[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Pages 74770-74772]
[FR Doc No: 2020-25731]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90440; File No. SR-CBOE-2020-109]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Interpretations and Policies to Rule 5.33 in Connection With
Market-Makers' Complex Orders, Quoting Obligations and Volume

November 17, 2020.
    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 November 3, 2020, Cboe Exchange, Inc. (the ``Exchange'' or
``Cboe Options'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposal 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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe'') proposes to
amend its Interpretations and Policies to Rule 5.33 in connection with
Market-Makers' complex orders, quoting obligations and volume. The text
of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (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 Exchange proposes to adopt new Interpretation and Policy .02 to
Rule 5.33 to codify how complex strategy volume is counted when
determining whether a Market-Maker exceeds the 25% volume threshold in
its non-appointed classes pursuant to Rule 5.52(g) and when determining
whether a Market-Maker exceeds the electronic volume thresholds in its
appointed classes pursuant to 5.52(d)(1) and (d)(2).\5\ The Exchange
also proposes to make clarifying, nonsubstantive updates to
Interpretation and Policy .01 to Rule 5.33.
---------------------------------------------------------------------------

    \5\ As a result of the proposed Interpretation and Policy, the
proposed rule change accordingly updates the subsequent
Interpretation and Policy numbering.
---------------------------------------------------------------------------

    Rule 5.33 governs trading of complex orders on the Exchange and,
currently, Interpretation and Policy .01 to Rule 5.33 specifically
provides that Market-Makers are not required to quote on the Complex
Order Book (``COB''). Complex strategies are not subject to any quoting
requirements that are applicable to Market-Makers in the simple market
for individual options series or classes. Interpretation and Policy .01
to Rule 5.33 also states that volume executed in complex strategies is
not taken into consideration when determining whether Market Makers are
meeting quoting obligations applicable to Market Makers in the simple
market for individual options. The proposed rule change updates
Interpretation and Policy .01 to Rule 5.33 as it inadvertently refers
to volume executed rather than orders, as ``quoting'' obligations
relate to the submission of quotes and orders rather than executed
volume. More specifically, pursuant to Rule 5.52, a Market-Maker's bids
and offers entered in the simple market are considered in determining
whether a Market-Maker satisfies its quoting obligations, therefore,
the proposed rule change amends Interpretation and Policy .01 to Rule
5.33 to more appropriately reflect this. The proposed change also
harmonizes the spelling of Market-Maker with the definition set forth
in Rule 1.1 and updates the language to read in plain English, and, to
the extent possible, with the language in corresponding Interpretation
and Policy .01 to Rule 6.13 of its affiliated options exchange, Cboe C2
Exchange, Inc. (``C2'').
    Current Rule 5.52(g) provides that a Market-Maker is considered an
order entry firm (``OEF'') \6\ under the Rules in all classes in which
the Market-Maker has no appointment, and limits the total number of
contracts a Market-Maker may execute in classes in which it has no
appointment to 25% of the total number of all contracts the Market-

Marker executes on the Exchange in any calendar quarter. Rule
5.52(d)(1) provides that if a Market-Maker never trades more than 20%
of the Market-Maker's contract volume electronically in an appointed
class during any calendar quarter, a Market-Maker will not be obligated
to quote electronically in any designated percentage of series within
that class pursuant to subparagraph (d)(2), and Rule 5.52(d)(2)
provides that If a Market-Maker trades more than 20% of the Market-
Maker's contract volume electronically in an appointed class during any
calendar quarter, commencing the next calendar quarter, a Market-Maker
must provide continuous electronic quotes. The Exchange currently
considers all contracts executed by a Market-Maker, regardless of
whether they are executed in the simple or complex book, in determining
whether a Market-Maker has exceeded the 25% volume threshold in its
non-appointed classes and the 20% electronic volume threshold in its
appointed classes. The Exchange now proposes to codify this in proposed
Interpretation and Policy .02 to Rule 5.33. Specifically, the proposed
rule change makes it clear that a Market-Maker's orders for complex
strategies executed in classes in which it has no appointment are
included in the total number of all contracts the Market-Maker executes
on the Exchange in any calendar quarter in determining whether the
Market-Maker exceeds the 25% threshold pursuant to Rule 5.52(g) and
makes it clear that a Market-Maker's orders for complex strategies
executed in classes in which it has an appointment are included in the
total number of all contracts the Market-Maker executes electronically
in an appointed class during any calendar quarter in determining
whether the Market-Maker exceeds the electronic volume threshold
pursuant to Rule 5.52(d)(1) and (d)(2).
---------------------------------------------------------------------------

    \6\ See Rule 1.1., which defines an ``Order Entry Firm'' or
``OEF'' as a Trading Permit Holder that represents as agent customer
orders on the Exchange or that is a non-Market-Maker conducting
proprietary trading.
---------------------------------------------------------------------------

