[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49359-49362]
[FR Doc No: 2019-20222]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86960; File No. SR-NYSEAMER-2019-35]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Change Amending the NYSE
American Options Fee Schedule by Revising the Options Regulatory Fee

September 13, 2019.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on August 30, 2019, NYSE American LLC (``NYSE American'' or
the ``Exchange'') 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 self-
regulatory organization. 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\ 15 U.S.C. 78a.
    \3\ 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 proposes to amend the NYSE American Options Fee
Schedule (``Fee Schedule'') by revising the Options Regulatory Fee
(``ORF'') and notice language related to the ORF, effective August 30,
2019. The proposed change is available on the Exchange's website at
www.nyse.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 self-regulatory organization
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 those 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedule to revise the ORF
charged solely for the August 30, 2019 trading day and to modify
language regarding notice requirements for any changes to the ORF,
effective August 30, 2019.
Background Regarding the ORF
    As a general matter, the Exchange may only use regulatory funds
such as ORF ``to fund the legal, regulatory, and surveillance
operations'' of the Exchange.\4\ More specifically, the ORF is designed
to recover a material portion, but not all, of the Exchange's
regulatory costs for the supervision and regulation of ATP Holders (the
``ATP Regulatory Costs''). The majority of the ATP Regulatory Costs are
direct expenses, such as the costs related to in-house staff, third-
party service providers, and technology. The direct expenses support
the day-to-day regulatory work relating to the ATP Holders, including
surveillance, investigation, examinations and enforcement. Such direct
expenses represent approximately 91% of the Exchange's total ATP
Regulatory Costs. The indirect expenses include human resources and
other administrative costs.
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    \4\ The Exchange considers surveillance operations part of
regulatory operations. The limitation on the use of regulatory funds
also provides that they shall not be distributed. See Twelfth
Amended and Restated Operating Agreement of NYSE American LLC,
Article IV, Section 4.05 and Securities Exchange Act Release No.
79114 (October 18, 2016), 81 FR 73117 (October 24, 2016) (SR-
NYSEMKT-2013-93).
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    The ORF is assessed on ATP Holders for options transactions that
are cleared by the ATP Holder through the Options Clearing Corporation
(``OCC'') in the Customer range regardless of the exchange on which the
transaction occurs.\5\ All options transactions must clear via a
clearing firm and such clearing firms can then choose to pass through
all, a portion, or none of the cost of the ORF to its customers, i.e.,
the entering firms. Because the ORF is collected from ATP Holder
clearing firms by the OCC on behalf of NYSE American,\6\ the Exchange
believes that using options transactions in the Customer range serves
as a proxy for how to apportion regulatory costs among such ATP
Holders. In addition, the Exchange notes that the regulatory costs
relating to monitoring ATP Holders with respect to Customer trading
activity are generally higher than the regulatory costs associated with
ATP Holders that do not engage in Customer trading activity, which
tends to be more automated and less labor-intensive. By contrast,
regulating ATP Holders that engage in Customer trading activity is
generally more labor intensive and requires a greater expenditure of
human and technical resources as the Exchange needs to review not only
the trading activity on behalf of Customers, but also the ATP Holder's
relationship with its Customers via more labor-intensive exam-based
programs.\7\ As a result, the costs

