[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27300-27302]
[FR Doc No: 2017-12258]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80882; File No. SR-C2-2017-020]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to the Penny Pilot Program

June 8, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 31, 2017, C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II which Items have been prepared by the Exchange. The
Exchange filed the proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule
19b-4(f)(6) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).

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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the operation of Penny Pilot
Program through December 31, 2017. The text of the proposed rule change
is provided below.
(additions are in italics; deletions are [bracketed])
* * * * *

C2 Options Exchange, Incorporated Rules

* * * * *

Rule 6.4. Minimum Increments for Bids and Offers

    The Board of Directors may establish minimum quoting increments for
options traded on the Exchange. When the Board of Directors determines
to change the minimum increments, the Exchange will designate such
change as a stated policy, practice, or interpretation with respect to
the administration of this Rule within the meaning of subparagraph
(3)(A) of subsection 19(b) of the Exchange Act and will file a rule
change for effectiveness upon filing with the Commission. Until such
time as the Board of Directors makes a change to the minimum
increments, the following minimum increments shall apply to options
traded on the Exchange:
    (1) No change.
    (2) No change.
    (3) The decimal increments for bids and offers for all series of
the option classes participating in the Penny Pilot Program are: $0.01
for all option series quoted below $3 (including LEAPS), and $0.05 for
all option series $3 and above (including LEAPS). For QQQQs, IWM, and
SPY, the minimum increment is $0.01 for all option series. The Exchange
may replace any option class participating in the Penny Pilot Program
that has been delisted with the next most actively-traded, multiply-
listed option class, based on national average daily volume in the
preceding six calendar months, that is not yet included in the Pilot
Program. Any replacement class would be added on the second trading day
following [January 1, 2017]July 1, 2017. The Penny Pilot shall expire
on [June 30, 2017]December 31, 2017. Also, for so long as SPDR options
(SPY) and options on Diamonds (DIA) participate in the Penny Pilot
Program, the minimum increments for Mini-SPX Index Options (XSP) and
options on the Dow Jones Industrial Average (DJX), respectively, may be
$0.01 for all option series quoting less than $3 (including LEAPS), and
$0.05 for all option series quoting at $3 or higher (including LEAPS).
    (4) No change.
* * * * *
    The text of the proposed rule change is also available on the
Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Penny Pilot Program (the ``Pilot Program'') is scheduled to
expire on June 30, 2017. C2 proposes to extend the Pilot Program until
December 31, 2017. C2 believes that extending the Pilot Program will
allow for further analysis of the Pilot Program and a determination of
how the Pilot Program should be structured in the future.
    During this extension of the Pilot Program, C2 proposes that it may
replace any option class that is currently included in the Pilot
Program and that has been delisted with the next most actively traded,
multiply listed option class that is not yet participating in the Pilot
Program (``replacement class''). Any replacement class would be
determined based on national average daily volume in the preceding six
months,\5\ and would be added on the second trading day following July
1, 2017. C2 will announce to its Trading Permit Holders by circular any
replacement classes in the Pilot Program. The Exchange notes that it
intends to utilize the same parameters to prospective replacement
classes as was originally approved.
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    \5\ The month immediately preceding a replacement class's
addition to the Pilot Program (i.e., June) would not be used for
purposes of the six-month analysis. Thus, a replacement class to be
added on the second trading day following July 1, 2017 would be
identified based on The Option Clearing Corporation's trading volume
data from December 1, 2016 through May 31, 2017.
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    C2 is specifically authorized to act jointly with the other options
exchanges participating in the Pilot Program in identifying any
replacement class.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\6\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \7\ 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 facilitation
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)8 requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers. In particular, the proposed rule change allows for
an extension of the Pilot Program for the benefit of market
participants.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    C2 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. Specifically, the Exchange
believes that, by extending the expiration of the Pilot Program, the
proposed rule change will allow for further analysis of the Pilot
Program and a determination of how the Program shall be structured in
the future. In doing so, the proposed rule change will also serve to
promote regulatory clarity and consistency, thereby reducing burdens on
the marketplace and facilitating investor protection. In addition, the
Exchange has been authorized to act jointly in extending the Pilot
Program and believes the other exchanges will be filing similar
extensions.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act\9\ and Rule 19b-4(f)(6) thereunder.\10\
Because the 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 prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing.\12\ However, pursuant to Rule 19b-4(f)(6)(iii),\13\ the
Commission may designate a shorter time if such action is consistent
with the protection of investors and the public interest. Without a
waiver of 30-day operative delay, CBOE's Pilot Program will expire
before the extension of the Pilot Program is operative. The Commission
believes that waiving the 30-day operative delay for the instant filing
is consistent with the protection of investors and the public interest
because doing so will allow the Pilot Program to continue without
interruption in a manner that is consistent with the Commission's prior
approval of the extension and expansion of the Pilot Program and will
allow the Exchange and the Commission additional time to analyze the
impact of the Pilot Program. Accordingly, the Commission designates the
proposed rule change as operative upon filing with the Commission.\14\
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    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and the 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 pre-filing requirement.
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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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 Number SR-C2-2017-020 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-C2-2017-020. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2017-020 and should be
submitted on or before July 5, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-12258 Filed 6-13-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Pages 9925-9926]
[FR Doc No: 2016-04199]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Ninety-Fifth Meeting: RTCA Special Committee (159) Global
Positioning System (GPS)

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Notice of Ninety-Fifth RTCA Special Committee 159 meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of the
Ninety-Fifth RTCA Special Committee 159 meeting.

DATES: The meeting will be held March 7-11, 2016 from 9:00 a.m.-5:00
p.m.

ADDRESSES: The meeting will be held at RTCA Inc. Conference Room, 1150
18th NW., Suite 910, Washington, DC Tel:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC, 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or
Jennifer Iversen, Program Director, RTCA, Inc<EMAIL_ADDRESS>
(202) 330-0662.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of RTCA Special Committee 159. The agenda
will include the following:

Monday, March 7, 2016

1. Working Group 2, GPS/WAAS, 4th Floor Large Board Room Opening
remarks: DFO, RTCA, Chairman, and Hosts (9:00 a.m.-5:00 p.m.)

Tuesday, March 8, 2016

1. Noon p.m., Working Group 2, GPS/WAAS, 4th Floor Large Board Room
(9:00 a.m.-12:00 p.m.)
2. Working Group 2A, GPS/GLONASS, Garmin Board Room (1:00 a.m.-5:00
p.m.)

