[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Notices]
[Pages 24193-24196]
[FR Doc No: 2023-08277]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1168]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
statutory and regulatory requirements that govern certain human cells,
tissues, and cellular and tissue-based products (HCT/Ps).

DATES: Either electronic or written comments on the collection of
information must be submitted by June 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 20, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-1168 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Cells, Tissues, and
Cellular and Tissue-Based Products.'' Received comments, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information

redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpoinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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

Human Cells, Tissues, and Cellular and Tissue-Based Products--21 CFR
Part 1271

OMB Control Number 0910-0543--Extension

    This information collection helps support the implementation of
statutory and regulatory requirements that govern certain human cells,
tissues, and cellular and tissue-based products (HCT/Ps). Manufacturers
of HCT/Ps regulated solely under the authority of section 361 of the
Public Health Service Act (the PHS Act) (42 U.S.C. 264) are required to
register and list HCT/Ps pursuant to part 1271 (21 CFR part 1271)
whether or not the HCT/P enters into interstate commerce. Manufacturers
of HCT/Ps regulated as drugs, devices and/or biological products under
section 351 of the PHS Act (42 U.S.C. 262) and/or section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), are required to
register and list HCT/Ps following the procedures in part 207 (21 CFR
part 207) (if a drug and/or biological product) or part 807 (21 CFR
part 807) (if a device). Information collection associated with the
registration and listing requirements in parts 207 and 807 are
currently approved in OMB control numbers 0910-0045 and 0910-0625,
respectively.
    Agency regulations in part 1271 set forth general provisions
applicable to HCT/Ps in subpart A (Sec. Sec.  1271.1 through 1271.20).
Those HCT/Ps that are regulated solely under the authority of section
361 of the PHS Act are described in Sec.  1271.10. Provisions in part
1271, subpart B (Sec. Sec.  1271.21 through 1271.37), establish
procedures for registration and listing including format and content
elements along with scheduled timeframes for the submission of certain
information and action by FDA. The regulations also provide for waivers
from the electronic format requirement, amendments to establishment
registration, and requesting information on registration and listing
from FDA.
    Registrants use Form FDA 3356, Establishment Registration and
Listing for HCT/Ps, to submit HCT/P establishment registration and
listing information to the Electronic Human Cell and Tissue
Establishment Registration System (eHCTERs). Electronic submission of
HCT/P establishment and product listing information is required under
Sec.  1271.22. However, a request for waiver of the electronic
submission requirement may be submitted pursuant to Sec.  1271.23. If
the waiver request is granted, Form FDA 3356 (and accompanying
instructions) may be downloaded to complete and submit by mail. The
Tissue Establishment Registration page (https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration) provides access to eHCTERs, instructions
for using eHCTERs, and other resource information that may be helpful
to respondents.
    Provisions in part 1271, subpart C (Sec. Sec.  1271.45 through
1271.90), establish requirements for determining donor eligibility,
including donor screening and testing, explaining these requirements
are a component of current good tissue practice (CGTP) requirements set
forth in part 1271, subpart D (Sec. Sec.  1271.145 through 1271.320).
The provisions in part 1271, subparts C and D, govern the methods used
in, and the facilities and controls used for, the manufacture of HCT/
Ps, including but not limited to all steps in recovery, donor
screening, donor testing, processing, storage, labeling, packaging, and
distribution.
    The regulations in part 1271, subpart E and subpart F (Sec. Sec.
1271.330 through 1271.440), establish additional requirements for
establishments described in Sec.  1271.10, including inspection and
enforcement provisions, and recordkeeping requirements providing for
the retention, notification to third parties, and disclosure of such
records to FDA.
    Description of Respondents: Respondents to this information
collection are establishments that recover, process, store, label,
package, or distribute any HCT/P that is regulated solely under section
361 of the PHS Act and regulations in part 1271 or perform donor
screening or testing.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
     21 CFR section; reporting activities          Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses                                                    \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b); register and               2,374               1           2,374  0.5 (30 minutes)........................           1,187
 submit list of each HCT/P manufactured by
 existing establishments.
1271.10(b)(1) and (2), 1271.21(a), and                     157               1             157  0.75 (45 minutes).......................             118
 1271.25(a) and (b); register and submit list
 of each HCT/P manufactured by new
 establishments.
1271.10(b)(2), 1271.21(c)(2)(ii), and                      566               1             566  0.5 (30 minutes)........................             283
 1271.25(c); update list.
1271.23; request electronic format waiver.....               1               1               1  1.......................................               1
1271.26; location/ownership amendments........             346               1             346  0.25 (15 minutes).......................              87
1271.155(a); request exemption or alternative               18           1.333              24  3.......................................              72
 to any requirement.
1271.350(a)(1) and (3); investigate and report              15          14.266             214  1.......................................             214
 adverse actions.
1271.420(a); notify FDA (imports).............             200             2.8             560  0.25 (15 minutes).......................             140
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............          23.399           4,242  ........................................           2,102
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the nearest whole number.

    Based on current data from eHCTERS, we estimate there are 2,374
HCT/P current registrants and 157 new registrants, for a total of 2,531
respondents annually. Information collection provisions that include
reporting activities are identified in table 1. The estimated burden
for each of the individual reporting activities was calculated based on
the annual number of submissions, averaged among respondents, and based
on informal communications with industry.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
   21 CFR part 1271; establish and maintain       Number of      records per    Total annual                                                Total hours
                   records                      recordkeepers   recordkeeper       records       Average  burden per  recordkeeping \2\         \3\
                                                                     \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.47; Establishing SOPs...................             157               1             157  48.......................................           7,536
1271.47; Updating SOPs.......................           2,374               1           2,374  24.......................................          56,976
1271 Subpart C & Subpart D: Establishing and            2,531        3,311.36       8,381,049  0.26 (~15 minutes).......................       2,170,493
 maintaining records documenting methods used
 in, and the facilities and controls used
 for, the manufacture of HCT/Ps, including
 but not limited to all steps in recovery,
 donor screening, donor testing, processing,
 storage, labeling, packaging, and
 distribution.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............       8,383,580  .........................................       2,235,005
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded to the nearest hundredth.
\3\ Rounded to the nearest whole number.

    To calculate burden associated with the establishment and
maintenance of operating procedures in accordance with applicable CGTP
requirements, we assume twice the time is necessary for new
establishments. Burden we attribute to recordkeeping activities
associated with the remaining provisions in part 1271 is assumed to be
distributed among the individual elements and averaged among
respondents.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR part 1271--human cells, tissues, and                      Number of
    cellular and tissue-based products;         Number of     disclosures per    Total annual     Average  burden per  disclosure \2\      Total hours
                  activity                     respondents     respondent \2\    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosing information as required under              1,611         4,984.75        8,030,435   0.30 (~18 minutes).....................       2,389,226
 applicable good manufacturing practices/
 CGTP provisions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded to the nearest hundredth.