associated with administering the customer component of the Exchange's
overall regulatory program are materially higher than the costs
associated with administering the non-customer component (e.g., ATP
Holder proprietary transactions) of its regulatory program.
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    \5\ See Fee Schedule, Section VII, Regulatory Fees, Options
Regulatory Fee (``ORF''), available here, https://www.nyse.com/publicdocs/nyse/markets/american-options/NYSE_American_Options_Fee_Schedule.pdf.
    \6\ See id. The Exchange uses reports from OCC when assessing
and collecting the ORF. The ORF is not assessed on outbound linkage
trades. An ATP Holder is not assessed the fee until it has satisfied
applicable technological requirements necessary to commence
operations on NYSE American. See id.
    \7\ The Exchange notes that many of the Exchange's market
surveillance programs require the Exchange to look at and evaluate
activity across all options markets, such as surveillance for
position limit violations, manipulation, front-running and contrary
exercise advice violations/expiring exercise declarations. The
Exchange and other options SROs are parties to a 17d-2 agreement
allocating among the SROs regulatory responsibilities relating to
compliance by the common members with rules for expiring exercise
declarations, position limits, OCC trade adjustments, and Large
Option Position Report reviews. See, e.g., Securities Exchange Act
Release No. 61588 (February 25, 2010).
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ORF Revenue and Monitoring of ORF
    Exchange rules establish that the Exchange may only increase or
decrease the ORF semi-annually, that any such fee change will be
effective on the first business day of February or August, and that
market participants must be notified of any such change via Trader
Update at least 30 calendar days prior to the effective date of the
change.\8\
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    \8\ See Fee Schedule, supra note 5.
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    Because the ORF is based on options transactions volume, ORF
revenue to the Exchange is variable. For example, if options
transactions reported to OCC in a given month increase, the ORF
collected from ATP Holders will increase as well. Similarly, if options
transactions reported to OCC in a given month decrease, the ORF
collected from ATP Holders will decrease as well. Accordingly, the
Exchange monitors the amount of revenue collected from the ORF to
ensure that this revenue does not exceed regulatory costs. If the
Exchange determines regulatory revenues exceed regulatory costs, the
Exchange will adjust the ORF by submitting a fee change filing to the
Securities and Exchange Commission (the ``Commission'').
OIP and Current Proposal
    In July 2019, the Exchange filed to lower the ORF to $0.0054 (from
$0.0055) per contract side for the remainder of 2019 in response to
increased options transaction volumes in 2018, which reverted (in part)
in the first half of 2019 (the ``July ORF Filing'').\9\ However, on
August 30, 2019, the Commission issued the Suspension of and Order
Instituting Proceedings to Determine Whether to Approve or Disapprove a
Proposed Rule Change to Modify the Options Regulatory Fee (the
``OIP'').\10\ As a result of the OIP, on August 30, 2019, the last
trading day of the month, the ORF reverted back to $0.0055 (from
$0.0054).
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    \9\ See Securities Exchange Act Release No. 86391 (July 16,
2019), 84 FR 35165 (July 22, 2019) (SR-NYSEAMER-2019-27).
    \10\ See Securities and Exchange Release No. 86832 (August 30,
2019) (SR-NYSEAMER-2019-27).
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    To ensure consistency of ORF assessments for the full month of
August 2019, the Exchange proposes to modify the Fee Schedule to
specify that the amount of ORF that will be collected by the Exchange
for the trading day of August 30, 2019 will be $0.0054 per contract
side (the ``August 30th ORF Rate'').\11\ The Exchange believes that
revenue generated from the ORF, including the August 30th ORF Rate,
will continue to cover a material portion, but not all, of the
Exchange's regulatory costs.
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    \11\ See proposed Fee Schedule, Section VII, Regulatory Fees,
ORF. This proposal is not intended to be responsive to the issues
raised in the OIP, but to instead address the immediate issue of
billing for August 30th.
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    Per the current Fee Schedule, the Exchange is required to notify
participants via a Trader Update of any change in the amount of the fee
at least 30 calendar days prior to the effective date of the change;
\12\ however, given the OIP, the Exchange proposes to modify this
requirement with the following caveat: ``except in the case of the
August 30th ORF rate change.'' \13\
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    \12\ See Fee Schedule, Section VII, Regulatory Fees, ORF.
    \13\ See proposed Fee Schedule, Section VII, Regulatory Fees,
ORF.
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    For avoidance of doubt, the Exchange notes that the August 30th
Rate applies for that day only and as a result of the OIP, the ORF
effective September 3, 2019 will be $0.0055--the rate in place prior to
the (now suspended) July ORF Filing.
    Finally, The Exchange proposes to delete obsolete language in the
ORF rule text, regarding Mini Options, which was inadvertently not
eliminated when the Exchange filed a ``clean up'' fee filing to remove
all such references.\14\
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    \14\ See id. See also Securities Exchange Act Release No. 84603
(November 14, 2018), 83 FR 58795 (November 21, 2018) (NYSEAmer-2018-
48) (filing to eliminate obsolete charges, including removing
obsolete references to fees for Mini Options).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6(b) \15\ of the Act, in general, and
Section 6(b)(4) and (5) \16\ of the Act, in particular, in that it is
designed to provide for the equitable allocation of reasonable dues,
fees, and other charges among its members and other persons using its
facilities and does not unfairly discriminate between customers,
issuers, brokers, or dealers.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(4) and (5).
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The Proposal Is Reasonable
    The Exchange believes the proposed August 30th ORF Rate is
reasonable because it would help maintain fair and orderly markets and
benefit investors and the public interest because it would ensure
transparency and consistency of ORF for August 2019. Specifically, the
proposal would ensure that the amount of ORF collected by the Exchange
for the trading day of August 30, 2019 will be the same rate collected
on every other trading day in August (i.e., $0.0054 per contract side).
The Exchange believes this will avoid disruption to its OTP Holders and
OTP Firms that are subject to the ORF. As noted above, the Exchange may
only use regulatory funds such as ORF ``to fund the legal, regulatory,
and surveillance operations'' of the Exchange.\17\
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    \17\ See supra note 4.
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    The Exchange believes that the proposal deleting outdated reference
to products no longer traded (i.e., Mini Options) is reasonable as it
would streamline the Fee Schedule by removing superfluous language
thereby making the Fee Schedule easier for market participants to
navigate.\18\
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    \18\ See supra note 14.
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The Proposal Is an Equitable Allocation of Fees
    The Exchange believes its proposal is an equitable allocation of
fees among its market participants. The Exchange believes that the
proposed August 30th ORF Rate would not place certain market
participants at an unfair disadvantage because all options transactions
must clear via a clearing firm. Such clearing firms can then choose to
pass through all, a portion, or none of the cost of the ORF to its
customers, i.e., the entering firms. Because the ORF is collected from
ATP Holder clearing firms by the OCC on behalf of NYSE American, the
Exchange believes that using options transactions in the Customer range
serves as a proxy for how to apportion regulatory costs among such ATP
Holders. In addition, the Exchange notes that the regulatory costs
relating to monitoring ATP Holders with respect to Customer trading
activity are generally higher than the regulatory costs associated with
ATP Holders that do not engage in Customer trading activity, which
tends to be more automated and less labor-intensive. By contrast,
regulating ATP Holders that engage in Customer trading activity is
generally more labor intensive and requires a greater

