[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57391-57394]
[FR Doc No: 2013-22674]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1119]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Canning Establishment Registration, Process
Filing, and Recordkeeping for Acidified Foods and Thermally Processed
Low-Acid Foods in Hermetically Sealed Containers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 invites comments on the information collection
provisions of reporting and recordkeeping requirements for firms that
process acidified foods and thermally processed low-acid foods in
hermetically sealed containers, and provides notice of and invites
comments on our proposed revisions to the

electronic submission system and paper-based forms for this collection.

DATES: Submit either electronic or written comments concerning the
collection of information by November 18, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under the PRA (44 U.S.C. 3501-3520), 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, we are publishing this notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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.

Food Canning Establishment Registration, Process Filing, and
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid
Foods in Hermetically Sealed Containers--21 CFR 108.25 and 108.35, and
Parts 113 and 114 (OMB Control Number 0910-0037)--Revision

    Section 402 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 342) deems a food to be adulterated, in part, if the
food bears or contains any poisonous or deleterious substance which may
render it injurious to health. Section 301(a) of the FD&C Act (21
U.S.C. 331(a)) prohibits the introduction or delivery for introduction
into interstate commerce of adulterated food. Under section 404 of the
FD&C Act (21 U.S.C. 344), our regulations require registration of food
processing establishments, filing of process or other data, and
maintenance of processing and production records for acidified foods
and thermally processed low-acid foods in hermetically sealed
containers. These requirements are intended to ensure safe
manufacturing, processing, and packing procedures and to permit us to
verify that these procedures are being followed. Improperly processed
low-acid foods present life-threatening hazards if contaminated with
foodborne microorganisms, especially Clostridium botulinum. The spores
of C. botulinum need to be destroyed or inhibited to avoid production
of the deadly toxin that causes botulism. This is accomplished with
good manufacturing procedures, which must include the use of adequate
heat processes or other means of preservation.
    To protect the public health, our regulations require that each
firm that manufactures, processes, or packs acidified foods or
thermally processed low-acid foods in hermetically sealed containers
for introduction into interstate commerce register the establishment
with us using Form FDA 2541 (Sec. Sec.  108.25(c)(1) and 108.35(c)(2)
(21 CFR 108.25(c)(1) and 108.35(c)(2))). In addition to registering the
plant, each firm is required to provide data on the processes used to
produce these foods, using Form FDA 2541a for all methods except
aseptic processing, or Form FDA 2541c for aseptic processing of low-
acid foods in hermetically sealed containers (Sec. Sec.  108.25(c)(2)
and 108.35(c)(2)). Plant registration and process filing may be
accomplished simultaneously. Process data must be filed prior to
packing any new product, and operating processes and procedures must be
posted near the processing equipment or made available to the operator
(21 CFR 113.87(a)).
    Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and
114) require firms to maintain records showing adherence to the
substantive requirements of the regulations. These records must be made
available to FDA on request. Firms also must document corrective
actions when process controls and procedures do not fall within
specified limits (Sec. Sec.  113.89, 114.89, and 114.100(c) (21 CFR
113.89, 114.89, and 114.100(c))); to report any instance of potential
health-endangering spoilage, process deviation, or contamination with
microorganisms where any lot of the food has entered distribution in
commerce (Sec. Sec.  108.25(d) and 108.35(d) and (e)); and to develop
and keep on file plans for recalling products that may endanger the
public health (Sec. Sec.  108.25(e) and 108.35(f)). To permit lots to
be traced after distribution, acidified foods and thermally processed
low-acid foods in hermetically sealed containers must be marked with an
identifying code (Sec. Sec.  113.60(c) (21 CFR 113.60(c) (thermally
processed foods) and 114.80(b) (21 CFR 114.80(b) (acidified foods)).
    The records of processing information are periodically reviewed
during factory inspections by FDA to verify fulfillment of the
requirements in parts 113 or 114. Scheduled thermal processes are
examined and reviewed to determine their adequacy to protect public
health. In the event of a public health emergency, records are used to
pinpoint potentially hazardous foods rapidly and thus limit recall
activity to affected lots.
    As described in our regulations, processors may obtain the paper
versions of Forms FDA 2541, FDA 2541a, and FDA 2541c by contacting us
at a particular address. Processors mail completed paper forms to us.
However, processors who are subject to Sec.  108.25, 108.35, or both,
have an option to submit Forms FDA 2541, FDA 2541a, and FDA 2541c
electronically (Ref. 1) (see also 76 FR 11783 at 11785; March 3, 2011).
    In this document, we are providing notice that we are updating the
process filing portion of the electronic submission system to
incorporate ``smart form'' technology. The updated process filing
portion of the electronic submission system will query the processor
about the processes used to produce the food and present only those
data entry fields that are applicable. This will reduce the burden on
processors and reduce errors in process filing because processors will
no longer need to evaluate whether particular data entry fields are
applicable to their products. For example, when a processor submits a
process filing for a

