[Federal Register Volume 76, Number 139 (Wednesday, July 20, 2011)]
[Notices]
[Pages 43370-43372]
[FR Doc No: 2011-17968]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Passenger Facility Charge (PFC) Approvals and
Disapprovals

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Monthly Notice of PFC Approvals and Disapprovals. In June 2011,
there were seven applications approved. This notice also includes
information on one application, approved in May 2011, inadvertently
left off the May 2011 notice. Additionally, 18 approved amendments to
previously approved applications are listed.

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SUMMARY: The FAA publishes a monthly notice, as appropriate, of PFC
approvals and disapprovals under the provisions of the Aviation Safety
and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget
Reconciliation Act of 1990) (Pub. L. 101-508) and Part 158 of the
Federal Aviation Regulations (14 CFR part 158). This notice is
published pursuant to paragraph d of Sec.  158.29.

PFC Applications Approved

    Public Agency: Springfield Airport Authority, Springfield,
Illinois.
    Application Number: 11-12-C-00-SPI.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $1,122,457.
    Earliest Charge Effective Date: December 1, 2011.
    Estimated Charge Expiration Date: July 1, 2016.
    Class of Air Carriers Not Required to Collect PFC'S: Nonscheduled/
on-demand air carriers filing FAA Form 1800-31.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Abraham Lincoln Capital Airport.
    Brief Description of Projects Approved for Collection and Use:
    Seelbach property I--runway approach protection.
    Seelbach property II--runway approach protection.
    Gatschenberger property I--runway approach protection.
    Gatschenberger property II--runway approach protection.
    Woods property--runway approach protection.
    Ingram property--runway approach protection.
    Myers property--runway approach protection.
    West property--runway approach protection.
    Acquire vacuum sweeper vehicle (with liquid recovery), snow plow
vehicle and snow plows.
    Snow removal equipment broom.
    Acquire aircraft rescue and firefighting vehicle and rehabilitate
aircraft rescue and firefighting building.
    Wildlife study.
    Update airport layout plan/geographic information system/Exhibit A
update.
    Perimeter fence, phase 2.
    Perimeter fence, phase 3.
    Security system construction.
    Terminal lighting and ceiling rehabilitation.
    Terminal boiler plant renovation.
    Upgrade terminal fire alarm system, phase 2.
    Terminal parking lot reconfiguration/rehabilitation.
    Terminal passenger services area improvements.
    Terminal Americans with Disabilities Act improvements.
    Install runway guard lights.
    North quadrant general aviation ramp.
    Taxiway G widening and access taxiway construction.
    Taxiway Yankee phase 1 design.
    Runway \13/31\ rehabilitation, phase 1.
    Runway \13/31\ rehabilitation, phase 2.
    Runway \18/36\ rehabilitation.
    Decision Date: May 31, 2011.
    For Further Information Contact: Chad Oliver, Chicago Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Birmingham Airport Authority, Birmingham, Alabama.
    Application Number: 11-10-U-00-BHM.
    Application Type: Use PFC revenue.
    PFC Level: $4.50.
    Total PFC Revenue Approved for Use in this Decision: $4,133,110.
    Earliest Charge Effective Date: July 1, 2010.
    Estimated Charge Expiration Date: February 1, 2031.
    Class of Air Carriers Not Required to Collect PFC'S: No change from
previous decision.
    Brief Description of PROJECT APPROVED for Use: Terminal demolition.
    Decision Date: June 2, 2011.
    For Further Information Contact: Jonathan Linguist, Jackson
Airports District Office,<PHONE_NUMBER>.

    Public Agency: County of Broward, Fort Lauderdale, Florida.
    Application Number: 11-12-C-00-FLL.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $1,102,698,394.
    Earliest Charge Effective Date: January 1, 2018.
    Estimated Charge Expiration Date: September 1, 2030.
    Class of Air Carriers Not Required to Collect PFC'S: Nonscheduled/
on-demand air carriers.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Fort Lauderdale/Hollywood International Airport.
    Brief Description of Projects Approved for Collection and Use at a
$4.50 PFC Level:
    Terminal 4--design for eastern expansion.
    Security access control system.
    Replace old airfield signage.
    Land acquisition and demolition related to expansion of runway 10R/
28L.
    Brief Description Of Project Partially Approved for Collection and
Use at a $4.50 PFC LEVEL: Runway 10R/28L expansion and enabling
projects.
    Determination: The public agency proposed that PFCs finance 35-foot
wide runway and taxiway shoulders. The FAA found that only 25-foot wide
shoulders were eligible and justified.
    Brief Description of Project Approved for Collection and USE at a
$3.00 PFC Level: In-roadway crosswalk warning lights.
    Brief Description of Disapproved Project: Geographic information
system--implementation.
    Determination: The FAA determined that this project did not meet
the requirements of Sec.  158.15(b).
    Decision Date: June 6, 2011.
    For Further Information Contact: Susan Moore, Orlando Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Monterey Peninsula Airport District, Monterey,
California.
    Application Number: 11-17-C-00-MRY.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $775,000.
    Earliest Charge Effective Date: December 1, 2011.
    Estimated Charge Expiration Date: December 1, 2012.
    Class of Air Carriers Not Required to Collect PFC'S: Nonscheduled/
on-demand air carriers filing FAA Form 1800-31.