expenditure of human and technical resources as the Exchange needs to
review not only the trading activity on behalf of Customers, but also
the ATP Holder's relationship with its Customers via more labor-
intensive exam-based programs. As a result, the costs associated with
administering the customer component of the Exchange's overall
regulatory program are materially higher than the costs associated with
administering the non-customer component (e.g., ATP Holder proprietary
transactions) of its regulatory program. Thus, the Exchange believes
the August 30th ORF (like the rate assessed for every other trading day
in August 2019) would be equitably allocated in that it is charged to
all OTP Holders or OTP Firms on all their transactions that clear in
the Customer range at the OCC.
The Proposed Fee Is Not Unfairly Discriminatory
    The Exchange believes that the proposal is not unfairly
discriminatory. The Exchange believes that the proposed August 30th ORF
Rate would not place certain market participants at an unfair
disadvantage because all options transactions must clear via a clearing
firm. Such clearing firms can then choose to pass through all, a
portion, or none of the cost of the ORF to its customers, i.e., the
entering firms. Because the ORF is collected from ATP Holder clearing
firms by the OCC on behalf of NYSE American, the Exchange believes that
using options transactions in the Customer range serves as a proxy for
how to apportion regulatory costs among such ATP Holders. In addition,
the Exchange notes that the regulatory costs relating to monitoring ATP
Holders with respect to Customer trading activity are generally higher
than the regulatory costs associated with ATP Holders that do not
engage in Customer trading activity, which tends to be more automated
and less labor-intensive. By contrast, regulating ATP Holders that
engage in Customer trading activity is generally more labor intensive
and requires a greater expenditure of human and technical resources as
the Exchange needs to review not only the trading activity on behalf of
Customers, but also the ATP Holder's relationship with its Customers
via more labor-intensive exam-based programs. As a result, the costs
associated with administering the customer component of the Exchange's
overall regulatory program are materially higher than the costs
associated with administering the non-customer component (e.g., ATP
Holder proprietary transactions) of its regulatory program. Thus, the
Exchange believes the August 30th ORF Rate (like the rate assessed for
every other trading day in August 2019), is not unfairly discriminatory
because it is charged to all OTP Holders or OTP Firms on all their
transactions that clear in the Customer range at the OCC.