product that is processed using a low-acid retorted method with a
process mode of ``agitating'', ``smart form'' technology would bypass
questions that are not applicable to this process mode option.
    Although we encourage commercial processors to use the electronic
submission system for plant registration and process filing, we will
continue to make paper-based forms available. To standardize the burden
associated with process filing, regardless of whether the process
filing is submitted electronically or using a paper form, we are
proposing to eliminate Forms FDA 2541a (Ref. 2) and FDA 2541c (Ref. 3)
and replace these two forms with a total of four forms. Each of the
four proposed replacement forms will pertain to a specific type of
commercial processing and will be available both on the electronic
submission system and as a paper-based form. The electronic submission
system and the paper-based form will ``mirror'' each other to the
extent practicable. The four proposed replacement process filing forms
are as follows:
     Form FDA 2541d (Food Process Filing for Low-Acid Retorted
Method) (Ref.4);
     Form FDA 2541e (Food Process Filing for Acidified Method)
(Ref. 5);
     Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method) (Ref. 6); and
     Form FDA 2541g (Food Process Filing for Low-Acid Aseptic
Systems) (Ref. 7).
    Some of the data entry fields on the four proposed replacement
process filing forms are not on current Forms FDA 2541a and FDA 2541c.
We added certain data entry fields to improve the efficiency of our
review of the process filings. For example, the four proposed
replacement forms include data entry fields for the ``food product
group'' (such as liquid, ready-to-eat ``breakfast foods''). We estimate
that any time it would take to provide such information not already on
Form FDA 2541a or FDA 2541c would be offset by the time processors will
save by not having to evaluate whether certain data entry fields on
Form FDA 2541a or FDA 2541c are applicable to their products. At this
time, the paper-based versions of the four proposed replacement forms
and their instructions are all available for review as references to
this document (Refs. 4 through 11) or at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. After we review the comments received in response to
this notice, we will determine what, if any, changes will be made to
the paper-based versions of the forms. We will then complete the
development of the electronic submission system to mirror the revised
paper forms. The draft electronic versions of the forms will be made
available for review on OMB's Web site when we publish a second notice
in the Federal Register announcing the submission of the information
collection request to OMB. That notice will have a 30-day public
comment period.
    Description of Respondents: The respondents to this information
collection are commercial processors and packers of acidified foods and
thermally processed low-acid foods in hermetically sealed containers.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of                        Average
                     21 CFR section                        FDA form No.      Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   108.25(c)(1) and 108.35(c)(2); Food canning            2541             645               1             645            0.17             110
 establishment registration.............................                                                                      (10 mins.)
Sec.   108.25(c)(2); Food process filing for acidified             2541e             726              11           7,986           0.333           2,659
 method.................................................                                                                      (20 mins.)
Sec.   108.35(c)(2); Food process filing for low-acid              2541d             336              12           4,032           0.333           1,343
 retorted method........................................                                                                      (20 mins.)
Sec.   108.35(c)(2); Food process filing for water                 2541f              37               6             222           0.333              74
 activity/formulation control method....................                                                                      (20 mins.)
Sec.   108.35(c)(2); Food process filing for low-acid              2541g              42              22             924            0.75             693
 aseptic systems........................................                                                                      (45 mins.)
Sec.  Sec.   108.25(d) and 108.35(d) and (e); Report of              N/A               1               1               1               4               4
 any instance of potential health-endangering spoilage,
 process deviation, or contamination with microorganisms
 where any lot of the food has entered distribution in
 commerce...............................................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           4,883
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate of the number of respondents in table 1 on
registrations, process filings, and reports received over the past 3
years. The hours per response reporting estimates are based on our
experience with similar programs and information received from
industry. The reporting burden for Sec. Sec.  108.25(d) and 108.35(d)
and (e) is minimal because notification of spoilage, process deviation,
or contamination of product in distribution occurs less than once a
year. Most firms discover these problems before the product is
distributed and, therefore, are not required to report the occurrence.
We estimate that we will receive one report annually under Sec. Sec.
108.25(d) and

108.35(d) and (e). The report is expected to take 4 hours per response,
for a total of 4 hours.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                Number of                      Average  burden
                            21 CFR part                                 Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
108, 113, and 114..................................................          10,392                1           10,392              250        2,598,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate of 10,392 recordkeepers in table 2 on its
records of the number of registered firms, excluding firms that were
inactive or out of business, yet still registered. To avoid double-
counting, we have not included estimates for Sec. Sec.  108.25(g),
108.35(c)(2)(ii), and 108.35(h) because they merely cross-reference
recordkeeping requirements contained in parts 113 and 114 and have been
accounted for in the recordkeeping burden estimate. We estimate that
10,392 firms will expend approximately 250 hours per year to fully
satisfy the recordkeeping requirements in parts 108, 113 and 114, for a
total of 2,598,000 hours.
    Finally, our regulations require that processors mark thermally
processed low-acid foods in hermetically sealed containers (Sec.
113.60(c) and acidified foods (Sec.  114.80(b)) with an identifying
code to permit lots to be traced after distribution. We seek OMB
approval of the third party disclosure requirements in Sec. Sec.
113.60(c) and 114.80(b). However, we have not included a separate table
to report the estimated burden of these regulations. No burden has been
estimated for the third party disclosure requirements in Sec. Sec.
113.60(c) and 114.80(b) because the coding process is done as a usual
and customary part of normal business activities. Coding is a business
practice in foods for liability purposes, inventory control, and
process control in the event of a problem. Under 5 CFR 1320.3(b)(2)),
the time, effort, and financial resources necessary to comply with a
collection of information are excluded from the burden estimate if the
reporting, recordkeeping, or disclosure activities needed to comply are
usual and customary because they would occur in the normal course of
activities.

II. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (We
have verified the Web site addresses in this reference section, but we
are not responsible for any subsequent changes to Web sites after this
document publishes in the Federal Register.)
    1. FDA 2012. ``Guidance for Industry: Submitting Form FDA 2541
(Food Canning Establishment Registration) and Forms FDA 2541a and FDA
2541c (Food Process Filing Forms) to FDA in Electronic or Paper
Format''. Available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm.
    2. Form FDA 2541a. Food Process Filing for All Methods Except Low-
Acid Aseptic. Available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076784.pdf.
    3. Form FDA 2541c. Food Process Filing for Low-Acid Aseptic
Systems. Available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM123687.pdf.
    4. Draft Form 2541d. Food Process Filing for Low-Acid Retorted
Method. Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM365066.pdf.
    5. Draft Form 2541e. Food Process Filing for Acidified Method.
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM365058.pdf.
    6. Draft Form 2541f. Food Process Filing for Water Activity/
Formulation Control Method. Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM365059.pdf.
    7. Draft Form 2541g. Food Process Filing for Low-Acid Aseptic
Systems. Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM365060.pdf.
    8. Draft Instructions for Paper Submission of Form FDA 2541d.
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM366881.pdf.
    9. Draft Instructions for Paper Submission of Form FDA 2541e.
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM366882.pdf.
    10. Draft Instructions for Paper Submission of Form FDA 2541f.
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM366884.pdf
    11. Draft Instructions for Paper Submission of Form FDA 2541g.
Available at http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/UCM366885.pdf.