    As part of the recordkeeping requirements, certain provisions in
part 1271 require the disclosure of information to third parties,
particularly as it pertains to the distribution of HCT/Ps. We estimate
a proportion of the respondents to the information collection (1,611)
will incur burden resulting from these disclosures and have therefore
accounted for burden that may be attributable to these distinct
activities.
    Our estimated burden for the information collection reflects an
overall reduction of 150,137 hours and 347,843 responses annually,
which corresponds to a decrease in the number HCT/P establishments and
a decrease in the number HCT/Ps distributed since our last evaluation.

    Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08277 Filed 4-18-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Rules and Regulations]
[Pages 22364-22367]
[FR Doc No: 2023-07737]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1482; Project Identifier MCAI-2022-00697-T;
Amendment 39-22389; AD 2023-06-03]
RIN 2120-AA64

Airworthiness Directives; De Havilland Aircraft of Canada Limited
(Type Certificate Previously Held by Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain De Havilland Aircraft of Canada Limited Model DHC-8-401 and -
402 airplanes. This AD was prompted by an investigation of incorrectly
manufactured sleeves that were potentially installed in the main
landing gear (MLG) forward door linkage assembly. This AD requires
review of technical records and inspections to determine if a
discrepant sleeve is installed, replacement of any discrepant sleeve
and re-identification of the MLG forward door linkage assembly. This AD
also prohibits the installation of affected parts. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective May 18, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 18,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at under Docket No. FAA-
2022-1482; 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 mandatory continuing airworthiness information
(MCAI), any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket

Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact De Havilland Aircraft of Canada Limited, Dash 8 Series Customer
Response Centre, 5800 Explorer Drive, Mississauga, Ontario, L4W 5K9,
Canada; telephone North America (toll-free):<PHONE_NUMBER>, Direct: 647-
277-5820; email dehavilland.com">[email protected]dehavilland.com; website dehavilland.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-1482.

FOR FURTHER INFORMATION CONTACT: Gabriel Kim, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain De Havilland
Aircraft of Canada Limited Model DHC-8-401 and -402 airplanes. The NPRM
published in the Federal Register on November 25, 2022 (87 FR 72424).
The NPRM was prompted by AD CF-2022-29, dated May 27, 2022, issued by
Transport Canada, which is the aviation authority for Canada (referred
to after this as the MCAI). The MCAI states that some forward door
linkage sleeves, part number (P/N) 46878-1, have been manufactured
without lubrication grooves on the outer diameter. An investigation
confirmed that incorrectly manufactured sleeves were potentially
supplied from October 2019 to July 2021. A discrepant sleeve with
missing lubrication grooves can result in the fatigue failure of the
forward door linkage, leading to possible interference with the
extension or retraction of the corresponding MLG. This condition, if
not corrected and when combined with other failures, could result in an
asymmetric MLG configuration at landing and a subsequent runway
excursion.
    In the NPRM, the FAA proposed to require review of technical
records and inspections to determine if a discrepant sleeve is
installed, replacement of any discrepant sleeve and re-identification
of the MLG forward door linkage assembly. The FAA also proposed to
prohibit the installation of affected parts. The FAA is issuing this AD
to address the unsafe condition on these products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1482.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from The Air Line Pilots Association,
International (ALPA), who supported the NPRM without change.
    The FAA received an additional comment from Horizon Air. The
following presents the comment received on the NPRM and the FAA's
response to the comment.

Request To Refer to Latest Revision of Service Bulletin and Allow
Credit for Required Actions Using Previous Service Bulletin

    Horizon Air stated De Havilland Aircraft of Canada Limited Service
Bulletin 84-32-169, Revision A, dated July 21, 2022, has been released.
Horizon Air asked the FAA to revise the proposed AD to refer to De
Havilland Aircraft of Canada Limited Service Bulletin 84-32-169,
Revision A, dated July 21, 2022. Horizon Air also asked the FAA to
allow credit for required actions done in accordance with De Havilland
Aircraft of Canada Limited Service Bulletin 84-32-169, dated February
28, 2022, prior to the effective date of the AD.
    The FAA agrees to use the updated service information. De Havilland
Aircraft of Canada Limited Service Bulletin 84-32-169, Revision A,
dated July 21, 2022, including Collins Aerospace Service Bulletin
46860-32-150, Revision 1, dated June 28, 2022, does not substantively
affect the requirements proposed in the NPRM and only makes minor
changes by adding references to an advisory document and the MCAI AD.
The FAA has revised this final rule to refer to De Havilland Aircraft
of Canada Limited Service Bulletin 84-32-169, Revision A, dated July
21, 2022, including Collins Aerospace Service Bulletin 46860-32-150,
Revision 1, dated June 28, 2022. The FAA has also added paragraph (i)
to this AD to provide credit for actions done in accordance with De
Havilland Aircraft of Canada Limited Service Bulletin 84-32-169, dated
February 28, 2022, including Collins Aerospace Service Bulletin 46860-
32-150, dated February 1, 2022, prior to the effective date of this AD.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data, considered the
comments received, and determined that air safety requires adopting
this AD as proposed. Accordingly, the FAA is issuing this AD to address
the unsafe condition on this product. Except for minor editorial
changes, and any other changes described previously, this AD is adopted
as proposed in the NPRM. None of the changes will increase the economic
burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed De Havilland Aircraft of Canada Limited Service
Bulletin 84-32-169, Revision A, dated July 21, 2022, including Collins
Aerospace Service Bulletin 46860-32-150, Revision 1, dated June 28,
2022. This service information specifies procedures for review of the
airplane records to determine the date of replacement, if any, of
sleeve P/N 46878-1, a visual inspection of affected sleeves for the
presence of lubrication grooves, and a visual inspection of the swivel
link, clevis assembly, and swivel end assembly for discrepancies
including signs of damage, deformation, erosion, and corrosion.
Corrective actions include replacement of any sleeve that has missing
lubrication grooves; repair or replacement of any discrepant swivel
link, clevis assembly, and swivel end assembly; and re-identification
of the forward door linkage. Assemble the forward door linkage, torque
self-locking nuts, and re-install the forward door linkage assemblies.
    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

    The FAA estimates that this AD affects 56 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
3 work-hours x $85 per hour = $255...........................              $0             $255          $14,280
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
3 work-hours x $85 per hour = $255 to           $1,284           $1,539
 replace the sleeve...................
------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the on-condition repairs specified in this AD.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2023-06-03 De Havilland Aircraft of Canada Limited (Type Certificate
Previously Held by Bombardier, Inc.): Amendment 39-22389; Docket No.
FAA-2022-1482; Project Identifier MCAI-2022-00697-T.

