Comment Info: =================

General Comment:Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder: proof-of-concept and proof-of-product studies.


[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4573-4574]
[FR Doc No: 2012-1908]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2009-0384]

Maritime Security Directive 104-6 (Rev 6); Guidelines for U.S.
Vessels Operating in High Risk Waters

AGENCY: Coast Guard, DHS.

ACTION: Notice of Availability.

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SUMMARY: The Coast Guard announces the release of Maritime Security
(MARSEC) Directive 104-6 (Rev 6). This Directive only applies to U.S.-
flagged vessels subject to the Maritime Transportation Security Act
(MTSA) on international voyages through or in designated high risk
waters, and provides additional counter-piracy guidance and mandatory
measures for these vessels operating in these areas where acts of
piracy and armed robbery against ships are prevalent. MARSEC Directive
104-6 (Rev 6) also includes an annex that provides specific direction
for vessels operating around the Horn of Africa. Although MARSEC
Directives are designated Sensitive Security Information (SSI) and are
not subject to public release, a non-SSI version of this directive is
available.

DATES: MARSEC Directive 104-6 (Rev 6) has been available since December
30, 2011. MARSEC Directive 104-6 (Rev 5) is no longer valid after that
date.

ADDRESSES: The latest MARSEC Directives are available at your local
Captain of the Port (COTP) office. Phone numbers and addresses for your
local COTP office can be found in the Port Directory at http://homeport.uscg.mil.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call LCDR James T. Fogle, Office of Vessel Activities, Coast Guard,
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
questions on viewing material in the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    Somali pirates operate along a 2,300 mile coast and in 2.5 million
square miles of ocean. The international community has engaged with
local officials in a focused domestic and international anti-piracy
effort to address the enforcement difficulties caused by the affected
area's size and political complexity. Despite these efforts, piracy
persists and the combination of piracy and weak rule of law in the
region provides a potential breeding ground for additional
transnational threats. Accordingly, the United States uses existing
statutory authority to develop security standards designed to protect
U.S.-flagged vessels and continues to work with international partners
to prevent piracy.
    On February 10, 2006, the Coast Guard announced the release of
MARSEC Directive 104-6 (71 FR 7054) for those owners and operators of
vessels subject to 33 CFR parts 101 and 104. MARSEC Directive 104-6
provides direction to U.S.-flagged vessels operating in high risk areas
where acts of piracy and armed robbery against ships are prevalent.
    MARSEC Directive 104-6 has been revised five times. MARSEC
Directive 104-6 (Rev 1) provided an updated list of high risk waters
based on a biennial review of global piracy and terrorism threats.
    MARSEC Directive 104-6 (Rev 2) provided additional counter-piracy
guidance to U.S.-flagged vessels operating in high risk waters where
acts of piracy and armed robbery against ships are prevalent. It also
provided a listing of additional high risk waters, updated from the
previous version of the Directive.
    MARSEC Directive 104-6 (Rev 3) encouraged the use of industry best
management practices that have proven to be successful in thwarting
pirate attacks and incorporates lessons-learned since the issuance of
Revision 2.
    MARSEC Directive 104-6 (Rev 4) provided clarification for U.S.-
flagged vessels berthed or anchored in high risk waters. Vessels at
anchor should operate in a manner consistent with vessels that transit
through high risk waters. Whether at anchor or underway, the vessels
are subjected to the same type of threats from attacking pirates.
Vessels berthed in high risk waters should implement enhanced security
measures as required by the MARSEC Directive.
    MARSEC Directive 104-6 (Rev 5) addressed the expanding operating
area of Somali pirates and provides U.S.-flagged vessels additional
guidance for operations in the Indian Ocean.
    MARSEC Directive 104-6 (Rev 6), the Directive that is the subject
of this notice of availability, provides a revised and updated list of
designated high risk waters and areas. MARSEC Directive 104-6 (Rev 5)
is no longer valid with the issuance of (Rev 6).
    We developed piracy-related Port Security Advisories (PSAs) to
provide further guidance and direction to U.S.-flagged vessels
operating in high risk waters to help facilitate compliance with MARSEC
Directive 104-6 (series). The PSAs can be found at http://homeport.uscg.mil/piracy, including a non-SSI version of this MARSEC
Directive in PSA (2-09) (Rev 3).

Procedural

    COTPs and District Commanders can access all MARSEC directives on
Homeport by logging in and going to Missions > Maritime Security >
Maritime Transportation Security Act (MTSA) > Policy. Owners and
operators of U.S.-flagged vessels that travel on international voyages
must contact their local COTP, cognizant District Commander or the
Office of Vessel Activities to acquire a copy of MARSEC Directive 104-6
(Rev 6). COTPs or cognizant District Commanders may provide this MARSEC
Directive to appropriate vessel owners and operators via mail or fax in
accordance with SSI handling procedures.
    Pursuant to 33 CFR 101.405, we consulted with the Department of
State, Office of the Secretary of Defense, Joint Chiefs of Staff,
Department of Transportation/Maritime Administration, Office of Naval
Intelligence, Department of Commerce, Department of Justice, Military
Sealift Command, Global Maritime Situational Awareness, Overseas
Security Advisory Council, United States Agency for International
Development, Naval Criminal Investigative Service, Customs and Border
Protection, Transportation Security Administration, U.S. Africa
Command, U.S. Central Command, and