    Dated: September 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22674 Filed 9-17-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Page 27128]
[FR Doc No: 2019-12287]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1740]

Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of
Six Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of six abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 11, 2019.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
      Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 070185...............  Fluor-Op               Novartis
                             (fluorometholone)      Pharmaceuticals
                             Ophthalmic             Corp., One Health
                             Suspension, 0.1%.      Plaza, East Hanover,
                                                    NJ 07936.
ANDA 070858...............  Trazodone              Watson Laboratories,
                             Hydrochloride          Inc., Subsidiary of
                             Tablets USP, 100       Teva Pharmaceuticals
                             milligrams (mg).       USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 076023...............  Hydrocodone            Teva Pharmaceuticals
                             Bitartrate and         USA, Inc., 400
                             Ibuprofen Tablets,     Interpace Pkwy.,
                             7.5 mg/200 mg.         Bldg. A, Parsippany,
                                                    NJ 07054.
ANDA 078167...............  Paclitaxel Injection   Sandoz, Inc., 100
                             USP, 6 mg/milliliter.  College Rd. West,
                                                    Princeton, NJ 08540.
ANDA 088726...............  Chlorpropamide         Aurolife Pharma, LLC,
                             Tablets USP, 250 mg.   279 Princeton
                                                    Hightstown Rd., East
                                                    Windsor, NJ 08520.
ANDA 089852...............  Chlorzoxazone Tablets  Do.
                             USP, 250 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
11, 2019. Approval of each entire application is withdrawn, including
any strengths or products inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on July 11, 2019 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12287 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Notices]
[Pages 59435-59439]
[FR Doc No: 2018-25470]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84613; File No. SR-MIAX-2018-36]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Filing of a Proposed Rule Change To Amend
Exchange Rule 518, Complex Orders

November 16, 2018.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on November 9, 2018, Miami International
Securities Exchange, LLC (``MIAX Options'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') a proposed rule
change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rule 518,
Complex Orders [sic]
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/ at MIAX Options'
principal office, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change 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 Exchange Rule 518, Complex Orders,
to (i) adopt a new Simple Market Auction or Timer (``SMAT'') Event
(defined below); (ii) amend the Response Time Interval and Defined Time
Period for Complex Auctions (each defined below); (iii) adopt a new
Complex Liquidity Exposure Process (``cLEP''); (iv) make minor changes
to the Complex MIAX Options Price Collar Protection; and (v) clarify
that the Calendar Spread Variance (``CSV'') price protection applies
only to strategies in American-style option \3\ classes.
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    \3\ The term ``American-style option'' means an option contract
that, subject to the provisions of Rule 700 (relating to the cutoff
time for exercise instructions) and to the Rules of the Clearing
Corporation, can be exercised on any business day prior to its
expiration date and on its expiration date. See Exchange Rule 100.
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    Specifically, the Exchange proposes to amend subsection (a)(16), to
adopt a new Simple Market Auction or Timer (SMAT) Event. A SMAT Event
is

defined as any one of the following; a PRIME Auction (pursuant to Rule
515A),\4\ a Route Timer (pursuant to Rule 529),\5\ or a liquidity
refresh pause (pursuant to Rule 515(c)(2).\6\ The Exchange now proposes
to adopt new rule text to add the liquidity exposure process timer
(pursuant to proposed Rule 515(c)(2)(i)) as a SMAT Event. The liquidity
exposure process timer, which is not to exceed three (3) seconds, is
engaged as part of the liquidity exposure process for orders in
Proprietary Products \7\ that would be posted, managed, or would trade
at a price more aggressive than the order's protected price. If a SMAT
Event exists during free trading for an option component of a complex
strategy, trading in the complex strategy will be suspended.\8\ The
Exchange also proposes to correct an internal cross reference in
subsection (a)(16)(iii) from Rule 515(c)(2) to Rule 515(c)(3) to
reflect the new citation under a currently pending proposed rule
change. The purpose of adding the liquidity exposure process timer as a
SMAT Event is to enhance the continuity, trade-through protection, and
orderliness in the simple market and to protect complex order
components from being executed at prices that could improve following a
SMAT Event.
---------------------------------------------------------------------------

    \4\ The MIAX Price Improvement Mechanism (``PRIME'') is a
process by which a Member may electronically submit for execution
(``Auction'') an order it represents as agent (``Agency Order'')
against principal interest, and/or an Agency Order against solicited
interest. See Exchange Rule 515A.
    \5\ The Exchange may automatically route orders to other
exchanges under certain circumstances (``Routing Services''). In
connection with such services, one of two Route Mechanisms,
Immediate Routing or the Route Timer, will be used when a Public
Customer order is received and/or reevaluated that is both routable
and marketable against the opposite side ABBO upon receipt and the
Exchange's disseminated market is not equal to the opposite side
ABBO, or is equal to the opposite side ABBO and of insufficient size
to satisfy the order. For those initiating Public Customer orders
that are routable, but do not meet the additional criteria for
Immediate Routing, the System will implement a Route Timer not to
exceed one second (the duration of the Timer will be announced to
Members through a Regulatory Circular), in order to allow Market
Makers and other participants an opportunity to interact with the
initiating order. See Exchange Rule 529.
    \6\ The System will pause the market for a time period not to
exceed one second to allow additional orders or quotes refreshing
the liquidity at the MBBO to be received (``liquidity refresh
pause'') when at the time of receipt or reevaluation of the
initiating order by the System: (A) Either the initiating order is a
limit order whose limit price crosses the NBBO or the initiating
order is a market order, and the limit order or market order could
only be partially executed; (B) a Market Maker quote was all or part
of the MBBO when the MBBO is alone at the NBBO; and (C) and the
Market Maker quote was exhausted. See Exchange Rule 515(c)(2).
    \7\ The term ``Proprietary Product'' means a class of options
that is listed exclusively on the Exchange and any of its
affiliates. See proposed Exchange Rule 100.
    \8\ See Exchange Rule 518, Interpretations and Policies
.05(e)(2)(i).
---------------------------------------------------------------------------

    Additionally, the Exchange proposes to amend subsection (d)(3)
which describes the Response Time Interval of a Complex Auction, which
is a single-sided auction. The Exchange offers Complex Auction
functionality as described in Exchange Rule 518 \9\ and also a cPRIME
process, which is unaffected by this proposal, as described in Exchange
Rule 515A.12.
---------------------------------------------------------------------------

    \9\ Certain option classes, as determined by the Exchange and
communicated to Members via Regulatory Circular, will be eligible to
participate in a Complex Auction (an ``eligible class''). Upon
evaluation as set forth in subparagraph (c)(5) of Rule 518, the
Exchange may determine to automatically submit a Complex Auction-
eligible order into a Complex Auction. Upon entry into the System or
upon evaluation of a complex order resting at the top of the
Strategy Book, Complex Auction-eligible orders may be subject to an
automated request for responses (``RFR''). See Exchange Rule 518(d).
---------------------------------------------------------------------------