(a) Effective Date

    This airworthiness directive (AD) is effective May 18, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to De Havilland Aircraft of Canada Limited (type
certificate previously held by Bombardier, Inc.) Model DHC-8-401 and
-402 airplanes, certificated in any category, serial numbers 4001,
4003 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear.

(e) Unsafe Condition

    This AD was prompted by an investigation of incorrectly
manufactured sleeves that were potentially installed in the main
landing gear (MLG) forward door linkages. The FAA is issuing this AD
to address the discrepant sleeves with missing lubrication grooves,
which can result in the fatigue failure of the forward door linkage,
leading to possible interference with the extension or retraction of
the corresponding MLG. The unsafe condition, if not corrected and
when combined with other failures, could result in an asymmetric MLG
configuration at landing and a subsequent runway excursion.

(f) Compliance

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

(g) Airplane Records Review

    Within 30 days after the effective date of this AD, review the
airplane records to determine whether any sleeve P/N 46878-1 was
replaced after October 29, 2019, on any MLG forward door linkage
assembly P/N 46860.
    (1) For any sleeve P/N 46878-1 that was replaced after October
29, 2019, and for any sleeve for which its replacement date cannot
be conclusively determined from the records: Within 1,500 flight
cycles after the effective date of this AD, do the actions specified
in paragraphs (g)(1)(i) and (ii) of this AD, in accordance with
Section 3.B. of the Accomplishment Instructions of De Havilland
Aircraft of Canada Limited Service Bulletin 84-32-169, Revision A,
dated July 21, 2022, including Collins Aerospace Service Bulletin
46860-32-150, Revision 1, dated June 28, 2022.
    (i) Do a general visual inspection of the sleeve for the
presence of lubrication grooves, and before further flight replace
any sleeve that does not have lubrication grooves.
    (ii) Do a general visual inspection of the MLG forward door
linkage assemblies (swivel

link, clevis assembly, and swivel end assembly) for damage,
deformation, erosion, and corrosion, and before further flight
repair or replace the discrepant parts.
    (2) If the records confirm that no maintenance was performed on
the MLG forward door linkage assembly P/N 46860 after October 29,
2019, no further action is required by this paragraph.

(h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install, on
any airplane, a sleeve P/N 46878-1 with missing lubrication grooves.

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD, using the service information identified in De
Havilland Aircraft of Canada Limited Service Bulletin 84-32-169,
dated February 28, 2022, including Collins Aerospace Service
Bulletin 46860-32-150, dated February 1, 2022.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York 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 responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to the attention of the person identified in
paragraph (k)(2) of this AD. Information may be emailed to: [email protected] or send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO Branch, 1600 Stewart Avenue,
Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>. Before using
any approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada; or De Havilland Aircraft of Canada
Limited's Transport Canada Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Additional Information

    (1) Refer to Transport Canada AD CF-2022-29, dated May 27, 2022,
for related information. This Transport Canada AD may be found in
the AD docket at regulations.gov under Docket No. FAA-2022-1482.
    (2) For more information about this AD contact Gabriel Kim,
Aerospace Engineer, Mechanical Systems and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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 this AD specifies otherwise.
    (i) De Havilland Aircraft of Canada Limited Service Bulletin 84-
32-169, Revision A, dated July 21, 2022, including Collins Aerospace
Service Bulletin 46860-32-150, Revision 1, dated June 28, 2022.
    Note 1 to paragraph (l)(2)(i): De Havilland issued De Havilland
Service Bulletin 84-32-169, Revision A, dated July 21, 2022, with
Collins Aerospace Service Bulletin 46860-32-150, Revision 1, dated
June 28, 2022, attached as one ``merged'' file for the convenience
of affected operators.
    (ii) Reserved
    (3) For service information identified in this AD, contact De
Havilland Aircraft of Canada Limited, Dash 8 Series Customer
Response Centre, 5800 Explorer Drive, Mississauga, Ontario, L4W 5K9,
Canada; telephone North America (toll-free):<PHONE_NUMBER>, Direct:
647-277-5820; email dehavilland.com">[email protected]dehavilland.com; website dehavilland.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 14, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-07737 Filed 4-12-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Notices]
[Pages 5236-5238]
[FR Doc No: 2013-01376]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68684; File No. SR-NSX-2013-01]

Self-Regulatory Organizations; National Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change to
Provide for the Payment of Exchange Fees Through an Integrated Billing
Process

January 17, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 10, 2013, National Stock Exchange, Inc.
(``NSX[supreg]'' or the ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change, as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comment 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 the
Substance of the Proposed Rule Change

    The Exchange is proposing to: (1) define the term ``Clearing
Member'' under Exchange Rule 1.5; and (2) adopt Exchange Rule 16.4 to
allow Equity Trading Permit (``ETP'') \3\ Holders to pay their Exchange
and vendor invoices for Exchange-related services through the
Exchange's integrated billing system (``IBS'').
---------------------------------------------------------------------------

    \3\ Exchange Rule 1.5 defines the term ``ETP'' as an Equity
Trading Permit issued by the Exchange for effecting approved
securities transactions on the Exchange's Trading Facilities.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nsx.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 parts of such
statements.