    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Monterey Peninsula Airport.
    Brief Description of Projects Approved for Collection and Use:
Runway 10R/28L safety area construction, phase 2. Terminal
improvements--weather protection canopies.
    Decision Date: June 9, 2011.
    For Further Information Contact: Gretchen Kelly, San Francisco
Airports District Office,<PHONE_NUMBER>, extension 623.

    Public Agency: Piedmont Triad Airport Authority, Greensboro, North
Carolina.
    Application Number: 11-01-C-00-GSO.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $43,872,158.
    Earliest Charge Effective Date: September 1, 2011.
    Estimated Charge Expiration Date: May 1, 2022.
    Class of Air Carriers Not Required to Collect PFC'S: Air taxi/
commercial operators.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Piedmont Triad International Airport.
    Brief Description of projects Approved for Collection and Use:
    Runway 5L/23R construction.
    Terminal expansion--security checkpoints.
    Decision Date: June 10, 2011.
    For Further Information Contact: John Marshall, Atlanta Airports
District Office,<PHONE_NUMBER>.

    Public Agency: City of Kansas City, Missouri.
    Application Number: 11-07-U-00-MCI.
    Application Type: Use PFC revenue.
    PFC Level: $3.00.
    Total PFC Revenue Approved for Use in this Decision: $11,000,000.
    Earliest Charge Effective Date: July 1, 2014.
    Estimated Charge Expiration Date: June 1, 2015.
    Class of Air Carriers Not Required to Collect PFC'S: No change from
previous decision.
    Brief Description of Projects Approved for Use: Airfield sand and
deicing facility.
    Airfield snow removal equipment building.
    Decision Date: June 15, 2011.
    For Further Information Contact: Todd Madison, Central Region
Airports Division,<PHONE_NUMBER>.

    Public Agency: City of Colorado Springs, Colorado.
    Application Number: 11-18-C-00-COS.
    Application Type: Impose and use a PFC.
    PFC Level: $3.00.
    Total PFC Revenue Approved in this Decision: $4,490,089.
    Earliest Charge Effective Date: August 1, 2013.
    Estimated Charge Expiration Date: April 1, 2015.
    Class of Air Carriers Not Required to Collect PFC'S: None.
    Brief Description of Projects Approved for Collection and Use:
    Rehabilitation of taxiways M and F (phase 1)--design.
    Rehabilitation of taxiways E, G and H (phase III).
    Fleet improvement (phase IV).
    Airfield guidance signs and surface painted holding position signs.
    Security checkpoint expansion.
    Decision Date: June 22, 2011.
    For Further Information Contact: Chris Schaffer, Denver Airports
District Office,<PHONE_NUMBER>.

    Public Agency: City of Eugene, Oregon.
    Application Number: 11-11-C-00-EUG.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $5,513,282.
    Earliest Charge Effective Date: May 1, 2012.
    Estimated Charge Expiration Date: December 1, 2014.
    Class of Air Carriers Not Required to Collect PFC'S:
    Nonscheduled/on-demand air carriers filing FAA Form 1800-31.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Mahlon Sweet Field.
    Brief Description of Projects Approved for Collection and Use:
Terminal checkpoint reconfiguration. Baggage claim expansion. North
terminal stairway enclosure.
    Decision Date: June 23, 2011.
    For Further Information Contact: Trang Tran, Seattle Airports
District Office,<PHONE_NUMBER>.