3. Working Group 4, GPS/Precision Landing, 4th Floor Large Board Room
(1:00 p.m.-5:00 p.m.)
4. Working Group 2C, GPS/Inertial, 4th Floor Small Board Room (9:00
a.m.-5:00 p.m.)

Wednesday, March 9, 2016

1. Working Group 2A, GPS/GLONASS, Garmin Board Room (9:00 a.m.-12:00
p.m.)
2. Working Group 2C, GPS/Inertial, 4th Floor Small Board Room (9:00
a.m.-5:00 p.m.)
3. Working Group 4, GPS/Precision Landing, 4th Floor Large Board Room
(9:00 a.m.-5:00 p.m.)

Thursday, March 10, 2016

1. Working Group 7, GPS/Antennas, Garmin Board Room (9:00 a.m.-12:00
p.m.)
2. Working Group 2C, GPS/Inertial, 4th Floor Small Board Room (9:00
a.m.-12:00 p.m.)
3. Working Group 6, GPS/Interference, Garmin Board Room (1:00 p.m.-5:00
p.m.)
4. Working Group 4, GPS/Precision Landing, 4th Floor Large Board Room
(9:00 a.m.-5:00 p.m.)

Friday, March 11, 2016

1. Plenary Session (9:00 a.m.)

    a. Chairman's Introductory Remarks
    b. Approval of Summary of the Ninety-Fourth Meeting held October
23, 2015, RTCA Paper No. 041-16/SC159-1047
    c. Review Working Group (WG) Progress and Identify Issues for
Resolution
    i. GPS/WAAS (WG-2)
    ii. GPS/GLONASS (WG-2A)
    iii. GPS/Inertial (WG-2C)
    iv. GPS/Precision Landing Guidance (WG-4)
    v. GPS/Interference (WG-6)
    vi. GPS/Antennas (WG-7)
    d. Review of EUROCAE Activities
    e. Action Item Review
    i. Coordination of SC-159 TOR dates and DFMC MOPS efforts with
other standards bodies
    ii. DME Interference to GNSS signals in the future
    iii. Updating SC-159 Document Schedules in the SC-159 TOR
    f. Assignment/Review of Future Work
    g. Other Business
    h. Date and Place of Next Meeting
    i. Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Plenary information will be
provided upon request. Persons who wish to present statements or obtain
information should contact the person listed in the FOR FURTHER
INFORMATION CONTACT section. Members of the public may present a
written statement to the committee at any time.

    Issued in Washington, DC, on February 22, 2016.
Latasha Robinson,
Management & Program Analyst, NextGen, Enterprise Support Services
Division, Federal Aviation Administration.
[FR Doc. 2016-04199 Filed 2-23-16; 4:15 pm]
 BILLING CODE 4910-13-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ Office of Water/ Office of Science and Technology 2. OMB control number b.

None a__ _ 2040  NEW_ __ __ __ __ __ __

3. Type of information collection ( check one) a. x New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. x Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes x No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. x Three years from approval date b. G Other Specify: / /___

7. Title Minimum Monitoring Requirements for Direct and Indirect Discharging Mills in the Bleached Papergrade Kraft and Soda Subcategory and the Papergrade Sulfite Subcategory of the Pulp, Paper, and Paperboard Point Source Category 8. Agency form number( s) ( If applicable) ICR No. 1878.01 9. Keywords Pulp and Paper, Cluster Rules, Minimum Monitoring 10. Abstract The Environmental Protection Agency ( EPA) imposed minimum monitoring requirements on bleached papergrade kraft and soda ( Subpart B) and papergrade sulfite ( Subpart E) mills under 40 CFR Part 430 as part of the effluent limitations guidelines and standards promulgated on April 15, 1998. With approval of this ICR, the permitting and pretreatment control authority must require applicable facilities subject to Subparts B or E to monitor their effluent for adsorbable organic halides ( AOX), 2,3,7,8 tetrachlorodibenzo p dioxin ( TCDD), 2,3,7,8 tetrachlorodibenzofuran ( TCDF), chloroform, and 12 chlorinated phenolics at specified frequencies. See 40 CFR 430.02. Under 40 CFR 122.41 ( e)( 4), the discharger must then report these monitoring results to the permitting or pretreatment control authority using either Discharge Monitoring Reports ( DMRs) or Periodic Compliance Reports ( PCRs). These additional minimum monitoring requirements and corresponding additional reporting requirements are necessary to demonstrate compliance with the effluent limitations guidelines and standards promulgated at 40 CFR Part 430, Subparts B and E.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. x Business or other for profit e. x Federal Government c. Not for profit institutions f. x State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c.

Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 94 b. Total annual responses 104 1. Percentage of these responses collected electronically 0 % c. Total hours requested 36,858 d. Current OMB inventory 0 e. Difference 36,858 f. Explanation of difference 1. Program Change 36,858 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 6,415 b. Total annual costs ( O& M) $ 12,587 c. Total annualized cost requested $ 19,002 d. Current OMB inventory 0 e. Difference $ 19,002 f. Explanation of difference 1. Program change $ 19,002 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. x Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. x Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. x Other ( describe) not less than annually for direct dischargers and not less than twice annually for indirect dischargers.

17. Statistical methods Does this information collection employ statistical methods?

Q Yes x No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: M. Ahmar Siddiqui Phone: ( 202) 260 1826 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22079-22080]
[FR Doc No: 2018-10099]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-5592]

