[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Rules and Regulations]
[Pages 52131-52135]
[FR Doc No: 2018-22152]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0771; Product Identifier 2016-NM-212-AD; Amendment
39-19449; AD 2018-20-15]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2015-09-07,
which applied to all The Boeing Company Model 787 airplanes. AD 2015-
09-07 required a repetitive maintenance task for electrical power
deactivation. This AD requires installing new software for the
generator control unit (GCU). This AD also removes certain airplanes
from the applicability. This AD was prompted by the determination that
a Model 787 airplane that has been powered continuously for 248 days
can lose all alternating current (AC) electrical power due to the GCUs
simultaneously going into failsafe mode. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective November 20, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 20,
2018.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of May 1,
2015 (80 FR 24789, May 1, 2015).

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0771.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.govby searching for and locating Docket No. FAA-2017-
0771; 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, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) 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: Joe Salameh, Aerospace Engineer,
Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South
216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2015-09-07, Amendment 39-18153 (80 FR 24789,
May 1, 2015) (``AD 2015-09-07''). AD 2015-09-07 applied to all The
Boeing Company Model 787 airplanes. The NPRM published in the Federal
Register on August 15, 2017 (82 FR 38629). The NPRM was prompted by the
determination that a Model 787 airplane that has been powered
continuously for 248 days can lose all AC electrical power due to the
GCUs simultaneously going into failsafe mode. This condition is caused
by a software counter internal to the GCUs that will overflow after 248
days of continuous power. The NPRM proposed to require installing the
new GCU software developed to address the software counter overflow
anomaly. The NPRM also proposed to remove certain airplanes from the
applicability. We are issuing this AD to address loss of all AC
electrical power, which could result in loss of control of the
airplane.

Comments

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

Support for the NPRM

    The Air Line Pilots Association, International (ALPA) and American
Airlines indicated their support for the NPRM.

Request To Update Number of Affected Airplanes

    Boeing requested that we update the Costs of Compliance section of
the proposed AD to state that ``55 airplanes of U.S. registry'' are
affected. Boeing noted that its records show 55 N-registered airplanes,
not 47 as stated in the proposed AD.
    We agree with the commenter's request for the reason provided. We
have updated the Costs of Compliance section of this AD accordingly.

Request To Revise Warranty Information in Costs of Compliance Section

    Boeing requested that we revise the Costs of Compliance section of
the proposed AD to state that warranty remedies are not available for
Boeing Service Bulletin B787-81205-SB240063-00, Issue 002, dated June
7, 2016. Boeing noted that Boeing Service Bulletin B787-81205-SB240063-
00, Issue 002, dated June 7, 2016, states ``Boeing warranty remedies
are not available for the configuration changes set forth in this
service bulletin. Notwithstanding, Boeing will provide the supplier
software referenced in this service bulletin at no charge. This offer
will expire eight years from the original issue date of this service
bulletin.''
    We acknowledge the commenter's request and agree to clarify. The
warranty information in the Costs of Compliance section of this AD is
meant to be informational, and is included when the manufacturer's
service information states warranty coverage may be available. We do
not control warranty coverage and operators must work with the
manufacturer to determine if they are eligible for a warranty. We have
revised the warranty information in the Costs of Compliance section of
this AD to note that some of the software costs may be covered under
warranty.

Request To Clarify Requirements Related to Software Installation

    Boeing requested that we clarify or confirm that requiring
operators to concurrently install new software as specified in
paragraph (i) of the proposed AD will not require operators to request
alternative methods of compliance (AMOCs) for installing later-approved
software revisions in accordance with future service bulletins. Boeing
noted that Boeing Service Bulletin B787-81205-SB420006-00 includes
instructions to install several software part numbers that will bring
airplanes up to common interface control document (ICD) 9.3
configuration, which is not a safety-related project. Boeing further
noted that several other service bulletins call out common ICD 9.3 as a
concurrent requirement.
    Based on the commenter's request, we have changed paragraphs (h),
(i)(1)(i), (i)(1)(ii), and (i)(2) of this AD to allow operators to
install later-approved software versions, provided those later-approved
versions meet certain conditions. Therefore, operators will not be
required to obtain AMOCs to install newer versions of the software
required by paragraph (i) of this AD. Similarly, operators will not be
required to obtain AMOCs to install newer versions of the software
required by paragraph (h) of this AD.

Request To Provide Additional Credit

    Boeing and United Airlines (UAL) requested that we provide credit
for certain actions done in accordance with Issue 002 of Boeing Service
Bulletin B787-81205-SB420006-00. Boeing also requested that we provide
credit for certain actions done in accordance with Issue 001 of Boeing
Service Bulletin B787-81205-SB420006-00. UAL noted that it had
accomplished Boeing Service Bulletin B787-81205-SB420006-00, Issue 002,
dated February 13, 2015, on its fleet. UAL added that Boeing Service
Bulletin B787-81205-SB420006-00, Issue 003, dated October 15, 2015, was
issued to correct software part numbers for certain groups of
airplanes, and none of those airplanes are in its fleet. Boeing noted
that Issue 002 and Issue 003 of Boeing Service Bulletin B787-81205-
SB420006-00 were issued to provide clarification and to provide
additional required work for a limited group of airplanes. Boeing
suggested that we revise paragraph (j) of the proposed AD to provide
credit for the earlier service bulletin revisions for certain airplanes
and provide credit for the earlier revisions for certain other
airplanes provided that additional work is done on those airplanes.
    We agree with the commenters' requests for the reasons provided. We
have changed paragraphs (j)(1) and (j)(2) of this AD and added
paragraph (j)(3) to this AD to provide credit for actions required by
paragraphs (i)(1)(ii) and (i)(2) of this AD for certain airplanes.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously, and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed the following service information.
     Boeing Service Bulletin B787-81205-SB240063-00, Issue 002,
dated June 7, 2016, which describes procedures for installing
operational program software (OPS) into each of the six GCUs and doing
a software check. This service information specifies to concurrently
accomplish the following two service bulletins.
     Boeing Service Bulletin B787-81205-SB280018-00, Issue 001,
dated April 17, 2014, which describes procedures for installing fuel
quantity management program software and doing a software check.
     Boeing Service Bulletin B787-81205-SB420006-00, Issue 003,
dated October 15, 2015, which describes procedures for installing
common interface control document 9.3 software and doing a software
check.
     Boeing Multi Operator Message MOM-MOM-15-0248-01B, dated
April 19, 2015; and Boeing Multi Operator Message MOM-MOM-15-0248-
01B(R1), dated April 20, 2015. This service information describes
procedures for electrical power deactivation of Model 787 airplanes.
These documents are distinct due to editorial revisions.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 55 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost on U.S.
             Action                    Labor cost        Parts cost     Cost per product          operators
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Electrical power deactivation    1 work-hour x $85 per           $0  $85 per deactivation   $4,675 per
 (actions retained from AD        hour = $85 per                      cycle.                 deactivation cycle.
 2015[dash]09[dash]07).           deactivation cycle.
Software installation (new       5 work-hours x $85               0  $425.................  $23,375.
 required action).                per hour = 425.
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                                     Estimated Costs for Concurrent Actions
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                Action                           Labor cost            Parts cost     Cost on U.S.  operators
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Install fuel quantity management       1 work-hour x $85 per hour =           \1\  Up to $4,675.
 program software.                      $85.