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.\7\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \8\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \9\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes the proposed rule change will
remove impediments to and perfect the mechanism of a free and open
market and a national market system by codifying that the Exchange
considers a Market-Maker's complex order volume when calculating the
25% threshold of volume in non-appointed classes pursuant to Rule
5.52(g) and when calculating the 20% threshold of electronic volume in
its appointed classes. Specifically, Rule 5.52(g) is designed to
prevent a Market-Maker from executing volume in non-appointed option
classes in an amount disproportionate to volume executed in its
appointed option classes. Similarly, Rule 5.52(d)(1) and (d)(2) are
designed to prevent a Market-Maker from executing electronic volume in
its appointed classes in an amount disproportionate to volume executed
on the trading floor in its appointed classes without being obligated
to stream continuous electronic quotes. Both Rule 5.52(g) and Rule
5.52(d)(1) and (d)(2) prevent a Market-Maker from executing volume in a
manner that potentially derogates the performance of its obligations
and provision of liquidity in its appointed option classes. As such,
the Exchange believes that including complex volume in these
calculations is consistent with and supports the purpose of Rule
5.52(g) and Rule 5.52(d)(1) and (d)(2), which, thereby, will help to
ensure that a Market-Maker executes volume in a manner that is
consistent with the performance of its quoting obligations and
provision of liquidity in its appointed classes. The proposed rule
change makes it clear that a Market-Maker's orders executed in complex
strategies are considered representative of a Market-Maker's total
volume on the Exchange. The Exchange believes this may mitigate any
potential confusion regarding this calculation so that Market-Makers
have more clarity regarding their obligations in appointed classes in
an appropriate manner as compared to non-appointed classes. As such,
the Exchange believes the proposed rule change will contribute to the
protection of investors and the public interest by adding transparency
and clarity to the Exchange's Rules by codifying an existing practice
in calculating a Market-Maker's executed volume on the Exchange. In
addition, the Exchange believes the proposed changes to Interpretation
and Policy .01 of Exchange Rule 5.33 will add clarity by revising the
Rule to provide that orders entered in appointed classes, rather than
volume executed, is considered in connection with determining whether a
Market-Maker meets its quoting obligations pursuant to Rule 5.52 in its
appointed classes, conforming the spelling of Market-Maker with its
applicable definition in Rule 1.1 and (to the extent possible) with the
language of its affiliated options exchange's corresponding provisions,
and updating the language to read in plain English.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange reiterates that
the proposed rule change is intended to codify a current Exchange
interpretation that a Market-Maker's complex strategy execution volume
is considered when calculating its volume per quarter pursuant to Rule
5.52(g) and correct an inadvertent error indicating that executed
volume rather than entered orders are considered when determining
compliance with a Market-Maker's quoting obligations. Thus, the
Exchange believes this proposed rule change will benefit Exchange
participants by providing clarity within the Exchange Rules.
    Additionally, the Exchange believes that the proposed rule change
regarding the applicability of Rule 5.52(g) to a Market-Maker's
executions in the COB does not impose any burden on intramarket
competition because it applies to all Market-Makers in the same manner.
The proposed rule change codifies an existing interpretation of the
Rules and therefore does not modify any existing Market-Maker
obligations or manner in which a Market-Maker's non-appointed volume is
calculated. The Exchange believes that the proposed rule change does
not impose any burden on intermarket competition because it relates to
an obligation regarding Market-Maker executed volume only on the
Exchange.

    Additionally, the proposed nonsubstantive updates to Interpretation
and Policy .01 to Rule 5.33 are not competitive in nature and, instead,
are intended to correct an inadvertently used term and provide clarity
and consistency within the Rules and, to the extent possible, with the
corresponding rule language of its affiliated options exchange.

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

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \10\ and
Rule 19b-4(f)(6) \11\ thereunder. At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission will institute proceedings to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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-CBOE-2020-109 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-CBOE-2020-109. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2020-109, and should be submitted
on or before December 14, 2020.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-25731 Filed 11-20-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Proposed Rules]
[Page 20370]
[FR Doc No: 2022-07287]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2021-0411; FRL-9547-01-R5]

Air Plan Approval; Minnesota; Bulk Silos FESOP Update

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a site-specific revision to the Minnesota State Implementation
Plan (SIP) for particulate matter less than 10 microns
(PM10) for the portland cement distribution terminal owned
and operated by Bulk Silos, LLC (Bulk Silos), formerly known as Lafarge
North America Corporation on Childs Road Terminal (Lafarge-Childs Road
Terminal) located in Saint Paul, Ramsey County, Minnesota. In its June
16, 2021, submittal, the Minnesota Pollution Control Agency (MPCA)
requested that EPA approve certain conditions contained in Bulk Silos'
federally enforceable state operating permit (FESOP) into the Minnesota
PM SIP. The request is approvable because it satisfies the requirements
of the Clean Air Act (CAA). MPCA's submission included an updated
modeling demonstration to show the construction changes incorporated in
the Title I SIP Conditions will not interfere with the ability to
maintain the National Ambient Air Quality Standards (NAAQS), as Bulk
Silos' allowable PM10 emissions limits will be decreased
with this action.

DATES: Comments must be received on or before May 9, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2021-0411 at http://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Olivia Davidson, Physical Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch
(AR18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
[email protected]. The EPA Region 5 office is open from 8:30 a.m.
to 4:30 p.m., Monday through Friday, excluding Federal holidays and
facility closures due to COVID-19.

SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
rule, no further activity is contemplated. If EPA receives such
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: March 31, 2022.
Debra Shore,
Regional Administrator, Region 5.
[FR Doc. 2022-07287 Filed 4-6-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Rules and Regulations]
[Page 60896]
[FR Doc No: 2012-24598]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0888]

Drawbridge Operation Regulation; Delaware River, Between
Burlington, NJ and Bristol, PA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Burlington-Bristol Bridge on Route 413, across the Delaware River, at
mile 117.8, between Burlington, NJ and Bristol, PA. This deviation
restricts the operation of the draw span in order to facilitate the
adjustment of the operating lift cables.