    Currently, Rule 518(d)(3) provides that the Response Time Interval
means the period of time during which responses to the Request for
Responses (``RFR'') message may be entered. The Rule further provides
that the Exchange determines the duration of the Response Time
Interval, which shall not exceed 500 milliseconds, and communicates it
to Members via Regulatory Circular.\10\ The Exchange now proposes to
adopt new rule text to state that, ``the end of the trading session
will also serve as the end of the Response Time Interval for a Complex
Auction still in progress.'' In connection with this proposed change
the Exchange proposes to amend subsection (d)(2) to remove the
reference to the Defined Time Period for a Complex Auction. The Defined
Time Period represents the period of time preceding the end of a
trading session during which a Complex Auction will not be initiated.
Currently, the Defined Time Period is 2,000 milliseconds \11\ while the
duration of a Complex Auction is just 200 milliseconds. The Exchange
believes that removing this restriction will allow for increased price
improvement opportunities. The Exchange also proposes to amend
subsection (c)(2)(i) to remove the restriction that a cAOA order \12\
received during the Defined Time Period will not initiate a new Complex
Auction. Under the current rules there is no opportunity at all for
price improvement via a Complex Auction when there is less than two
seconds left in the trading session. The Exchange believes that
removing the Defined Time Period and allowing the end of the trading
session to serve as the end of the Response Time Interval in the
limited instance that a Complex Auction is initiated with less than 200
milliseconds left in the trading session will allow for more
opportunities for price improvement via the auction process. The
Exchange warrants that is has the System capability to conduct auctions
and execute transactions in a timely fashion at any time during the
trading session.
---------------------------------------------------------------------------

    \10\ The Exchange notes that the Response Time Interval is
currently set to 200 milliseconds. See MIAX Regulatory Circular
2016-46.
    \11\ See MIAX Regulatory Circular 2016-63.
    \12\ A ``Complex Auction-on-Arrival'' or ``cAOA'' order is a
complex order designated to be placed into a Complex Auction upon
receipt or upon evaluation . See Exchange Rule 518(b)(2).
---------------------------------------------------------------------------

    The Exchange also proposes to adopt new subsection (e) to describe
a Complex Liquidity Exposure Process (``cLEP'') for complex orders and
complex eQuotes that would violate their Complex MIAX Price Collar
(``MPC'') price . The MPC price protection feature is an Exchange-wide
mechanism under which a complex order or complex eQuote to sell will
not be displayed or executed at a price that is lower than the opposite
side cNBBO \13\ bid at the time the MPC is assigned by the System \14\
(i.e., upon receipt or upon opening) by more than a specific dollar
amount expressed in $0.01 increments (the ``MPC Setting''), and under
which a complex order or eQuote to buy will not be displayed or
executed at a price that is higher than the opposite side cNBBO offer
at the time the MPC is assigned by the System by more than the MPC
Setting (each the ``MPC Price'').\15\ The MPC Price is established (i)
upon receipt of the complex order or eQuote during free trading, or
(ii) if the complex order or eQuote is not received during free
trading, at the opening (or reopening following a halt) of trading in
the complex strategy; or (iii) upon evaluation of the Strategy Book by
the System when a wide market condition, as described in
Interpretations and Policies .05(e)(1) of this Rule, no longer
exists.\16\ Once established the MPC Price will not change during the
life of the complex order or eQuote.\17\ If the MPC Price is priced
less aggressively than the limit price of the complex order or eQuote
(i.e., the MPC Price is less than the complex order or eQuote's bid
price

for a buy, or the MPC Price is greater than the complex order or
eQuote's offer price for a sell), or if the complex order is a market
order, the complex order or eQuote will be displayed and/or executed up
to its MPC Price. Any unexecuted portion of such a complex order or
eQuote: (A) Will be cancelled if it would otherwise be displayed or
executed at a price that is outside the MPC Price; and (B) may be
subject to the managed interest process described in Rule
518(c)(4).\18\ If the MPC Price is priced more aggressively than the
limit price of the complex order or eQuote (i.e., the MPC Price is
greater than the complex order or eQuote's bid price for a buy, or the
MPC Price is less than the complex order or eQuote's offer price for a
sell), the complex order or eQuote will be displayed and/or executed up
to its limit price. Any unexecuted portion of such a complex order will
be submitted, if eligible, to the managed interest process described in
Rule 518(c)(4), or placed on the Strategy Book at its limit price. Any
unexecuted portion of such a complex eQuote will be cancelled.\19\
---------------------------------------------------------------------------

    \13\ The term cNBBO means the Complex National Best Bid or Offer
and is calculated using the National Best Bid or Offer (``NBBO'')
for each component of a complex strategy to establish the best net
bid and offer for a complex strategy. See Exchange Rule 518(a)(2).
    \14\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \15\ See Exchange Rule 518.05(f).
    \16\ See Exchange Rule 518.05(f)(3).
    \17\ See Exchange Rule 518.05(f)(4).
    \18\ See Exchange Rule 518.05(f)(6).
    \19\ See Exchange Rule 518.05(f)(7).
---------------------------------------------------------------------------

    The Exchange now proposes to initiate a Complex Liquidity Exposure
Auction (``cLEP Auction'') whenever a complex order or complex eQuote
would violate its MPC Price. To begin the cLEP Auction, the System will
first broadcast a liquidity exposure message to all subscribers of the
Exchange's data feeds. The liquidity exposure message will include the
symbol, side of the market, auction start price (MPC Price), quantity
of matched contracts, and the imbalance quantity. The inclusion of the
quantity of matched contracts at the price included in the RFR message
is intended to inform participants considering submitting an RFR
Response the number of contracts for which there is matched interest,
and the purposes of including the imbalance quantity in the RFR message
is to inform such participants of the number of contracts that do not
have matched interest.
    The System will initiate a Response Time Interval, as determined by
the Exchange and communicated via Regulatory Circular which shall be no
less than 100 milliseconds and no more than 5,000 milliseconds.\20\ The
Exchange recently surveyed its Members and established that Members'
Systems could submit auction responses in 100 milliseconds or less on
average.\21\ At the conclusion of the Complex Liquidity Exposure
Auction if the resulting trade price is less aggressive than the MPC
Price, liquidity will be handled in accordance to Exchange Rule
518(c)(2), Execution of Complex Orders and Quotes. Orders and quotes
executed in a cLEP Auction will be allocated in accordance with the
Complex Auction allocation procedures described in Exchange Rule
518(d)(7), Allocation at the Conclusion of a Complex Auction.
---------------------------------------------------------------------------