Install common interface control       Up to 15 work-hours x $85 per          \1\  Up to $70,125.
 document 9.3 software.                 hour = $1,275.
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\1\ We have received no definitive data that would enable us to provide parts cost estimates for the concurrent
  actions specified in this AD.

    According to the manufacturer, some of the software costs of this
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all available costs in our
cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    We have 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) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of 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 removing Airworthiness Directive (AD)
2015-09-07, Amendment 39-18153 (80 FR 24789, May 1, 2015), and adding
the following new AD:

2018-20-15 The Boeing Company: Amendment 39-19449; Docket No. FAA-
2017-0771; Product Identifier 2016-NM-212-AD.

(a) Effective Date

    This AD is effective November 20, 2018.

(b) Affected ADs

    This AD replaces AD 2015-09-07, Amendment 39-18153 (80 FR 24789,
May 1, 2015) (``AD 2015-09-07'').

(c) Applicability

    This AD applies to The Boeing Company Model 787-8 and 787-9
airplanes, certificated in any category, as identified in Boeing
Service Bulletin B787-81205-SB240063-00, Issue 002, dated June 7,
2016.

(d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical
power.

(e) Unsafe Condition

    This AD was prompted by the determination that a Model 787
airplane that has been powered continuously for 248 days can lose
all alternating current (AC) electrical power due to the generator
control units (GCUs) simultaneously going into failsafe mode. This
condition is caused by a software counter internal to the GCUs that
will overflow after 248 days of continuous power. We are issuing
this AD to address loss of all AC electrical power, which could
result in loss of control of the airplane.

(f) Compliance

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

(g) Retained Repetitive Maintenance Task: Electrical Power Deactivation
With a New Reference to Terminating Action

    This paragraph restates the actions required by paragraph (g) of
AD 2015-09-07, with a new reference to terminating action. At the
latest of the times specified in paragraphs (g)(1), (g)(2), and
(g)(3) of this AD, accomplish electrical power deactivation on the
airplane, in accordance with step 2) in ``DESIRED ACTION'' of Boeing
Multi Operator Message MOM-MOM-15-0248-01B, dated April 19, 2015; or
Boeing Multi Operator Message MOM-MOM-15-0248-01B(R1), dated April
20, 2015. The main and auxiliary power unit (APU) batteries do not
need to be disconnected when performing the electrical power
deactivation. Repeat the electrical power deactivation thereafter at
intervals not to exceed 120 days until the software installation
required by paragraph (h) of this AD is done.
    (1) Within 120 days after the last electrical power deactivation
in accordance with step 2) in ``DESIRED ACTION'' of Boeing Multi
Operator Message MOM-MOM-15-0248-01B, dated April 19, 2015; or
Boeing Multi Operator Message MOM-MOM-15-0248-01B(R1), dated April
20, 2015.
    (2) Within 120 days after the date of issuance of the original
certificate of airworthiness or the date of issuance of the original
export certificate of airworthiness.
    (3) Within 7 days after May 1, 2015 (the effective date of AD
2015-09-07).

(h) New Requirement of This AD: Software Installation

    Within 12 months after the effective date of this AD: Install
new operational program software (OPS), or later-approved version,
into each of the six GCUs, do a software check, and do all
applicable corrective actions before further flight, in accordance
with the Accomplishment Instructions of Boeing Service Bulletin
B787-81205-SB240063-00, Issue 002, dated June 7, 2016.

Later-approved versions of the software are only those Boeing
software versions that are approved as a replacement for the
applicable software, and are approved as part of the type design by
the FAA or the Boeing Commercial Airplanes Organization Designation
Authorization (ODA) after issuance of Boeing Service Bulletin B787-
81205-SB240063-00, Issue 002, dated June 7, 2016. If any software
check fails, before further flight, do corrective actions, repeat
the check, and do applicable corrective actions until the software
passes the check. Accomplishment of the actions required by this
paragraph on all six GCUs on an airplane terminates the requirements
of paragraph (g) of this AD for that airplane.