Determination That SODIUM IODIDE I 123 (Sodium Iodide I-123),
Oral Solution, 2 Millicuries/Milliliter, Was Not Withdrawn From Sale
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that SODIUM IODIDE I 123 (sodium iodide I-123), oral
solution, 2 millicuries (mCi)/milliliter (mL), was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
sodium iodide I 123, oral solution, 2 mCi/mL, if all other legal and
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-6650.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness
(Sec.  314.162 (21 CFR 314.162)).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to FDA's approval of an ANDA that refers to the
listed drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an
ANDA that does not refer to a listed drug.
    SODIUM IODIDE I 123 (sodium iodide I-123), oral solution, 2 mCi/mL,
is the subject of NDA 017630, held by GE Healthcare, and initially
approved on March 24, 1976. SODIUM IODIDE I 123 is indicated for use in
the evaluation of thyroid function or morphology.
    SODIUM IODIDE I 123 (sodium iodide I-123), oral solution, 2 mCi/mL,
is currently listed in the ``Discontinued Drug Product List'' section
of the Orange Book.
    International Isotopes, Inc. submitted a citizen petition dated
September 6, 2017 (Docket No. FDA-2017-P-5592), under 21 CFR 10.30,
requesting that the Agency determine whether SODIUM IODIDE I 123
(sodium iodide I-123), oral solution, 2 mCi/mL, was withdrawn from sale
for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that SODIUM IODIDE I 123 (sodium iodide I-123),
oral solution, 2 mCi/mL, was not withdrawn from sale for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that SODIUM IODIDE I 123 (sodium iodide I-123),
oral solution, 2 mCi/mL, was withdrawn from sale for reasons of safety
or effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of SODIUM IODIDE I 123 (sodium iodide I-123),
oral solution, 2 mCi/mL, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this drug product was withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list SODIUM IODIDE I 123
(sodium iodide I-123), oral solution, 2 mCi/mL, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to SODIUM IODIDE I 123 (sodium iodide
I-123), oral solution, 2 mCi/mL, may be approved by the Agency as long
as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10099 Filed 5-10-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 66 (Thursday, April 8, 2021)]
[Notices]
[Pages 18330-18333]
[FR Doc No: 2021-07197]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91461; File No. SR-NASDAQ-2021-004]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Order
Approving Proposed Rule Change, as Modified by Amendment No. 2, To
Disseminate Abbreviated Order Imbalance Information for the Nasdaq
Opening Cross, Amend Certain Cutoff Times for On-Open Orders Entered
for Participation in the Nasdaq Opening Cross, and Extend the Time
Period for Accepting Certain Limit-On-Open Orders

April 2, 2021.

I. Introduction

    On February 3, 2021, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to disseminate abbreviated order imbalance
information for the Nasdaq opening cross, amend certain cutoff times
for on-open orders entered for participation in the Nasdaq opening
cross, and extend the time period for accepting certain limit-on-open
orders. The proposed rule change was published for comment in the
Federal Register on February 17, 2021.\3\ On April 1, 2021, the
Exchange filed Amendment No. 2 to the proposed rule change.\4\ The
Commission received no comment letters on the proposed rule change.
This order approves the proposed rule change, as modified by Amendment
No. 2.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 91096 (February 10,
2021), 86 FR 9972 (``Notice'').
    \4\ On April 1, 2021, the Exchange also filed and withdrew
Amendment No. 1 to the proposed rule change. In Amendment No. 2, the
Exchange specified April 26, 2021 as the implementation date for the
proposed rule change and amended a footnote to reflect that the
proposal would not affect the handling of market-on-open orders or
market hours orders with market pegging that are entered after 9:28
a.m. Because Amendment No. 2 does not materially alter the substance
of the proposed rule change and makes conforming and technical
changes, it is not subject to notice and comment. Amendment No. 2 is
available on the Commission's website at: https://www.sec.gov/rules/sro/nasdaq.htm.
---------------------------------------------------------------------------

II. Description of the Proposal

    The Nasdaq opening cross is the process for determining the price
at which orders would be executed at the open and for executing those
orders, and it establishes the Nasdaq official opening price for a
security.\5\ Under the current process, market-on-open (``MOO'') orders
\6\ and limit-on-open (``LOO'') orders \7\ may be entered, cancelled,
or modified between 4:00 a.m.\8\ and immediately prior to 9:28 a.m.\9\
Opening imbalance only (``OIO'') orders may be entered between 4:00
a.m. until the time of execution of the Nasdaq opening cross, and may
be

cancelled or modified between 4:00 a.m. and immediately prior to 9:28
a.m.\10\ At 9:28 a.m., the Exchange begins to disseminate an order
imbalance indicator (also known as the net order imbalance indicator or
``NOII'') every second until market open.\11\ The NOII is a message
disseminated by electronic means containing information about MOO, LOO,
OIO, and early market hours orders,\12\ and information about the price
at which those orders would execute at the time of dissemination.\13\
---------------------------------------------------------------------------

    \5\ See Nasdaq Equity 4, Rule (``Rule'') 4752(a)(5) and Notice,
supra note 3, at 9972-73.
    \6\ A MOO order is an order type entered without a price that
may be executed only during the Nasdaq opening cross. See Rule
4702(b)(8)(A); see also Notice, supra note 3, at 9973 n.8.
    \7\ A LOO order is an order type entered with a price that may
be executed only in the Nasdaq opening cross, and only if the price
determined by the Nasdaq opening cross is equal to or better than
the price at which the LOO order was entered. See Rule
4702(b)(9)(A); see also Notice, supra note 3, at 9973 n.9.
    \8\ All times referenced are in Eastern Time.
    \9\ See Rule 4702(b)(8)(A) and (b)(9)(A); see also Notice, supra
note 3, at 9973 n.8-9.
    \10\ An OIO order is an order type entered with a price that may
be executed only in the Nasdaq opening cross and only against MOO,
LOO, or early market hours orders. If the entered price of an OIO
order to buy (sell) is higher than (lower than) the highest bid
(lowest offer) on the Nasdaq book, the price of the OIO order will
be modified repeatedly to equal the highest bid (lowest offer) on
the Nasdaq book; provided, however, that the price of the order will
not be moved beyond its stated limit price. See Rule 4702(b)(10)(A);
see also Notice, supra note 3, at 9973 n.10.
    \11\ See Rule 4752(d)(1); see also Notice, supra note 3, at
9973.
    \12\ Market hours orders means any order that may be entered
into the system and designated with a time-in-force of MIOC, MDAY,
and MGTC; market hours orders are designated as ``early market hours
orders'' if they are entered into the system prior to 9:28 a.m. See
Rule 4752(a)(7).
    \13\ Specifically, the NOII contains: (1) The current reference
price; (2) the number of shares represented by MOO, LOO, OIO, and
early market hours orders that are paired at the current reference
price; (3) the size of any imbalance; (4) the buy/sell direction of
any imbalance; and (5) the indicative prices at which the Nasdaq
opening cross would occur if it were to occur at that time and the
percent by which the indicative prices are outside the then current
Nasdaq market center best bid or best offer, whichever is closer.
See Rule 4752(a) (also providing the definitions for current
reference price, imbalance, and indicative prices); see also Notice,
supra note 3 at 9973.
---------------------------------------------------------------------------

