[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Rules and Regulations]
[Pages 24029-24034]
[FR Doc No: 2022-08539]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0032; Project Identifier AD-2020-01314-P;
Amendment 39-22013; AD 2022-08-10]
RIN 2120-AA64

Airworthiness Directives; Hamilton Sundstrand Corporation
Propellers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2020-12-07
for certain Hamilton Sundstrand Corporation (Hamilton Sundstrand) 54H
model propellers. AD 2020-12-07 required initial and repetitive eddy
current inspections (ECI) of certain propeller blades and replacement
of the propeller blades that fail the inspection. This AD was prompted
by a report of the separation of a 54H60 model propeller blade
installed on a United States Marine Corps Reserve (USMCR) KC-130T
airplane during a flight in July 2017. This AD requires initial and
repetitive ECI of all propeller blades installed on Hamilton Sundstrand
54H60 propeller hubs and replacement of any propeller blade that fails
inspection. The FAA is issuing this AD to address the unsafe condition
on these products.

DATES: This AD is effective May 27, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 27, 2022.

ADDRESSES: For service information identified in this final rule,
contact Hamilton Sundstrand, 1 Hamilton Road, Windsor Locks, CT 06096-
1010; 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
(817) 222-5110. It is also available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0032.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.govby
searching for and locating Docket No. FAA-2021-0032; 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: Michael Schwetz, Aviation Safety
Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA
01803; phone:<PHONE_NUMBER>; 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 2020-12-07, Amendment 39-21142 (85 FR
36145, June 15, 2020), (``AD 2020-12-07''). AD 2020-12-07 applied to
certain Hamilton Sundstrand 54H model propellers. Note that AD 2020-12-
07 and the Hamilton Sundstrand service information reference 54H60
model propellers whereas this AD references 54H model propellers.
Hamilton Sundstrand 54H60 model propellers are 54H model propellers
with a 54H60 model propeller hub.
    The NPRM published in the Federal Register on February 25, 2021 (86
FR 11473). The NPRM was prompted by a report of the separation of a
54H60 model propeller blade installed on a USMCR KC-130T airplane
during a flight in July 2017. The USMCR investigation of this event
revealed the Hamilton Sundstrand 54H60 model propeller blade separated
due to corrosion pitting and a resultant intergranular radial crack
that was not corrected at the last propeller overhaul. From this
intergranular crack, a fatigue crack initiated and grew under service
loading until the Hamilton Sundstrand 54H60 model propeller blade could
no longer sustain the applied loads and ultimately the blade separated.
The separation of the blade resulted in the loss of the airplane and 17
fatalities. The investigation further revealed that 54H60 model
propeller blades manufactured before 1971 are susceptible to cracks of
the propeller blade in the area of the internal taper bore. The
applicability of AD 2020-12-07 was therefore limited to those Hamilton
Sundstrand 54H60 model propellers blades with a blade serial number (S/
N) below 813320, which are those propeller blades manufactured before
1971.
    Since the FAA issued AD 2020-12-07, the manufacturer determined
that all propeller blades installed on Hamilton Sundstrand 54H model
propellers with a 54H60 model propeller hub are susceptible to
intergranular corrosion cracking in the blade taper bore. As a result,
the manufacturer published Hamilton Sundstrand Alert Service Bulletin
(ASB) 54H60-61-A154, Revision 1, dated May 29, 2020 (ASB 54H60-61-
A154), to expand the effectivity to include propeller blades with a
blade S/N below 813320, all propeller blades if the propeller contains
a propeller blade with a blade S/N below 813320, and all propeller
blades that have not been overhauled within ten years. ASB 54H60-61-
A154 also provides instructions for concurrent compliance with Hamilton
Sundstrand ASB 54H60-61-A155, dated May 29, 2020, to ECI an expanded
and deeper taper bore area. In the NPRM, the FAA proposed to require
initial and repetitive ECI of all propeller blades installed on
Hamilton Sundstrand 54H60 propeller hubs and replacement of any
propeller blade that fails inspection. The FAA is issuing this AD to
address the unsafe condition on these products.

Discussion of Final Airworthiness Directive

    The FAA received comments from one commenter, Lynden Air Cargo, LLC
(LAC). The following presents the comments received on the NPRM and the
FAA's response to each comment.

Request To Remove ``All'' From Proposed AD Requirements

    LAC noted that the proposed AD used the word ``all'' in reference
to propeller blades in the preamble of the NPRM. LAC stated that this
AD should not apply to newly manufactured (-2A)

propeller blades because those propeller blades are manufactured with
an enhanced process to reduce the risk of failure.
    While the -2A propeller blades (P/Ns A7111D-2A and A7111E-2A) and
overhauled blades (P/Ns A7111D-2A2, A7111D-2A3, A7111E-2A2, and A7111E-
2A3) have an enhanced process and improved protection, these blades are
still susceptible to cracking in the propeller blade taper bore. The
unsafe condition is still under investigation by the manufacturer and,
depending on the results of that investigation, the FAA may consider
further rulemaking action. The FAA did not change this AD as a result
of this comment.

Comment Concerning Estimated Costs and the Availability of Replacement
Propeller Blades

    LAC stated that it disagrees with the Estimated Costs section in
the NPRM. LAC noted that the proposed AD underestimated the cost of
compliance, and determined that the total costs associated with the
performance of an ECI of all propeller blades installed on the
propeller and reporting the ECI results for U.S. operators was
approximately $1,948,280 per inspection interval. LAC used a labor rate
of $130 per hour in its estimate, suggesting the FAA's estimated $85
per hour amount in the proposed AD was inaccurate. LAC also determined
that the total compliance cost over the typical life of a new propeller
(4 inspections) was $7,793,120 for propellers installed on aircraft of
U.S. registry, not including lost revenue due to the aircraft being out
of service. LAC provided a table within its comment, specifying LAC's
breakdown of costs associated with complying with this AD. LAC also
noted that Derco, the only supplier of new manufactured replacement
propeller blades, was quoting $68,000 per blade, which was higher than
the FAA's estimated $63,500 per blade, and would not guarantee or
specify any delivery dates or quantities available.
    The comments from LAC are addressed in paragraph 2 of the
Regulatory Flexibility Determination of this AD. The FAA did not make
any changes to this AD as a result of this comment.

Comment on Effect of AD on Small Entities

    LAC noted that due to the small population of civil certified
aircraft using the 54H model propellers, the proposed AD could be
considered a significant regulatory action due to it being economically
significant. LAC also noted that the proposed AD would have a
significant economic impact on a substantial number of small entities
because the majority of civil operators affected by the AD are
categorized by the Small Business Administration (SBA) as small
businesses, having fewer than 500 employees.
    As set forth in this preamble, this AD is not a ``significant
regulatory action'' under Executive Order 12866. Regarding LAC's
comment on the economic impact to small entities, that comment is
addressed in paragraph 2 of the Regulatory Flexibility Determination in
the preamble of this AD. The FAA did not change this AD as a result of
this comment.

Comment on Effect of AD on Intrastate Aviation in Alaska

    LAC noted that the proposed AD would affect intrastate aviation in
Alaska because LAC is based in Anchorage, Alaska and operates
throughout the state.
    The FAA disagrees. LAC did not include in its comment any
information to suggest that performance of the ECI on the propeller
blades would affect service to remote Alaskan communities that are not
available by other modes of transportation, while LAC's airplanes are
out of service for the ECI of the taper bore. The FAA has determined
that this AD would not have a significant negative impact on the
availability of transportation services to a remotely located Alaskan
community that is not serviced by other modes of transportation. Even
if this AD did have a significant negative impact on the availability
of LAC's transportation services to a remotely located Alaskan
community not serviced by other modes of transportation, the safety
concerns explained in this AD outweigh the benefits of making said
transportation available.