(i) New Requirement of This AD: Concurrent Actions

    (1) For Group 1 airplanes as identified in Boeing Service
Bulletin B787-81205-SB240063-00, Issue 002, dated June 7, 2016:
Prior to or concurrently with accomplishing the actions required by
paragraph (h) of this AD, do the actions specified in paragraph
(i)(1)(i) and (i)(1)(ii) of this AD.
    (i) Install new fuel quantity management program software, or
later-approved version, and do a software check, in accordance with
the Accomplishment Instructions of Boeing Service Bulletin B787-
81205-SB280018-00, Issue 001, dated April 17, 2014. Later-approved
versions of the software are only those Boeing software versions
that are approved as a replacement for the applicable software, and
are approved as part of the type design by the FAA or the Boeing
Commercial Airplanes ODA after issuance of Boeing Service Bulletin
B787-81205-SB280018-00, Issue 001, dated April 17, 2014. If any
software check fails, before further flight, do corrective actions,
repeat the check, and do applicable corrective actions until the
software passes the check.
    (ii) Install new common interface control document 9.3 software,
or later-approved version, and do software checks, in accordance
with the Accomplishment Instructions of Boeing Service Bulletin
B787-81205-SB420006-00, Issue 003, dated October 15, 2015. Later-
approved versions of the software are only those Boeing software
versions that are approved as a replacement for the applicable
software, and are approved as part of the type design by the FAA or
the Boeing Commercial Airplanes ODA after issuance of Boeing Service
Bulletin B787-81205-SB420006-00, Issue 003, dated October 15, 2015.
If any software check fails, before further flight, do corrective
actions, repeat the check, and do applicable corrective actions
until the software passes the check.
    (2) For Group 2 airplanes as identified in Boeing Service
Bulletin B787-81205-SB240063-00, Issue 002, dated June 7, 2016:
Prior to or concurrently with accomplishing the actions required by
paragraph (h) of this AD, install new common interface control
document 9.3 software, or later-approved version, and do software
checks, in accordance with the Accomplishment Instructions of Boeing
Service Bulletin B787-81205-SB420006-00, Issue 003, dated October
15, 2015. Later-approved versions of the software are only those
Boeing software versions that are approved as a replacement for the
applicable software, and are approved as part of the type design by
the FAA or the Boeing Commercial Airplanes ODA after issuance of
Boeing Service Bulletin B787-81205-SB420006-00, Issue 003, dated
October 15, 2015. If any software check fails, before further
flight, do corrective actions, repeat the check, and do applicable
corrective actions until the software passes the check.

(j) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using Boeing Service Bulletin B787-81205-
SB240063-00, Issue 001, dated December 22, 2015.
    (2) This paragraph provides credit for the actions specified in
paragraph (i)(1)(ii) and (i)(2) of this AD, if those actions were
performed before the effective date of this AD using Boeing Service
Bulletin B787-81205-SB420006-00, Issue 001, dated January 22, 2015,
provided that the applicable actions specified in Table 13 and Table
14, as applicable, of paragraph 4, ``Description,'' of Boeing
Service Bulletin B787-81205-SB420006-00, Issue 003, dated October
15, 2015, are done within 12 months after the effective date of this
AD.
    (3) This paragraph provides credit for the actions specified in
paragraph (i)(1)(ii) and (i)(2) of this AD, if those actions were
performed before the effective date of this AD using Boeing Service
Bulletin B787-81205-SB420006-00, Issue 002, dated February 13, 2015,
provided that the applicable actions specified in Table 14 of
paragraph 4, ``Description,'' of Boeing Service Bulletin B787-81205-
SB420006-00, Issue 003, dated October 15, 2015, are done within 12
months after the effective date of this AD.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (l)(1) of this AD. Information may be
emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes ODA that has
been authorized by the Manager, Seattle ACO Branch, to make those
findings. To be approved, the repair method, modification deviation,
or alteration deviation must meet the certification basis of the
airplane, and the approval must specifically refer to this AD.
    (4) AMOCs approved previously for AD 2015-09-07 are approved as
AMOCs for the corresponding provisions of paragraph (g) of this AD.
    (5) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(k)(5)(i) and (k)(5)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(l) Related Information

    (1) For more information about this AD, contact Joe Salameh,
Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO
Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax:
206-231-3536; email: [email protected].
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (m)(5) and (m)(6) of this AD.

(m) 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.
    (3) The following service information was approved for IBR on
November 20, 2018.
    (i) Boeing Service Bulletin B787-81205-SB240063-00, Issue 002,
dated June 7, 2016.
    (ii) Boeing Service Bulletin B787-81205-SB280018-00, Issue 001,
dated April 17, 2014.
    (iii) Boeing Service Bulletin B787-81205-SB420006-00, Issue 003,
dated October 15, 2015.
    (4) The following service information was approved for IBR on
May 1, 2015 (84 FR 24789, May 1, 2015).
    (i) Boeing Multi Operator Message MOM-MOM-15-0248-01B, dated
April 19, 2015. The date appears only on the first page of this
document.
    (ii) Boeing Multi Operator Message MOM-MOM-15-0248-01B(R1),
dated April 20, 2015. The date appears only on the first page of
this document.
    (5) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (6) You may view this service information at the FAA, Transport
Standards Branch,

2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (7) 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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on September 25, 2018.
John P. Piccola,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-22152 Filed 10-15-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64226-64227]
[FR Doc No: 2022-23035]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5553]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Annual Summary
Reporting Requirements Under the Right to Try Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by November 23, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0893. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Annual Summary Reporting Requirements Under the Right to Try Act

OMB Control Number 0910-0893

    This information collection helps to implement provisions of the
Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Right to
Try Act, which requires sponsors and manufacturers who provide an
``eligible investigational drug'' under the Right to Try Act to submit
to FDA an annual summary of such use. Regulations under Sec.  300.200
(21 CFR 300.200) will require that sponsors and manufacturers submit to
FDA an annual summary no later than March 31 of each year, including
data for the preceding calendar year, that includes the following data
elements:
     The name of the eligible investigational drug and
applicable investigational new drug application number.
     The number of doses supplied to the eligible patient.
     The number of eligible patients treated.
     The use for which the eligible investigational drug was
made available to the eligible patient.
     Any known serious adverse events and outcomes that the
eligible patient treated with an eligible investigational drug
experienced.
    Description of Respondents: Respondents to the information
collection are sponsors and manufacturers who provide an eligible
investigational drug to eligible patients in accordance with the Right
to Try Act and will submit to FDA annual summaries.
    In the Federal Register of September 14, 2022 (87 FR 56269), we
published a final rule (RIN 0910-AI36), including an analysis of the
information collection, and discussed the development of an associated
form to facilitate submission of the requisite information.
Accordingly, we have developed Form FDA 5023 entitled ``Right To Try
Reporting Requirement: Annual Summary,'' which is currently available
in the docket for comment purposes only, and we are inviting public
comment. As required by the applicable statute, section 561B of the
FD&C Act (21 U.S.C. 360bbb-0a), the information is submitted to an FDA-
designated point of contact, and in accordance with instructions to be
posted at: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                     Activity; 21 CFR citation                          Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sponsors and manufacturers submit annual summaries in accordance                  6                1                6              2.5               15
 with the Right to Try Act (Sec.   300.200) using Form FDA 5023....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Consistent with estimates in our Final Regulatory Impact Analysis
for the associated final rule, we estimate that six sponsors and
manufacturers will prepare and submit Form FDA 5023 and assume it takes
2.5 hours to prepare and submit each summary, which results in a total
of 15 hours annually.