DATES: This deviation is effective from 7 a.m. on October 30, 2012 to 3
p.m. on November 1, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2012-0888 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0888 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Terrance Knowles, Environmental Protection Specialist,
Fifth Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Burlington County Bridge Commission, who
owns and operates this vertical-lift type drawbridge, has requested a
temporary deviation from the current operating regulations set out in
33 CFR 117.5 and 117.716(b) to facilitate the adjustment of the
operational lift cables.
    The Burlington-Bristol Bridge on Route 413, at mile 117.8, across
the Delaware River, between Burlington NJ and Bristol PA, has a
vertical clearance in the closed position to vessels of 62 feet above
mean high water.
    Under the regular operating schedule the bridge opens on signal as
required by 33 CFR 117.5 and the opening of a bridge may not be delayed
more than five minutes for a highway bridge, after the signal to open
is given as required by 33 CFR 117.716(b).
    Under this temporary deviation, the Burlington-Bristol Bridge will
be closed to navigation and unable to open on signal each day from 7
a.m. until 3 p.m. on October 30, 2012 and November 1, 2012.
    Vessels that can pass under the bridge without a drawbridge opening
may do so at all times. There are no alternate routes for vessels
transiting this section of the Delaware River.
    There are approximately four to six vessels per week from four
facilities whose vertical clearance surpasses the closed bridge
position, requiring an opening of the draw span. The Coast Guard has
coordinated this replacement work with the Mariners' Advisory Committee
for the Bay & River Delaware, and will inform the other users of the
waterway through our Local and Broadcast Notices to Mariners of the
closure periods for the bridge so that vessels can arrange their
transits to minimize any impact caused by the temporary deviation. The
bridge will not be able to open in an emergency during lift cable
tension adjustments.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: September 25, 2012.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2012-24598 Filed 10-4-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 244 (Friday, December 18, 2020)]
[Notices]
[Pages 82578-82580]
[FR Doc No: 2020-27942]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2020-0089]

National Emergency Medical Services Advisory Council;
Solicitation of Applications

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Solicitation of Nominations for Appointment to the National
Emergency

Medical Services Advisory Council (NEMSAC).

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

SUMMARY: NHTSA is soliciting applications for appointment/reappointment
to the U.S. Department of Transportation's (DOT) NEMSAC. The purpose of
NEMSAC is to serve as a nationally recognized council of Emergency
Medical Services (EMS) representatives and consumers to provide advice
and recommendations regarding EMS to DOT. Through NHTSA, NEMSAC's
advice is provided to the Federal Interagency Committee on EMS
(FICEMS).

DATES: Applications for membership must be received by NHTSA on or
before 5 p.m. EST, January 15, 2021.

ADDRESSES: If you wish to apply for membership, your application should
be submitted to:
     Email<EMAIL_ADDRESS>     Mail: Use only overnight mail such as UPS or FedEx to:
U.S. Department of Transportation, National Highway Traffic Safety
Administration, Office of Emergency Medical Services, Attn: NEMSAC,
1200 New Jersey Avenue SE, NTI-140, Washington, DC 20590.
    Additional information on NEMSAC, including the current roster,
charter, and previous meeting minutes can be found at: https://www.ems.gov/nemsac.html.

FOR FURTHER INFORMATION CONTACT: Clary Mole, EMS Specialist, National
Highway Traffic Safety Administration, U.S. Department of
Transportation<EMAIL_ADDRESS>or<PHONE_NUMBER>. Any committee
related questions should be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION: Background:
    NEMSAC is an advisory council established by DOT in accordance with
the provisions of the Federal Advisory Committee Act (FACA), Public Law
92-463, as amended (5 U.S.C. App.) and DOT Order 1120.3C NEMSAC
provides information, advice, and recommendations to the Secretary via
the Administrator of NHTSA, and through NHTSA to FICEMS on matters
relating to all aspects of development and implementation of EMS.
    Description of Duties:
    Consistent with Sections 3 and 5, NEMSAC is authorized to:
    a. Consider information on EMS issues to define, develop positions,
and make recommendations on such issues for the Secretary of
Transportation and/or FICEMS.
    b. Provide recommendations or advice relating to EMS on such topics
as:
     Improved coordination and support of EMS systems among
Federal programs;
     Strategic planning;
     EMS standards, guidelines, performance benchmarks, and
other guidelines;
     Guidelines for conducting needs assessments for improving
community-based EMS systems at State and local levels;
     Enhancing the National EMS Information System (NEMSIS)
through adoption, utilization and revision of the NEMSIS standard and
supporting EMS systems with new uses of EMS data and information; and
     Strengthening EMS systems through enhanced workforce
development, education, training, exercises, sustainability, equipment,
medical oversight, and other areas.
    c. Respond to requests for consultation and advice on EMS issues
from the Secretary of Transportation (via the National Highway Traffic
Safety Administration's (NHTSA) Designated Federal Officer (DFO)) and/
or from FICEMS.
    d. NEMSAC shall prepare an annual report to the Secretary of
Transportation, with copies sent to the Secretary of Health and Human
Services and Secretary of Homeland Security, and to FICEMS, regarding
NEMSAC's actions and recommendations.