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 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.
    Intramarket Competition. The Exchange believes the proposed fee
change would not impose an undue burden on competition as it is charged
to all ATP Holders on all their transactions that clear in the Customer
range at the OCC; thus, the amount of ORF imposed is based on the
amount of Customer volume transacted. The Exchange believes that the
proposed ORF would not place certain market participants at an unfair
disadvantage because all options transactions must clear via a clearing
firm. Such clearing firms can then choose to pass through all, a
portion, or none of the cost of the ORF to its customers, i.e., the
entering firms. In addition, because the ORF is collected from ATP
Holder clearing firms by the OCC on behalf of NYSE American, the
Exchange believes that using options transactions in the Customer range
serves as a proxy for how to apportion regulatory costs among such ATP
Holders.
    Intermarket Competition. The proposed fee change is not designed to
address any competitive issues. Rather, the proposed change is designed
to help the Exchange adequately fund its regulatory activities while
seeking to ensure that total regulatory revenues do not exceed total
regulatory costs.
    Finally, the Exchange does not believe that the proposed deletion
of obsolete references to Mini Options would impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act as these changes are not intended to address any
competitive issues and would instead add more specificity, clarity and
transparency regarding this functionality.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \19\ of the Act and subparagraph (f)(2) of Rule
19b-4 \20\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(2).
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    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 under
Section 19(b)(2)(B) \21\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \21\ 15 U.S.C. 78s(b)(2)(B).
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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 No. SR-NYSEAMER-2019-35 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 No. SR-NYSEAMER-2019-35. 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 No. SR-NYSEAMER-2019-35, and should be submitted
on or before October 10, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-20222 Filed 9-18-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Notices]
[Pages 67699-67701]
[FR Doc No: 2022-24431]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-2046]

Determination of Regulatory Review Period for Purposes of Patent
Extension; NEXLETOL

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for NEXLETOL and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 9, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 8, 2023. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

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 January 9, 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-2020-E-2046 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NEXLETOL.'' 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, 240-
402-7500.
     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 Sec.  10.20 (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.govinfo.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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, NEXLETOL
(bempedoic acid). NEXLETOL is indicated as an adjunct to diet and
maximally tolerated statin therapy for the treatment of adults with
heterozygous familial hypercholesterolemia or established
atherosclerotic cardiovascular disease who require additional lowering
of LDL-C. Subsequent to this approval, the USPTO received a patent term
restoration application for NEXLETOL (U.S. Patent No. 7,335,799) from
Esperion Therapeutics, Inc., and the USPTO requested FDA's assistance
in determining the patent's eligibility for patent term restoration. In
a letter dated December 14, 2020, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of NEXLETOL represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
NEXLETOL is 3,774 days. Of this time, 3,408 days occurred during the
testing phase of the regulatory review period, while 366 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 24, 2009. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
October 24, 2009.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: February 21,
2019. FDA has verified the applicant's claim that the new drug
application (NDA) for NEXLETOL (NDA 211616) was initially submitted on
February 21, 2019.
    3. The date the application was approved: February 21, 2020. FDA
has verified the applicant's claim that NDA 211616 was approved on
February 21, 2020.
    This determination of the regulatory review period establishes the
maximum