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

1. Purpose
    The Exchange is proposing to: (1) define the term ``Clearing
Member'' under Exchange Rule 1.5; and (2) adopt Exchange Rule 16.4 to
allow ETP Holders to pay their Exchange and vendor invoices for
Exchange-related services through the Exchange's IBS.
Definition of Clearing Member
    The Exchange is proposing to: (1) define the term ``Clearing
Member'' under Exchange Rule 1.5 as ``[a]n ETP Holder that is a member
of a Qualified Clearing Agency defined in Section Q below.'' Section Q
of Exchange Rule 1.5 defines ``Qualified Clearing Agency'' as ``a
clearing agency registered with the Commission pursuant to Section 17A
of the Act that is deemed qualified by the Exchange.'' In adding a
definition of Clearing Member to Exchange Rule 1.5, the Exchange does
not propose to add a new category of Exchange member or alter current
ETP Holder obligations. The Exchange simply proposes this definition to
describe ETP Holders that may also be members of a Qualified Clearing
Agency as a means to add clarity to the integrated billing solution

under proposed Exchange Rule 16.4, described below.
Integrated Billing Solution
    The Exchange also proposes to adopt Exchange Rule 16.4 to allow ETP
Holders to pay their Exchange and vendor invoices for Exchange-related
services through the Exchange's IBS, unless payment by check of [sic]
bank transfer is agreed to between the Exchange and ETP Holder.\4\ In
lieu of payment by check or bank transfer, ETP Holders will now be
required to designate an ETP Holder that is also Clearing Member (as
defined above) to pay their Exchange invoices via IBS. The ETP Holder
will continue to receive monthly statements which outline their monthly
fees and charges. The Clearing Member will pay to the Exchange on a
timely basis any amount that the ETP holder does not dispute. The
Exchange will obtain these payments from the Clearing Member's account
at the Qualified Clearing Agency. The Qualified Clearing Agency will
not be liable in connection with its forwarding to the Exchange each
month a payment representing the total amount that the Exchange advises
the Qualified Clearing Agency is owed to the Exchange.
---------------------------------------------------------------------------

    \4\ The Exchange represents that, in the Exchange's written
agreement with each vendor for which the Exchange will collect
payments via IBS, the Exchange will require the vendor to include a
provision in the vendor's written agreement with each member from
which payments via IBS will be collected in which the member
authorizes NSX to assess and collect from the member through NSX's
billing procedures and automated systems, on behalf of the vendor,
the fees assessed by the vendor to the member for the vendor's
service. The Exchange does not currently collect payments from ETP
Holders for vendor invoices, but may do so in the future.
---------------------------------------------------------------------------

    Payment of invoices via the Exchange's IBS will increase efficiency
and reduce financial risk by allowing the Exchange to draft against the
Clearing Member's account the amount due rather than invoicing each ETP
Holder separately and awaiting payment via check or bank transfer. In
addition, the Exchange notes the Chicago Board Options Exchange, Inc.
(``CBOE'') \5\ has implemented a similar process for the payment of
invoices by its members. The only difference between CBOE's
requirements and those proposed by the NSX, is that the CBOE rule
appears to required [sic] payment via IBS as mandatory for all its
members, while the NSX's proposed rule would allow alternative payment
methods if agreed to with the Exchange.
---------------------------------------------------------------------------

    \5\ CBOE Rule 3.23.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6 of the Act,\6\ and the rules and regulations thereunder and,
in particular, the requirements of Section 6(b) of the Act.\7\
Specifically, the Exchange believes the proposed rule change furthers
the objective of Section 6(b)(5) of the Act \8\ because allowing ETP
Holders to pay their Exchange and vendor invoices via IBS is designed
to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, and processing information with respect
to transactions in securities, and to remove impediments to and
perfects [sic] the mechanism of a free and open market and a national
market system. Payment of invoices via the Exchange's IBS would
increase efficiency and reduce financial risk by allowing the Exchange
to draft against the Clearing Member's account the amount due, rather
than the ETP Holder paying their invoices via check or bank transfer
each month. Lastly, the Exchange notes that the proposed rule change is
not unfairly-discriminatory because payment of invoices via IBS is
voluntary and each ETP Holder is able to continue to remit payment of
their invoices by check or bank transfer.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(5).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed definition of ``Clearing
Member'' under Exchange Rule 1.5 is consistent with Section 6 of the
Act,\9\ and the rules and regulations thereunder and, in particular,
the requirements of Section 6(b) of the Act.\10\ Specifically, the
Exchange believes the proposed definition furthers the objective of
Section 6(b)(5) of the Act \11\ because the proposed definition of
``Clearing Member'' is designed to describe ETP Holders who may also be
members of a Qualified Clearing Agency, thereby adding clarity to the
IBS under proposed Exchange Rule 16.4. Therefore, the Exchange believes
the proposed definition of ``Clearing Member'' fosters cooperation and
coordination with persons engaged in regulating, clearing, settling,
and processing information with respect to transactions in securities,
and removes impediments to and perfect [sic] the mechanism of a free
and open market and a national market system.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change
will provide ETP Holders the choice of paying their invoices through
IBS rather than via check or bank transfer, which is designed to
increase efficiency and reduce financial risk. The proposed definition
of ``Clearing Member'' under Exchange Rule 1.5 is designed to add
clarity to the integrated billing solution under proposed Exchange Rule
16.4 and does not propose to add a new category of Exchange members or
alter current ETP Holder obligations. Therefore, the Exchange believes
the proposed rule change does not impose a burden on competition
because ETP Holders are free to choose the payment method they wish.

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

    Written comments on the proposed rule change were neither solicited
nor received.

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

    Because the foregoing proposed rule change does not:
    (i) Significantly affect the protection of investors or the public
interest;
    (ii) Impose any significant burden on competition; and
    (iii) Become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) \12\ of the Act and
Rule 19b-4(f)(6) \13\ thereunder.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of the filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) of the Act \14\
normally does not become operative prior to 30 days after the date of
the filing. However, pursuant to Rule 19b-4(f)(6)(iii) of the Act,\15\
the Commission may designate a shorter time if such action is
consistent with the protection of investors and the public interest.
The Exchange has asked the Commission to waive the 30-day operative
delay so that ETP Holders may use the IBS system for invoicing and
payment processing immediately. The Commission believes

that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest as it will facilitate a
more efficient method for ETP Holders to pay invoices to the Exchange
and for the Exchange to collect undisputed payments owed by ETP Holders
to the Exchange and to vendors.\16\ Therefore, the Commission hereby
waives the 30-day operative delay and designates the proposed rule
change to be operative upon filing with the Commission.
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NSX-2013-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSX-2013-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such
filing also will be available for inspection and copying at the
principal offices of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NSX-2013-01, and should be submitted on or before
February 14, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01376 Filed 1-23-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Notices]
[Pages 48960-48963]
[FR Doc No: 2019-20016]

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

[Release No. 34-86926; File No. SR-CboeEDGX-2019-056]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating To Amend Its Fee Schedule

September 11, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 3, 2019, Cboe EDGX Exchange, Inc. (the ``Exchange''
or ``EDGX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the 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