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23035 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 122 (Monday, June 25, 2018)]
[Rules and Regulations]
[Pages 29451-29454]
[FR Doc No: 2018-13450]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2017-0387; FRL-9979-78-Region 4]

Air Plan Approval; SC; Definitions and Open Burning

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve changes to the South Carolina State Implementation
Plan (SIP) to revise definitions and a regulation for open burning. EPA
is approving portions of SIP revisions submitted by the State of South
Carolina, through the South Carolina Department of Health and
Environmental Control (SC DHEC) on the following dates: July 18, 2011,
June 17, 2013, April 10, 2014, August 8, 2014, and July 27, 2016. These
actions are being taken pursuant to the Clean Air Act (CAA or Act).

DATES: This rule will be effective July 25, 2018.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2017-0387. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT:  D. Brad Akers, Air Regulatory
Management Section, Air Planning and Implementation Branch, Pesticides
and Toxics Management Division, Region 4, U.S. Environmental Protection
Agency, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Akers
can be reached via electronic mail at [email protected] or via
telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?

    On July 18, 2011, June 17, 2013, April 10, 2014, August 8, 2014,
and July 27, 2016, SC DHEC submitted SIP revisions to EPA for approval
that involve changes to South Carolina's SIP regulations to add
definitions, make administrative and clarifying amendments, and correct
typographical errors. These SIP submittals make changes to several air
quality rules in South Carolina Code of Regulations Annotated (S.C.
Code Ann. Regs.). The changes EPA is approving into the SIP in this
action modify portions of Regulation 61-62.1 ``Definitions and General
Requirements'' at Section I--``Definitions'' and make a revision to
Regulation 61-62.2,--``Prohibition of Open Burning.''
    At this time, EPA is not acting on the changes detailed in Table 1
below, which include portions of several SIP submittals that EPA has
approved previously. EPA will address all remaining requested changes
to the South Carolina SIP in the relevant SIP submissions as listed
below in a separate action.
---------------------------------------------------------------------------

    \1\ In its July 18, 2011, submittal, South Carolina is removing
entirely a rule for setting alternative emission limitations at
Regulation 61-62.5, Standard No. 6, ``Alternative Emission
Limitation Options (`Bubble'),'' and replacing it with ``Reserved.''
This change is not presently before EPA for action because
Regulation 61-62.5, Standard No. 6 is not part of the State's
federally approved SIP. EPA rescinded the original approval of this
regulation and disapproved a further revision to it on March 8, 1995
(60 FR 12700).
    \2\ EPA did not approve one portion of 61-62.5, Standard No. 7
from the April 10, 2014 submittal making revisions to certain
provisions corresponding to EPA's May 1, 2007 rule regarding ethanol
production facilities (72 FR 24060). EPA will evaluate this portion
of the April 10, 2014 submittal in a separate action.

          Table 1--Other Portions of South Carolina Submittals
------------------------------------------------------------------------
          Submittal                Regulation              Status
------------------------------------------------------------------------
July 18, 2011...............  Regulation 61-62.1,   EPA will evaluate in
                               Section II.           a separate action.
July 18, 2011...............  Regulation 61-62.5,   EPA will evaluate in
                               Standard No. 1.       a separate action.
July 18, 2011...............  Regulation 61-62.5,   Approved April 3,
                               Standard No. 2.       2013 (78 FR 19994).
July 18, 2011...............  Regulation 61-62.3..  Approved August 21,
                                                     2017 (82 FR 39537).
July 18, 2011...............  Regulation 61-62.5,   EPA will evaluate in
                               Standard No. 4.       a separate action.
July 18, 2011...............  Regulation 61-62.5,   Not part of the
                               Standard No. 6.       SIP.\1\
July 18, 2011...............  Regulation 61-62.5,   Approved August 10,
                               Standard No. 7.       2017 (82 FR 37299).
July 18, 2011...............  Regulation 61-62.5,   Approved August 10,
                               Standard No. 7.1.     2017 (82 FR 37299).
June 17, 2013...............  Regulation 61-62.1,   EPA will evaluate in
                               Section II.           a separate action.
June 17, 2013...............  Regulation 61-62.1,   Approved August 21,
                               Section IV.           2017 (82 FR 39537).
June 17, 2013...............  Regulation 61-62.3..  Approved August 21,
                                                     2017 (82 FR 39537).
June 17, 2013...............  Regulation 61-62.5,   EPA will evaluate in
                               Standard No. 4.       a separate action.
June 17, 2013...............  Regulation 61-62.5,   Approved August 16,
                               Standard No. 5.       2017 (82 FR 38825).
April 10, 2014..............  Regulation 61-62.5,   Partially approved
                               Standard No. 7.       August 10, 2017 (82
                                                     FR 37299).\2\
April 10, 2014..............  Regulation 61-62.6..  Approved August 21,
                                                     2017 (82 FR 39537).
August 8, 2014..............  Regulation 61-62.1,   EPA will evaluate in
                               Section II.           a separate action.
August 8, 2014..............  Regulation 61-62.1,   Approved June 12,
                               Section III.          2015 (80 FR 33413)
                                                     and May 31, 2017
                                                     (82 FR 24851).
August 8, 2014..............  Regulation 61-62.1,   Approved August 21,
                               Section IV.           2017 (82 FR 39537).
August 8, 2014..............  Regulation 61-62.1,   Approved August 21,
                               Section V.            2017 (82 FR 39537).
August 8, 2014..............  Regulation 61-62.5,   EPA will evaluate in
                               Standard No. 1.       a separate action.
August 8, 2014..............  Regulation 61-62.5,   EPA will evaluate in
                               Standard No. 4.       a separate action.
July 27, 2016...............  Regulation 61-62.1,   EPA will evaluate in
                               Section II.           a separate action.
July 27, 2016...............  Regulation 61-62.5,   EPA will evaluate in
                               Standard No. 4.       a separate action.