Membership

    In accordance with the NEMSAC charter, members should represent a
cross-section of the diverse agencies, organizations, and individuals
involved in EMS activities and programs in the United States. NEMSAC
consists of 25 members, each of whom shall be appointed by the
Secretary of Transportation, in coordination with the U.S. Departments
of Homeland Security and Health and Human Services through their
respective representatives on FICEMS. The NEMSAC members shall
collectively be representative of all sectors of the EMS community.
    The NEMSAC's broad-based membership will ensure that it has
sufficient EMS system expertise and geographic and demographic
diversity to accurately reflect the whole EMS community.
    To the extent practical, the final NEMSAC membership shall ensure
representation from the following sectors of the EMS community:

 Volunteer EMS
 Fire-based (career) EMS
 Private (career non-fire) EMS
 Hospital-based EMS
 Tribal EMS
 Air Medical EMS
 Local EMS service directors/administrators
 EMS Medical Directors
 Emergency Physicians
 Trauma Surgeons
 Pediatric Emergency Physicians
 State EMS Directors
 State Highway Safety Directors
 EMS Educators
 Public Safety Call-taker/Dispatcher (911)
 EMS Data Managers
 EMS Quality Improvement
 EMS Researchers
 Emergency Nurses
 Hospital Administration
 Public Health
 Emergency Management
 EMS Practitioners
 Consumers (not directly affiliated with an EMS or healthcare
organization)
 State or local legislative bodies (e.g., city/county councils;
state legislatures)

    Members serve in a ``representative'' capacity on NEMSAC and not as
Special Government Employees. The Secretary of Transportation shall
appoint each member for up to a 2-year term and members may be
reappointed but may not serve more than two consecutive terms unless
the Secretary determines that additional terms are permitted to ensure
representation of all sectors of EMS. NEMSAC members will not receive
pay or other compensation from NHTSA for their NEMSAC service, but are
entitled to reimbursement of their travel expenses, including per diem.
The NEMSAC meets in plenary session approximately three to four times
per year.

Qualifications

    Members will be selected for their ability to reflect a balanced
representation of interests from across the EMS community, but no
member will represent a specific organization.

Materials To Submit

    Qualified individuals interested in serving on the NEMSAC are
invited to apply for appointment by submitting a resume or CV along
with letters of recommendation to one of the locations listed in the
ADDRESSES section by the deadline listed in the DATES section. Each
applicant must identify the EMS sector or discipline that he or she
seeks to represent. Current NEMSAC members whose terms are ending
should notify the person listed in the FOR FURTHER INFORMATION CONTACT
section of their interest in reappointment in lieu of submitting a new
application, and should provide an updated resume or

CV and a restatement of the current sector they represent by the
deadline. Nominations are open to all individuals without regard to
race, color, religion, sex, national origin, age, mental or physical
disability, marital status, or sexual orientation. Evaluations will be
based on the materials submitted.

    Authority: 42 U.S.C. 300d-4(b); 49 CFR 1.95(i)(4).

    Issued in Washington, DC.
Nanda Narayanan Srinivasan,
Associate Administrator, Research and Program Development.
[FR Doc. 2020-27942 Filed 12-17-20; 8:45 am]
BILLING CODE 4910-59-P


                   UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

Docket: OST-2002-12503					Served: July 16, 2004

U.S.-Ecuador All-Cargo Frequencies

Notice Inviting Applications

By this notice we request that all U.S. carriers interested in new or
additional frequencies for all-cargo scheduled services to Ecuador file
applications, as specified below, with the Department no later than July
30, 2004.

While there are no limitations on the number of U.S. all-cargo carriers
that may provide scheduled all-cargo services to Ecuador under the
U.S.-Ecuador aviation agreement, there are limitations on the number of
weekly frequencies that may be provided.  U.S. all-cargo carriers

are limited to 30 weekly frequencies.  Current frequency allocations for
U.S. carriers are as follows: United Parcel Service – 7; Arrow Air –
7; Gemini Air Cargo – 3; Atlas Air – 6; and Florida West – 5.  The
remaining 2 frequencies are currently unallocated as outlined below.

By Order 2004-3-16, served on March 16, 2004, the Department awarded
Evergreen International two frequencies to operate all-cargo services in
the U.S.-Ecuador market.  The award was subject to the condition that
the selected carrier institute its proposed services within 90 days
(i.e., no later than June 14, 2004).

By letter dated May 13, 2004, Evergreen gave notice to the Department
that it does not intend to implement its proposal to use two all-cargo
frequencies.  Thus, two U.S.-Ecuador all-cargo frequencies are now
available for reallocation by the Department.  Before we decide to award
the available frequencies, to ensure that we have applications from all
interested carriers, we request that all U.S. carriers interested in
making use of the available frequencies file applications, as specified
below, with the Department no later than July 30, 2004.  Answers to
applications should be filed by August 6, 2004, and replies should be
filed by August 11, 2004.

Carriers without the requisite operating authority should file
exemption/frequency allocation applications.  Carriers with the
requisite underlying authority need only file requests for frequency
allocation.  Except for the procedural dates, exemption/frequency
applications should conform to Part 302, Subpart C of our regulations
(14 CFR Part 302).  All applications should include, at a minimum, the
following information: (a) the market(s) to be served; (b) complete
routings from origin to destination of all flights; (c) days scheduled;
(d) frequencies requested per market; (e) capacity/type of aircraft to
be used; (f) the startup date for the proposed services; and (g) a
statement as to whether the aircraft to be used in the proposed schedule
are on hand or on order, and variation of frequencies/routings by
traffic season, if applicable.  We note that two carriers, Arrow and
Amerijet, have already filed applications in Docket OST-2002-12503.
These carriers should, if necessary, update their applications with the
information requested in this notice by the established application
date, or file a new application, making clear whether such new
application supersedes that which was previously filed, or is intended
to supplement that which has already been filed.  All applications (for
operating authority and/or allocation of frequencies) should be filed in
Docket OST-2002-12503 with the Department of Transportation, Dockets,
Room PL-401, 400 Seventh Street, SW, Washington, DC 20590.

We intend to allocate the available frequencies based on the
applications and responsive pleadings filed in response to this notice.
We intend to make our decision using written, show-cause procedures in
accordance with Part 302 of our regulations (14 CFR Part 302).