    Cboe EDGX Exchange, Inc. (the ``Exchange'' or ``EDGX'') is filing
with the Securities and Exchange Commission (``Commission'') a proposed
rule change to amend its Fee Schedule. The text of the proposed rule
change is attached [sic] as Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/edgx/), at the Exchange's Office of the Secretary, 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 Exchange proposes to amend its fee schedule for its equity
options platform (``EDGX Options''), effective September 3, 2019.
    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 options venues to which market participants
may direct their order flow. Based on publicly available information,
no single options exchange has more than 24% of the market share and
currently the Exchange represents only 3% of the market share.\3\ Thus,
in such a low-concentrated and highly competitive market, no single
options exchange, including the Exchange, possesses significant pricing
power in the execution of option order flow. The Exchange believes that
the ever-shifting market share among the exchanges from month to month
demonstrates that market participants can shift order flow, or
discontinue to reduce use of certain categories of products, in
response to fee changes. Accordingly, competitive forces constrain the
Exchange's transaction fees, and market participants can readily trade
on competing venues if they deem pricing levels at those other venues
to be more favorable. The Exchange's Fees Schedule sets forth standard
rebates and rates applied per contract. For example, the Exchange
assesses a standard fee of $0.20 per contract for Market Maker orders
that add liquidity in both Penny and Non-Penny Securities.
Additionally, in response to the competitive environment, the Exchange
also offers tiered pricing which provides Members opportunities to
qualify for higher rebates or reduced fees where certain volume
criteria and thresholds are met. Tiered pricing provides an incremental
incentive for Members to strive for higher tier levels, which provides
increasingly higher benefits or discounts for satisfying increasingly
more stringent criteria.
---------------------------------------------------------------------------

    \3\ See Cboe Global Markets U.S. Options Market Volume Summary
(August 30, 2019), available at https://markets.cboe.com/us/options/market_statistics/.
---------------------------------------------------------------------------

    For example, the Exchange currently offers seven Market Maker
Volume Tiers under Footnote 2 of the fee schedule which provide reduced
fees between $0.17 per contract and $0.01 per contract for qualifying
Market Maker orders which meet certain add liquidity thresholds and
yield fee codes PM and NM. Under the current Market Maker Volume Tiers,
a Member receives a reduced fee between $0.01--$0.17 per contract,
where the Member has an ADV \4\ in Market Maker orders greater or equal
to a specified percentage of OCV \5\ (Tiers 1-5). Members also have an
opportunity to receive a reduced fee of $0.03-$0.04 per contract under
Tiers 6 and 7 where the Member satisfies alternative criteria
including, reaching specified ADV thresholds in (i) in Customer orders,
(ii) Customer or Market Maker orders, (iii) AIM Agency Orders and (iv)
complex Customer orders. The Exchange proposes to adopt a new Market
Maker Volume Tier, ``Tier 2'' and renumber the remaining tiers
accordingly.
---------------------------------------------------------------------------

    \4\ ``ADV'' means average daily volume calculated as the number
of contracts added or removed, combined, per day. ADV is calculated
on a monthly basis. See Cboe EDGX Options Exchange Fee Schedule.
    \5\ ``OCV'' means the total equity and ETF options volume that
clears in the Customer range at the Options Clearing Corporation
(``OCC'') for the month for which the fees apply, excluding volume
on any day that the Exchange experiences an Exchange System
Disruption and on any day with a scheduled early market close. See
Cboe EDGX Options Exchange Fee Schedule.
---------------------------------------------------------------------------

    The Exchange believes the proposed MM Penny Add Tier will provide
Members an additional opportunity and alternative means to receive a
reduced fee for meeting the corresponding proposed criteria. The
Exchange believes the proposed tier, along with the existing tiers,
also provide an incremental incentive for Members to strive for the
highest tier levels, which provide increasingly higher discounts for
such transactions.
    Particularly, the Exchange proposes to add new Market Maker Volume
Tier 2, which would provide a reduced fee of $0.13 per contract where a
Member (i) has an ADV in Market Maker orders greater than or equal to
0.15% of average OCV, (ii) Member has a Step-Up ADAV \6\ in Market
Maker orders from

July 2019 greater than or equal to 0.10% of average OCV; and (iii)
Member has on EDGX Equities an ADAV greater than or equal to 0.30% of
average TCV.\7\ As such, under the proposed Tier, the Exchange is
adopting an alternative set of criteria that Members must meet in
addition to the standard ADV in Market Maker orders threshold.
Particularly, Members must additionally satisfy a (i) cross-asset
threshold, which is designed to incentivize members to achieve certain
levels of participation on both the Exchange's options and equities
platform (``EDGX Equities'') and (ii) a step-up ADAV threshold, which
is designed to encourage growth (i.e., Members must increase their
relative liquidity each month over a predetermined baseline (in this
case the month being July 2019)). Overall, the proposed reduced fee and
corresponding criteria is designed to encourage Members to increase
their order flow, thereby contributing to a deeper and more liquid
market, which benefits all market participants and provides greater
execution opportunities on the Exchange.
---------------------------------------------------------------------------

    \6\ ``ADAV'' means average daily added volume calculated as the
number of contracts added. ADAV is calculated on a monthly basis.
See Cboe EDGX Options Exchange Fee Schedule. To alleviate confusion,
the Exchange also proposes to adopt the definition of ``Step-Up
ADAV'' in the Fees Schedule, which term shall mean ADAV in the
relevant baseline month subtracted from current ADAV.
    \7\ ``TCV'' means total consolidated volume calculated as the
volume reported by all exchanges to the consolidated transaction
reporting plan for the month for which the fees apply. See Cboe EDGX
Options Exchange Fee Schedule.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Act,\8\ in general, and furthers the requirements
of Section 6(b)(4),\9\ in particular, as it is designed to provide for
the equitable allocation of reasonable dues, fees and other charges
among its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers. The Exchange operates in a
highly-competitive market in which market participants can readily
direct order flow to competing venues if they deem fee levels at a
particular venue to be excessive or incentives to be insufficient. The
proposed rule change reflects a competitive pricing structure designed
to incentivize market participants to direct their order flow to the
Exchange, which the Exchange believes would enhance market quality to
the benefit of all Members.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    In particular, the Exchange believes the proposed tier is
reasonable because it provides an additional opportunity for Members to
receive lower fees by providing a different set of criteria they can
reach for. The Exchange notes that volume-based incentives and
discounts have been widely adopted by exchanges,\10\ including the
Exchange,\11\ and are reasonable, equitable and non-discriminatory
because they are open to all members on an equal basis and provide
additional benefits or discounts that are reasonably related to (i) the
value to an exchange's market quality and (ii) associated higher levels
of market activity, such as higher levels of liquidity provision and/or
growth patterns. Additionally, as noted above, the Exchange operates in
highly competitive market. The Exchange is only one of several options
venues to which market participants may direct their order flow, and it
represents a small percentage of the overall market. Competing options
exchanges offer similar tiered pricing structures to that of the
Exchange, including schedules of rebates and fees that apply based upon
members achieving certain volume and/or growth thresholds. These
competing pricing schedules, moreover, are presently comparable to
those that the Exchange provides, including pricing incentives tied to
comparable tiers.\12\
---------------------------------------------------------------------------