Comment on Determining Manufacture Date of Affected Propeller Blades

    LAC commented that, in reference to ``since new'' used in paragraph
(g)(3) of the Required Actions, LAC has been advised by Collins
Aerospace that the date code method of assigning S/Ns for propeller
blades was not in effect for propeller blades until the late 1990s. As
a result, LAC commented, each S/N must be manually researched from hand
written production records, and a quick reference S/N database is not
available. LAC also noted that this will make determining the blade
date of manufacture problematic and time consuming.
    The FAA acknowledges that the process to determine the propeller
blade's date of manufacture may be time consuming. However, the FAA
notes that paragraph (g)(3) of this AD assumes that a date record
exists for each installed propeller blade that has been through
overhaul activities because propeller maintenance records must comply
with 14 CFR 43.11. The FAA did not change this AD as a result of this
comment.

Request for Clarification on Installation Prohibition

    LAC stated that, in reference to paragraph (h)(1) of the NPRM,
Installation Prohibition, this AD should not apply to newly
manufactured (-2A) propeller blades because those propeller blades are
manufactured with an enhanced process to reduce the risk of failure.
LAC also commented that paragraph (h)(2) of the NPRM, Installation
Prohibition, would prohibit installation of a propeller blade unless
that propeller blade has first passed the initial inspection required
by paragraphs (g)(1) through (4) of this AD. LAC understood this
installation prohibition to apply to propeller blades that were removed
and installed for maintenance that is unrelated to the propeller blade
inspection. LAC disagrees with the inclusion of this installation
prohibition because propeller assemblies are routinely removed and
replaced in the field for a variety of unrelated maintenance tasks
where there may be limited tooling, propeller stands, or non-
destructive test equipment. The added requirement to fully disassemble
the propeller and inspect the blades before they are due for the
initial inspection is an unnecessary burden on the operators, and
logistically problematic.
    The FAA disagrees with excluding newly manufactured propeller
blades from the installation prohibition section of this AD for the
same reasons explained in response to LAC's comment on excluding newly
manufactured propeller blades from the applicability section of this
AD. Regarding LAC's comment on removing and installing the propeller
blade assembly for unrelated maintenance, the FAA agrees to clarify
paragraph (h)(2) Installation Prohibition, of this AD to account for
those circumstances. The FAA acknowledges that a propeller assembly may
require specific maintenance activity to remove the propeller blade
assembly and control assembly from the aircraft, but not require the
rotating barrel and propeller blade assembly to be disassembled or
``split,'' where the propeller blades are not readily accessible for
the inspection. The FAA added a note to paragraph

(h)(2) of this AD clarifying that operators may install a propeller
assembly with a propeller blade identified in paragraphs (g)(1) through
(3) of this AD if the propeller blade assembly is not disassembled and
the propeller blades are not yet due for an ECI as required by
paragraphs (g)(1) through (4) of this AD.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adoption of the AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for the addition of a note to
paragraph (h) Installation Prohibition, this AD is adopted as proposed
in the NPRM. None of the changes will increase the economic burden on
any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Hamilton Sundstrand ASB 54H60-61-A154, Revision 1,
dated May 29, 2020. This ASB identifies the affected propeller models
and specifies procedures for performing an ECI of the propeller blade
taper bore.
    The FAA also reviewed Hamilton Sundstrand ASB 54H60-61-A155, dated
May 29, 2020. This ASB also identifies affected propeller models and
specifies procedures for performing an expanded ECI of the propeller
blade taper bore. 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.

Interim Action

    The FAA considers this AD to be an interim action. This unsafe
condition is still under investigation by the manufacturer and,
depending on the results of that investigation, the FAA may consider
further rulemaking action.

Costs of Compliance

    The FAA estimates that this AD affects 212 propellers installed on
53 aircraft of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
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ECI all propeller blades installed on   16 work-hours x $85 per             $700          $2,060        $436,720
 propeller.                              hour = $1,360.
Report results of ECI.................  1 work-hour x $85 per                  0              85          18,020
                                         hour = $85.
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    The FAA estimates the following costs to do any necessary
replacement that would be required based on the results of the
inspection. The agency has no way of determining the number of aircraft
that might need this replacement:

                                               On-Condition Costs
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                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
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Replace propeller blade.......................  1 work-hour x $85 per hour = $85         $63,500         $63,585
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Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to be
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

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 Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation.
    To achieve this principle, agencies are required to solicit and
consider flexible regulatory proposals and to explain the rationale for
their actions to assure that such proposals are given serious
consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If

the agency determines that it will, the agency must prepare a
regulatory flexibility analysis as described in the RFA.
    The FAA published an Initial Regulatory Flexibility Analysis (IRFA)
(86 FR 40376, July 28, 2021) for Docket No. FAA-2021-0032; Project
Identifier AD-2020-01314-P to aid the public in commenting on the
potential impacts to small entities. The FAA considered the public
comments in developing both the final rule and this Final Regulatory
Flexibility Analysis (FRFA). A FRFA must contain the following:
    (1) A statement of the need for, and objectives of, the rule;
    (2) A statement of the significant issues raised by the public
comments in response to the IRFA, a statement of the assessment of the
agency of such issues, and a statement of any changes made in the final
rule as a result of such comments;
    (3) The response of the agency to any comments filed by the Chief
Counsel for Advocacy of the SBA in response to the proposed rule, and a
detailed statement of any change made in the final rule as a result of
the comments;
    (4) A description of and an estimate of the number of small
entities to which the rule will apply or an explanation of why no such
estimate is available;
    (5) A description of the projected reporting, recordkeeping, and
other compliance requirements of the proposed rule, including an
estimate of the classes of small entities which will be subject to the
requirement and the type of professional skills necessary for
preparation of the report or record; and
    (6) A description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.

1. Need for and Objectives of the Rule

    This AD was prompted by a report of the separation of a 54H60 model
propeller blade installed on a USMCR KC-130T airplane during a flight
in July 2017. It requires initial and repetitive ECIs of all propeller
blades installed on Hamilton Sundstrand 54H model propellers with a
propeller hub, model 54H60, installed. Additionally, this final rule AD
requires replacement of any propeller blade that fails inspection. The
FAA is issuing this AD to detect cracking in the propeller blade taper
bore. The unsafe condition, if not addressed, could result in failure
of the propeller blade, blade separation, and loss of the airplane.
    The FAA's legal basis for this AD is discussed in detail under the
``Authority for this Rulemaking'' section.