We will authorize service of documents by facsimile and by electronic
mail.  Carriers that are interested in such service, however, should
state if they want service by email and should provide interested
parties with their fax number and/or email address.  We will serve this
notice on all certificated U.S. air carriers, the National Air Carrier
Association, the Air Transport Association, the U.S. Department of State
(Office of Aviation Negotiations), the Federal Aviation Administration
(AFS-200), and the Ambassador of Ecuador in Washington DC.

By:

						Paul L. Gretch

						Director, Office of International Aviation

(Seal)

Dated:  July 13, 2004

An electronic version of this order is available on the World Wide Web
at

http://dms.dot.gov//reports/reports_ aviation.asp

The U.S.-Ecuador agreement provides that U.S. all-cargo carriers may
operate services from the United States via the intermediate points of
Mexico City, Mexico; Guatemala City, Guatemala; San Salvador, El
Salvador; San Pedro Sula and Tegucigalpa, Honduras; Panama City, Panama;
Cali, Bogota, and Medellin, Colombia; to the coterminal points of Quito,
Guayaquil, Manta and Latacunga, Ecuador; and beyond Ecuador to Lima,
Peru; Santiago, Chile; Buenos Aires, Argentina; La Paz and Santa Cruz,
Bolivia; Asuncion, Paraguay; and Rio de Janeiro and Sao Paulo, Brazil.

If aircraft are on hand, applicants should indicate where and to what
extent those aircraft are currently being used by the applicant.  If
aircraft are on order, the applicant should indicate when the aircraft
will be delivered and how the aircraft will be financed.  The applicant
should further indicate whether the aircraft to be used comply with
FAR-36; if not, they should indicate specific plans for achieving
compliance.

Arrow filed a separate “application or re-application” seeking the
same U.S.-Ecuador authority in Docket OST-2004-18183.  By this notice,
we consolidate Docket OST-2004-18183 into Docket OST-2002-12503.

The original filing should be on 8½" x 11" white paper using dark ink
(not green) and be unbound without tabs, which will expedite use of our
docket imaging system.  In the alternative, filers are encouraged to use
the electronic submission capability available through the dockets/DMS
Internet site (  HYPERLINK "http://dms.dot.gov"  http://dms.dot.gov ) by
following the instructions at the web site.

 PAGE

 PAGE   2


[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 924-926]
[FR Doc No: 2020-00071]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5799]

Modernizing the Food and Drug Administration's Data Strategy;
Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Modernizing FDA's
Data Strategy.'' The purpose of the public meeting and the request for
comments is to discuss possible Agency level approaches to modernizing
FDA's data strategy, including approaches to data quality, data
stewardship, data exchange, and data analytics.

DATES: The public meeting will be held on March 27, 2020, from 9 a.m.
to 5 p.m. Eastern time. The public meeting may be extended or may end
early. Submit electronic or written comments on this public meeting by
April 30, 2020. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rooms 1503B/C), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before April 30, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of April 30, 2020. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-5799 for ``Modernizing FDA's Data Strategy; Public Meeting;
Request for Comments.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     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.

FOR FURTHER INFORMATION CONTACT: Jessica Berrellez, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2308, Silver
Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In September 2019, FDA announced its Technology Modernization
Action Plan (TMAP; https://www.fda.gov/about-fda/reports/fdas-technology-modernization-action-plan). The TMAP describes important
near-term actions that FDA is taking to modernize use of technology--
computer hardware, software, data, and analytics--to advance FDA's
public health mission. The TMAP will provide a foundation for
developing a more fluid, agile, and efficient FDA that is responsive to
novel technologies and rapidly increasing workloads.
    To achieve these goals, FDA intends to develop a modernized Agency-
wide, strategic approach not only to technology, but to data itself.
Data is at the heart of FDA's work as a science-based Agency, and we
anticipate ongoing, rapid increases in the amount and complexity of the
data that informs FDA's regulatory decision-making process and how we
advance our public health mission. FDA will hold a public meeting on
March 27, 2020, from 9 a.m. to 5 p.m., to provide an opportunity to
hear from FDA staff and outside experts on topics directly related to
modernizing FDA's data strategy, including data quality, data
stewardship, data exchange, and data analytics.

II. Topics for Discussion at the Public Meeting

    FDA is gathering scientific and technical information to help
inform its development of an Agency-wide, strategic approach to
modernizing its data strategy, including data quality, data
stewardship, data exchange, and data analytics. The Agency has
determined that a public meeting and an open public docket will
encourage public input and engagement in this important topic.
    The Agency welcomes any relevant scientific and technical
information related to FDA's consideration of the following topics:
    1. Standards and policy, including:
    a. How can FDA best use policy and common data standards to help
ensure the effective and efficient use of data assets?
    b. What are the consequences/issues as we move from ``static point-
in-time data sets'' to updating digital data streams for analyses?
    c. As we move into increased sharing and integrated data sets, how
might FDA manage data in a way that avoids unnecessary duplication?
    2. Data security, privacy, and management including:
    a. How can FDA modernize its data strategy to continue ensuring
privacy and security of data?
    b. What should FDA do to promote the management and organization of
data assets across the Agency, as the amount and complexity of data
(e.g., in regulatory submissions to FDA) is rapidly increasing?
    3. Data strategies and data sharing, including:
    a. How can FDA's data strategy facilitate broader goals of
integration and interoperability of health care data, and scientific
data/virtual patient data generated using scientific models?
    b. How can FDA design its data strategy to reflect a global
marketplace and promote clarity to data providers like regulated
industry and other stakeholders?
    c. How can FDA design its data strategy and policy development to
facilitate appropriate data access, data sharing within the Agency and
via data sharing agreements, as well as the appropriate reuse and
repurposing of data to advance Agency regulatory science priorities?
    d. For stakeholders, including regulated industry, that submit data
to FDA, how can FDA enhance the efficiency of the preparation and
submission of data to FDA?