                                           Amendments to PFC Approvals
----------------------------------------------------------------------------------------------------------------
                                                                                Original     Amended
                                            Amendment      Original         Amended      estimated    estimated
        Amendment No. city, state            approved    approved net    approved net   charge exp.  charge exp.
                                               date       PFC revenue     PFC revenue       date         date
----------------------------------------------------------------------------------------------------------------
06-05-C-01-CLL, College Station, TX......     06/01/11        $799,557        $755,492     04/01/09     04/01/09
06-05-C-03-MOB, Mobile, AL...............     06/02/11       4,835,101       4,850,267     02/01/12     06/01/15
07-02-C-01-ECP, Panama City, FL..........     06/02/11      41,968,640      41,968,640     04/01/39     04/01/39
92-01-C-06-STL, St. Louis, MO............     06/02/11      58,088,964      84,607,850     08/01/95     03/01/95
06-06-C-01-RSW, Fort Myers, FL...........     06/03/11       6,932,692       4,846,352     02/01/15     11/01/14
05-05-C-06-SJU, San Juan, PR.............     06/07/11     499,314,667     479,036,578     08/01/31     06/01/30
09-06-C-01-FNL, Loveland, CO.............     06/08/11         350,000         470,000     01/01/13     12/01/11
01-04-C-01-IMT, Iron Mountain, MI........     06/09/11          73,815          45,815     06/01/04     06/01/04
08-13-C-01-MRY, Monterey, CA.............     06/09/11         856,394         573,074     08/01/09     08/01/09
10-11-C-01-ATL, Atlanta, GA..............     06/14/11     422,480,178     422,480,178     01/01/23     01/01/23
10-12-C-01-ATL, Atlanta, GA..............     06/14/11      19,332,000      19,332,000     03/01/23     03/01/23
07-09-C-01-DBQ, Dubuque, IA..............     06/14/11         885,694          28,654     10/01/15     10/01/15
07-09-C-02-DBQ, Dubuque, IA..............     06/16/11          28,654               0     10/01/15     10/01/15
07-03-C-02-HRL, Harlingen, TX............     06/16/11       3,590,824       3,876,104     07/01/09     07/01/09
95-01-C-01-MMH, Monterey, CA.............     06/17/11         166,632               0     09/01/02     09/01/05
*03-02-C-01-SFB, Orlando, FL.............     06/17/11      13,312,090      13,312,090     07/01/14     12/01/12
09-14-C-01-MRY, Monterey, CA.............     06/24/11         980,026         909,255     08/01/10     12/01/10

11-16-U-03-MRY, Monterey, CA.............     06/24/11              NA              NA     12/01/11    12/01/11.
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Notes: The amendment denoted by an asterisk (*) include a change to the PFC level charged from $2.00 per
  enplaned passenger to $4.00 per enplaned passenger. For Orlando, FL, this change is effective on September 1,
  2011.

    Issued in Washington, DC, on July 7, 2011.
Joe Hebert,
Manager, Financial Analysis and Passenger Facility Charge Branch.
[FR Doc. 2011-17968 Filed 7-19-11; 8:45 am]
BILLING CODE 4910-13-M


information. It further provides that if a Member fails to submit the
fingerprint information within 30 days after filing of an electronic
Form U4, the person's registration will be deemed inactive, requiring
the person to immediately cease all activities requiring registration
or performing any duties and functioning in any capacity requiring
registration. Under this proposed rule, the Exchange must
administratively terminate a registration that is inactive for a period
of two years. A person whose registration is administratively
terminated could reactivate the registration only by reapplying for
registration and meeting the qualification requirements of the
applicable provisions of proposed Exchange Rule 3101. Upon application
and a showing of good cause, the Exchange could extend the 30-day
period.
    Proposed Exchange Rule 3104(e) would require initial filings and
amendments of Form U5 to be submitted electronically. As part of the
Member's recordkeeping requirements, it would be required to retain
such records for a period of not less than three years, the first two
years in an easily accessible place, in accordance with Rule 17a-4
under the Act, and to make such records available promptly upon
regulatory request.
    Finally, under proposed Exchange Rule 3104, Interpretation and
Policy .02, a Member could enter into an agreement with a third party
pursuant to which the third party agrees to file the required forms
electronically on behalf of the Member and the Member's associated
persons. Notwithstanding the existence of such an agreement, the Member
would remain responsible for complying with the requirements of the
Rule.
Q. Exchange Rule 100, Definitions
    The Exchange proposes to amend Exchange Rule 100, Definitions, to
amend the term ``associated person'' or ``person associated with a
Member.'' Currently, the term associated person or person associated
with a Member means any partner, officer, director, or branch manager
of a Member (or any person occupying a similar status or performing
similar functions), any person directly or indirectly controlling,
controlled by, or under common control with a Member, or any employee
of a Member.
    The Exchange proposes to amend the term associated person or person
associated with a Member to insert, at the end of the definition, the
phrase ``except that any person associated with a Member whose
functions are solely clerical or ministerial shall not be included in
the meaning of such term for purposes of these Rules.'' With the
proposed change, the definition for associated person or person
associated with a Member would be as follows:

    The term ``associated person'' or ``person associated with a
Member'' means any partner, officer, director, or branch manager of
a Member (or any person occupying a similar status or performing
similar functions), any person directly or indirectly controlling,
controlled by, or under common control with a Member, or any
employee of a Member, except that any person associated with a
Member whose functions are solely clerical or ministerial shall not
be included in the meaning of such term for purposes of these Rules.

    Additionally, the Exchange proposes to amend Exchange Rule 100,
Definitions to adopt definitions for the following terms: Person,
proprietary trading, and proprietary trading firm. The Exchange
proposes that the term ``person'' shall refer to a natural person,
corporation, partnership (general or limited), limited liability
company, association, joint stock company, trust, trustee of a trust
fund, or any organized group of persons whether incorporated or not and
a government or agency or political subdivision thereof.
    The Exchange proposes that the term ``proprietary trading'' for the
purpose of proposed Exchange Rule 3100, means trading done by a Member
having the following characteristics: (i) The Member is not required by
Section 15(b)(8) of the Act to become a FINRA member but is a Member of
another registered securities exchange not registered solely under
Section 6(g) of the Act; (ii) all funds used or proposed to be used by
the Member are the trading member's own capital, traded through the
Member's own accounts; (iii) the Member does not, and will not, have
customers; and (iv) all persons registered on behalf of the Member
acting or to be acting in the capacity of a trader must be owners of,
employees of, or contractors to the Member.
    The Exchange proposes that the term ``proprietary trading firm''
for the purpose of proposed Exchange Rule 3100, means a Member
organization or applicant with the following characteristics: (i) The
applicant is not required by Section 15(b)(8) of the Act to become a
FINRA Member but is a Member of another registered securities exchange
not registered solely under Section 6(g) of the Act; (ii) all funds
used or proposed to be used by the applicant for trading are the
applicant's own capital, traded through the applicant's own accounts;
(iii) the applicant does not, and will not have customers; and (iv) all
principals and representatives of the applicant acting or to be acting
in the capacity of a trader must be owners of, employees of, or
contractors to the applicant.
    As described above, in connection with the Exchange's proposal to
adopt Exchange Rule 3101(b)(7), Registered Options Principal, the
Exchange proposes to delete the definition for ``Options Principal''
from Exchange Rule 100 in order to provide consistency and clarity
within the rule text. In proposed Exchange Rule 3101(b)(7), the
Exchange sets forth the requirements and qualifications for a
``Registered Options Principal,'' which incorporates, and adds to, the
rule text for the Exchange's current definition for ``Options
Principal.'' Accordingly, the Exchange proposes to delete the term
``Options Principal'' and replace all references in the rule text to
``Options Principal'' with the new proposed term ``Registered Options
Principal.'' The Exchange also proposes to adopt a definition for a
``Registered Options Principal'' in Exchange Rule 100, that will
provide a cross-reference to Exchange Rule 3101(b)(7).
R. Exchange Rule 601, Registered Options Traders
    In accordance with the proposed change to delete Exchange Rule 203
in its entirety, revise and relocate the provisions of Exchange Rule
203 to the newly proposed 3100 Series, the Exchange proposes to amend a
cross-reference in Exchange Rule 601(b)(2). Currently, Exchange Rule
601(b)(2) has a cross-reference to Exchange Rule 203(a). The Exchange
proposes to amend that cross-reference to proposed Exchange Rule 3100.
S. Exchange Rule 1000, Disciplinary Jurisdiction
    The Exchange proposes to amend a cross-reference in Exchange Rule
1000(c). Currently, Exchange Rule 1000(c) has a cross-reference to
Exchange Rule 1302. The Exchange proposes to amend that cross-reference
to proposed Exchange Rule 3100, Interpretation and Policy .12.
T. Exchange Rule 1014, Imposition of Fines for Minor Rule Violations
    The Exchange proposes to amend the cross-references in Exchange
Rule 1014(d)(14) that are to current Exchanges Rules 1301, 1302 and
1303. The Exchange proposes to amend the cross-references in Exchange
1014(d)(14) that are to Exchange Rules 1301, 1302 and 1303 to the newly
proposed Exchange Rule 3104, which incorporates that deleted rule text.
Accordingly, the Exchange proposes to