Early Opening Order Imbalance Indicator and Cutoff Times for On-Open
Orders
    The Exchange proposes to amend Rule 4752 to establish an early
opening order imbalance indicator (``EOII'') that would be disseminated
by electronic means every 10 seconds beginning at 9:25 a.m. until the
NOII begins to disseminate at 9:28 a.m.\14\ As proposed, the EOII would
contain the same information as the NOII, except it would exclude
information about indicative prices.\15\ Specifically, the EOII would
contain: (1) The current reference price; (2) the number of shares
represented by MOO, LOO, OIO, and early market hours orders that are
paired at the current reference price; (3) the size of any imbalance;
and (4) the buy/sell direction of any imbalance.\16\ The Exchange
believes that an early release of a subset of the NOII information
would offer participants additional time and flexibility to react to
imbalance information in advance of 9:28 a.m. and aid them in making
informed decisions about whether and how to participate in the opening
cross.\17\ The Exchange also believes that the EOII would enhance price
discovery and liquidity by attracting more participants to its opening
cross.\18\ In addition, the Exchange believes that disseminating the
EOII every 10 seconds would provide participants more time to digest
the information and enter MOO, LOO, and OIO orders in between
dissemination periods.\19\
---------------------------------------------------------------------------

    \14\ See proposed Rule 4752(a)(1) and (d)(1); see also Notice,
supra note 3, at 9973. The Exchange also proposes to renumber
certain provisions of Rule 4752 to incorporate newly proposed
defined terms into the rule, and to make a non-substantive change in
current Rule 4752(a)(2)(E)(i) to delete the word ``both.''
    \15\ See proposed Rule 4752(a)(1).
    \16\ See id.; see also Notice, supra note 3, at 9973.
    \17\ See Notice, supra note 3, at 9973.
    \18\ Id.
    \19\ See id. at 9974.
---------------------------------------------------------------------------

    As stated above, the EOII would differ from the NOII in that the
EOII would not include information about indicative prices.\20\ The
Exchange believes that the exclusion of the near and far clearing
prices (which are part of the indicative price information) from the
EOII would enhance stability in the opening cross process because it
would reduce the possibility of large indicative price movements during
the early moments of the price formation process.\21\ By contrast, the
Exchange proposes to include in the EOII the current reference price
because it reflects the Nasdaq best bid and best offer at the time of
dissemination and it is used to calculate any imbalance direction and
imbalance size.\22\ According to the Exchange, providing the current
reference price in the EOII would increase transparency and allow
participants to provide additional orders to improve the price
discovery process in the opening cross.\23\
---------------------------------------------------------------------------

    \20\ See supra note 15 and accompanying text.
    \21\ The Exchange also states that, because participants may
freely enter new orders that contribute to price discovery before
9:28 a.m., indicative prices may change more substantially before
9:28 a.m. than after. See Notice, supra note 3, at 9973-74.
    \22\ See id. at 9974 n.19.
    \23\ See id.
---------------------------------------------------------------------------

    In connection with the establishment of the EOII that would begin
disseminating at 9:25 a.m., the Exchange proposes to amend Rule 4702(b)
to prohibit participants from cancelling or modifying MOO, LOO, and OIO
orders beginning at 9:25 a.m.\24\ The Exchange does not propose to
similarly change the cutoff times for entering MOO, LOO, and OIO orders
for participation in the opening cross. Thus, under the proposal, MOO
orders may continue to be entered until immediately prior to 9:28 a.m.;
\25\ LOO orders may be entered until immediately prior to 9:28 a.m. or,
in certain circumstances as described below, until 9:29:30 a.m.; \26\
and OIO orders may continue to be entered until the time of execution
of the opening cross.\27\ But any such orders, once entered, may not be
cancelled or modified at or after 9:25 a.m.\28\
---------------------------------------------------------------------------

    \24\ See proposed Rule 4702(b)(8), (b)(9), and (b)(10); see also
Notice, supra note 3, at 9974. Relatedly, the Exchange proposes to
amend current Rule 4752(a)(7) to provide that requests to cancel or
modify market hours orders would be suspended beginning at 9:25 a.m.
(rather than 9:28 a.m. as the rule currently provides) until after
completion of the Nasdaq opening cross, at which time such requests
will be processed to the extent that such orders remain available
within the system. The Exchange also proposes to amend current Rule
4752(a)(7) to utilize certain defined terms and abbreviated terms.
    \25\ See proposed Rule 4702(b)(8)(A).
    \26\ See proposed Rule 4702(b)(9)(A).
    \27\ See proposed Rule 4702(b)(10)(A).
    \28\ See proposed Rule 4702(b)(8), (b)(9), and (b)(10); see also
Notice, supra note 3, at 9974.
---------------------------------------------------------------------------

LOO Order Type Changes
    The Exchange proposes to amend Rule 4702(b)(9)(A) to permit the
entry of LOO orders between 9:28 a.m. and 9:29:30 a.m. (``late LOO
orders''), provided that the security has a first opening reference
price or a second opening reference price.\29\ The Exchange believes
that allowing the entry of eligible LOO orders after 9:28 a.m. would
enhance the price discovery process for and liquidity of a given
security in the opening cross.\30\ As proposed, any LOO order entered
after 9:29:30 a.m. that is designated as immediate-or-cancel (``IOC'')
would be rejected.\31\
---------------------------------------------------------------------------