July 27, 2016...............  Regulation 61-62.5,   EPA will evaluate in
                               Standard No. 5.2.     a separate action.
------------------------------------------------------------------------

II. Background

    On August 21, 2017, EPA published a proposed rulemaking (82 FR
39551), which accompanied a direct final rulemaking (82 FR 39537)
published on the same date. The proposed rule proposed to approve the
portions of South Carolina's SIP revisions described above. It also
stated that if EPA received adverse comment on the direct final rule,
then the Agency would withdraw the direct final rule and address public
comments received in a subsequent final rule based on the proposed
rule. EPA received one adverse comment letter from a Commenter
regarding the portion of the direct final rule revising Regulation 61-
62.1, Section I--``Definitions,'' and the revision to Regulation 61-
62.2,--``Prohibition of Open Burning,'' and EPA accordingly withdrew
those portions of the direct final rule proposing to approve changes to
these rules on October 13, 2017 (82 FR 47636). After considering the
adverse comments, EPA is now taking final action, based on the proposed
rule, on the portions of South Carolina's SIP revisions modifying
Regulation 61-62.1, Section I and Regulation 61-62.2, as described
above.

III. Analysis of South Carolina's Submittals

A. Definitions

    South Carolina is amending its list of applicable definitions
related to the regulation of air quality at Regulation 61-62.1, Section
I--``Definitions.'' The July 18, 2011, submittal makes several changes
to the definitions as follows: (1) Adds a definition for ``CAA [Clean
Air Act];'' (2) adds definitions for ``PM2.5,'' or fine
particulate matter with an aerodynamic diameter less than or equal to a
nominal 2.5 micrometers, and ``PM2.5 emissions;'' (3)
revises the definition of ``fugitive emissions'' to match the federal
definition at 40 CFR 51.165(a)(1)(ix), 40 CFR 51.166(b)(20), and 40 CFR
52.21(b)(20); and (4) makes other clarifying and administrative edits
to definitions throughout Section I, including renumbering. The June
17, 2013, submittal further revises the definitions to make several
administrative edits only.
    The April 10, 2014, submittal makes one revision to the definitions
at Regulation 61-62.1, Section I.94.--``Volatile Organic Compound
(VOC),'' to add a compound to the list of compounds determined by EPA
to have negligible photochemical reactivity and therefore exempted from
being considered a VOC, consistent with the federal definition. This
revision in the April 10, 2014, submittal was superseded by another
revision to the definition of VOC at I.94. in the August 8, 2014,
submittal. This latter submittal changes the format of the definition
of VOC at I.99., renumbered from I.94., to incorporate directly the
list of compounds exempted by EPA from the federal regulatory
definition of VOC by making an explicit reference to the definition at
40 CFR 51.100(s). The August 8, 2014, submittal also revises Section I
by: (1) Adding definitions for ``Code of Federal Regulations (CFR),''
``NAICS [North American Industrial Classification System] Code,'' and
``SIC [Standard Industrial Classification] Code''; and (2) making
administrative changes throughout.
    Finally, the July 27, 2016, submittal makes subsequent revisions to
Section I to add the definition of ``emission'' and makes
administrative edits throughout. EPA has reviewed the changes made to
South Carolina's definitions and is approving the aforementioned
changes to Regulation 61-62.1, Section I into the SIP pursuant to CAA
section 110 because the revisions are consistent with the CAA.

B. Open Burning

    South Carolina is making a minor change to its rules covering open
burning at Regulation 61-62.2--``Prohibition of Open Burning.'' The
April 10, 2014, submittal revises the regulation to make an
administrative edit to a referenced manual only and makes no
substantive changes. Specifically, the State is changing the font for
the referenced manual for internal consistency. EPA has reviewed this
purely administrative change made to South Carolina's rules for open
burning and is approving the aforementioned change to Regulation 61-
62.2 into the SIP pursuant to CAA section 110.

IV. Response to Comments

    As noted above, EPA previously proposed to approve these changes,
and others, to the South Carolina SIP on August 21, 2017 (82 FR 39551),
along with a direct final rule published the same date (82 FR 39537).
EPA received adverse comments from a Commenter regarding the portions
of the direct final rule revising Regulation 61-62.1, Section I--
``Definitions,'' and the revision to Regulation 61-62.2,--``Prohibition
of Open Burning,'' and EPA accordingly withdrew those portions of the
direct final rule on October 13, 2017 (82 FR 47636). EPA's responses to
the adverse comments are below.

A. Definitions

    The Commenter stated that South Carolina's definition of
PM2.5 ``should also include condensable and filterable PM.''
South Carolina's SIP, under Regulation 61-62.1, Section I, defines
PM2.5 as ``[p]articulate matter with an aerodynamic diameter
less than or equal to a nominal 2.5 micrometers emitted to the ambient
air as measured by a reference method based on Appendix L of 40 CFR 50
and designated in accordance with 40 CFR 53 or by an equivalent method
designated in accordance with 40 CFR 53.'' This definition is
consistent with the way EPA uses the term in federal regulations. For
example, PM2.5 is defined in the National Ambient Air
Quality Standards as ``particles with an aerodynamic diameter less than
or equal to a nominal 2.5 micrometers.'' (See 40 CFR 50.7, 50.13 and
50.18.) Therefore, EPA disagrees with the Commenter's implication that
South Carolina's definition of PM2.5 is not sufficient.
    Although the Commenter did not mention South Carolina's definition
of ``PM2.5 emissions,'' EPA notes that the State has added
this term to R. 61-62.1 and defines it as ``[f]inely divided solid or
liquid material with an aerodynamic diameter less than or equal to a
nominal 2.5 micrometers emitted to the ambient air as measured by a
reference method approved by the Department, with concurrence of the
U.S. Environmental Protection Agency.'' With regard to ``filterable
PM'' as mentioned by the Commenter, this component is included in the
definition as ``[f]inely divided solid . . . material'' emitted to the
ambient air. With regard to ``condensable PM'' as mentioned by the
Commenter, South Carolina's definition differs from the federal
definition of

``direct PM2.5 emissions'' \3\ in that it does not specify
the inclusion of ``condensable PM2.5 emissions.'' However,
South Carolina's definition is sufficient for purposes of the State's
SIP because, as explained below, the condensable component of source
PM2.5 emissions will be included whenever a determination of
a source's PM2.5 emissions is required.
---------------------------------------------------------------------------