    \10\ See e.g., Cboe BZX U.S. Options Exchange Fee Schedule,
Footnotes 6 and 7, Market Maker Penny Pilot and Non-Penny Pilot
Volume Tiers which provide enhanced rebates for Market Maker orders
where Members meet certain volume thresholds.
    \11\ See e.g., Cboe EDGX U.S. Options Exchange Fee Schedule,
Footnote 2, Market Maker Volume Tiers, which provide reduced fees
between $0.01 and $0.17 per contract for Market Maker Penny and Non-
Penny orders where Members meet certain volume thresholds.
    \12\ See e.g., Cboe BZX U.S. Options Exchange Fee Schedule,
Footnotes 6 and 7, Market Maker Penny Pilot and Non-Penny Pilot Add
Volume Tiers, which provide enhanced rebates between $0.33-$0.54 per
contract where Members, among other things including a cross-asset
threshold, meet a specified level of ADAV in Market Maker orders as
a percentage of OCV.
---------------------------------------------------------------------------

    Moreover, the Exchange believes the proposed Market Maker Tier 2 is
a reasonable means to encourage Members to increase their liquidity on
the Exchange and also their participation on EDGX Equities. The
Exchange believes that adopting a tier with alternative criteria to the
existing Market Maker Volume Tiers, will encourage those Members who
could not previously achieve the criteria under the existing Market
Maker Volume Tiers, to increase their order flow on EDGX options and
equities. For example, the proposed tier would provide an opportunity
for Members who have an ADV in Market Makers Orders of at least 0.15%
of average OCV, but less than 0.25% of average OCV (the requirement
under current Tier 2), to receive the same lower fee as offered under
current Tier 2 if they can otherwise meet the threshold requirement
based on EDGX equities participation and can grow a modest amount since
July 2019. Similarly, for Market Makers that participate on both EDGX
Options and Equities, and do not currently meet the ADV threshold under
current Tier 2 (i.e., 0.25%), but can or do meet the proposed equities
ADAV threshold, the proposed tier may incentivize those participants to
grow their options volume in order to receive reduced fees. Increased
liquidity benefits all investors by deepening the Exchange's liquidity
pool, offering additional flexibility for all investors to enjoy cost
savings, supporting the quality of price discovery, promoting market
transparency and improving investor protection. The Exchange also
believes that proposed reduced fee is reasonable based on the
difficulty of satisfying the tier's criteria and ensures the proposed
fee and threshold appropriately reflects the incremental difficulty to
achieve the existing Market Maker Volume Tiers. The proposed reduced
fee amount also does not represent a significant departure from the
reduced fees currently offered under the Exchange's existing Market
Maker Volume Tiers. Indeed, the proposed reduced fee amount is the same
offered as the existing Market Maker Volume Tier 2 (i.e., $0.13 per
contract) and within the range of the reduced fees offered under the
remaining Market Maker Volume Tiers (i.e., $0.17-$0.01 per contract).
    The Exchange believes that the proposal represents an equitable
allocation of fees and is not unfairly discriminatory because it
applies uniformly to all Market Makers. Additionally a number of Market
Makers have a reasonable opportunity to satisfy the tier's criteria,
which the Exchange believe is less stringent than other existing Market
Maker Volume Tiers. While the Exchange has no way of knowing whether
this proposed rule change would definitively result in any particular
Market Maker qualifying for the proposed tier, the Exchange anticipates
one to three members meeting, or being reasonably able to meet, the
proposed criteria. The Exchange believes the proposed tier could
provide an incentive for other Members to submit additional liquidity
on EDGX Options and Equities to qualify for the proposed reduced fee.
To the extent a Member participates on the Exchange but not on EDGX
Equities, the Exchange does believe that the proposal is still
reasonable, equitably allocated and non-discriminatory with respect to
such Member based on the overall benefit to the Exchange resulting from

the success of EDGX Equities. Particularly, the Exchange believes such
success allows the Exchange to continue to provide and potentially
expand its existing incentive programs to the benefit of all
participants on the Exchange, whether they participate on EDGX Equities
or not. The proposed pricing program is also fair and equitable in that
membership in EDGX Equities is available to all market participants,
which would provide them with access to the benefits on EDGX Equities
provided by the proposed change, even where a member of EDGX Equities
is not necessarily eligible for the proposed reduced fee on the
Exchange.
    The Exchange lastly notes that the proposal will not adversely
impact any Member's pricing or their ability to qualify for other
tiers. Rather, should a Member not meet the proposed criteria, the
Member will merely not receive the proposed reduced fee. Furthermore,
the proposed reduced fee would apply to all Members that meet the
required criteria under proposed Market Maker Volume Tier 2.

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 intramarket or intermarket competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
Rather, as discussed above, the Exchange believes that the proposed
change would encourage the submission of additional liquidity to a
public exchange, thereby promoting market depth, price discovery and
transparency and enhancing order execution opportunities for all
Members. As a result, the Exchange believes that the proposed change
furthers the Commission's goal in adopting Regulation NMS of fostering
competition among orders, which promotes ``more efficient pricing of
individual stocks for all types of orders, large and small.'' \13\
---------------------------------------------------------------------------