    \29\ The Exchange also proposes to make conforming changes in
Rule 4702(b)(9)(B). Specifically, Rule 4702(b)(9)(B) currently
specifies the handling of opening cross/market hours orders (i.e.,
orders with a time-in-force that continues after the time of the
Nasdaq opening cross and are flagged to participate in the opening
cross) entered between 9:28 a.m. and the time of the Nasdaq opening
cross. The Exchange proposes to amend this time interval such that
it refers to opening cross/market hours orders entered between
9:29:30 a.m. and the time of the Nasdaq opening cross. Relatedly,
the Exchange proposes to specify in Rule 4702(b)(9)(B) that certain
LOO orders entered at or after 9:28 a.m. would not be rejected.
Moreover, the Exchange states that market hours orders entered
between 9:28 a.m. and 9:29:30 a.m. would be treated as late LOO
orders, as applicable. See Notice, supra note 3, at 9974 n.21 and
Amendment No. 2, supra note 4. In addition, the Exchange proposes to
make a conforming change in current Rule 4752(a)(7) to provide that
orders entered at or after 9:29:30 a.m. (rather than 9:28 a.m. as
the rule currently provides) with a time-in-force other than IOC
would be designated as ``late market hours orders.''
    \30\ See Notice, supra note 3, at 9974.
    \31\ See proposed Rule 4702(b)(9)(A). Relatedly, the Exchange
proposes to amend Rule 4702(b)(9)(B) to provide that LOO orders that
are opening cross/market hours orders and entered between 9:29:30
a.m. (as proposed) and the time of the Nasdaq opening cross are
subject to the handling described in that rule only if the orders
have a time-in-force other than IOC. The Exchange states that this
is a clarifying, non-substantive change because opening cross/market
hours orders, by definition, have a time-in-force other than IOC.
See Notice, supra note 3, at 9974 n.24. The Exchange also proposes
to remove language from Rule 4702(b)(9)(B) regarding how it handles
routable orders with a time-in-force other than IOC that are flagged
to participate in the Nasdaq opening cross and entered at or after
9:28 a.m. because the Exchange believes that language is duplicative
of other language in the same rule. See id. at 9975. Moreover, the
Exchange proposes to make a conforming change in current Rule
4752(a)(7) to provide that orders entered at or after 9:29:30 a.m.
(as proposed) would be designated as ``late market hours orders'' if
they have a time-in-force other than IOC.

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

    The Exchange proposes to define the first opening reference price
as the previous day's Nasdaq official closing price of the security for
Nasdaq-listed securities or the consolidated closing price for non-
Nasdaq-listed securities.\32\ For new exchange-traded products that do
not have a Nasdaq official closing price or a consolidated closing
price, the first opening reference price would be the offering
price.\33\ The Exchange states that it proposes to use the Nasdaq
official closing price as the first opening reference price because the
Nasdaq official closing price is a well-defined benchmark for the
security's market price that serves as the most relevant price of a
security at or before regular trading hours.\34\ The Exchange proposes
to define the second opening reference price as the current reference
price in the NOII disseminated at 9:28 a.m.\35\ The Exchange states
that it proposes to use the current reference price in the NOII
disseminated at 9:28 a.m. as the second opening reference price because
it is consistent with the Exchange's functionality with respect to the
closing cross and late limit-on-close (``LOC'') orders, and is intended
to promote price stability of the opening cross.\36\
---------------------------------------------------------------------------

    \32\ See proposed Rule 4752(a)(8).
    \33\ See id.
    \34\ See Notice, supra note 3, at 9974.
    \35\ See proposed Rule 4752(a)(9).
    \36\ See Notice, supra note 3, at 9974.
---------------------------------------------------------------------------

    In addition, the Exchange proposes to accept a LOO order entered
between 9:28 a.m. and 9:29:30 a.m. at its limit price, unless its limit
price is higher (lower) than the higher (lower) of the first opening
reference price and the second opening reference price for a LOO order
to buy (sell), in which case the LOO order would be handled consistent
with the participant's instruction that the LOO order is to be: (1)
Rejected; or (2) re-priced to the higher (lower) of the first opening
reference price and the second opening reference price, provided that
if either the first opening reference price or the second opening
reference price is not at a permissible minimum increment, the first
opening reference price or the second opening reference price, as
applicable, would be rounded (i) to the nearest permitted minimum
increment (with midpoint prices being rounded up) if there is no
imbalance, (ii) up if there is a buy imbalance, or (iii) down if there
is a sell imbalance.\37\ The default configuration for participants
that do not specify otherwise would be to have such LOO order re-priced
rather than rejected.\38\ The Exchange states that this repricing
mechanism is designed to reduce order imbalances and volatility for
securities that participate in the opening cross, and believes that
allowing such LOO orders to be priced at the more aggressive of the two
reference prices would provide flexibility to market participants by
allowing them to consider information in both the EOII and NOII within
the context of the previous day's Nasdaq official closing price or
consolidated closing price to facilitate informed decisions about
whether and how to participate in the opening cross.\39\
---------------------------------------------------------------------------

    \37\ See proposed Rule 4702(b)(9)(A). The Exchange proposes to
use natural rounding when there is no imbalance. When there is an
imbalance, the Exchange would round such that more offsetting
interest can participate. Thus, when there is a buy imbalance, the
Exchange would round the first opening reference price or second
opening reference price up to allow more sell interest to
participate, and when there is a sell imbalance, the Exchange would
round the first opening reference price or second opening reference
price down to allow more buy interest to participate. See Notice,
supra note 3, at 9974 n.22.
    \38\ See proposed Rule 4702(b)(9)(A).
    \39\ See Notice, supra note 3, at 9974.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendment No. 2, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities exchange.\40\ In particular, the
Commission finds that the proposed rule change is consistent with
Section 6(b)(5) of the Act,\41\ which requires, among other things,
that the rules of a national securities 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 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.
---------------------------------------------------------------------------

    \40\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \41\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    As described above, the Exchange proposes to disseminate the EOII
beginning at 9:25 a.m., which would provide market participants with
certain information relating to the Nasdaq opening cross earlier than
the current NOII.\42\ The Commission believes that the EOII would
provide earlier transparency regarding the current reference price, the
number of paired shares at that price, the size of any imbalance, and
the direction of any imbalance for the Nasdaq opening cross, which
would provide market participants with additional time before the
opening cross to consider this information and flexibility in
determining whether and how to participate in the opening cross.\43\
The Commission also believes that the proposed 10-second interval
between EOII disseminations would provide market participants with time
to consider any EOII updates, while avoiding excessive message traffic.
Accordingly, the Commission believes that the dissemination of the EOII
could lead to increased participation and liquidity and promote price
discovery in the Nasdaq opening cross.\44\
---------------------------------------------------------------------------

    \42\ As described above, the EOII would contain the same
information as the NOII, except it would exclude information about
indicative prices in order to reduce the possibility of large
indicative price movements during the early moments of the price
formation process.
    \43\ As described above, participants may enter MOO, LOO, and
OIO orders after the Exchange begins disseminating the EOII at 9:25
a.m. Specifically, MOO orders may continue to be entered until
immediately prior to 9:28 a.m., LOO orders may be entered until
immediately prior to 9:28 a.m. (or, in certain circumstances, until
9:29:30 a.m.), and OIO orders may continue to be entered until the
time of execution of the opening cross.
    \44\ The Exchange also provides a similar early order imbalance
indicator for the Nasdaq closing cross, which is also disseminated
with a 10-second interval. See Rule 4754(a)(10) and (b)(1).
---------------------------------------------------------------------------