    \3\ Under the federal definition, ``direct PM2.5
emissions'' means solid or liquid particles emitted directly from an
air emissions source or activity, or reaction products of gases
emitted directly from an air emissions source or activity which form
particulate matter as they reach ambient temperatures. Direct
PM2.5 emissions include filterable and condensable
PM2.5 emissions composed of elemental carbon, directly
emitted organic carbon, directly emitted sulfate, directly emitted
nitrate, and other organic or inorganic particles that exist or form
through reactions as emissions reach ambient temperatures (including
but not limited to crustal material, metals, and sea salt). 40 CFR
51.1000.
---------------------------------------------------------------------------

    The inclusion of the condensable component in determining a
source's PM2.5 emissions is driven by the applicable source
test method(s) required under a relevant rule. First, South Carolina's
federally approved SIP includes emission limits for ``PM'' but does not
include emission limits for ``PM2.5.'' Therefore,
``particulate matter emissions'' (as defined in the South Carolina
SIP), not ``PM2.5 emissions,'' is the term that is relevant
for the purpose of determining a source's status of compliance with
applicable PM emission limits of the South Carolina SIP. Second, South
Carolina's PSD rules (which apply throughout the State) and
Nonattainment New Source Review rules (which do not currently apply for
PM2.5 in the State) both require sources to include the
condensable portion of PM2.5 emissions. (See definitions of
``Regulated NSR pollutant'' at Regulation 61-62.5, Standard No.
7(b)(44)(i)(a) and Standard No. 7.1(c)(13)(D), respectively.) \4\
Third, under federal rules such as the New Source Performance Standards
(NSPS) and National Emission Standards for Hazardous Air Pollutants
(NESHAPs), whether the condensable PM2.5 component must be
measured is dictated by the testing methods that are specified to apply
under those rules. Finally, with regard to emissions inventories, EPA
has provided guidance to assist states in appropriately accounting for
the condensable PM2.5 component in making annual reports of
PM2.5 emissions.\5\ Moreover, the federal provisions
regarding regular emissions inventory reporting at subpart A to part 51
require states to include the condensable and filterable portions of
both PM2.5 and PM10 as applicable in the
triennial reports of annual emissions for all sources and the annual
reports of larger stationary source emissions. See 40 CFR
51.15(a)(1)(vi)-(vii).
---------------------------------------------------------------------------

    \4\ The specific adoption of condensable PM2.5 as a
regulated NSR pollutant was included in a March 14, 2011, SIP
revision, which was approved on June 23, 2011 (76 FR 36875), and
corrected for Standard No. 7 on August 10, 2017 (82 FR 37299).
    \5\ See ``Emissions Inventory Guidance for Implementation of
Ozone and Particulate Matter National Ambient Air Quality Standards
(NAAQS) and Regional Haze Regulations,'' EPA-454/B-17-003, July
2017.
---------------------------------------------------------------------------

    South Carolina's definition of ``PM2.5'' is consistent
with EPA's definition of the term. In addition, as discussed above,
omitting the phrase ``condensable PM2.5 emissions'' from
South Carolina's definition of ``PM2.5 emissions'' has no
effect on the State's implementation of its PM2.5 program
because the South Carolina SIP currently has no limits on
``PM2.5 emissions'' and because the other programs that
regulate particulate matter specify the required source test methods,
and those methods require measurement of the condensable component in
determining a source's PM2.5 emissions. Accordingly, EPA
considers South Carolina's definitions of these terms approvable under
the CAA.

B. Open Burning

    The Commenter suggests that EPA cannot approve changes to South
Carolina's open burning rules if the rules do not apply ``at all
times.'' EPA notes that no substantive change was made to the SIP-
approved rule at Regulation 61-62.2, Prohibition of Open Burning. The
only change made in the April 10, 2014, submittal was a change to the
font from italics to non-italics for a referenced manual within the
regulation. As stated in the proposed rule (82 FR 39551, August 21,
2017), EPA proposed to approve changes to the South Carolina SIP
submitted by SC DHEC. The existing text of Regulation 61-62.2 is
already part of South Carolina's federally approved SIP, and only the
revision to the rule (i.e., the font change) was subject to comment
through the proposal action. The change that was made is purely
administrative in nature, and the Commenter has not raised a concern
relevant to the revision. Nevertheless, EPA finds that Regulation 61-
62.2 adequately prescribes the conditions under which open burning is
allowed or prohibited. The only provisions of this rule related to
timing are 62.2.E.6., 62.2.G.4. and 62.2.G.5., which are restrictions,
not relaxations, on when open burning may be conducted in the State.
    EPA received no additional comments regarding the changes to
Regulation 61-62.1, Section I nor to the change made to Regulation 61-
62.2. The public comments received are located in the Docket for this
final action at www.regulations.gov.

V. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of South
Carolina Regulation 61-62.1, Section I--``Definitions,'' effective June
24, 2016, which revises definitions applicable to the SIP, and
Regulation 61-62.2, ``Prohibition of Open Burning,'' effective December
27, 2013, which revises formatting for consistency. EPA has made, and
will continue to make, these materials generally available through
www.regulations.gov and at the EPA Region 4 Office (please contact the
person identified in the For Further Information Contact section of
this preamble for more information). Therefore, these materials have
been approved by EPA for inclusion in the State's implementation plan,
have been incorporated by reference by EPA into that plan, are fully
federally-enforceable under sections 110 and 113 of the CAA as of the
effective date of the final rulemaking of EPA's approval, and will be
incorporated by reference in the next update to the SIP compilation.\6\
---------------------------------------------------------------------------

    \6\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VI. Final Action

    This is a final action based on the proposed rule (82 FR 39551).
For the reasons discussed above, EPA is approving the aforementioned
changes to the South Carolina SIP, submitted on July 18, 2011, June 17,
2013, April 10, 2014, August 8, 2014, and July 27, 2016, because they
are consistent with the CAA and federal regulations.

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:

     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this final action for the State of South Carolina does
not have Tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), because it does not have substantial
direct effects on an Indian Tribe. The Catawba Indian Nation
Reservation is located within the boundary of York County, South
Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C.
Code Ann. 27-16-120, ``all state and local environmental laws and
regulations apply to the [Catawba Indian Nation] and Reservation and
are fully enforceable by all relevant state and local agencies and
authorities.'' EPA notes this action will not impose substantial direct
costs on Tribal governments or preempt Tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 24, 2018. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, Volatile organic compounds.