amend the cross-reference in Exchange Rule 1014(d)(14) to now be to
proposed Exchange Rule 3104.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\77\ Specifically, the Exchange believes the proposed rule change
is consistent with the Section 6(b)(5) \78\ requirements that the rules
of an exchange be 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 mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \79\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \77\ 15 U.S.C. 78f(b).
    \78\ 15 U.S.C. 78f(b)(5).
    \79\ Id.
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    The Exchange believes that the proposed rule changes will
streamline, and bring consistency and uniformity to, the Exchange's
registration rules. The Exchange believes that this will, in turn,
assist Members and their associated persons in complying with these
rules and improve regulatory efficiency. The proposed rule changes will
also improve the efficiency of the examination program, without
compromising the qualification standards, by eliminating duplicative
testing of general securities knowledge on examinations and by removing
examinations that currently have limited utility. In addition, the
proposed rule changes will expand the scope of permissive
registrations, which, among other things, will allow Members to develop
a depth of associated persons with registrations to respond to
unanticipated personnel changes and will encourage greater regulatory
understanding. Further, the proposed rule changes will provide a more
streamlined and effective waiver process for individuals working for a
financial services industry affiliate of a Member, and it will require
such individuals to maintain specified levels of competence and
knowledge while working in areas ancillary to the securities business.
The proposed rule changes will improve the supervisory structure of
firms by imposing an experience requirement for representatives that
are designated by firms to function as principals for a 120-day period
before having to pass an appropriate principal qualification
examination. The proposed rule change will also prohibit unregistered
persons from accepting customer orders under any circumstances, which
will enhance investor protection.
    The Exchange believes that, with the introduction of the SIE and
expansion of the pool of individuals who are eligible to take the SIE,
the proposed rule change has the potential of enhancing the pool of
prospective securities industry professionals by introducing them to
securities laws, rules and regulations and appropriate conduct before
they join the industry in a registered capacity.
    The extension of the Securities Trader registration requirement to
developers of algorithmic trading strategies requires associated
persons primarily responsible for the design, development or
significant modification of an algorithmic trading strategy or
responsible for the day-to-day supervision or direction of such
activities to register and meet a minimum standard of knowledge
regarding the securities rules and regulations applicable to the Member
employing the algorithmic trading strategy. This minimum standard of
knowledge is identical to the standard of knowledge currently
applicable to traditional securities traders. The Exchange believes
that improved education of firm personnel may reduce the potential for
problematic market conduct and manipulative trading activity.
    The proposed rule changes, including additional definitions and
changes to cross-references, make organizational changes to the
Exchange's registration and qualification rules, in order to prevent
unnecessary regulatory burdens and to promote efficient administration
of the rules. The change also makes minor updates and corrections to
the Exchange's rules which improve readability.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule changes are
designed to ensure that all associated persons of Members engaged in a
securities business are, and will continue to be, properly trained and
qualified to perform their functions, will be supervised, and can be
identified by regulators. The proposed new 3100 Series of rules, which
are similar in many respects to the registration-related requirements
adopted by FINRA effective October 1, 2018, as well as the Exchange's
affiliate, MIAX, should enhance the ability of member firms to comply
with the Exchange's rules as well as with the Federal securities laws.
Additionally, as described above, the Exchange intends the amendments
described herein to eliminate inconsistent registration-related
requirements across the Exchange, thereby promoting uniformity of
regulation across markets. The proposed 3100 Series of rules should in
fact remove administrative burdens that currently exist for Members
seeking to register associated persons on the Exchange featuring
varying registration-related requirements. Additionally, all similarly-
situated associated persons of Members will be treated similarly under
the new 3100 Series of rules in terms of standards of training,
experience and competence for persons associated with Exchange Members.
    With respect in particular to registration of developers of
algorithmic trading strategies, the Exchange recognizes that the
proposal would impose costs on member firms employing associated
persons engaged in the activity subject to the registration
requirement. Specifically, among other things, additional associated
persons would be required to become registered under the proposal, and
the firm would need to establish policies and procedures to monitor
compliance with the proposed requirement on an ongoing basis. However,
given the prevalence and importance of algorithmic trading strategies
in today's markets, the Exchange believes that associated persons
engaged in the activities covered by this proposal must meet a minimum
standard of knowledge regarding the applicable securities rules and
regulations. To mitigate the costs imposed on member firms, the
proposed rule change limits the scope of registration requirement by
excluding technological or development support personnel who are not
primarily responsible for the covered activities. It also excludes
supervisors who are not responsible for the covered activities. It also
excludes supervisors who are not responsible for the ``day-to-day''
supervision or direction of the covered activities.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \80\ and Rule 19b-
4(f)(6) thereunder.\81\
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    \80\ 15 U.S.C. 78s(b)(3)(A).
    \81\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \82\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \83\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay so
that the proposed rule change may become effective and operative
immediately upon filing. According to the Exchange, the proposal is
part of a larger effort to create uniform rules relating to
registration, qualification examinations and continuing education of
associated persons of Members among the Exchange and its affiliates,
MIAX and MIAX Emerald, LLC. For this reason, the Commission believes
that waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest. Accordingly, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\84\
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    \82\ 17 CFR 240.19b-4(f)(6).
    \83\ 17 CFR 240.19b-4(f)(6)(iii).
    \84\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-PEARL-2020-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-PEARL-2020-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-PEARL-2020-01, and should be submitted
on or before February 6, 2020.
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    \85\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\85\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-00589 Filed 1-15-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: March 4, 2008 (Volume 73, Number 43)]
[Notices]
[Page 11648-11649]
[DOCID:fr04mr08-71]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0132]