2. Significant Issues Raised in Public Comments

    The FAA published an IRFA for Docket No. FAA-2021-0032; Project
Identifier AD-2020-01314-P and requested comments.
    LAC commented that the proposed AD underestimated the cost of
compliance, and determined that the true cost on U.S. operators will be
approximately $1,948,280 per inspection interval. LAC also determined
that the total compliance cost over the typical life of a new propeller
(4 inspections) is expected to be $7,793,120, not including lost
revenue due to the aircraft being out of service. LAC also noted that
Derco, the only supplier of new manufactured replacement propeller
blades, was currently quoting $68,000 per propeller blade, and would
not guarantee or specify any delivery dates or quantities available.
    The FAA disagrees with updating the estimated costs of this AD. The
cost analysis in AD rulemaking actions typically includes only the
costs associated with complying with the AD, and does not include
secondary costs. The FAA's cost estimate includes the work hours and
parts costs to inspect and replace the parts. Using the compliance cost
estimate that LAC provided in its public comment to the proposed AD
($9,190 to inspect all propeller blades installed on each propeller, or
$36,760 to inspect an airplane with four propellers), the FAA
calculated the total compliance costs of this AD on 15 small businesses
that own and operate 27 airplanes at $992,520 ($36,760 x 27). Eight
small businesses that own and operate one airplane would incur $36,760.
The compliance costs of one small entity with five airplanes would be
$183,800. The average compliance costs of this AD on small entities
would be $66,168 ($992,520/15).
    The FAA estimated the revenue impact of complying with this AD's
requirements on these 15 small entities would vary from under 1 percent
(0.12 percent) of affected companies' annual revenues to approximately
2 percent (1.69 percent) of their annual revenues.
    LAC also noted that the proposed AD will have a significant
economic impact on a substantial number of small entities because the
majority of civil operators affected by this AD are categorized by the
SBA as ``Small Businesses'' having fewer than 500 employees.
    The FAA identified 33 airplanes with 54H model propellers having
propeller hub, model 54H60, installed, that are owned and operated by
16 private entities and fall under the 481112 NAICS Code (Scheduled
Freight Air Transportation) with a small business size standard of a
maximum of 1,500 employees to be considered small business. Six of
these 33 airplanes are registered to LAC, affiliated with the Lynden
Incorporated, which, with 2,500 employees on its payroll, is not a
small entity per the SBA definition. The FAA considered all other
entities that own and operate similar airplanes as small entities since
they all employ less than 1,500 employees. The FAA also estimated the
revenue impact of complying with this AD's requirements would vary from
under 1 percent (0.12 percent) of affected companies' annual revenues
to approximately 2 percent (1.69 percent) of their annual revenues. The
FAA determined that no changes are necessary to this AD as a result of
these comments.

3. Response to SBA Comments

    The Chief Counsel for Advocacy of the SBA did not file any comments
in response to the proposed rule. Thus, the FAA did not make any
changes to this AD.

4. Small Entities to Which the Rule Will Apply

    FAA used the definition of small entities in the RFA for this
analysis. The RFA defines small entities as small businesses, small
governmental jurisdictions, or small organizations. In 5 U.S.C. 601(3),
the RFA defines ``small business'' to have the same meaning as ``small
business concern'' under section 3 of the Small Business Act. The Small
Business Act authorizes the SBA to define ``small business'' by issuing
regulations.
    SBA (2019) has established size standards for various types of
economic activities, or industries, under the North American Industry
Classification System (NAICS).\1\ These size standards generally define
small businesses based on the number of employees or annual receipts.
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    \1\ Small Business Administration (SBA). 2019. Table of Size
Standards. Effective August 12, 2019. https://www.sba.gov/document/support--table-size-standards.
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    The FAA identified 53 airplanes with 54H model propellers having
propeller hub, model 54H60, installed. These 53 airplanes are
registered to 20 entities. Of these 53 airplanes, 20 are registered to

United States Government entities, including the U.S. Customs and
Border Protection, which operates 13 of these airplanes. The FAA
determined that these government entities are not small businesses or
other forms of small entity.
    The remaining 33 airplanes are owned and operated by 16 private
entities. All of these private entities fall under the 481112 NAICS
Code (Scheduled Freight Air Transportation) with a small business size
standard of a maximum of 1,500 employees to be considered small
business.
    Six of these 33 airplanes are registered to LAC, affiliated with
the Lynden Incorporated, which, with 2,500 employees on its payroll, is
not a small entity per the SBA definition. The FAA considered all other
entities that own and operate similar airplanes as small entities since
they all employ less than 1,500 employees. Therefore, the FAA estimated
that this AD would impact 15 small entities.

5. Projected Reporting, Recordkeeping, and Other Compliance
Requirements

    Small entities will incur a new reporting requirement as a result
of this AD. Results of the ECI required by paragraphs (g)(1) through
(5) of this AD must be reported in accordance with the Accomplishment
Instructions, paragraph 3.C.(6), of Hamilton Sundstrand ASB 54H60-61-
A154, Revision 1, dated May 29, 2020. The FAA also estimated that there
would be compliance costs due to the new requirements as discussed in
this preamble.
    Using the compliance cost estimate that LAC provided in its public
comment to the proposed AD ($9,190 to inspect all propeller blades
installed on each propeller, or $36,760 to inspect an airplane with
four propellers), the total compliance costs of this AD on 15 small
businesses that own and operate 27 airplanes would be $992,520 ($36,760
x 27). Eight small businesses that own and operate one airplane would
incur $36,760. The compliance costs of one small entity with five
airplanes would be $183,800. The average compliance costs of this AD on
small entities would be $66,168 ($992,520/15).
    The FAA estimated the revenue impact of complying with this AD's
requirements on these 15 small entities would vary from under 1 percent
(0.12 percent) of affected companies' annual revenues to approximately
2 percent (1.69 percent) of their annual revenues.
    To the extent that small entities provide more unique services or
serve markets with less competition, they may also be able to pass on
costs in the form of price increases. However, the FAA assumed that
none of these small entities would be able to pass these compliance
costs to their customers in terms of higher prices.

6. Significant Alternatives Considered

    As part of the FRFA, the FAA is required to consider regulatory
alternatives that may be less burdensome.
    The FAA did not find any significant regulatory alternatives that
would still accomplish the safety objectives of this AD.

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 2020-12-07, Amendment 39-21142 (85
FR 36145, June 15, 2020); and
0
b. Adding the following new airworthiness directive:

2022-08-10 Hamilton Sundstrand Corporation: Amendment 39-22013;
Docket No. FAA-2021-0032; Project Identifier AD-2020-01314-P.

(a) Effective Date

    This airworthiness directive (AD) is effective May 27, 2022.

(b) Affected ADs

    This AD replaces AD 2020-12-07, Amendment 39-21142 (85 FR 36145,
June 15, 2020).

(c) Applicability

    This AD applies to all Hamilton Sundstrand Corporation (Hamilton
Sundstrand) 54H model propellers with a propeller hub, model 54H60,
installed.
    Note to paragraph (c): Hamilton Sundstrand references propeller
model 54H60 in Hamilton Sundstrand Alert Service Bulletin (ASB)
54H60-61-A154, Revision 1, dated May 29, 2020. These are model 54H
propellers with a 54H60 model propeller hub.

(d) Subject

    Joint Aircraft System Component (JASC) Code 6111, Propeller
Blade Section.

(e) Unsafe Condition

    This AD was prompted by the separation of a propeller blade that
resulted in the loss of an airplane and 17 fatalities. The FAA is
issuing this AD to detect cracking in the propeller blade taper
bore. The unsafe condition, if not addressed, could result in
failure of the propeller blade, blade separation, and loss of the
airplane.