    Dated: June 12, 2018.
Onis ``Trey'' Glenn, III,

Regional Administrator, Region 4.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42.U.S.C. 7401 et seq.

Subpart PP--South Carolina

0
2. In Sec.  52.2120, the table in paragraph (c) is amended by revising
under ``Regulation No. 62.1'' the entry ``Section I'' and the entry
``Regulation No. 62.2'' to read as follows:

Sec.  52.2120  Identification of plan.

* * * * *
    (c) * * *

                              Air Pollution Control Regulations for South Carolina
----------------------------------------------------------------------------------------------------------------
                                                       State
         State citation            Title/subject     effective   EPA approval date           Explanation
                                                        date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section I......................  Definitions......    6/24/2016  6/25/2018,         ............................
                                                                  [insert Federal
                                                                  Register
                                                                  citation].

                                                  * * * * * * *
Regulation No. 62.2............  Prohibition of      12/27/2013  6/25/2018,         ............................
                                  Open Burning.                   [insert Federal
                                                                  Register
                                                                  citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-13450 Filed 6-22-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24310-24311]
[FR Doc No: 2022-08726]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4206]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device User
Fee Small Business Qualification and Certification

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 25,
2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. All comments should be
identified with the OMB control number 0910-0508. Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-45, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Device User Fee Small Business Qualification and Certification

OMB Control Number 0910-0508--Extension

    This information collection helps support implementation of the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L.
107-250) and FDA's Medical Device User Fee program. Current
authorization for medical device user fees will be in place from
October 1, 2017, until September 30, 2022.
    Section 738(d)(2)(A) and (e)(2)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(d)(2)(A) and (e)(2)(A)) define a ``small
business'' as an entity that reported $100 million or less of gross
receipts or sales in its most recent Federal income tax return,
including such returns of its affiliates, partners, and parent firms.
If a firm's gross receipts or sales are no more than

$30 million (including all affiliates, partners, and parent firms),
they will also qualify for a waiver of the fee for their first (ever)
premarket application, product development protocol, biological
licensing application, or premarket report. A ``small business'' is
eligible for reduced or waived fees. If an applicant does not provide
information to FDA demonstrating to FDA's satisfaction that the
applicant is a small business, the applicant must pay the standard
(full) fee for any application it submits.
    Forms FDA 3602 (``MDUFA Small Business Certification Request for a
Business Headquartered in the United States'') and 3602A (``MDUFA
Foreign Small Business Certification Request for a Business
Headquartered Outside the United States'') are submitted to FDA to
demonstrate that an applicant qualifies as a MDUFA small business. The
guidance ``Medical Device User Fee Small Business Qualification and
Certification; Guidance for Industry, Food and Drug Administration
Staff and Foreign Governments'' \1\ describes the process by which a
business may request certification as a small business and the criteria
FDA will use to decide whether an entity qualifies as a MDUFA small
business and is eligible for a reduction in user fees.
---------------------------------------------------------------------------

    \1\ The guidance ``Medical Device User Fee Small Business
Qualification and Certification Guidance for Industry, Food and Drug
Administration Staff and Foreign Governments'' is available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification.
---------------------------------------------------------------------------

    In the Federal Register of December 23, 2021 (86 FR 72983), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received, however it did not
respond to the functional elements solicited in our 60-day notice or
suggest a revision to our burden estimate.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
          FDA form No.               Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
FDA 3602--MDUFA Small Business             2,500               1           2,500               1           2,500
 Certification Request For a
 Business Headquartered in the
 United States..................
FDA 3602A--MDUFA Foreign Small             2,000               1           2,000               1           2,000
 Business Certification Request
 For a Business Headquartered
 Outside the United States......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden is based on the number of applications
received in the last few years and includes the time we assume
necessary to prepare and submit required information. Based on our
experience with Forms FDA 3602 and 3602A, we assume it will take
respondents 1 hour to complete either form. We have adjusted our
estimated ``No. of Respondents'' to better reflect recent submission
volume. This adjustment results in a 2,500-hour decrease to the
information collection.

    Dated: April 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08726 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 24, 2010 (Volume 75, Number 226)]
[Rules and Regulations]
[Page 71534-71535]
[DOCID:fr24no10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0764; Directorate Identifier 2009-NM-260-AD;
Amendment 39-16519; AD 2010-24-01]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 737-900ER
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD requires doing a one-time general visual
inspection for a keyway in two fuel tank access door cutouts, and
related investigative and corrective actions if necessary. This AD was
prompted by reports of cracks emanating from the keyway of the fuel
tank access hole. We are issuing this AD to detect and correct such
cracking, which could result in the loss of the lower wing skin load
path and consequent structural failure of the wing.

DATES: This AD is effective December 29, 2010.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of December 29,
2010.

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
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: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6440; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
the specified products. That NPRM published in the Federal Register on
August 10, 2010 (75 FR 48281). That NPRM proposed to require a general
visual inspection for a keyway in the fuel tank access door cutout on
the left and right wings, and related investigative and corrective
actions if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comments received. The Boeing Company
supports the NPRM. Continental Airlines submitted information to make a
comment, but no specific comment on the NPRM or request to change it.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD as proposed.

Costs of Compliance

    We estimate that this AD affects 30 airplanes of U.S. registry. We
estimate that it will take 3 work-hours per product to comply with this
AD. The average labor rate is $85 per work-hour. Based on these
figures, we estimate the cost of the AD to the U.S. operators to be
$7,650, or $255 per product.

Authority for This Rulemaking

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

Regulatory Findings

    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) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 adding the following new airworthiness
directive (AD):

2010-24-01 The Boeing Company: Amendment 39-16519; Docket No. FAA-
2010-0764; Directorate Identifier 2009-NM-260-AD.

Effective Date

    (a) This AD is effective December 29, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to The Boeing Company Model 737-900ER series
airplanes, certificated in any category, as identified in Boeing
Alert Service Bulletin 737-57A1308, Revision 1, dated October 1,
2009.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Unsafe Condition

    (e) This AD results from reports of cracks emanating from the
keyway of the fuel tank access hole. The Federal Aviation
Administration is issuing this AD to detect and correct such
cracking, which could result in the loss of the lower wing skin load
path and consequent structural failure of the wing.