potential length of a patent extension. However, the USPTO applies
several statutory limitations in its calculations of the actual period
for patent extension. In its application for patent extension, this
applicant seeks 1,826 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24431 Filed 11-8-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 24, 2009 (Volume 74, Number 141)]
[Notices]
[Page 36688]
[DOCID:fr24jy09-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

July 16, 2009.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER99-2369-006.
    Applicants: Alliance for Cooperative Energy Services.
    Description: Amendment to May 4, 2009 Notice of Non-Material Change
in Status of Alliance for Cooperative Energy Services Power Marketing
LLC.
    Filed Date: 07/15/2009.
    Accession Number: 20090715-5149.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 05, 2009.

    Docket Numbers: ER99-2948-017; ER00-2918-016; ER00-2917-016; ER05-
261-009; ER01-556-015; ER01-1654-018; ER02-2567-016; ER05-728-009;
ER04-485-013; ER07-247-008; ER07-245-008; ER07-244-008.
    Applicants: Baltimore Gas and Electric Company, Constellation Power
Source Generation LLC, Calvert Cliffs Nuclear Power Plant, Inc.,
Constellation Energy Commodities Group, Inc., Handsome Lake Energy,
LLC, Nine Mile Point Nuclear Station, LLC, Nine Mile Point Nuclear
Station LLC, Constellation NewEnergy, Inc., Constellation Energy
Commodities Group Maine, R.E. Ginna Nuclear Power Plant, LLC, Raven
One, LLC, Raven Two, LLC, Raven Three, LLC.
    Description: Baltimore Gas and Electric Company et al. submit
Substitute Third Revised Sheet 2 et al. to FERC Electric Tariff,
Original Volume 1 under ER99-2948 et al.
    Filed Date: 07/13/2009.
    Accession Number: 20090715-0093.
    Comment Date: 5 p.m. Eastern Time on Monday, August 03, 2009.

    Docket Numbers: ER04-925-021.
    Applicants: Merrill Lynch Commodities, Inc.
    Description: Notification of Non-Material Change in Status.
    Filed Date: 07/15/2009.
    Accession Number: 20090715-5105.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 05, 2009.

    Docket Numbers: ER09-553-001.
    Applicants: Vista Energy Marketing, LP.
    Description: Vista Energy Marketing, LP supplements its 1/26/09
application for market based rate authority and its 4/10/09 amendment
filing pursuant to FERC's 6/9/09 Order.
    Filed Date: 07/09/2009.
    Accession Number: 20090714-0071.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 30, 2009.

    Docket Numbers: ER09-873-001.
    Applicants: ISO New England, Inc.
    Description: ISO New England, Inc. submits Compliance filing
providing information required by FERC's June 11, 2009 Order, for
acceptance.
    Filed Date: 07/13/2009.
    Accession Number: 20090714-0088.
    Comment Date: 5 p.m. Eastern Time on Monday, August 03, 2009.

    Docket Numbers: ER09-991-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits its proposal for a transition program for Emergency Demand
Response Day-Ahead Offers to comply with FERC's June 12, 2009 Order.
    Filed Date: 07/13/2009.
    Accession Number: 20090714-0089.
    Comment Date: 5 p.m. Eastern Time on Monday, August 03, 2009.
    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES09-32-001.
    Applicants: System Energy Resources, Inc.
    Description: Supplemental Information of System Energy Resources,
Inc.
    Filed Date: 07/15/2009.
    Accession Number: 20090715-5144.
    Comment Date: 5 p.m. Eastern Time on Monday, July 27, 2009.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-17625 Filed 7-23-09; 8:45 am]

BILLING CODE 6717-01-P