(f) Compliance

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

(g) Required Actions

    (1) For propellers with an installed propeller blade having a
blade serial number (S/N) below 813320, that has not been overhauled
within the past sixty (60) months, within one year or 500 flight
hours (FHs) after July 20, 2020 (the effective date of AD 2020-12-
07), whichever occurs first, perform an eddy current inspection
(ECI) of all blades installed on the propeller.
    (2) For propellers with an installed propeller blade having a
blade S/N below 813320, that has been overhauled within the past
sixty (60) months, within two years or 1,000 FHs after July 20, 2020
(the effective date of AD 2020-12-07), whichever occurs first,
perform an ECI of all blades installed on the propeller.
    (3) For propellers with an installed propeller blade, blade S/N
813320 and above, that has not been overhauled within ten years
since new or since last overhaul, within one year or 500 FHs after
the effective date of this AD, whichever occurs first, perform an
ECI of all blades installed on the propeller.
    (4) Perform the ECI of the propeller blades required by
paragraphs (g)(1) through (3) of this AD in accordance with the
Accomplishment Instructions, paragraph 3.C.(5), of both Hamilton
Sundstrand ASB 54H60-61-A154, Revision 1, dated May 29, 2020, and of
Hamilton Sundstrand ASB 54H60-61-A155, dated May 29, 2020.
    (5) For all propellers identified in paragraphs (g)(1) through
(3) of this AD, repeat the inspection required by paragraphs

(g)(1) through (4) of this AD at intervals not exceeding 3 years or
1,500 FHs, whichever comes first, from the previous inspection.
    (6) If a propeller blade fails any inspection required by this
AD, based on the criteria in Accomplishment Instructions, paragraph
3.C.(5)(g) of Hamilton Sundstrand ASB 54H60-61-A154, Revision 1,
dated May 29, 2020, and paragraph 3.C.(5)(j) of Hamilton Sundstrand
ASB 54H60-61-A155, dated May 29, 2020, remove the blade from service
before further flight and replace with a blade eligible for
installation.
    (7) Report the results of the ECI required by paragraphs (g)(1)
through (5) of this AD in accordance with the Accomplishment
Instructions, paragraph 3.C.(6), of Hamilton Sundstrand ASB 54H60-
61-A154, Revision 1, dated May 29, 2020.

(h) Installation Prohibition

    (1) After the effective date of this AD, do not install onto any
propeller a Hamilton Sundstrand propeller blade identified in
paragraphs (g)(1) through (3) of this AD, unless the blade has first
passed the initial inspection required by paragraphs (g)(1) through
(4) of this AD.
    (2) After the effective date of this AD, do not install any
propeller assembly with a propeller blade identified in paragraphs
(g)(1) through (3) of this AD onto any aircraft unless the propeller
blades have first passed the initial inspection required by
paragraphs (g)(1) through (4) of this AD.
    Note to paragraph (h)(2): Operators may install a propeller
assembly with a propeller blade identified in paragraphs (g)(1)
through (3) of this AD if the propeller blade assembly is not
disassembled and the propeller blades are not yet due for an ECI as
required by paragraphs (g)(1) through (4) of this AD.

(i) Credit for Previous Actions

    You may take credit for the initial ECI of a propeller blade
required by paragraphs (g)(1) and (2) of this AD and the replacement
of a propeller blade required by paragraph (g)(6) of this AD if the
actions were completed before the effective date of this AD using
Hamilton Sundstrand ASB 54H60-61-A154, dated August 26, 2019.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (k) of this AD.
    (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 Michael Schwetz,
Aviation Safety Engineer, Boston ACO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: (781) 238-
7199; email: [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Hamilton Sundstrand Alert Service Bulletin (ASB) 54H60-61-
A154, Revision 1, dated May 29, 2020.
    (ii) Hamilton Sundstrand ASB 54H60-61-A155, dated May 29, 2020.
    (3) For service information identified in this AD, contact
Hamilton Sundstrand, 1 Hamilton Road, Windsor Locks, CT 06096-1010;
phone:<PHONE_NUMBER>; email: [email protected].
    (4) 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>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 7, 2022.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-08539 Filed 4-21-22; 8:45 am]
BILLING CODE 4910-13-P


 [Federal Register: October 23, 2009 (Volume 74, Number 204)] [ Notices]                [Page 54801-54803] [DOCID:fr23oc09-34]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R03-CBP-2009-0500; FRL-8972-5]

  Agency Information Collection Activities; Proposed Collection;

Comment Request; Chesapeake Registry; EPA ICR No. 2365.01, OMB Control

No.<PHONE_NUMBER>-001

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this

document announces that EPA is planning to submit a request to renew an

existing, approved Information Collection Request (ICR) to the Office

of Management and Budget (OMB). EPA prepared the ICR, ``Chesapeake

Registry,'' on behalf of the Chesapeake Bay Program (CBP) partnership.

Before submitting the ICR renewal request to OMB for review and

approval, EPA is soliciting comments on specific aspects of the

proposed information collection as described below.

DATES: Comments must be submitted on or before December 22, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-

CBP-2009-0500, by one of the following methods:

     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.

     Mail: Chesapeake Registry, Attn: Marguerite Duffy,

Chesapeake Bay Program Office, 410 Severn Avenue, Suite 109, Annapolis,

Maryland 21403.

     Hand Delivery: Chesapeake Registry, Attn: Marguerite

Duffy, EPA Chesapeake Bay Program Office, 410 Severn Avenue, Suite 109,

Annapolis, Maryland 21403. Such deliveries are only accepted during the

Docket's normal hours of operation (8:30 a.m. to 4:30 p.m. Monday

through Friday, excluding legal holidays), and special arrangements

should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-R03-CBP-

2009-0500. EPA's policy is that all comments received will be included

in the public docket without change and may be made available online at

http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be

Confidential Business Information (CBI) or other information whose

disclosure is restricted by statute. Do not submit information that you

consider to be CBI or otherwise protected through http://

www.regulations.gov. The http://www.regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your

identity or contact information unless you provide it in the body of

your comment. If you submit a disk or CD-ROM, EPA recommends that you

include your name and other contact information in the body of your

comment. If EPA cannot read your comment due to technical difficulties

and cannot contact you for clarification, EPA may not be able to

consider your comment. Electronic files should avoid the use of special

characters, any form of encryption, and be free of any defects or

viruses. For additional information about EPA's public docket visit the

EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Marguerite Duffy, USEPA Region III--

Chesapeake Bay Program Office, Annapolis City Marina, 410 Severn

Avenue, Suite 109 (3CB10), Annapolis, MD 21403; telephone number: (410)

267-5764; fax number:<PHONE_NUMBER>; e-mail address:

<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID

No. EPA-R03-CBP-2009-0500, which is available for online viewing at

http://www.regulations.gov, or in person viewing at the EPA Chesapeake

Bay Program Office, 410 Severn Avenue, Suite 109, Annapolis, Maryland

21403. Materials are available for viewing from 8:30 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal holidays; telephone number 410-

267-5700. An electronic version of the public docket is available at:

http://www.regulations.gov. This site can be used to obtain a copy of

the draft information collection request, submit or view public

comments, access the index listing of the contents of the docket, and

to access those documents in the public docket that are available

electronically. Once in the system, select ``search,'' then key in the

docket ID number identified in this document (EPA-R03-CBP-2009-0500).