Compliance

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

Inspection

    (g) Before the accumulation of 7,500 total flight cycles, or
within 1,000 flight cycles after the effective date of this AD,
whichever occurs later, do a one-time general visual inspection for
a keyway in the fuel tank access door cutouts 531BB and 631BB, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-57A1308, Revision 1, dated October 1, 2009
(``the service bulletin'').

    Note 1: For the purposes of this AD, a general visual inspection
is: ``A visual examination of an interior or exterior area,
installation, or assembly to detect obvious damage, failure, or
irregularity. This level of inspection is made from within touching
distance unless otherwise specified. A mirror may be necessary to
ensure visual access to all surfaces in the inspection area. This
level of inspection is made under normally available lighting
conditions such as daylight, hangar lighting, flashlight, or
droplight and may require removal or opening of access panels or
doors. Stands, ladders, or platforms may be required to gain
proximity to the area being checked.''

    (1) If both access door cutouts do not have a keyway, no further
action is required by this AD.
    (2) If any access door has a keyway, before the accumulation of
7,500 total flight cycles, or within 1,000 flight cycles after the
effective date of this AD, whichever occurs later, do a high
frequency eddy current (HFEC) inspection for cracking of the keyway,
in accordance with the Accomplishment Instructions of the service
bulletin.
    (i) If no cracking is found during the HFEC inspection, before
further flight, modify the profile of the keyway of the fuel tank
access door cutout, in accordance with the Accomplishment
Instructions of the service bulletin.
    (ii) If any cracking is found and the crack is 0.030 inch or
less in length, before further flight repair the keyway, in
accordance with the Accomplishment Instructions of the service
bulletin.
    (iii) If any cracking is found and the crack is greater than
0.030 inch in length, before further flight, repair the crack using
a method approved in accordance with the procedures specified in
paragraph (h) of this AD.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Nancy Marsh, Aerospace Engineer, Airframe Branch, ANM-120S,
FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
917-6590. Information may be e-mailed to: 9-ANM-Seattle-ACO-AMOC-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

Related Information

    (i) For more information about this AD, contact Nancy Marsh,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>
Material Incorporated by Reference

    (j) You must use the Boeing Alert Service Bulletin 737-57A1308,
Revision 1, dated October 1, 2009, to do the actions required by
this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on November 5, 2010.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-28936 Filed 11-23-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58670-58671]
[FR Doc No: 2017-26820]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82229; File No. SR-ISE-2017-95]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Clarify the
Application of the Crossing Fee Cap

December 7, 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 November 28, 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 Schedule of Fees to
clarify the application of the Crossing Fee Cap.
    The text of the proposed rule change is available on the Exchange's
website at http://ise.cchwallstreet.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 provide greater
clarity as to the manner in which the Exchange applies the Crossing Fee
Cap.
    By way of background, Crossing Orders are contracts that are
submitted as part of a Facilitation, Solicitation, PIM, Block or QCC
Order. Crossing Order fees are capped at $90,000 per month per member
on all Firm Proprietary and Non-Nasdaq ISE Market Maker transactions
that are part of the originating or contra side of a Crossing Order.\3\
The following fees are not included in the calculation of the monthly
Crossing Fee Cap: (1) Fees for Responses to Crossing Orders; (2)
surcharge fees for licensed products and the fees for index options as
set forth in Section I; and (3) service fee.\4\ The manner in which the
Exchange calculates the Crossing Fee Cap is not changing.
---------------------------------------------------------------------------

    \3\ Members that elect prior to the start of the month to pay
$65,000 per month will have these crossing fees capped at that level
instead. All eligible volume from affiliated Members is aggregated
for purposes of the Crossing Fee Cap, provided there is at least 75%
common ownership between the Members as reflected on each Member's
Form BD, Schedule A.
    \4\ A service fee of $0.00 per side applies to all order types
that are eligible for the fee cap. The service fee does not apply
once a Member reaches the fee cap level and does apply to every
contract side above the fee cap. A Member who does not reach the
monthly fee cap will not be charged the service fee. Once the fee
cap is reached, the service fee applies to eligible Firm Proprietary
and Non-Nasdaq ISE market Maker orders in all Nasdaq ISE products.
The service fee is not calculated in reaching the cap.
---------------------------------------------------------------------------

    The Exchange proposes to make clear how it attributes eligible
volume for purposes of the Crossing Fee Cap. The Exchange proposes to
add the following language to the rule text, ``For purposes of the
Crossing Fee Cap the Exchange will attribute eligible volume to the ISE
Member on whose behalf the Crossing Order was executed.'' Only ISE
Members are subject to the Crossing Fee Cap. This is the manner in
which the Exchange attributes eligible volume for purposes of the
Crossing Fee Cap today. To provide greater transparency to the Schedule
of Fees, the Exchange proposes to include this language in the rule
text. While the Exchange is not aware of any confusion with respect to
this fee with its Members, the Exchange believes this specificity will
avoid any confusion.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\6\ 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.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange's proposal to add the clarifying language regarding
the Crossing Fee Cap to the Schedule of Fees is reasonable because the
proposed rule text will bring greater clarity to the manner in which
the Exchange attributes eligible volume for purposes of the Crossing
Fee Cap today and applies the Crossing Fee Cap. The calculation and the
application of the Crossing Fee Cap are not changing with this
proposal. This rule text is intended to provide additional clarity to
the current rule to describe who benefits from the volume for purposes
of the application of the cap.
    The Exchange's proposal to add the clarifying language regarding
the Crossing Fee Cap to the Schedule of Fees is equitable and not
unfairly discriminatory because the Exchange

will continue to calculate and apply the Crossing Fee Cap in a uniform
manner to all ISE Members that are eligible for this cap.

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 proposal is intended to
provide greater transparency to the Schedule of Fees and does not amend
the current manner in which the Exchange calculates or applies the
Crossing Fee Cap. The Exchange's proposal to add the clarifying
language regarding the Crossing Fee Cap to the Schedule of Fees does
not impose an undue burden on competition because the Exchange will
continue to calculate and apply the Crossing Fee Cap in a uniform
manner to all ISE Members that are eligible for this cap.

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,\7\ and Rule 19b-4(f)(2) \8\ 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.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 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-2017-95 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-2017-95. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 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-2017-95 and should be submitted on
or before January 3, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-26820 Filed 12-12-17; 8:45 am]
BILLING CODE 8011-01-P