III. Participating in the Public Meeting

    Registration: If you wish to attend this public meeting in person,
please register via https://fdapublicmeetingmodernizingdatastrategy.eventbrite.com by 11:59 p.m.
Eastern Time on March 24, 2020. Those without email access can register
to attend in person by contacting Jessica Berrellez at<PHONE_NUMBER> by
March 24, 2020 (see FOR

FURTHER INFORMATION CONTACT). Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by 11:59 p.m. Eastern Time on March 24, 2020.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization.
    If you need special accommodations due to a disability, please
contact<EMAIL_ADDRESS>(see FOR FURTHER INFORMATION
CONTACT) no later than 11:59 p.m. Eastern Time on March 20, 2020.
    Presenters and Panelists: FDA is interested in gathering scientific
and technical information from individuals with a broad range of
perspectives on the topics to be discussed at the public meeting.
Presenters and panelists will discuss their scientific and/or technical
knowledge on the questions and presentations in each session.
Presenters and panelists will be responsible for their own travel
arrangements.
    To be considered to serve as a presenter and/or panelist, please
provide the following:
     Presenters: A brief abstract for each presentation. The
abstract should identify the specific topic(s) to be addressed and the
amount of time requested.
     Presenters and panelists: A one-page biosketch that
describes and supports your scientific or technical expertise on the
specific topic(s) being presented, nature of your experience and
research in the scientific field, positions held, and any program
development activities.
    If you are interested in serving as a presenter or a panelist, you
must submit the above information, along with the topic(s) on which you
would like to speak, to<EMAIL_ADDRESS>by January 28,
2020.
    We will do our best to accommodate requests to make presentations
and serve on the panel. Individuals and organizations with common
interests are urged to consolidate or coordinate their presentations,
and request time for a joint presentation. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify presenters and panelists by March 6, 2020.
If selected for presentation, any presentation materials must be
emailed to<EMAIL_ADDRESS>no later than 11:59 p.m.
Eastern Time on March 20, 2020. No commercial or promotional material
will be permitted to be presented or distributed at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Please register for the streaming webcast of the
workshop via https://fdapublicmeetingmodernizingdatastrategy.eventbrite.com by 11:59 p.m.
Eastern Time on March 24, 2020. Pre-registration for the webcast is
recommended, but not required. The webcast will be available and active
during the public meeting at https://collaboration.fda.gov/fdadmpm/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    An agenda for the public meeting and any other background materials
will be made available 5 days before the public meeting at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/modernizing-fdas-data-strategy-03272020-03272020.
    Persons attending FDA's meetings are advised that the Agency is not
responsible for providing access to electrical outlets.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/modernizing-fdas-data-strategy-03272020-03272020.

    Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00071 Filed 1-7-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Rules and Regulations]
[Pages 31821-31822]
[FR Doc No: 2011-13559]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-1171; Airspace Docket No. 10-ASW-16]

Amendment of Class D Airspace; Corpus Christi, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, technical amendment.

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

SUMMARY: This action amends Class D airspace within the Corpus Christi,
TX, area by updating the geographic coordinates for Cabaniss Navy
Outlying Field (NOLF). This action does not change the boundaries or
operating requirements of the airspace.

DATES: Effective date: 0901 UTC, August 25th, 2011. 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: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by adjusting the geographic coordinates, within Class D
airspace, of the Cabaniss NOLF, Corpus Christi, TX, to coincide with
the FAAs aeronautical database. This is an administrative change and
does not affect the boundaries, altitudes, or operating requirements of
the airspace, therefore, notice and public procedures under 5 U.S.C.
553(b) are unnecessary.
    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.
Therefore, this regulation: (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 so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, 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
controlled airspace at Cabaniss NOLF, Corpus Christi, TX.

List 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 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 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 the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010, is amended as follows:

Paragraph 5000 Class D Airspace

* * * * *

ASW TX D Corpus Christi, TX [Amended]

Cabaniss NOLF, TX
    (Lat. 27[deg]42'10'' N., long. 97[deg]26'20'' W.)

    That airspace extending upward from the surface to but not
including 1,200 feet MSL within a 4.4-mile radius of Cabaniss NOLF,
excluding that airspace within the Corpus Christi International
Airport, TX, Class C airspace area; and excluding that airspace
within the Corpus Christi, Waldron NOLF, TX, Class D airspace area;
and excluding that airspace west of a line between lat.
27[deg]38'15'' N., long. 97[deg]28'40'' W., and lat. 27[deg]41'30''
N., long. 97[deg]28'40'' W. This Class D airspace area is effective
during the specific dates and times established in advance by a
Notice to Airmen. The effective date and time will thereafter be
continuously published in the Airport/Facility Directory.

    Issued in Fort Worth, Texas, on May 23, 2011.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2011-13559 Filed 6-1-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59799-59801]
[FR Doc No: 2019-24202]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG20-21-000.