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically

solicits comments and information to enable it to:

    (i) Evaluate whether the proposed collection of information is

necessary for the proper performance of the functions of the Agency,

including whether the information will have practical utility;

    (ii) Evaluate the accuracy of the Agency's estimate of the burden

of the proposed collection of information, including the validity of

the methodology and assumptions used;

    (iii) Enhance the quality, utility, and clarity of the information

to be collected; and

    (iv) Minimize the burden of the collection of information on those

who are to respond, including through the use of appropriate automated

electronic, mechanical, or other technological collection techniques or

other forms of information technology, e.g., permitting electronic

submission of responses. In particular, EPA is requesting comments from

very small businesses (those that employ less than 25) on examples of

specific additional efforts that EPA could make to reduce the paperwork

burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your

comments:

    1. Explain your views as clearly as possible and provide specific

examples.

    2. Describe any assumptions that you used.

    3. Provide copies of any technical information and/or data you used

that support your views.

    4. If you estimate potential burden or costs, explain how you

arrived at the estimate that you provide.

    5. Offer alternative ways to improve the collection activity.

    6. Make sure to submit your comments by the deadline identified

under DATES.

    7. To ensure proper receipt by EPA, be sure to identify the docket

ID number assigned to this action in the subject line on the first page

of your response. You may also provide the name, date, and Federal

Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are

state and local governments and non-government

organizations within the Chesapeake Bay watershed.

    Title: Chesapeake Registry (formerly called Activity Integration

Plan).

    ICR numbers: EPA ICR No. 2365.01, OMB Control No.<PHONE_NUMBER>-001.

    ICR status: This ICR is currently scheduled to expire on 02/28/

2010. An Agency may not conduct or sponsor, and a person is not

required to respond to, a collection of information, unless it displays

a currently valid OMB control number. The OMB control numbers for EPA's

regulations in title 40 of the CFR, after appearing in the Federal

Register when approved, are listed in 40 CFR part 9, are displayed

either by publication in the Federal Register or by other appropriate

means, such as on the related collection instrument or form, if

applicable. The display of OMB control numbers in certain EPA

regulations is consolidated in 40 CFR part 9.

    Abstract: In 2008, EPA's Region III Chesapeake Bay Program Office

and its partners developed the Chesapeake Action Plan (CAP) to

strengthen and expand partnerships in the watershed, enhance

coordination of restoration activities, and increase the collective

accountability for protecting the Chesapeake Bay. One component

described in the CAP is a Web-enabled reporting system known as the

Activity Integration Plan now titled Chesapeake Registry. Through this

reporting system, participating organizations provide data about the

activities in which they are currently engaged, or plan to be engaged

in, to protect and restore the Chesapeake Bay and its watershed. The

ability to capture and account for Bay-wide implementation activities

was developed in response to recommendations by the Government

Accountability Office and directives of the Explanatory Statement of

the FY 2008 Consolidated Appropriations Act (Public Law 110-161). CBPO

conducted its first activity data call in 2008 that included 10 federal

agencies, 7 states, and 2 local organizations.

    The EPA, on behalf of the partnership, intends to expand the data

call to more than 10 non-federal agencies and organizations to

strengthen the information base on which to support implementation

decisions and more recently, to support Executive Order (EO) 13508,

signed by President Barack Obama on May 12, 2009. Section 203(d) of the

EO directs EPA to identify the ``mechanisms that will assure that

governmental and other activities, including data collection and

distribution, are coordinated and effective, relying on existing

mechanisms where appropriate.'' Section 204 further directs that

``Federal actions to protect and restore the Chesapeake Bay are closely

coordinated with actions by State and local agencies in the watershed

and that the resources, authorities, and expertise of Federal, State,

and local agencies are used as efficiently as possible.'' The

Chesapeake Registry and associated data calls provide a mechanism for

coordinated data collections among federal and non-federal entities

protecting and restoring the Bay and its watershed, and the information

necessary to adaptively manage the program in support of these

mandates.

    The Chesapeake Registry includes detailed information about the

activities and funding conducted and planned by partner organizations.

The organizations provide project information on the nature of the

activity, responsible organization, organizational point of contact,

resource levels, geographic location, and major milestones on progress

towards Chesapeake Bay protection and restoration efforts. Funds

reported in the Chesapeake Registry are linked to an organization's own

resource base so that data associated with a set of funds is entered

only by the originator of the funding. The information is organized by

programmatic goal and desired result, which aligns activities to the

goals of the program and helps to provide an accurate depiction of

restoration activities, progress, and results. The information

collection, as envisioned, will be conducted annually. Summary level

information from the Chesapeake Registry is available at http://

cap.chesapeakebay.net.

    Each reporting organization is assigned a user ID and password.

Security measures have been established to protect data that have been

entered, including maintaining the data on a secure server on a secure

network, and confirming the data with each reporting organization.

Participants in the information collection are able to search the

reporting system database application and view standard reports.

Partners will use the enhanced and expanded data to update performance

management dashboards that summarize and synthesize information so the

program partners can understand, at a glance, the progress being made

in key program areas. The dashboards include measures of progress,

information about resources and strategic analyses of what needs to be

done to improve implementation. In addition, EPA anticipates that some

of the partners will use the reporting system as a tool for their own

management and planning efforts.

    Burden Statement: The annual public reporting and recordkeeping

burden for this collection of information is estimated to average 64.8

hours per response for state and local government agencies and 11.5

hours per response for non-government organizations. Burden means the

total time, effort, or financial resources expended by persons to

generate, maintain, retain, or disclose or provide information to or

for a Federal agency. This includes the time needed to review

instructions; develop, acquire, install, and utilize technology and

systems for the purposes of collecting, validating, and verifying

information, processing and maintaining information, and disclosing and

providing information; adjust the existing ways to comply with any

previously applicable instructions and requirements which have

subsequently changed; train personnel to be able to respond to a

collection of information; search data sources; complete and review the

collection of information; and transmit or otherwise disclose the

information. The ICR provides a detailed explanation of the Agency's

estimate, which is only briefly summarized here:

    Estimated total number of potential respondents: 50 (30 state and

local governments, 20 non-government organizations) initially but will

likely increase over time.

    Frequency of response: Annual.

    Estimated total average number of responses for each respondent: 1.

    Estimated total annual burden hours: 2,174.0 (64.8 hours per

response for state and local governments, 11.5 hours per response for

non-government organizations).

    Estimated total annual costs: $104,974.20. This includes an

estimated burden cost of $104,974.20 and an estimated cost of $0.00 for

capital investment or maintenance and operational costs.

Are There Changes in the Estimates From the Last Approval?

    EPA anticipates an annual, gradual change in the total estimated

respondent burden compared with that identified in the ICR currently

approved by OMB.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as

appropriate. The final ICR package will then be submitted to OMB for

review and approval pursuant to 5 CFR 1320.12. At that time, EPA will

issue another Federal Register notice pursuant to 5 CFR

1320.5(a)(1)(iv) to announce the submission of the ICR to

OMB and the opportunity to submit additional comments to OMB. If you

have any questions about this ICR or the approval process, please

contact the technical person listed under FOR FURTHER INFORMATION

CONTACT.

    Dated: October 13, 2009.

James Edward,

Deputy Director, Chesapeake Bay Program Office, Region III.

[FR Doc. E9-25588 Filed 10-22-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30744-30746]
[FR Doc No: 2018-14049]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6209]

Assessing User Fees Under the Biosimilar User Fee Amendments of
2017; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Assessing
User Fees Under the Biosimilar User Fee Amendments of 2017.'' This
guidance concerns FDA's implementation of the Biosimilar User Fee
Amendments of 2017 (BsUFA II) and certain changes in policies and
procedures surrounding its application.