    \20\ The Exchange notes that the current duration of a cPRIME
Auction is 100 milliseconds and the current duration of a Complex
Auction is 200 milliseconds.
    \21\ See Securities Exchange Release No.80940 (June 15, 2017),
82 FR 28369 (June 21, 2017) (SR-MIAX-2017-16).
---------------------------------------------------------------------------

    At the conclusion of a cLEP Auction the System will calculate the
next potential MPC Price using the auction start price plus (minus) the
next MPC increment for buy (sell) orders. Liquidity with an original
price equal to or less aggressive than the new MPC Price is no longer
subject to the MPC price protection. Liquidity with an original price
more aggressive than the new MPC Price (or market order liquidity) is
subject to the MPC price protection feature using the new MPC Price.
    The current rule provides that if the MPC Price is priced less
aggressively than the limit price of the complex order or eQuote (i.e.,
the MPC Price is less than the complex order or eQuote's bid price for
a buy, or the MPC Price is greater than the complex order or eQuote's
offer price for a sell), or if the complex order is a market order, the
complex order or eQuote will be displayed and/or executed up to its MPC
Price. Any unexecuted portion of such a complex order or eQuote: (A)
Will be cancelled if it would otherwise be displayed or executed at a
price that is outside the MPC Price, and (B) may be subject to the
managed interest process described in 518(c)(4).\22\
---------------------------------------------------------------------------

    \22\ See Exchange Rule 518.05(f)(6).
---------------------------------------------------------------------------

    The Exchange now proposes to amend subsection(f)(6)(A) to provide
that any unexecuted portion of such a complex order or eQuote will be
subject to the cLEP as described in proposed subsection (e). The
Exchange believes it to be in the best interest of the Member to seek
liquidity via the Complex Liquidity Exposure Process as described
above, rather than cancel any unexecuted portion of the order.
    The examples below demonstrate an order subject to the Complex
Liquidity Exposure Process.
Example 1
MPC: $0.25

    The Exchange has one order resting on its Strategy Book: \23\ +1
component A, -1 component B:
---------------------------------------------------------------------------

    \23\ The term ``Strategy Book'' is the Exchange's electronic
book of complex orders and complex quotes. See Exchange Rule
518(a)(17).

Order 1 is to sell 10 at $1.90
MBBO component A: 4.00(10) x 5.00(10)
MBBO component B: 2.00(10) x 2.50(10)
NBBO component A: 4.05(10) x 4.15(10)
NBBO component B: 2.30(10) x 2.40(10)
cMBBO: 1.50 (10) x 3.00 (10)
cNBBO: 1.65 (10) x 1.85 (10)

    The Exchange receives a new order (Order 2) to buy 20 at $2.25.
    Order 2 buys 10 from Order 1 at $1.90 and initiates the Complex
Liquidity Exposure Process: Order 2 reprices to its protected price of
$2.10 (cNBO of 1.85 + 0.25) and is posted at that price on the Complex
Order Book and the Complex Liquidity Exposure Process Timer begins.
    During the cLEP Auction the Exchange receives a new order (Order 3)
to sell 10 at $2.10. This order locks the current same side Book Price
of $2.10 and Order 3 sells 10 to Order 2 at $2.10, filling Order 2 and
ending the Liquidity Exposure Process.
Example 2
MPC: $0.25

    The Exchange has one order resting on its book in Strategy +1
component A, -1 component B:

Order 1 is to sell 10 at $1.90
MBBO component A: 4.00(10) x 5.00(10)
MBBO component B: 2.00(10) x 2.50(10)
NBBO component A: 4.05(10) x 4.15(10)
NBBO component B: 2.30(10) x 2.40(10)
cMBBO: 1.50 (10) x 3.00 (10)
cNBBO: 1.65 (10) x 1.85 (10)

    The Exchange receives a new order (Order 2) to buy 20 at $2.25.
    Order 2 buys 10 from Order 1 at $1.90 and initiates the Complex
Liquidity Exposure Process: Order 2 reprices to its protected price of
$2.10 (cNBO of 1.85 + 0.25) and is posted at that price on the Strategy
Book and the Complex Liquidity Exposure Process Timer begins.
    No new liquidity arrives during the Liquidity Exposure Process. At
the end of the timer, Order 2 reprices to its limit of $2.25 and is
posted at that price on the Strategy Book, ending the Liquidity
Exposure Process.
    The Exchange also proposes to make minor technical changes to
Interpretations and Policies .05 of Exchange Rule 518 to reflect the
proposed changes described above. Specifically, the Exchange proposes
to remove subparagraph (f)(4) that provides that once established, the
MPC

Price will not change during the life of the complex order or eQuote.
As described above the MPC Price for certain liquidities will be
subject to a re-evaluation process and may change as a result of such
re-evaluation. Also, the Exchange proposes to amend subparagraph (6)(A)
to remove the provision that any unexecuted portion of such a complex
order or eQuote will be cancelled if it would otherwise be displayed or
executed at a price that is outside the MPC Price, and to state instead
that it will be subject to the cLEP as described in subsection (e) of
this Rule. Additionally, as a result of the removal of paragraph (4) it
is necessary to renumber the remaining paragraphs for consistency
within the numbering hierarchy of the Exchange's rules. Therefore
current paragraph (5) will be renumbered as new paragraph (4); current
paragraph (6) will be renumbered as new paragraph (5); and current
paragraph (7) will be renumbered as new paragraph (6).
    Finally, the Exchange proposes to amend subsection (b) of
Interpretations and Policies .05 to adopt new rule text stating that
the Calendar Spread Variance (``CSV'') price protection applies only to
strategies in American-style option classes. A Calendar Spread is a
complex strategy consisting of the purchase of one call (put) option
and the sale of another call (put) option overlying the same security
that have different expirations but the same strike price. The CSV
establishes a minimum trading price limit for Calendar Spreads. The
maximum possible value of a Calendar Spread is unlimited, thus there is
no maximum price protection for Calendar Spreads. The minimum possible
trading price limit of a Calendar Spread is zero minus the pre-set
value of $.10. This ensures that the Strategy doesn't trade more than
$.10 away from its intrinsic value. (On a basic level the price of an
American-style option is comprised of two components; intrinsic value
and time value. If the strike price of a call option is $5.00 and the
stock is priced at $6.00, there is $1.00 of intrinsic value in the
price of the call option, anything above $1.00 represents the time
value component.) An American-style option must be worth at least as
much as its intrinsic value because the holder of the option can
realize the intrinsic value by immediately exercising the option. In a
Calendar Spread strategy comprised of American-style options, ceteris
paribus, the far month should be worth more than the near month due to
its having a greater time to expiration and therefore a higher time
value. As European-style options \24\ may only be exercised on their
expiration date, the relationship between the stock price, option
price, and option strike price that exists for American-style options
does not exist for European-style options. Therefore the CSV price
protection would be ineffective and will not be available for
strategies comprised of European-style options.
---------------------------------------------------------------------------