    As described above, in connection with the proposal to begin
disseminating the EOII at 9:25 a.m., the Exchange also proposes to
prohibit participants from cancelling or modifying MOO, LOO, and OIO
orders beginning at 9:25 a.m. The Commission believes that this
proposed change would allow the Exchange to begin disseminating the
EOII at a time when on-open interest is relatively settled, and could
reduce the possibility of large price movements in the opening cross
process that may otherwise result from cancellations or modifications
of MOO, LOO, and OIO orders in response to the EOII. Moreover, because
the Exchange is

not proposing a similar 9:25 a.m. cutoff time for the entry of MOO,
LOO, and OIO orders, market participants may consider the information
in the EOII and NOII, as applicable, in entering these orders.\45\
---------------------------------------------------------------------------

    \45\ The Exchange also has a cutoff time for cancellations or
modifications of on-close interest that aligns with the time that
the Exchange begins disseminating the early order imbalance
indicator for the Nasdaq closing cross. See Rules 4702(b)(11)-(13)
and 4754(b)(1).
---------------------------------------------------------------------------

    In addition, as described above, the Exchange proposes to permit
the entry of LOO orders between 9:28 a.m. and 9:29:30 a.m. if there is
either a first opening reference price or a second opening reference
price, with such orders priced no more aggressively than the first
opening reference price and the second opening reference price. The
Commission believes that these proposed changes would allow
participants to retain control over the entry of LOO orders until a
later time, and would allow participants to consider the information
contained in the EOII and the NOII, as well as the previous day's
closing price, in deciding whether to enter late LOO orders. The
Commission also believes that the proposed re-pricing of late LOO
orders such that they are priced no more aggressively than the first
opening reference price and the second opening reference price could
promote price stability in the opening cross process. Accordingly, the
Commission believes that the proposed changes relating to late LOO
orders could encourage additional participation and reduce imbalances
in the Nasdaq opening cross, while promoting price stability in the
opening process.\46\
---------------------------------------------------------------------------

    \46\ The Exchange also has a similar late LOC order type for the
Nasdaq closing cross. See Rule 4702(b)(12).
---------------------------------------------------------------------------

    Finally, the Commission believes that the Exchange's proposed
technical and conforming changes to Rules 4702 and 4752 would allow
those rules to consistently reflect the proposed 9:29:30 a.m. cutoff
time for entering late LOO orders and the proposed 9:25 a.m. cutoff
time for cancellations and modifications of MOO, LOO, and OIO orders,
and would add clarity with respect to how the Exchange conducts its
opening process and handles orders in connection with that process.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\47\ that the proposed rule change (SR-NASDAQ-2021-004), as
modified by Amendment No. 2, be, and hereby is, approved.
---------------------------------------------------------------------------

    \47\ 15 U.S.C. 78s(b)(2).
    \48\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\48\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-07197 Filed 4-7-21; 8:45 am]
BILLING CODE 8011-01-P


Reader’s Guide Sodium disaccharide

CRM: Joy Schnackenbeck

EPA/OPPTS/OPP/SRRD

Reader’s Guide to Sodium disaccharide Docket # EPA-HQ-2008-0441

Publication Date: June 25, 2008

EPA has created this document to provide an organizational structure to
the Sodium disaccharide docket. The docket index lists the caption
entries sequentially, while this document lists them by subject matter.
The Agency is providing the “Readers Guide” to allow the reader to
more easily access and navigate the various entries contained in the
Sodium disaccharide docket.

Federal Register and Docket Organizational Documents:

Docket Entry 1. Federal Register Notice:  Sodium disaccharide
Reregistration Review

Docket Entry 2.  Reader’s Guide to Sodium disaccharide Docket #
EPA-HQ-OPP-2008-0441

Docket Entry 3.  Sodium disaccharide Summary Document Registration
Review:  Initial Docket June 25, 2008

Docket Entry 4.  Amended Problem Formulation for Ecological Risk
Assessment for Denatonium Saccharide (May 2, 2008)

Docket Entry 5.  Denatonium Saccharide (PC code 129045).  Revised Human
Health Risk Scoping Document in Support of Registration Review (June 2,
2008)

Docket Entry 6.  Registration Review

Docket Entry 7.  Appendix A (Food/Feed & Non-Food/Non-Feed Uses Eligible
for Reregistration) Sodium disaccharide


[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Rules and Regulations]
[Page 38197]
[FR Doc No: 2013-15137]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 71

[Docket FAA No. FAA-2013-0505; Airspace Docket No. 13-AWP-4]

Amendment of Class D Airspace; El Monte, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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

SUMMARY: This action corrects a final rule published in the Federal
Register of May 14, 2013, that amends Class D airspace at El Monte
Airport, El Monte, CA. In that rule, the legal description references
the airport bearing incorrectly.

DATES: Effective Date: 0901 UTC, August 22, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Rick Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register amending
Class D airspace at El Monte Airport, El Monte, CA (78 FR 28132, May
14, 2013). In the regulatory text, the El Monte Airport 097[deg]
bearing was incorrect, and is now corrected to the 111[deg] bearing.

Correction to Final Rule

0
Accordingly, pursuant to the authority delegated to me, the legal
description as published in the Federal Register on May 14, 2013 (78 FR
28132), Airspace Docket No. 11-AWP-16, FR Doc. 2013-11182, is corrected
as follows:

Sec.  71.1  [Amended]

0
On page 28133, column 1, line 41, remove `097[deg] bearing', and insert
`111[deg] bearing'.

    Issued in Seattle, Washington, on June 17, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-15137 Filed 6-25-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87782-87784]
[FR Doc No: 2023-27852]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4395]

Use of Real-World Evidence To Support Regulatory Decision-Making
for Medical Devices, Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Use of Real-World
Evidence to Support Regulatory Decision-Making for Medical Devices.''
FDA is issuing this draft guidance to clarify how FDA evaluates real-
world data (RWD) to determine whether they are of sufficient quality
for generating real-world evidence (RWE) that can be used in FDA
regulatory decision-making for medical devices. This draft guidance
proposes expanded recommendations to the 2017 guidance entitled ``Use
of Real-World Evidence to Support Regulatory Decision-Making for
Medical Devices.'' This draft guidance is not final nor is it for
implementation at this time.