DATES: The announcement of the guidance is published in the Federal
Register on June 29, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6209 for ``Assessing User Fees Under the Biosimilar User Fee
Amendments of 2017.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Beena Alex, Division of User Fee
Management and Budget Formulation, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm.
2185, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments
of 2017.'' This guidance concerns the implementation of BsUFA II,
including an explanation about the new fee structure and types of fees
for which entities are responsible. BsUFA II extends FDA's authority to
collect user fees from fiscal year (FY) 2018 to 2022 and introduces a
number of technical revisions that affect what fees are collected and
how fees are collected. Fees authorized by this legislation help fund
the process for the review of biosimilar biological product
applications and have played an important role in expediting the review
and approval process.
    BsUFA II authorizes biosimilar biological product development
program fees (BPD fees), biosimilar biological product application
fees, and biosimilar biological product program fees. This guidance
describes when these fees are incurred and the process by which
applicants can submit payments. The guidance also provides information
on consequences of failing to pay BsUFA II fees and the processes for
submitting reconsideration and appeal requests.
    In the Federal Register of November 16, 2017 (82 FR 53505), FDA
announced the availability of a draft version of this guidance and
provided interested parties an opportunity to submit comments. We have
reviewed the comment submitted to the docket. This guidance does not
include any substantive changes from the draft guidance.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance, when finalized,
will represent the current thinking of FDA on assessing user fees under
the biosimilar user fee amendments of 2017. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
are given under this section with an estimate of the annual reporting
burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
    With respect to the collection of information associated with this
document, 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.
    Title: Assessing User Fees Under the Biosimilar User Fee Amendments
of 2017: Guidance for Industry.
    Description: This guidance provides information on the assessment
of biosimilar biological product user fees, describes the types of user
fees authorized, the process for submitting payments to FDA, and
consequences for failing to pay BsUFA fees. The guidance also describes
how FDA determines which products are subject to a fee and the changes
to certain FDA policies regarding BsUFA fees. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Act
of 2012 and recently renewed in 2017 (BsUFA) under the FDA
Reauthorization Act of 2017, authorizes FDA to assess and collect user
fees from companies that produce biosimilar biological products in
conjunction with the review of biosimilar biological product
applications. The guidance includes processing and policies for the
initial and the annual biosimilar biological product development (BPD)
fees; the BPD discontinuation process requirements and BPD reactivation
fees; process and policies for biosimilar biological product
application fees including exceptions to the application fees and
refund of fees; process and policies for the small business waiver of
the biosimilar application fee; and implementation of the biosimilar
biological product program fee.
    The burdens associated with requesting a small business waiver of
BsUFA fees and the associated burdens for new activities as noted in
the guidance are listed in table 1.
    FDA estimates the annual burden of these new collections of
information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
                Activity                      Number of       responses per     Total annual     Average burden per  response  (hours)     Total hours
                                             respondents       respondent         responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for discontinuation from BPD                     2                 1                 2  1.....................................                 2
 program.
Request to move products to discontinued                 5                 1                 5  0.5 (30 minutes)......................               2.5
 section of the biosimilar list.
Small business waiver of the BsUFA                       1                 1                 1  16....................................                16
 application fee.
Small business waiver reconsiderations..                 1                 1                 1  24....................................                24
Small business waiver appeals...........                 1                 1                 1  12....................................                12
Annual Fee Determination Survey.........                35                 1                35  1.....................................                35
Annual BsUFA fees correspondence........                35                 1                35  2.....................................                70
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................  ................  ................  ................  ......................................             161.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This guidance also refers to previously approved collections of
information found in FDA forms developed to support its user fee
program. Specifically, the guidance refers to Form FDA 3792; Forms FDA
3913 and 3914; and Form FDA 3971, which have been approved under OMB
control numbers 0910-0718, 0910-0719, 0910-0805, and 0910-0693,
respectively. The guidance also refers to previously approved
collections of information found in FDA regulations. The collections of
information in 21 CFR part 312 are currently approved under OMB control
number 0910-0014; the collections of information regarding new drug
applications under the FD&C Act are approved under OMB control number
0910-0001; and biologics license applications under sections 351(a) or
351(k) of the Public Health Service Act are approved under OMB control
numbers 0910-0338 and 0910-0719, respectively.
    This final guidance contains information collection provisions
subject to review by OMB under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520). Except for the provisions listed in table 1, the
information collections already have been approved. The applicable
provisions are shaded in the guidance to identify those for which OMB
approval has not yet been obtained. When approval of these provisions
has been received, FDA will provide notice. BsUFA II provides the
statutory authority to collect user fees from FY 2018 through FY 2022.
Consistent with the statutory requirements of BsUFA II, FDA is issuing
this guidance to facilitate understanding and enhancing implementation
of the policies and processes in the assessment of biosimilar user fees
in upcoming fiscal years.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14049 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 209 (Tuesday, October 31, 2017)]
[Notices]
[Pages 50469-50472]
[FR Doc No: 2017-23580]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81941; File No. SR-ISE-2017-93]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Rules for
Excluding Days From the Exchange's ADV and Market Maker Plus Tier
Calculations in the Schedule of Fees

October 25, 2017.
    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 October 11, 2017, Nasdaq ISE, LLC (``ISE'' 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 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 the Exchange's provisions for
excluding a day from its volume calculations for purposes of
determining volume based pricing, and to adopt language that allows the
Exchange to remove a day from Market Maker Plus tiers whenever a day is
removed from the Exchange's volume calculations.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, 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
    The purpose of the proposed rule change is to amend the Exchange's
provisions for excluding a day from its volume calculations for
purposes of determining volume based pricing, and to adopt language
that allows the Exchange to remove a day from Market Maker Plus tiers
whenever a day is removed from the Exchange's volume calculations.
    To avoid penalizing members when aberrant low volume days result
from systems or other issues at the Exchange,

or where the Exchange closes early for holiday observance, the Exchange
has language in its Schedule of Fees allowing it to exclude certain
days from its average daily volume (``ADV'') calculations. Currently,
language in the Exchange's Schedule of Fees provides that, for purposes
of determining ADV for certain incentive programs,\3\ any day that the
Exchange, or complex order book, as appropriate, is not open for the
entire trading day or the Exchange instructs members in writing to
route their orders to other markets may be excluded from such
calculation; provided that the Exchange will only remove the day for
members that would have a lower ADV with the day included. The proposed
rule change would: (1) Apply the rules for excluding a day to all ADV
calculations rather than specified incentive programs,\4\ and (2)
remove the Exchange's ability to separately exclude a day for the
regular and complex order books.\5\ As proposed, with these two
changes, the Exchange's rules will state that any day that the market
is not open for the entire trading day or the Exchange instructs
members in writing to route their orders to other markets may be
excluded from the ADV calculation; provided that the Exchange will only
remove the day for members that would have a lower ADV with the day
included. The Exchange will inform members of any day that is to be
excluded from its ADV calculations through an Options Trader Alert.
---------------------------------------------------------------------------