    \24\ The term ``European-style option'' means an option contract
that, subject to the provisions of Rule 700 (relating to the cutoff
time for exercise instructions) and to the Rules of the Clearing
Corporation, can be exercised only on its expiration date. See
Exchange Rule 100.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \25\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \26\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanisms of a free and open market and a national market
system and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78f(b).
    \26\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes its proposal to include the liquidity
exposure timer as a SMAT Event promotes just and equitable principles
of trade, removes impediments to and perfects the mechanisms of a free
and open market and a national market system and, in general, protects
investors and the public interest. SMAT Events represent temporary
interruptions of free trading in one or more components of a complex
strategy. The temporary suspension of trading in complex orders during
a SMAT Event is intended to enhance continuity, trade-through
protection, and orderliness in the simple market and to protect complex
order components from being executed at prices that could improve
following a SMAT Event. Once a SMAT Event is concluded or resolved, the
System will re-evaluate the Strategy Book.\27\
---------------------------------------------------------------------------

    \27\ See Exchange Rule 518, Interpretations and Policies
.05(f)(2)(i).
---------------------------------------------------------------------------

    The Exchange believes that its proposal to eliminate the Defined
Time Period to allow Complex Auctions \28\ to occur throughout the
trading session removes impediments to and perfects the mechanism of a
free and open market and a national market system and, in general,
protects investors and the public interest by removing an unnecessary
barrier which prevented Complex Auctions from occurring with less than
two seconds left in the trading session. The current duration of a
Complex Auction duration is just 200 milliseconds. The Exchange
believes it is in the best interest of the investor to allow for
opportunities for price improvement throughout the entire trading
session. In the event that a Member initiates a Complex Auction without
enough time for Members to respond, the initiating Member is no worse
off under the proposed rule than the Member would have been under the
current rule which prevents the Member from even attempting to initiate
a Complex Auction with less than two seconds left in the trading
session.
---------------------------------------------------------------------------

    \28\ Complex Auctions are described in Exchange Rule 518(d) and
are separate and distinct from cPRIME Auctions which are described
in Interpretations and Policies .12 of Exchange Rule 515A, MIAX
Price Improvement Mechanism (``PRIME'') and PRIME Solicitation
Mechanism.
---------------------------------------------------------------------------

    The Exchange also believes its proposal to adopt a Complex
Liquidity Exposure Process promotes just and equitable principles of
trade and removes impediments to and perfects the mechanisms of a free
and open market and a national market system and, in general, protects
investors and the public interest. The Complex Liquidity Exposure
Process provides an additional opportunity for price discovery for
those orders that would trade through their MPC Price. The Exchange
believes its proposal promotes just and equitable principles of trade
as it is in the best interest of the Member to seek liquidity for the
unexecuted portion of the order which exceeds the order's MPC Price
rather than to simply cancel the unexecuted portion back to the
Member.\29\
---------------------------------------------------------------------------

    \29\ The Exchange notes that Members who believe that an
execution has occurred at an erroneous price may avail themselves of
the protections provided in Exchange Rule 521, Nullification and
Adjustment of Options Transactions Including Obvious Errors.
---------------------------------------------------------------------------

    The Exchange also believes that its proposal to amend
Interpretations and Policies .05(f) to reflect the changes resulting
from the introduction of the Complex Liquidity Exposure Process
promotes just and equitable principles of trade, and removes
impediments to and perfects the mechanisms of a free and open market
and a national market system and, in general, protects investors and
the public interest by clearly describing the operation of the
Exchange's functionality in the Exchange's rules. The Exchange believes
it is in the interest of investors and the public to accurately
describe the behavior of the Exchange's System in its

rules as this information may be used by investors to make decisions
concerning the submission of their orders. Further, the Exchange's
proposal to make non-substantive changes to re-number certain
paragraphs for internal consistency within the rule benefits investors
and the public interest by providing clarity and accuracy in the
Exchange's rules.
    Finally, the Exchange believes its proposal to clarify that the
Calendar Spread Variance (CSV) price protection is available only for
American-style options promotes just and equitable principles of trade,
and removes impediments to and perfects the mechanisms of a free and
open market and a national market system and, in general, and protects
investors and the public interest by providing clarity and precision in
the Exchange's rules. The Exchange believes it is in the interest of
investors and the public to accurately describe the behavior of the
Exchange's System in its rules as this information may be used by
investors to make decisions concerning the submission of their orders.
Transparency and clarity are consistent with the Act because it removes
impediments to and helps perfect the mechanism of a free and open
market and a national market system, and, in general, protects
investors and the public interest by accurately describing the behavior
of the Exchange's System. In particular, the Exchange believes that the
proposed rule change will provide greater clarity to Members and the
public regarding the Exchange's Rules, and it is in the public interest
for rules to be accurate and concise so as to eliminate the potential
for confusion.

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 Exchange does not believe the proposed rule change will impose
any burden on inter-market competition. The Exchange's proposal seeks
to enhance complex order trading on the Exchange, and may potentially
enhance competition among the various markets for complex order
execution, potentially resulting in more active complex order trading
on all exchanges.
    Additionally, the Exchange does not believe the proposed rule
change will impose any burden on intra-market competition as the Rules
apply equally to all Members of the Exchange.

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be 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 protected]. Please include
File Number SR-MIAX-2018-36 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MIAX-2018-36. 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 a.m. and 3
p.m. Copies of the filing also will be available for inspection and
copying at the principal office of the Exchange. All comments received
will be posted without change. 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-MIAX-2018-36, and should be submitted on
or before December 14, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
---------------------------------------------------------------------------

    \30\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-25470 Filed 11-21-18; 8:45 am]
BILLING CODE 8011-01-P


 [Federal Register Volume 82, Number 159 (Friday, August 18, 2017)] [Rules and Regulations] [Pages 39341-39344] [FR Doc No: 2017-15484]

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

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0699; Directorate Identifier 2017-NM-004-AD;

Amendment 39-18968; AD 2017-15-08]

RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain

Bombardier, Inc., Model CL-600-2E25 (Regional Jet Series 1000)

airplanes. This AD requires modifying the bleed-air duct and detection

system; and revising the maintenance or inspection program, as

applicable. This AD was prompted by a report of a possibility that the

shrouds of the high pressure bleed air ducts could deteriorate and

their maximum permitted leakage rate could be exceeded. We are issuing

this AD to address the unsafe condition on these products.