Agency Information Collection Activities; Proposed Collection;
Comment Request; State Petitions for Exemption From Preemption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 solicits comments on reporting requirements
contained in existing FDA regulations governing State petitions for
exemption from preemption.

DATES: Submit written or electronic comments on the collection of
information by May 5, 2008.

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:  Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 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, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

State Petitions for Exemption From Preemption--21 CFR 100.1(d) (OMB
Control No. 0910-0277) --Extension

    Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption
from Federal preemption of State food labeling and standard of identity
requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth the
information a State is required to submit in such a petition. The
information required under Sec.  100.1(d) enables FDA to determine
whether the State food labeling or standard of identity requirement
satisfies the criteria of section 403A(b) of the act for granting
exemption from Federal preemption.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.1(d)                                                                1                     1                  1                 40                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting burden for Sec.  100.1(d) is minimal because
petitions for exemption from preemption are seldom submitted by States.
In the last 3 years, FDA has not received any new petitions for
exemption from preemption; therefore, the agency estimates that one or
fewer petitions will be submitted annually. Although FDA has not
received any new petitions for exemption from preemption in the last 3
years, it believes these information

collection provisions should be extended to provide for the potential
future need of a State or local government to petition for an exemption
from preemption under the provisions of section 403(A) of the act.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

    Dated: February 26, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4066 Filed 3-3-08; 8:45 am]

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[Federal Register Volume 88, Number 149 (Friday, August 4, 2023)]
[Notices]
[Pages 51836-51837]
[FR Doc No: 2023-16606]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-3278]

Determination of Regulatory Review Period for Purposes of Patent
Extension; DELSTRIGO--New Drug Application 210807

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 DELSTRIGO, new drug
application (NDA) 210807, 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 October 3, 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 January 31, 2024. 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 October 3, 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-2019-E-3278 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; DELSTRIGO--NDA 210807.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 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, DELSTRIGO--
NDA 210807 (doravirine, lamivudine, and tenofovir disoproxil fumarate).
DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1
infection in adult patients with no antiretroviral treatment history.
Subsequent to this approval, the USPTO received a patent term
restoration application for DELSTRIGO--NDA 210807 (U.S. Patent No.
8,486,975) from Merck Canada Inc., and the USPTO requested FDA's
assistance in determining the patent's eligibility for patent term
restoration. In a letter dated November 29, 2019, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of DELSTRIGO--NDA 210807 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
DELSTRIGO--NDA 210807 is 2,549 days. Of this time, 2,237 days occurred
during the testing phase of the regulatory review period, while 312
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:
September 9, 2011. The applicant claims April 21, 2015, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date of the first IND for
the active ingredient, doravirine, was September 9, 2011, which was 30
days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: October 23,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for DELSTRIGO (NDA 210807) was initially submitted on
October 23, 2017.
    3. The date the application was approved: August 30, 2018. FDA has
verified the applicant's claim that NDA 210807 was approved on August
30, 2018.
    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 328 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: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16606 Filed 8-3-23; 8:45 am]
BILLING CODE 4164-01-P