    Applicants: Emmons-Logan Wind Interconnection, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Emmons-Logan Wind .Interconnection, LLC.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5193.
    Comments Due: 5 p.m. ET 11/21/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-3297-014.
    Applicants: Powerex Corp.
    Description: Notice of Non-Material Change in Status of Powerex
Corp.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5102.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER19-2909-001.
    Applicants: Basin Electric Power Cooperative.
    Description: Tariff Amendment: Amendment to Submission of Initial
Rate Schedule A to be effective 12/31/9998.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5216.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-250-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: 3rd Quarter 2019 Revisions
to OA, Schedule 12 and RAA, Schedule 17 to be effective 9/30/2019.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5047.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-251-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: Att O-PSCo TBL 25--Deprec
and Amort Rates Filing to be effective 1/1/2020.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5052.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-252-000.
    Applicants: Otter Tail Power Company.
    Description: Sec.  205(d) Rate Filing: Operating Services Agreement
with Alexandria Light & Power Utilities to be effective 1/1/2020.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5073.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-253-000.
    Applicants: Otter Tail Power Company.
    Description: Sec.  205(d) Rate Filing: Operating Services Agreement
with Detroit Lakes Public Utilities to be effective 1/1/2020.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5074.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-254-000.
    Applicants: Wabash Valley Power Association, Inc., PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to OATT, Att. L &
CTOA, Att. A reflecting Wabash as a new TO (OATT) to be effective 12/
31/2019.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5082.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-255-000.
    Applicants: AEP Texas Inc.
    Description: Informational Filing and Notice of Cancellation of
ERCOT Transmission Service Agreement (No. 451) of AEP Texas Inc.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5088.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-256-000.
    Applicants: Wabash Valley Power Association, Inc., PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to CTOA, Att. A &
OATT, Att. L reflecting Wabash a new TO (CTOA) to be effective 12/31/
2019.
    Filed Date: 10/31/19
    Accession Number: 20191031-5093.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-257-000.
    Applicants: Southwestern Electric Power Company.
    Description: Informational Filing and Notice of Cancellation of
Four Operations Agreements of Southwestern Electric Power Company.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5097.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-258-000.
    Applicants: Appalachian Power Company.
    Description: Sec.  205(d) Rate Filing: APCo-Seven Islands Small GIA
to be effective 12/30/2019.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5111.
    Comments Due: 5 p.m. ET 11/21/19

    Docket Numbers: ER20-260-000.
    Applicants: California Power Exchange Corporation.
    Description: Sec.  205(d) Rate Filing: Rate Filing for Rate Period
36 to be effective 1/1/2020.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5129.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-261-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: WP_Depreciation Rates to be
effective 1/1/2020.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5165.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-262-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to OATT Sch. 12-
Appx A: Oct 2019 RTEP, 30-day Comments due to be effective 1/29/2020.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5167.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-263-000.
    Applicants: Doswell Limited Partnership.
    Description: Sec.  205(d) Rate Filing: Reactive Power Tariff Filing
to be effective 12/1/2019.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5170.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-264-000.
    Applicants: New England Power Pool Participants Committee.
    Description: Sec.  205(d) Rate Filing: Nov 2019 Membership Filing
to be effective 10/1/2019.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5181.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-265-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: BPA AC Intertie Agreement
16th Revised to be effective 12/31/2019.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5195.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-266-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: Reserve Capacity Revisions
to CCSF WDT SA (SA 275) to be effective 12/30/2019.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5213.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-267-000.
    Applicants: Gulf Power Company.
    Description: Sec.  205(d) Rate Filing: Cost-Based Rate Tariff to be
effective 1/1/2020.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5218.
    Comments Due: 5 p.m. ET 11/21/19.

    Docket Numbers: ER20-268-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: SCE 2020 TRBAA Update to be
effective 6/1/2019.
    Filed Date: 10/31/19.
    Accession Number: 20191031-5220.
    Comments Due: 5 p.m. ET 11/21/19.

    The filings are accessible in the Commission's eLibrary system by

clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 31, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-24202 Filed 11-5-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 8, 2008 (Volume 73, Number 5)]
[Notices]
[Page 1331]
[DOCID:fr08ja08-35]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC08-23-001]

Arrowhead Louisiana Gathering LLC; Notice of Filing

January 2, 2008.
    Take notice that on December 19, 2007, Arrowhead Louisiana
Gathering LLC (``Arrowhead'') submitted a request for waiver of the
requirement to file the FERC Form No. 6-Q for the second quarter of the
2007 calendar year.
    In support thereof, Arrowhead states that while its tariff became
effective June 9, 2007, it performed no service during the quarterly
period ended June 30, 2007, and has no operating revenues to report for
that period.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 or 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: February 1, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-97 Filed 1-7-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63210-63211]
[FR Doc No: 2014-25134]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2014-0019]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA confirms its decision to exempt 56 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on August 14, 2014. The exemptions
expire on September 15, 2016.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, R.N., Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316).

II. Background

    On August 14, 2014, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 56 individuals and requested
comments from the public (79 FR 47702). The public comment period
closed on September 15, 2014, and seven comments were received.
    FMCSA has evaluated the eligibility of the 56 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

III. Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The

September 3, 2003 (68 FR 52441), Federal Register notice in conjunction
with the November 8, 2005 (70 FR 67777), Federal Register notice
provides the current protocol for allowing such drivers to operate CMVs
in interstate commerce.
    These 56 applicants have had ITDM over a range of 1 to 48 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the August 14, 2014, Federal Register
notice and they will not be repeated in this notice.

IV. Discussion of Comments

    FMCSA received seven comments in this proceeding. The comments are
discussed below.
    E. Fajardo, Eman Saaidi, and three anonymous commenters are in
favor of granting all drivers included in this notice an exemption from
the diabetes standard.
    Rayman Al-Omeri is in favor of granting Ahmed Ali an exemption from
the diabetes standard.
    Richard Woodall is in favor of granting Raymond Lucero an exemption
from the diabetes standard.

V. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

VI. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) that each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VII. Conclusion

    Based upon its evaluation of the 56 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 949 CFR
391.64(b)):

Michael N. Bohn (MN)
Jonathan Bona (NJ)
Vincent M. Branch (VA)
Perry C. Bullis (PA)
Christopher J. Burkhart (MO)
James E. Cantrell, Jr. (AL)
Kristy S. R. Clark (VA)
Royce N. Cordova (WA)
Robert Curry (NY)
Bradley C. Dunlap (IL)
John C. Fisher III (PA)
Kenneth W. Foster (IN)
Andrew C. Frykholm (MA)
Lyle O. Gahler (MN)
John A. Gillingham (PA)
Ronald L. Glade (IL)
Brent C. Godshalk (IN)
Robert L. Gordon (IL)
Jeffrey R. Harnack (MN)
Daniel E. Harris (IL)
Elefterios Hatzigeorgalis (MD)
Drew J. Holtan (MN)
Randy S. Holz (IA)
Joseph C. House (AL)
Kenneth B. Huff (PA)
Henderson R. Hughes (NY)
Levi N. Hutchinson (PA)
Joseph T. Ingiosi (MI)
Michael J. Javenkoski (MN)
Katlin W. Johnson (LA)
Don L. Jorgensen (WY)
Steven T. Juhl (MN)
Christopher D. Lacasse, Sr. (MA)
Raymond S. Lucero (NM)
Richard M. Mackey (TX)
Kevin J. McGrath (MA)
Jerry W. Murphy (MS)
Christopher D. Murray (CA)
Robert D. Noe (IL)
Kyle W. Parker (CA)
Eric D. Roberts (MI)
Gary L. Roberts (CT)
Tommy A. Rollins (GA)
Janice M. Rowles (PA)
William B. Rupert, Jr. (PA)
Ahmed A. Saleh (MI)
Robert M. Schmitz (IA)
David C. Schultze (MN)
Brian R. Schwint (IA)
Dicky W. Shuttlesworth (TX)
Bryce J. Smith (UT)
David R. Sprenkel (PA)
Jeffrey R. Stevens (PA)
David W. Taggart (PA)
Artilla M. Thomas (IL)
William C. Tomlinson (GA)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: October 10, 2014.
 Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-25134 Filed 10-21-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Pages 10754-10755]
[FR Doc No: 2012-4164]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0327]

International Conference on Harmonisation; Final Recommendation
for the Revision of the Permitted Daily Exposure for the Solvent Cumene
According to the Maintenance Procedures for the Guidance Q3C
Impurities: Residual Solvents; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final recommendation for the revision of the
permitted daily exposure (PDE) for the solvent cumene according to the
maintenance procedures for the guidance for industry entitled ``Q3C
Impurities: Residual Solvents.'' The recommendation was prepared under
the auspices of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH).

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the
recommendation to the Division of Drug Information (HFD-240), Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002,
or the Office of Communication, Outreach and Development (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
requests. The draft recommendation may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft recommendation.
    Submit electronic comments on the recommendation to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Regarding the Q3C Guidance

    David Jacobson-Kram, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6488,
Silver Spring, MD 20993,<PHONE_NUMBER>.

Regarding the ICH

    Michelle Limoli, Office of International Programs, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3506, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory Agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In 1999, ICH instituted a Q3C maintenance agreement and formed a
maintenance Expert Working Group (Q3C EWG). The agreement provided for
the reconsideration of solvent PDEs and allowed for minor changes to
the tables and list that include the existing PDEs. The agreement also
provided that new solvents and PDEs could be added to the tables and
list based on adequate toxicity data. In the Federal Register of
February 12, 2002 (67 FR 6542), FDA briefly described the process for
proposing future revisions to the PDEs. In the same notice, the Agency
announced its decision to delink the tables and list from the Q3C
guidance and create a stand alone document entitled ``Q3C--Tables and
List'' to facilitate making changes recommended by ICH.

II. Revised PDE for Cumene

    In the Federal Register of July 20, 2010 (75 FR 42098), FDA
published a notice announcing the availability of a draft
recommendation for the revision of the PDE for cumene according to the
ICH maintenance procedures. The notice gave interested persons an
opportunity to submit comments by September 20, 2010.
    After consideration of the comments received and revisions to the
guidance, a final draft of the recommendation was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
Agencies in February 2011.
    The final recommendation addresses the safety classification of
cumene. When the Q3C guidance was published in 1997 (62 FR 67377,
December 24, 1997), cumene was listed as a class 3

solvent (i.e., a solvent with low toxicity). The Q3C EWG reviewed new
toxicity data derived from a carcinogenicity study performed by the
National Toxicology Program. The new data suggest a positive systemic
carcinogenic effect, and this observation raises the toxicity
associated with this solvent. The final recommendation is that cumene
be placed into class 2. A PDE of 0.7 milligrams per day and a
concentration limit of 70 parts per million are being declared for this
solvent. The analysis and recommendation are available for review on
the Internet (see section V of this document on electronic access). The
final recommendation is also available from the Division of Drug
Information (see ADDRESSES). The Agency will revise the tables in the
guidance ``Q3C--Tables and List'' to reflect the ICH final
recommendation for cumene.
    The final recommendation for the solvent cumene is being issued
consistent with FDA's good guidance practices regulation (21 CFR
10.115). The revised PDE for the solvent cumene contained in the
revised guidance ``Q3C--Tables and List'' represents the Agency's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. The recommendation and received comments may be seen in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the Q3C guidance
documents at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/;BiologicsBlood;Vaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    Information on the Q3C maintenance process as well as proposals,
data analysis, and draft and final recommendations for revisions to the
tables and list are available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm125820.htm.

    Dated: February 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4164 Filed 2-22-12; 8:45 am]
BILLING CODE 4160-01-P