    \3\ The current language in the Schedule of Fees applies to the
calculation of Priority Customer Complex ADV used to determine
pricing for Priority Customer complex order tiers and a discounted
Market Maker taker fee in complex orders. See Schedule of Fees, II.
Complex Order Fees and Rebates. It also applies to the calculation
of a member's ADV in unsolicited Crossing Orders for the Member
Order Routing Program. See Schedule of Fees, IV. Other Options Fees
and Rebates, E. Member Order Routing Program.
    \4\ See id. Since the proposed language will now apply to all
current and future programs administered by the Exchange that are
based on ADV, the Exchange proposes to move it to the Preface of its
Schedule of Fees. For example, PIM and FX Options tiered pricing,
currently in the Schedule of Fees at Sections III would now be
subject to the proposed rule change in the Preface as a result of
this rule change.
    \5\ See Securities Exchange Act Release No. 73601 (November 11,
2014), 79 FR 69170 (November 20, 2014) (SR-ISE-2014-51).
---------------------------------------------------------------------------

    Currently, the Exchange's rules for removing a day from its ADV
calculations apply to specific ADV calculations. In particular, the
Exchange can remove a day from tier calculations for the following
programs: (1) Priority Customer complex order rebates,\6\ and a Market
Maker taker fee discount in complex orders that is also based on
Priority Customer Complex ADV; \7\ and (2) Member Order Routing Program
rebates.\8\ The Exchange now believes that it is appropriate to expand
this provision to cover all ADV calculations rather than limit it to
specific enumerated programs. Applying this rule to all ADV
calculations will benefit members by permitting the Exchange to exclude
aberrant low volume days from its ADV calculations regardless of the
specific pricing program impacted. As is the case today, the Exchange
will only remove the day for members that would have a lower ADV with
the day included.
---------------------------------------------------------------------------

    \6\ The Exchange provides ADV based tiered rebates to Priority
Customer complex orders that trade with non-Priority Customer orders
in the complex order book or trade with quotes and orders on the
regular order book. See Section I and II of ISE's Schedule of Fees.
    \7\ The Market Maker complex order taker fee in Select Symbols
fee is reduced from $0.47 per contract to $0.44 per contract for
Market Makers with total affiliated Priority Customer Complex ADV of
150,000 or more contracts. See Section I of ISE's Schedule of Fees.
    \8\ The Member Order Routing Program is a program that provides
tiered rebates to order routing firms that select the Exchange as
the default routing destination for unsolicited Crossing Orders. See
Section IV, E of the Schedule of Fees.
---------------------------------------------------------------------------

    Furthermore, the current rules for removing a day may be applied
separately for the regular and complex order books, allowing the
Exchange to remove a day based on separate impact to the regular or
complex market. In connection with the changes discussed above, the
Exchange also proposes to eliminate the ability to separately exclude a
day for the regular and complex order books by adding the general
interpretation to the Preface section so that it applies universally.
Although the Exchange had previously filed rule changes that consider
the regular and complex order books separately, the Exchange no longer
believes that it is necessary to do so, and will therefore not exclude
days where, for example, only the complex order book experiences a
systems issue. With this rule change the Exchange would generally
exclude days for either the simple or complex order books where any
systems issue occurs. The Exchange' tiers seek to incentive market
participants to transact a greater amount of liquidity on the ISE
markets. The Exchange does not desire to disincentive a member simply
because the day is shortened due to a holiday or because the market has
experienced an unexpected closure. The proposal seeks to provide market
participants with the ability to plan for and in the case of unexpected
events, not be harmed by shortened or closed days. By not considering
the simple and complex order books separately, the Exchange believes
that market participants will be incentivized to send both simple and
complex order flow without concern on days whether a market event has
occurred. This rule change will simplify the operation of this rule.
The Exchange notes that NASDAQ PHLX, LLC (``Phlx''), which also trades
complex orders, excludes a day for the entire market rather than only
for a specific segment of order flow.\9\
---------------------------------------------------------------------------

    \9\ See the Preface to Phlx's Pricing Schedule.
---------------------------------------------------------------------------

    Finally, the Exchange operates a Market Maker Plus program that
provides tiered rebates to Market Makers \10\ in Select Symbols \11\
based on time at the national best bid or offer (``NBBO'').
Specifically, a Market Maker Plus is a Market Maker who is on the NBBO
a specified percentage of the time for series trading between $0.03 and
$3.00 (for options whose underlying stock's previous trading day's last
sale price was less than or equal to $100) and between $0.10 and $3.00
(for options whose underlying stock's previous trading day's last sale
price was greater than $100) in premium in each of the front two
expiration months. The specified percentage is at least 80% but lower
than 85% of the time for Tier 1, at least 85% but lower than 95% of the
time for Tier 2, and at least 95% of the time for Tier 3.\12\ Market
Makers that qualify for Market Maker Plus receive a maker rebate for
regular orders in Select Symbols of $0.15 per contract for Tier 1,
$0.18 per contract for Tier 2,\13\ and $0.22 per contract for Tier
3,\14\ instead of the regular maker fee of $0.10 per contract.\15\
Market Maker Plus is designed to reward Maker Makers that make quality
markets. As discussed above, however, member

participation, including Market Maker participation, is generally lower
on days when the Exchange is experiencing a system or other issue that
results in the market not being open for the entire trading day or the
Exchange instructing members in writing to route their orders to other
markets. Similar to the treatment described above for ADV calculations,
the Exchange similarly believes that it is appropriate to remove these
days from the Market Maker Plus calculation to avoid penalizing Market
Makers on days that the Exchange is experiencing an issue. The Exchange
therefore proposes to adopt language that provides that, other than
days where the Exchange closes early for holiday observance, any day
that the market is not open for the entire trading day or the Exchange
instructs members in writing to route their orders to other markets may
be excluded from the Market Maker Plus tier calculation; provided that
the Exchange will only remove the day for members that would have a
lower time at the NBBO for the specified series with the day included.
---------------------------------------------------------------------------

    \10\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \11\ ``Select Symbols'' are options overlying all symbols listed
on the Nasdaq ISE that are in the Penny Pilot Program.
    \12\ A Market Maker's single best and single worst quoting days
each month based on the front two expiration months, on a per symbol
basis, will be excluded in calculating whether a Market Maker
qualifies for this rebate, if doing so will qualify a Market Maker
for the rebate.
    \13\ This rebate is $0.16 per contract in SPY and QQQ, except
when trading against complex orders that leg into the regular book.
A Market Maker that achieves Tier 2 Market Maker Plus in either SPY
or QQQ will receive this rebate in both SPY and QQQ.
    \14\ This rebate is $0.20 per contract in SPY and QQQ, except
when trading against complex orders that leg into the regular book
under footnote 10 above. A Market Maker that achieves Tier 3 Market
Maker Plus in either SPY or QQQ will receive this rebate in both SPY
and QQQ.
    \15\ A $0.10 per contract fee applies when trading against
Priority Customer complex orders that leg into the regular order
book. There will be no fee charged or rebate provided when trading
against non-Priority Customer complex orders that leg into the
regular order book.
---------------------------------------------------------------------------

