. Customers will continue to
receive favorable pricing as compared to other market participants
because Customer liquidity enhances market quality on the Exchange by
providing more trading opportunities, which benefits all market
participants. Finally, the Exchange notes that market participants may
elect to market orders as Do Not Route to avoid any routing fees.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\19\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-Phlx-2023-47 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-Phlx-2023-47. This file
number should be included on the subject line if email 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 website (https://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 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. Do not include personal identifiable
information in submissions; you should submit only information that you
wish to make available publicly. We may redact in part or withhold
entirely from publication submitted material that is obscene or subject
to copyright protection. All submissions should refer to file number
SR-Phlx-2023-47 and should be submitted on or before December 12, 2023.
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25657 Filed 11-20-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)]
[Notices]
[Pages 10493-10494]
[FR Doc No: 2015-03974]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-20115-N-0456]

Pediatric Stakeholder Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration's (FDA) Office of Pediatric
Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation and Research (CBER) are
announcing a public meeting seeking input from patient groups, consumer
groups, regulated industry, academia and other interested parties to
obtain any recommendations or information relevant to the report to
Congress that FDA is required to submit concerning pediatrics, as
outlined in section 508 of the Food and Drug Administration Safety and
Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for
additional background information).

DATES: The public meeting will be held on March 25, 2015, from 9 a.m.
to 5 p.m. Registration to attend the meeting should be received by
March 20, 2015 (see the SUPPLEMENTARY INFORMATION section for
instructions).

ADDRESSES: The meeting will be held at FDA's White Oak Campus, 10903
New Hampshire Ave., Building 31 Conference Center, the Great Room
(1503-B & C), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For information on
parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.
    Submit either electronic or written comments by April 24, 2015.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
    FDA will post the agenda approximately 5 days before the meeting
at: http://wwww.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm433552.htm.

FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of
Pediatric Therapeutics, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>or Betsy Sanford, Office of Pediatric
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
Section 508 of FDASIA directs the Secretary of HHS to submit a report
to Congress on the implementation of the Best Pharmaceuticals for
Children Act (BPCA) and Pediatric Research Equity Act (PREA). The first
report must be submitted to Congress by July 9, 2016, and every 5 years
thereafter. FDASIA also requires FDA to obtain, at least 180 days prior
to submission of the report, stakeholder input from patient groups,
consumer groups, regulated industry, academia, and any other interested
parties to obtain any recommendations or information relevant to the
report including suggestions for modifications that would improve
pediatric drug research and pediatric labeling of drugs and biological
products.
    The basic content of the report will include: An assessment of the
effectiveness of BPCA (section 505A) and PREA (section 505B) in
improving information about pediatric uses for approved drugs and
biological products, including the number and type of labeling changes
made since the enactment of FDASIA and the importance of such uses in
the improvement of the health of children; various statistics related
to both PREA and BPCA, including the Written Request referral process
with the National Institutes of Health; an assessment of the timeliness
and effectiveness of pediatric study plans; an assessment of studying
biologics; efforts made to increase the number of studies conducted in
the neonatal population; the number and importance of drugs and
biologics studied in children with cancer and any recommendations for
modification to the programs that would improve pediatric drug research
and increase labeling of drugs and biologics; an assessment of the
successes of and limitations to studying drugs for rare diseases; an
assessment of the efforts to address the suggestions and options
described in any prior report issued by the Comptroller General,
Institute of Medicine, or the Secretary, and any stakeholder
recommendations or modifications that would improve pediatric drug
research and pediatric labeling of drugs and biological products.
    The specific topics to be discussed at the meeting will include,
but not be limited to, pediatric labeling changes, waivers and
deferrals, Written Requests, pediatric study plans, programmatic
activities with the NIH Written Request referral process, activities
concerning neonates, pediatric cancers and rare diseases, and
transparency.

II. Meeting Attendance and Participation

    If you wish to attend this meeting, visit http://stakeholderinput.eventbrite.com. Please register by March 20, 2015.
Those who are unable to attend the meeting in person can register to
view a live Webcast of the meeting. You will be asked to indicate in
your registration if you plan to attend in person or via the Webcast.
Your registration will also contain your complete contact information,
including name, title, affiliation, address, email address, and phone
number. Seating will be limited so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
Onsite registration on the day of the meeting will be based on space
availability. If you need special accommodations due to a disability,
please contact Betsy Sanford (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance. Persons attending the meeting are advised that
FDA is not responsible for providing access to electrical outlets.
    Persons interested in presenting comments at the meeting will be
asked to indicate this in their registration. FDA will try to
accommodate all participant requests to speak, however the duration of
comments may be limited by time constraints.
    Comments: Regardless of attendance at the public meeting, you can
submit electronic or written comments to the public docket (see
ADDRESSES) by April 24, 2015. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m.,

Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: As soon as a transcript is available, FDA will post it
at http://wwww.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm433552.htm.

    Dated: February 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03974 Filed 2-25-15; 8:45 am]
BILLING CODE 4164-01-P