DATES: This AD becomes effective September 5, 2017.

    The Director of the Federal Register approved the incorporation by

reference of certain publications listed in this AD as of September 5,

2017.

    We must receive comments on this AD by October 2, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR

11.43 and 11.45, by any of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.

     Mail: U.S. Department of Transportation, Docket

Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New

Jersey Avenue SE., Washington, DC 20590.

     Hand Delivery: U.S. Department of Transportation, Docket

Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New

Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday

through Friday, except Federal holidays.

    For service information identified in this final rule, contact

Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec

H4S 1Y9, Canada; Widebody Customer Response Center North America toll-

free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999;

fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this referenced service information at

the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,

WA. For information on the availability of this material at the FAA,

call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-

0699.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-

0699; or in person at the Docket Operations office between 9 a.m. and 5

p.m., Monday through Friday, except Federal holidays. The AD docket

contains this AD, the regulatory evaluation, any comments received, and

other information. The street address for the Docket Operations office

(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be

available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Joseph Catanzaro, Aerospace Engineer,

Propulsion and Services Branch, ANE-173, FAA, New York Aircraft

Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,

NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation

authority for Canada, has issued Canadian Airworthiness Directive CF-

2016-35, dated November 16, 2016 (referred to after this as the

Mandatory Continuing Airworthiness Information, or ``the MCAI''), to

correct an unsafe condition for certain Bombardier, Inc., Model CL-600-

2E25 (Regional Jet Series 1000) airplanes. The MCAI states:

    It is possible for the shrouds of the High Pressure (HP) bleed

air ducts located in the main wheel wells and overwing areas to

deteriorate and consequently, their maximum permitted leakage rate

could be exceeded. If a significant bleed air leak is not sensed by

the detection system, hot air impingement may cause damage to the

adjacent structure and system components or create a fire hazard.

    This [Canadian] AD is issued to mandate a modification of the

bleed-air duct and detection system, as well as a revision of the

Airworthiness Limitation tasks to correspond with this modification.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-

0699.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc. has issued Bombardier Service Bulletin 670BA-36-

022, Revision B, dated December 20, 2016. The service information

describes modifying the bleed-air duct and detection system.

    Bombardier, Inc. has issued the following service information.

     Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0553, dated August 19, 2016, which

describes an airworthiness limitation task for a detailed inspection of

the protection jackets (shields) and insulating blankets located on top

of the center wing and fuel tank and fuel vent lines for condition and

security.

     Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0554, dated August 19, 2016, which

describes an airworthiness limitation task for a functional check of

the bleed air duct shrouds.

     Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0555, dated August 19, 2016, which

describes an airworthiness limitation task for a detailed inspection of

the bleed air duct coupling covers and detection manifolds.

     Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0556, dated August 19, 2016, which

describes an airworthiness limitation task for a detailed inspection of

the overwing shield and the protection jackets for condition and

security.

     Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0557, dated August 19, 2016, which

describes an airworthiness limitation task for a detailed inspection of

the vent boot protection jackets for condition and security.

    This service information is reasonably available because the

interested parties have access to it through their normal course of

business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another

country, and is approved for operation in the United States. Pursuant

to our bilateral agreement with the State of Design Authority, we have

been notified of the unsafe condition described in the MCAI and service

information referenced above. We are issuing this AD because we

evaluated all pertinent information and determined the unsafe condition

exists and is likely to exist or develop on other products of the same

type design.

    This AD requires revisions to certain operator maintenance

documents to include new actions (e.g., inspections). Compliance with

these actions is required by 14 CFR 91.403(c). For airplanes that have

been previously modified, altered, or repaired in the areas addressed

by this AD, the operator may not be able to accomplish the actions

described in the revisions. In this situation, to comply with 14 CFR

91.403(c), the operator must request approval for an alternative method

of compliance according to paragraph (k)(1) of this AD. The request

should include a description of changes to the required inspections

that will ensure the continued operational safety of the airplane.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this product,

notice and opportunity for public comment before issuing this AD are

unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight

safety, and we did not precede it by notice and opportunity for public

comment. We invite you to send any written relevant data, views, or

arguments about this AD. Send your comments to an address listed under

the ADDRESSES section. Include ``Docket No. FAA-2017-0699; Directorate

Identifier 2017-NM-004-AD'' at the beginning of your comments. We

specifically invite comments on the overall regulatory, economic,

environmental, and energy aspects of this AD. We will consider all

comments received by the closing date and may amend this AD based on

those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we

receive about this AD.

Costs of Compliance

    We estimate that this AD affects 0 airplanes of U.S. registry.

    We also estimate that it will take about 91 work-hours per product

to comply with the basic requirements of this AD. The average labor

rate is $85 per work-hour. Required parts cost are not available. Based

on these figures, we estimate the cost of this AD on U.S. operators to

be $0, or $7,735 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to

issue rules on aviation safety. Subtitle I, section 106, describes the

authority of the FAA Administrator. ``Subtitle VII: Aviation

Programs,'' describes in more detail the scope of the Agency's

authority.

    We are issuing this rulemaking under the authority described in

``Subtitle VII, Part A, Subpart III, Section 44701: General

requirements.'' Under that section, Congress charges the FAA with

promoting safe flight of civil aircraft in air commerce by prescribing

regulations for practices, methods, and procedures the Administrator

finds necessary for safety in air commerce. This regulation is within

the scope of that authority because it addresses an unsafe condition

that is likely to exist or develop on

products identified in this rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications

under Executive Order 13132. This AD will not have a substantial direct

effect on the States, on the relationship between the national

government and the States, or on the distribution of power and

responsibilities among the various levels of government.

    For the reasons discussed above, I certify that this AD:

    1. Is not a ``significant regulatory action'' under Executive Order

12866;

    2. Is not a ``significant rule'' under the DOT Regulatory Policies

and Procedures (44 FR 11034, February 26, 1979);

    3. Will not affect intrastate aviation in Alaska; and

    4. Will not have a significant economic impact, positive or

negative, on a substantial number of small entities under the criteria

of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by

reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the

Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0

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

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

Sec.  39.13  [Amended]

0

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

directive (AD):

2017-15-08 Bombardier, Inc.: Amendment 39-18968; Docket No. FAA-

2017-0699; Directorate Identifier 2017-NM-004-AD.