U.S. Transportation Command prior to issuing these Directives.
    All MARSEC Directives issued pursuant to 33 CFR 101.405 are marked
as SSI in accordance with 49 CFR Part 1520. COTPs and District
Commanders will require individuals requesting a MARSEC Directive to
prove that they meet the standards for a ``covered person'' under 49
CFR 1520.7, have a ``need to know'' the information, as defined in 49
CFR 1520.11, and that they will safeguard the SSI in MARSEC Directive
104-6 (Rev 6) as required in 49 CFR 1520.9.

    Dated: January 20, 2012.
Paul F. Thomas, USCG,
Acting Director, Prevention Policy
[FR Doc. 2012-1908 Filed 1-27-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44874-44875]
[FR Doc No: 2018-19154]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1121; FRL-9983-20-OAR]

Proposed Information Collection Request; Comment Request;
Recordkeeping and Reporting Requirements for Diesel Fuels (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Recordkeeping and Reporting
Requirements for Diesel Fuels'' (EPA ICR No 1718.11, OMB Control No.
2060-0308) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. Before doing
so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This is a proposed
extension of the ICR, which is currently approved through March 31,
2019. An 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.

DATES: Comments must be submitted on or before November 5, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2007-1121, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Compliance
Division, Office of Transportation and Air Quality, 6405A,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: This ICR renewal is related to EPA's diesel fuel
regulations under 40 CFR part 80, Subpart I, applicable to highway
(motor vehicle) diesel fuel and non-road, locomotive and marine diesel
fuel (NRLM), Emission Control Area (ECA) marine fuel, and heating oil.
Most of the information collected under this ICR is used to evaluate
compliance with the requirements of the regulations. Motor vehicle
diesel fuel and just about all NRLM diesel fuel now meet a 15 part per
million sulfur standard. The activities associated with this ICR
include: registration (new refiners and importers, updates to existing
registrations); submission of corrections to prior compliance reports;
granting of research and development exemptions; generation and
retention of quality assurance records; general recordkeeping; batch
testing for sulfur content; and the production of product transfer
documents and pump labels.
    Form numbers: Only ECA0300 and DLQ001 are active. There may be
resubmissions of the others.

DSF0100 Form: Diesel Fuel Sulfur Credit Banking and Generation Report--
5900-334
DSF0200 Form: Diesel Fuel Sulfur Credit Transfer/conversion Report--
5900-333
ECA0300 Form: ECA Marine Fuel Precision Demonstration--5900-352
DSF0302 Form: Diesel Fuel Sulfur Facility Summary Report--5900-323
DSF0401 Form: Diesel Fuel Sulfur Batch Report--5900-324
DSF0504 Form: Designated and Track Handoff Report--5900-325
DSF0601 Form: Designate and Track Total Volume Report--5900-326
DSF0700 Form: Designate Track Facility Compliance Calculation Report--
5900-327
DSE0700 Form: Designate and Track Entity Compliance Calculation
Report--5900-328

DSE0900 Form: Motor Vehicle Diesel Sulfur Pre-Compliance Report--5900-
329
DSF0951 Form: NRLM Diesel Sulfur Pre-Compliance Report--5900-350
DLQ001 Form: (Used for lab test method)--EPA-420-B-14-066a

    Respondents/affected entities: Parties involved with diesel fuels.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 7,900 (total).
    Frequency of response: On occasion.
    Total estimated burden: 28,450 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $3,300,200 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: There is an increase of 17,372 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is due to burdens that were not
addressed in the current ICR, such as product transfer documents, the
testing of each batch of diesel fuel for sulfur content, and labels on
pumps that dispense hearing oil and certain offroad diesel fuels.

    Dated: August 23, 2018.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2018-19154 Filed 8-31-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44764-44765]
[FR Doc No: 2017-20514]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-257-000]