DATES: Submit either electronic or written comments on the draft
guidance by February 20, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-4395 for ``Use of Real-World Evidence to Support Regulatory
Decision-Making for Medical Devices.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access

the information at: https://www.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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Use of Real-World Evidence to Support Regulatory Decision-Making for
Medical Devices'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or to Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Soma Kalb, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 318, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this draft guidance to clarify how FDA evaluates RWD
to determine whether they are of sufficient quality for generating RWE
that can be used in FDA regulatory decision-making for medical devices.
This draft guidance proposes expanded recommendations to the 2017
guidance entitled ``Use of Real-World Evidence to Support Regulatory
Decision-Making for Medical Devices'' (the 2017 RWE Guidance). On
December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 (FDORA)
was signed into law as part of the Consolidated Appropriations Act,
2023 (Pub. L. 117-328). Section 3629 of FDORA ``Facilitating the Use of
Real World Evidence'' directs FDA to issue or revise existing guidance
on considerations for the use of RWD and RWE to support regulatory
decision making. FDA is issuing this draft guidance to propose
revisions to the 2017 RWE Guidance to satisfy the requirement under
section 3629(a)(2). This draft guidance also fulfills a commitment in
section V.F. of the Medical Device User Fee Amendments Performance
Goals and Procedures, Fiscal Years 2023 Through 2027 (MDUFA V).
    This draft guidance includes FDA's recommendations and
considerations on the factors that are expected to be assessed to
demonstrate whether the RWD are fit-for-purpose for a particular
regulatory decision relating to medical devices. When this draft
guidance is finalized, these recommendations and considerations will
apply regardless of the RWD source and will encompass processes for
conducting studies to generate RWE. A fit-for-purpose assessment should
evaluate both the relevance and reliability of a RWD source, as
discussed in more detail in the draft guidance. FDA recognizes that
there may be other approaches to address the considerations identified
in this draft guidance. We encourage sponsors to discuss their approach
with FDA, especially if the approach diverges from the recommendations
in this draft guidance, when finalized.
    The topics covered within this draft guidance are framed
specifically for the use of RWD/RWE in regulatory submissions. This
draft guidance includes additional clarity regarding the recommended
methodologies for collection and analysis of RWD to generate RWE, and
provides updated examples on previously used and accepted
methodologies. This draft guidance also provides additional clarity
regarding the use of clinical data collected from the use of a device
authorized under an Emergency Use Authorization (EUA) and to describe
the type of information that could be applicable to support a
determination under the Clinical Laboratory Improvement Amendments
(CLIA) (e.g., Waiver by Application).
    FDA recognizes and anticipates that the Agency and industry may
need up to 60 days to perform activities to operationalize the
recommendations within the final guidance. At this time, the Agency
anticipates that, for regulatory submissions that will be currently
pending with FDA after publication of the final guidance, as well as
those submissions received within 60 days following publication of the
final guidance, FDA generally would not anticipate that sponsors will
be ready to include the newly recommended information outlined in the
final guidance in their submission. FDA, however, would intend to
review any such information if submitted at any time.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Use of Real-
World Evidence to Support Regulatory Decision-Making for Medical
Devices.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Use of Real-World Evidence to Support Regulatory Decision-Making for
Medical Devices'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00500012 and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act (44 U.S.C. 3501-3521). The collections of information in the
following table have been approved by OMB:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Use              0910-0332
                                  Devices; Humanitarian
                                  Device Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
``Requests for Feedback and      Q-Submissions and Early       0910-0756
 Meetings for Medical Device      Payor Feedback Request
 Submissions: The Q-Submission    Programs for Medical
 Program''.                       Devices.
822............................  Postmarket Surveillance       0910-0449
                                  of Medical Devices.
50, 56.........................  Protection of Human           0910-0130
                                  Subjects and
                                  Institutional Review
                                  Boards.
601............................  Biologics License             0910-0338
                                  Application.
803............................  Medical Device                0910-0437
                                  Reporting.
``Administrative Procedures for  CLIA Administrative           0910-0607
 CLIA Categorization'' and        Procedures; CLIA
 ``Recommendations: Clinical      Waivers.
 Laboratory Improvement
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
800, 801, 809, and 830.........  Medical Device Labeling       0910-0485
                                  Requirements; Unique
                                  Device Identification.
860............................  Reclassification              0910-0138
                                  Petition for Medical
                                  Devices.
``Emergency Use Authorization    EUA....................       0910-0595
 of Medical Products and
 Related Authorities''.
------------------------------------------------------------------------

    Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27852 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P


BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

 advance \d 3

Application of

DELTA AIR LINES, INC.

for a waiver of the dormancy conditions applicable to certain of its U.S.-Japan frequencies 	)

))

)

)

)

))

)

Docket  OST-02-11706

 advance \d 3

NOTICE OF

DELTA AIR LINES, INC.

Communications with respect to this document should be addressed to:

D. Scott Yohe

Senior Vice President -

  Government Affairs

DELTA AIR LINES, INC.

1275 K Street, N.W.

Washington, D.C.  20005

(202) 216-0700

John J. Varley

Assistant General Counsel

Scott McClain

Attorney

DELTA AIR LINES, INC

Law Department (#981)

1030 Delta Boulevard

Atlanta, GA  30320-2574

(404) 715-2872

Robert E. Cohn

Alexander Van der Bellen

SHAW PITTMAN LLP

2300 N Street, N.W.

Washington, D.C.  20037

(202) 663-8060

Counsel for

DELTA AIR LINES, INC.

June 21, 2002

BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

June 21, 2002

 advance \d 3

Application of

DELTA AIR LINES, INC.

for a waiver of the dormancy conditions applicable to certain of its U.S.-Japan frequencies 	)

))

)

)

)

))

)

Docket  OST-02-11706

 advance \d 3

NOTICE OF

DELTA AIR LINES, INC.

Delta Air Lines, Inc. (“Delta”) hereby notifies the Department that Delta no longer seeks to maintain the dormancy waiver applicable to its seven (7) Los Angeles-Tokyo frequencies.  Delta is relinquishing these frequencies, effective immediately, to the Department for reallocation to another qualified U.S. carrier.