(a) Effective Date

    This AD becomes effective September 5, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model CL-600-2E25 (Regional

Jet Series 1000) airplanes, certificated in any category, serial

numbers 19001 through 19048 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 36, Pneumatic.

(e) Reason

    This AD was prompted by a report of a possibility that the

shrouds of the high pressure bleed air ducts could deteriorate and

their maximum permitted leakage rate could be exceeded. We are

issuing this AD to prevent a bleed air leak from exceeding the

maximum permitted leakage rate, which if not sensed by the detection

system, could cause hot air impingement to damage the adjacent

structure and system components or create a fire hazard.

(f) Compliance

    Comply with this AD within the compliance times specified,

unless already done.

(g) Modification

    At the earlier of the times specified in paragraphs (g)(1) and

(g)(2) of this AD: Modify the bleed-air duct and detection system,

in accordance with the Accomplishment Instructions of Bombardier

Service Bulletin 670BA-36-022, Revision B, dated December 20, 2016.

    (1) Within 6,600 flight hours or 32 months, whichever occurs

first after the effective date of this AD.

    (2) Within the next 10,000-flight-hours scheduled maintenance

check after the effective date of this AD.

(h) Maintenance or Inspection Program Revision

    Within 30 days after the effective date of this AD: Revise the

maintenance or inspection program, as applicable, by incorporating

the service information specified in figure 1 to paragraph (h) of

this AD. The initial compliance time for tasks 28-12-00-601 and 28-

12-00-602 is at the later of the applicable times specified in the

service information specified in figure 1 to paragraph (h) of this

AD, or within 30 days after the effective date of this AD, whichever

occurs later. The initial compliance times for tasks 25-85-00-101,

36-20-00-101, and 36-20-00-102 are specified in Figure 2 to

paragraph (h) of this AD. When these temporary revisions (TRs) have

been included in general revisions of the maintenance requirement

manual (MRM), the general revisions may be inserted in the MRM,

provided the relevant information in the general revision is

identical to the TRs specified in figure 1 to paragraph (h) of this

AD.

               Figure 1 to Paragraph (h) of This AD--Temporary Revisions Maintenance Requirements

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

                                                              Maintenance

                                                             requirements

           Temporary revision                 Task No.       manual (MRM)               Revision date

                                                            part 2 section

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

ALI-0553...............................       25-85-00-101            1-25  August 19, 2016.

ALI-0554...............................       36-20-00-101            1-36  August 19, 2016.

ALI-0555...............................       36-20-00-102            1-36  August 19, 2016.

ALI-0556...............................       28-12-00-601            4-28  August 19, 2016.

ALI-0557...............................       28-12-00-602            4-28  August 19, 2016.

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

     Figure 2 to Paragraph (h) of This AD--Initial Compliance Times

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

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

              Task No.                Initial compliance time (whichever

                                                 occurs later)

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

25-85-00-101.......................  Before the         Within 30 days

                                      accumulation of    after the

                                      8,000 total        effective date

                                      flight hours.      of this AD.

36-20-00-101.......................  Before the         Within 30 days

                                      accumulation of    after the

                                      10,000 total       effective date

                                      flight hours.      of this AD.

36-20-00-102.......................  Before the         Within 30 days

                                      accumulation of    after the

                                      10,000 total       effective date

                                      flight hours.      of this AD.

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

(i) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised, as

required by paragraph (h) of this AD, no alternative actions (e.g.,

inspections) or intervals may be used unless the actions or

intervals are approved as an alternative method of compliance (AMOC)

in accordance with the procedures specified in paragraph (k)(1) of

this AD.

(j) 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 Bombardier Service

Bulletin 670BA-36-022, dated May 30, 2016; or Bombardier Service

Bulletin 670BA-36-022, Revision A, dated September 16, 2016.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New

York Aircraft Certification Office (ACO), ANE-170, FAA, has the

authority to approve AMOCs for this AD, if requested using the

procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,

send your request to your principal inspector or local Flight

Standards District Office, as appropriate. If sending information

directly to the manager of the ACO, send it to ATTN: Program

Manager, Continuing Operational Safety, FAA, New York ACO, 1600

Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-

7300; fax<PHONE_NUMBER>. Before using any approved AMOC, notify your

appropriate principal inspector, or lacking a principal inspector,

the manager of the local flight standards district office/

certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD

to obtain corrective actions from a manufacturer, the action must be

accomplished using a method approved by the Manager, New York ACO,

ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or

Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If

approved by the DAO, the approval must include the DAO-authorized

signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information

(MCAI) Canadian Airworthiness Directive CF-2016-35, dated November

16, 2016, for related information. You may examine the MCAI on the

Internet at http://www.regulations.gov by searching for and locating

Docket No. FAA-2017-0699.

    (2) For more information about this AD, contact Joseph

Catanzaro, Aerospace Engineer, Propulsion and Services Branch, ANE-

173, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY

11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

    (3) Service information identified in this AD that is not

incorporated by reference is available at the addresses specified in

paragraphs (m)(3) and (m)(4) of this AD.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the

incorporation by reference (IBR) of the service information listed

in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do

the actions required by this AD, unless this AD specifies otherwise.

    (i) Bombardier Service Bulletin 670BA-36-022, Revision B, dated

December 20, 2016.

    (ii) Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0553, dated August 19, 2016.

    (iii) Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0554, dated August 19, 2016.

    (iv) Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0555, dated August 19, 2016.

    (v) Bombardier CRJ Series Regional Jet Airworthiness Limitations

Temporary Revision ALI-0556, dated August 19, 2016.

    (vi) Bombardier CRJ Series Regional Jet Airworthiness

Limitations Temporary Revision ALI-0557, dated August 19, 2016.

    (3) For service information identified in this AD, contact

Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,

Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center

North America toll-free telephone 1-866-538-1247 or direct-dial

telephone 1-514-855-2999; fax<PHONE_NUMBER>; email

<EMAIL_ADDRESS>Internet http://www.bombardier.com.

    (4) You may view this service information at the FAA, Transport

Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For

information on the availability of this material at the FAA, call

425-227-1221.

    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on July 13, 2017.

Dionne Palermo,

Acting Manager, Transport Airplane Directorate, Aircraft Certification

Service.

[FR Doc. 2017-15484 Filed 8-17-17; 8:45 am]

 BILLING CODE 4910-13-P