    The proposed rule text would allow the Exchange to provide relief
to Market Makers as to the Market Maker Plus tier calculation similar
to that provided for ADV tiers, except that the Exchange does not
proposes to use this authority to remove days from the Market Maker
Plus tier calculation where the Exchange closes early for holiday
observance. While Market Makers can plan for known events, such as a
holiday, they are unable to plan for market events which may close the
market for part of a trading day. The Exchange believes that permitting
the exception for the unanticipated event therefore provides
flexibility to Market Makers in anticipating where to send order flow.
The Exchange desires to incentivize Market Makers to send order flow to
ISE to meet their tier requirements.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\16\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\17\ 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.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed change to the ADV
calculation is reasonable and equitable as it provides a new framework
for removing days from the Exchange's volume calculations that the
Exchange believes is beneficial to members. The proposed rule change
would apply the rules for excluding a day to all ADV calculations
rather than specified incentive programs, thereby further protecting
members if the Exchange experiences a systems or other issue that
results in a day being excluded from the Exchange's ADV calculations.
Without this change, members would only have the day excluded for the
specific ADV based pricing programs described in this filing, and would
not get the benefit for other un-enumerated programs. While the
Exchange had previously filed to separately consider the regular and
complex books, the Exchange no longer believes that this authority is
necessary. By not considering the simple and complex order books
separately, the Exchange believes that market participants will be
incentivized to send both simple and complex order flow without concern
on days whether a market event has occurred. The Exchange believes that
this change will make this rule easier to administer without having a
significant impact on members. Moreover, the Exchange believes that the
proposed changes preserve the Exchange's intent behind adopting volume-
based pricing. Finally, the Exchange further believes that the proposed
change is not unfairly discriminatory because it applies equally to all
members and ADV calculations.
    The Exchange also believes that the proposed language for Market
Maker Plus tier calculations is reasonable and equitable since it would
allow the Exchange to remove a day from its Market Maker Plus tier
calculations in similar circumstances as the Exchange currently removes
days from its ADV calculations, and only when beneficial to the member.
The Exchange believes that this proposed change is appropriate as it
avoids penalizing Market Makers on days where the Exchange is
experiencing a systems or other issue. Without this change, Market
Makers that are wary of participation on the Exchange following an
issue at the Exchange could fall into a lower Market Maker Plus tier,
resulting in an effective cost increase for those members. The proposed
language for removing a day from the Market Maker Plus tier calculation
mirrors the language currently in place for the ADV calculation, except
that the Exchange proposes that it will not remove days where the
Exchange closes early for holiday observance. While Market Makers can
plan for known events, such as a holiday, they are unable to plan for
market events which may close the market for part of a trading day. The
Exchange believes that permitting the exception for the unanticipated
event therefore provides flexibility to Market Makers in anticipating
where to send order flow. The Exchange desires to incentivize Market
Makers to send order flow to ISE to meet their tier requirements. The
Exchange believes that this is appropriate to incentivize Market Makers
to continue making quality markets where the Exchange is not
experiencing an issue and merely closes early for holiday observance.
Finally, the Exchange believes that the proposed language for the
Market Maker Plus tier calculation is not unfairly discriminatory as
all Market Makers have the ability to qualify for Market Maker Plus by
making quality markets on the Exchange and can therefore benefit from
the proposed changes. As explained above, all members also benefit from
a similar provision that applies to the Exchange's ADV calculations.

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. The proposed rule change would
apply the rules for excluding a day to all ADV calculations rather than
specified incentive programs, thereby further protecting members if the
Exchange experiences a systems or other issue that results in a day
being excluded from the Exchange's ADV calculations. This rule changes
does not impose an undue burden on competition because without this
change, members would only have the day excluded for the specific ADV
based pricing programs described in this filing, and would not get the
benefit for other un-enumerated programs. The Exchange will uniformly
apply the proposed language related to ADV based pricing programs. The
proposal to not consider the simple and complex order books separately
does not impose an undue burden on competition because the Exchange
would uniformly calculate the ADV based pricing programs in a uniform
manner for all market participants. The Exchange believes that this
change will make this rule easier to administer without having a
significant impact on members. Moreover, the Exchange believes that the
proposed changes preserve the Exchange's intent behind adopting volume-
based pricing.

Finally, the Exchange further believes that the proposed change is not
unfairly discriminatory because it applies equally to all members and
ADV calculations.
    The proposed rule change is designed adopt a new provision covering
the Market Make Plus tier calculation. The proposed language for
removing a day from the Market Maker Plus tier calculation mirrors the
language currently in place for the ADV calculation, except that the
Exchange proposes that it will not remove days where the Exchange
closes early for holiday observance. While Market Makers can plan for
known events, such as a holiday, they are unable to plan for market
events which may close the market for part of a trading day. The
Exchange believes that permitting the exception for the unanticipated
event therefore provides flexibility to Market Makers in anticipating
where to send order flow. The Exchange desires to incentivize Market
Makers to send order flow to ISE to meet their tier requirements. The
Exchange believes that the proposed modifications to its ADV and Market
Maker Plus tier calculations are pro-competitive and will result in
lower total costs to end users, a positive outcome of competitive
markets.
    The Exchange operates in a highly competitive market in which
market participants can readily direct their order flow to competing
venues. In such an environment, the Exchange must continually review,
and consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed fee changes reflect this competitive environment.

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 \18\ and Rule 19b-4(f)(2) \19\ thereunder.
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.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \19\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-ISE-2017-93 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-ISE-2017-93. 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 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 Web site 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
10:00 a.m. and 3:00 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. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2017-93 and should be
submitted on or before November 21, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-23580 Filed 10-30-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 219 (Wednesday, November 15, 2017)]
[Notices]
[Pages 52949-52950]
[FR Doc No: 2017-24692]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-10435; 34-82042; File No. 265-28]

Investor Advisory Committee Meeting

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee.

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

SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting. The public is invited to submit
written statements to the Committee.

DATES: The meeting will be held on Thursday, December 7, 2017 from 9:00
a.m. until 3:30 p.m. (ET). Written statements should be received on or
before December 7, 2017.

ADDRESSES: The meeting will be held in Multi-Purpose Room LL-006 at the
Commission's headquarters, 100 F Street NE., Washington, DC 20549. The
meeting will be webcast on the Commission's Web site at www.sec.gov.
Written statements may be submitted by any of the following methods:

Electronic Statements

    [ssquf] Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to [email protected]. Please
include File No. 265-28 on the subject line; or

Paper Statements

    [ssquf] Send paper statements to Brent J. Fields, Secretary,
Securities and Exchange Commission, 100 F Street NE., Washington, DC
20549-1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1503,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change. Persons submitting comments are cautioned that we do not redact
or edit personal identifying information from comment submissions. You
should submit only information that you wish to make available
publicly.

FOR FURTHER INFORMATION CONTACT: Marc Oorloff Sharma, Chief Counsel,
Office of the Investor Advocate, at<PHONE_NUMBER>, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public,
except during that portion of the meeting reserved for an
administrative work session during lunch. Persons needing special
accommodations to take part because of a disability should notify the
contact person listed in the section above entitled FOR FURTHER
INFORMATION CONTACT.
    The agenda for the meeting includes: Remarks from Commissioners; a
discussion of a recommendation of the Investor as Purchaser
Subcommittee regarding electronic delivery of information to retail
investors; a discussion regarding retail investor protections and
transparency in municipal and corporate bond markets; a discussion
regarding cybersecurity risk disclosures (which may include a
recommendation of the Investor as Owner Subcommittee); a discussion
regarding dual-class share structures (which may include a
Recommendation of the Investor as Owner Subcommittee); a discussion
regarding retail investor disclosure: What works, what doesn't, and
best practices; subcommittee reports; and a nonpublic administrative
work session during lunch.

    Dated: November 9, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-24692 Filed 11-14-17; 8:45 am]
 BILLING CODE 8011-01-P