    \13\ Securities Exchange Act Release No. 51808, 70 FR 37495,
37498-99 (June 29, 2005) (S7-10-04) (Final Rule).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change does impose any
burden on intramarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Particularly, the proposed
change applies uniformly to market participants. As discussed above, to
the extent a Member participates on the Exchange but not on EDGX
Equities, the Exchange notes that the proposed change can provide an
overall benefit to the Exchange resulting from the success of EDGX
Equities. Such success enables the Exchange to continue to provide and
potentially expand its existing incentive programs to the benefit of
all participants on the Exchange, whether they participate on EDGX
Equities or not. The proposed pricing program is also fair and
equitable in that membership in EDGX Equities is available to all
market participants. Additionally the proposed change is designed to
attract additional order flow to the Exchange and EDGX Equities.
Greater liquidity benefits all market participants on the Exchange by
providing more trading opportunities and encourages Members to send
orders, thereby contributing to robust levels of liquidity, which
benefits all market participant.
    Next, the Exchange believes the proposed rule change does not
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market.
Members have numerous alternative venues that they may participate on
and director their order flow, including 15 other options exchanges and
off-exchange venues. Additionally, the Exchange represents a small
percentage of the overall market. Based on publicly available
information, no single options exchange has more than 24% of the market
share.\14\ Therefore, no exchange possesses significant pricing power
in the execution of option order flow. Indeed, participants can readily
choose to send their orders to other exchange and off-exchange venues
if they deem fee levels at those other venues to be more favorable.
Moreover, the Commission has repeatedly expressed its preference for
competition over regulatory intervention in determining prices,
products, and services in the securities markets. Specifically, in
Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \15\ The fact
that this market is competitive has also long been recognized by the
courts. In NetCoalition v. Securities and Exchange Commission, the D.C.
Circuit stated as follows: ``[n]o one disputes that competition for
order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S.
national market system, buyers and sellers of securities, and the
broker-dealers that act as their order-routing agents, have a wide
range of choices of where to route orders for execution'; [and] `no
exchange can afford to take its market share percentages for granted'
because `no exchange possesses a monopoly, regulatory or otherwise, in
the execution of order flow from broker dealers'. . . .''.\16\
Accordingly, the Exchange does not believe its proposed fee change
imposes any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \14\ See Cboe Global Markets U.S. Options Market Volume Summary
(August 30, 2019), available at https://markets.cboe.com/us/options/market_statistics/.
    \15\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \16\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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) of the Act \17\ and paragraph (f) of Rule 19b-4 \18\
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 necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

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

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_ADDRESS>Please include
File Number SR-CboeEDGX-2019-056 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-CboeEDGX-2019-056. 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-CboeEDGX-2019-056 and should be
submitted on or before October 8, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-20016 Filed 9-16-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Rules and Regulations]
[Pages 56369-56370]
[FR Doc No: 2015-23500]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 /
Rules and Regulations

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 141229999-5828-02]
RIN 0694-AG45

Implementation of the Australia Group (AG) November 2013
Intersessional Decisions; Correction

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Correcting amendments.

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

SUMMARY: The Bureau of Industry and Security (BIS) publishes this final
rule to correct typographical errors contained in a final rule
published on June 16, 2015 (80 FR 34266), which amended the Export
Administration Regulations (EAR) to implement the recommendations
presented at the November 2013 Australia Group (AG) intersessional
implementation meeting and later adopted pursuant to the AG silent
approval procedure. The typographical errors appear in a Note to ECCN
1C351.a, which includes viruses identified on the AG ``List of Human
and Animal Pathogens and Toxins for Export Control.'' This rule also
identifies another typographical error in the June 16, 2015, final rule
involving the ``Reason for Control'' paragraph for ECCN 1E351. This
error does not require a correction at this time, but is being
identified to provide clarification to the public.

DATES: This rule is effective September 18, 2015.

FOR FURTHER INFORMATION CONTACT: Richard P. Duncan, Ph.D., Director,
Chemical and Biological Controls Division, Office of Nonproliferation
and Treaty Compliance, Bureau of Industry and Security, Telephone:
(202) 482-3343, Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    On June 16, 2015, the Bureau of Industry and Security (BIS)
published the final rule ``Implementation of the Australia Group (AG)
November 2013 Intersessional Decisions'' (80 FR 34266), which amended
the Export Administration Regulations (EAR) to reflect the merger of
two AG common control lists by removing ECCN 1C352 (animal pathogens)
from the CCL and adding the pathogens previously controlled under ECCN
1C352 to ECCN 1C351 (human and zoonotic pathogens and ``toxins''). The
latter ECCN was renamed to indicate that it controls both human and
animal pathogens and ``toxins.'' That final rule also renumbered the
items in ECCN 1C351.a, and certain items in ECCN 1C351.c to accommodate
the addition to ECCN 1C351 of those items that had been controlled
under ECCN 1C352 prior to the publication of that rule.
    As amended by the June 16, 2015, final rule, the Note to ECCN
1C351.a.4 (which controls avian influenza viruses identified as having
high pathogenicity) incorrectly referenced ECCN 1C352.a.4, instead of
ECCN 1C351.a.4. This final rule corrects the references contained in
that Note. Specifically, the Note to ECCN 1C351.a.4 is corrected to
read as follows: ``Avian influenza (AI) viruses of the H5 or H7 subtype
that do not have either of the characteristics described in 1C351.a.4
(specifically, 1C351.a.4.a or a.4.b) should be sequenced to determine
whether multiple basic amino acids are present at the cleavage site of
the haemagglutinin molecule (HA0). If the amino acid motif is similar
to that observed for other HPAI isolates, then the isolate being tested
should be considered as HPAI and the virus is controlled under
1C351.a.4.'' The corrections to this Note do not affect the scope of
the controls described in ECCN 1C351.a.4.
    In addition, the text for ECCN 1E351, as published in the June 16,
2015, final rule incorrectly identified the applicable controls for
this ECCN under the ``Reason for Control'' paragraph in the License
Requirements section. Specifically, the ``Reason for Control''
paragraph mistakenly identified the applicable controls for ECCN 1E351
as ``NS, MT, NP, CB, RS, AT,'' instead of ``CB, AT.'' It is not
necessary, however, to amend ECCN 1E351 to correct this error, because
the amendatory instructions for ECCN 1E351 in the June 16, 2015, final
rule did not include a specific instruction to amend the ``Reason for
Control'' paragraph for this ECCN. Consequently, the ``Reason for
Control'' paragraph in ECCN 1E351 was not revised by the June 16, 2015,
final rule. The paragraph, as published in the CCL, continues to
correctly identify the applicable controls for this ECCN as ``CB, AT.''
BIS identifies this error to inform the public of the inconsistency
between the contents of the June 16, 2015, final rule and the CCL, and
to provide clarification regarding the applicable controls for ECCN
1E351.
    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March
8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of
August 7, 2015 (80 FR 48,233 (Aug. 11, 2015)), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act. BIS continues to carry out the provisions of the
Export Administration Act, as appropriate and to the extent permitted
by law, pursuant to Executive Order 13222, as amended by Executive
Order 13637.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been determined to be not significant for
purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid

Office of Management and Budget (OMB) Control Number. This rule
contains a collection of information subject to the requirements of the
PRA. This collection has been approved by OMB under Control Number
0694-0088 (Multi-Purpose Application), which carries a burden hour
estimate of 58 minutes to prepare and submit form BIS-748. Send
comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing the
burden, to Jasmeet Seehra, Office of Management and Budget (OMB), and
to the Regulatory Policy Division, Bureau of Industry and Security,
Department of Commerce, 14th Street & Pennsylvania Avenue NW., Room
2705, Washington, DC 20230.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking and the opportunity for
public participation are waived for good cause because they are
unnecessary and contrary to the public interest. (See 5 U.S.C.
553(b)(B)). The changes contained in this rule are non-substantive
technical corrections of a previously published rule that has already
been exempted from notice and comment. This rule is necessary to ensure
clarity in the regulations and accuracy regarding the scope of controls
in the Note to ECCN 1C351.a.4. If this rule were delayed to allow for
notice and comment, it would result in further confusion caused by the
incorrect cross-references in that ECCN. These changes are also
essential to ensuring the accurate and complete implementation of the
June 16, 2015, final rule.
    The provision of the Administrative Procedure Act (5 U.S.C. 553)
requiring a 30-day delay in effectiveness is also waived for good
cause. (5 U.S.C. 553(d)(3)). The corrections contained in this final
rule are non-substantive technical corrections of a previously
published rule that has already been exempted from notice and comment.
If this rule were delayed to allow for a 30-day delay in effectiveness,
it would result in further confusion caused by the incorrect cross-
references in the aforementioned ECCN. These changes are also essential
to ensuring the accurate and complete implementation of the June 16,
2015, final rule.
    Further, no other law requires that a notice of proposed rulemaking
and an opportunity for public comment be given for this final rule.
Because a notice of proposed rulemaking and an opportunity for public
comment are not required to be given for this rule under the
Administrative Procedure Act or by any other law, the analytical
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
are not applicable. Therefore, this regulation is issued in final form.

List of Subjects in 15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, part 774 of the Export
Administration Regulations (15 CFR parts 730-774) is amended as
follows:

PART 774--[AMENDED]

0
1. The authority citation for 15 CFR part 774 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Notice of August 7, 2015 (80 FR 48233 (Aug. 11, 2015)).

0
2. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1-- Special Materials and Related Equipment, Chemicals,
``Microorganisms'' and ``Toxins,'' ECCN 1C351 is amended under the
``Items'' paragraph in the List of Items Controlled section by revising
the Note immediately following paragraph a.4.b to read as follows:

Supplement No. 1 to Part 774--the Commerce Control List

* * * * *
1C351 Human and animal pathogens and ``toxins'', as follows (see List
of Items Controlled).
* * * * *

List of Items Controlled

* * * * *
Items:
    a. * * *
    a.4. * * *
    a.4.b. * * *

    Note: Avian influenza (AI) viruses of the H5 or H7 subtype that
do not have either of the characteristics described in 1C351.a.4
(specifically, 1C351.a.4.a or a.4.b) should be sequenced to
determine whether multiple basic amino acids are present at the
cleavage site of the haemagglutinin molecule (HA0). If the amino
acid motif is similar to that observed for other HPAI isolates, then
the isolate being tested should be considered as HPAI and the virus
is controlled under 1C351.a.4.

* * * * *

    Dated: September 10, 2015.
Karen H. Nies-Vogel,
Director, Office of Exporter Services.
[FR Doc. 2015-23500 Filed 9-17-15; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Page 40045]
[FR Doc No: 2021-15842]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8700-01-R9]

Clean Air Act Operating Permit Program: Petition To Object to
Operating Permits for the Drews and Century Power Generating Facilities
in Southern California

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final action.

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

SUMMARY: The Environmental Protection Agency (EPA) Administrator signed
an Order, dated May 10, 2021, denying a petition to object to Clean Air
Act (CAA) title V operating permits issued to two facilities by the
South Coast Air Quality Management District (SCAQMD). The EPA's May 10,
2021 Order responds to a November 24, 2020 petition submitted by the
Sierra Club and the Center for Community Action and Environmental
Justice (the ``Petitioners''). The Petitioners requested that the EPA
object to the issuance of two title V renewal operating permits issued
to Colton Power, LP's Drews Power Generating Station and Century Power
Generating Station, located in San Bernardino County, California. The
Order constitutes final action on the petition requesting the
Administrator object to the issuance of the proposed CAA title V
permits.

DATES: Pursuant to section 307(b)(1) of the Clean Air Act, 42 U.S.C.
7607(b)(1), judicial review of this final agency action, to the extent
it is available, may be sought by filing a petition for review in the
United States Court of Appeals for the Ninth Circuit within 60 days of
July 26, 2021.

ADDRESSES: Copies of the petition and Order are available at https://www.epa.gov/title-v-operating-permits/title-v-petition-database. For
additional information, please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Lisa Beckham, EPA Region 9, 75
Hawthorne Street (AIR-3-1), San Francisco, California 94105. By phone
at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The CAA affords the EPA a 45-day period to
review and, as appropriate, the authority to object to operating
permits proposed by state and local permitting authorities under title
V of the CAA, 42 U.S.C. 7661-7661f. Section 505(b)(2) of the CAA and 40
CFR 70.8(d) authorize any person to petition the EPA Administrator to
object to a title V operating permit within 60 days after the
expiration of EPA's 45-day review period if the EPA has not objected on
its own initiative. Petitions must be based only on objections to the
permit that were raised with reasonable specificity during the public
comment period provided by the state, unless the petitioner
demonstrates that it was impracticable to raise these issues during the
comment period or the grounds for the issues arose after the comment
period.
    On November 24, 2020, the EPA received a petition requesting that
the EPA object to the CAA title V renewal permits for Colton Power,
LP's Drews Power Generating Station (Facility ID No. 182561) and
Century Power Generating Station (Facility ID No. 182563)
(``Permits''). The Petitioners claim that the Permits must be revised
to include the more stringent oxides of nitrogen (NOX)
emissions limit in a recently amended version of local SCAQMD Rule
1134. The NOX emissions limit has a compliance date of
January 1, 2024 and the Petitioners argued that the Permits must be
revised now because the compliance date occurs before the expiration of
the Permits. The Petitioners further argued that if the operator has
not yet chosen one of the two compliance options from the local rule,
then the SCAQMD must revise the Permits to include both compliance
options.
    The EPA denied the petition because the Petitioners failed to
demonstrate that the recently amended version of SCAQMD Rule 1134 is an
applicable requirement as defined in 40 CFR 70.2 The Order provides
additional information, including the EPA's detailed basis for denying
the petition.

    Dated: July 8, 2021.
Elizabeth Adams,
Acting Regional Administrator, Region IX.
[FR Doc. 2021-15842 Filed 7-23-21; 8:45 am]
BILLING CODE 6560-50-P