In furtherance of this action, Delta states as follows:

1. 	By Notice of Action Taken dated March 27, 2002 (the “Notice”), the Department granted Delta a dormancy wavier for certain of its U.S.-Japan frequencies, including, inter alia, Los Angeles-Tokyo.  The dormancy waiver established by the Notice runs through October 1, 2002.  Delta does not have any current service plans for the Los Angeles-Tokyo frequencies.  Accordingly, Delta is returning these frequencies to the Department for reallocation.  Since another carrier has expressed an immediate interest in beginning service that would require the use of so-call “special” U.S.-Japan frequencies, Delta’s return of these frequencies will promote the public interest and the effective utilization of these bilateral rights.

2.	Delta does, however, seek to maintain in effect the dormancy waiver established by the Notice applicable to Delta’s other U.S.-Japan frequencies.   All actual and potential U.S.-Japan competitors now have access to ample frequencies to fund immediate and foreseeable future service plans.  No U.S. carrier has been blocked from instituting a proposed Japan service due to a lack of available frequencies.  In these circumstances, the Department should continue Delta’s waiver in effect in order to allow Delta the maximum flexibility to resume the use of its other U.S.-Japan frequencies when economic conditions warrant.

Respectfully submitted,

						/s/

Robert E. Cohn

Alexander Van der Bellen

SHAW PITTMAN LLP

2300 N Street, N.W.

Washington, D.C.  20037

<PHONE_NUMBER>

Attorneys for DELTA AIR LINES, INC.

CERTIFICATE OF SERVICE

I hereby certify that I have this 21st day of June, 2002, served the foregoing Application of Delta Air Lines, Inc., upon those persons listed below via email.

<EMAIL_ADDRESS>jmanley@wilmer.com@internet, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Nathaniel Breed/SPPT/US@SPPT, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>wkaras@steptoe.com@internet

/s/

____________________________

Alexander Van der Bellen

Application of Delta Airlines, Inc.

Page   PAGE  2


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency s Paperwork Clearance Officer.

Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA, Office of Compliance 2. OMB control number b. G None a. 2 0 6 0  0 360 __ __ __ __

3. Type of information collection ( check one)

a. G New collection b. G Revision of a currently approved collection c.

Extension of a currently approved collection d.

Reinstatement, without change, of a previously approved collection for which approval has expired e. X Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one)

a. X Regular b. G Emergency  Approval requested by: / /

c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title: MACT for Primary Aluminum Reduction Plants, 40 CFR, Subpart L.

8. Agency form number( s) ( If applicable) 1767.03 9. Keywords: electric arc furnaces, EAF dust handling systems, argon oxygen decarburization ( AOD) vessels, opacity 10. Abstract: In general all MACT standards require initial notifications, performance tests, and periodic reports and to maintain records according to the General Provisions ( 40 CFR Part 63, Subpart A). The recordkeeping and reporting requirements are needed to determine compliance with the applicable standards. These standards affect owners or operators of the followint affected facilities at primary aluminum reduction plants: new or existing potlines, paste production plants, or anode bake furnaces associated with primary aluminum production and located at a major source, and for each new pitch storage tank.

11. Affected public ( Mark primary with   P  and all others that apply with   X )

a. Individuals or households d. Farms b. X Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with   P  and all others that apply with   X )

a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 23 b. Total annual responses 50.9 1. Percentage of these responses collected electronically 50 %

c. Total annual hours requested 121,277 d. Current OMB inventory 0 e. Difference 121,277 f. Explanation of difference 1. Program Change 121,277 2. Adjustment 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 117 c. Total annualized cost requested 117 d. Current OMB inventory 0 e. Difference 117 f. Explanation of difference 1. Program change 117 2. Adjustment 15. Purpose of information collection ( Mark Primary With   P  and all others that apply with   X )

a. __ Application for benefits e. __ Program planning or b. __ Program evaluation management c. __ General purpose statistics f. __ Research d. __ Audit g. _ X_ Regulatory or compliance 16. Frequency of recordkeeping or reporting ( check all that apply)

a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. X Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission)

Name: Maria Malave Phone: 202 564 7027 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

© It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Michael Alushin Director, Compliance Assessment & Media Programs Division Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95


[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Rules and Regulations]
[Pages 14399-14400]
[FR Doc No: 2022-05393]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-1190; Airspace Docket No. 21-AEA-41]
RIN 2120-AA66

Amendment of Class E Airspace; Elkton, MD

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace extending upward from 700
feet above the surface for Claremont Airport, Elkton, MD, as an
airspace review found the airspace radius required an increase, as well
as updating the airport's name. Controlled airspace is necessary for
the safety and management of instrument flight rules (IFR) operations
in the area.

DATES: Effective 0901 UTC, May 19, 2022. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
part 51, subject to the annual revision of FAA Order JO 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-
8783. FAA Order JO 7400.11F is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of FAA Order JO 7400.11F at NARA, email
[email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface for Claremont Airport, Elkton, MD, to support IFR
operations in the area.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (87 FR 2373, January 14, 2022) for Docket No. FAA-2021-1190 to
amend Class E airspace extending upward from 700 feet above the surface
at Claremont Airport, Elkton, MD.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic routes, and reporting
points.

The Rule

    The FAA is amending 14 CFR part 71 by amending the Class E airspace
extending upward from 700 feet above the surface at Claremont Airport,
Elkton, MD, providing the controlled airspace required to support IFR
operations at this airport. This action increases the radius to 6.9
miles (previously 6.0 miles), and updates the airport's name to
Claremont Airport, (formerly Cecil County Airport). Also, this action
removes the city name from the airport's description, as it is
unnecessary (as per FAA Order 7400.2).

    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is minimal. Since this is a routine matter that only
affects air traffic procedures an air navigation, it is certified that
this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air)

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11F,
Airspace Designations and Reporting Points, dated August 10, 2021, and
effective September 15, 2021, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA MD E5 ELKTON, MD [Amended]

Claremont Airport, MD
    (Lat. 39[deg]34'27'' N, long. 75[deg]52'11'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of Claremont Airport.

    Issued in College Park, Georgia, on March 10, 2022.
Matthew N. Cathcart,
Manager, Operations Support Group, Eastern Service Center, AJV-E2.
[FR Doc. 2022-05393 Filed 3-14-22; 8:45 am]
BILLING CODE 4910-13-P