WBI Energy Transmission, Inc.; Notice of Availability of the
Environmental Assessment for the Proposed Valley Expansion Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the
Valley Expansion Project, proposed by WBI Energy Transmission, Inc.
(WBI Energy) in the above-referenced docket. WBI Energy requests
authorization to construct, operate, and maintain new natural gas
facilities in Clay County, Minnesota and Cass, Barnes, Stutsman, and
Burleigh Counties, North Dakota.
    The EA assesses the potential environmental effects of the
construction and operation of the Valley Expansion Project in
accordance with the requirements of the National Environmental Policy
Act (NEPA). The FERC staff concludes that approval of the proposed
project, with appropriate mitigating measures, would not constitute a
major federal action significantly affecting the quality of the human
environment.
    The proposed Valley Expansion Project includes the following
facilities:
     About 37.3 miles of 16-inch-diameter pipeline in Clay
County, Minnesota and Cass County, North Dakota;
     a new interconnect at the tie-in with the existing Viking
Gas Transmission Company Pipeline in Clay County, Minnesota;
     a new 3,000-horsepower compressor station to tie into WBI
Energy's existing Mapleton Town Border Station and Line Section No. 24
in Cass County, North Dakota;
     a new regulator station in Barnes County, North Dakota;
     replacement of the existing Jamestown Town Border Station
in Stutsman County, North Dakota; and
     replacement of the Apple Valley Town Border Station in
Burleigh County, North Dakota.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials; Native
American tribes; potentially affected landowners and other interested
individuals and groups; and newspapers and libraries in the project
area. In addition, the EA is available for public viewing on the FERC's
Web site (www.ferc.gov) using the eLibrary link. A limited number of
copies of the EA are available for distribution and public inspection
at: Federal Energy Regulatory Commission, Public Reference Room, 888
First Street NE., Room 2A, Washington, DC 20426<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this project, it is important
that we receive your comments in Washington, DC on or before October
20, 2017.
    For your convenience, there are three methods you can use to file
your comments with the Commission. In all instances, please reference
the project docket number (CP17-257-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on eRegister. You must select

the type of filing you are making. If you are filing a comment on a
particular project, please select ``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\1\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
---------------------------------------------------------------------------

    \1\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on General Search, and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP17-
257). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: September 20, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-20514 Filed 9-25-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 21 (Tuesday, February 1, 2022)]
[Notices]
[Pages 5548-5552]
[FR Doc No: 2022-01973]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94065; File No. SR-Phlx-2022-03]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Reduce Phlx's
Options Regulatory Fee

January 26, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 20, 2022, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Phlx's Pricing Schedule at Options
7, Section 6, Part D to reduce the Phlx Options Regulatory Fee or
``ORF''.
    While the changes proposed herein are effective upon filing, the
Exchange has designated the amendments become operative on February 1,
2022.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/

rulebook/phlx/rules, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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
    Phlx previously filed to waive its ORF from October 1, 2021 through
January 31, 2022.\3\ The Waiver Filing provided that Phlx would
continue monitoring the amount of revenue collected from the ORF to
determine if regulatory revenues would exceed regulatory costs when it
recommenced assessing ORF on February 1, 2022. If so, the Exchange
committed to adjust its ORF.\4\ At this time, after a review of its
regulatory revenues and regulatory costs, the Exchange proposes to
reduce the ORF from $0.0042 (the amount of the ORF prior to the waiver)
to $0.0034 per contract side as of February 1, 2022, to ensure that
revenue collected from the ORF, in combination with other regulatory
fees and fines, does not exceed the Exchange's total regulatory costs.
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    \3\ See Securities Exchange Act Release No. 92585 (August 5,
2021), 86 FR 44096 (August 11, 2021) (SR-Phlx-2021-39) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Amend
Phlx's Options Regulatory Fee) (``Waiver Filing'').
    \4\ Id. at 44098.
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    The options industry continues to experience high options trading
volumes and volatility. At this time, Phlx believes that the options
volume it experienced in the second half of 2021 is likely to persist
into 2022. The anticipated options volume would impact Phlx's ORF
collection which, in turn, has caused Phlx to propose reducing the ORF
to ensure that revenue collected from the ORF, in combination with
other regulatory fees and fines, would not exceed the Exchange's total
regulatory costs.
Collection of ORF
    Upon recommencement of the ORF on February 1, 2022,\5\ Phlx will
assess its ORF for each customer option transaction that is either: (1)
Executed by a member organization \6\ on Phlx; or (2) cleared by a Phlx
member organization at The Options Clearing Corporation (``OCC'') in
the customer range,\7\ even if the transaction was executed by a non-
member organization of Phlx, regardless of the exchange on which the
transaction occurs.\8\ If the OCC clearing member is a Phlx member
organization, ORF will be assessed and collected on all cleared
customer contracts (after adjustment for CMTA \9\); and (2) if the OCC
clearing member is not a Phlx member organization, ORF will be
collected only on the cleared customer contracts executed at Phlx,
taking into account any CMTA instructions which may result in
collecting the ORF from a non-member organization.\10\
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    \5\ Prior to the Waiver Filing, the Exchange similarly collected
ORF as described herein.
    \6\ The term ``member organization'' means a corporation,
partnership (general or limited), limited liability partnership,
limited liability company, business trust or similar organization,
transacting business as a broker or a dealer in securities and which
has the status of a member organization by virtue of (i) admission
to membership given to it by the Membership Department pursuant to
the provisions of General 3, Sections 5 and 10 or the By-Laws or
(ii) the transitional rules adopted by the Exchange pursuant to
Section 6-4 of the By-Laws. References herein to officer or partner,
when used in the context of a member organization, shall include any
person holding a similar position in any organization other than a
corporation or partnership that has the status of a member
organization. See General 1, Section 1(17).
    \7\ Participants must record the appropriate account origin code
on all orders at the time of entry of the order. The Exchange
represents that it has surveillances in place to verify that member
organizations mark orders with the correct account origin code.
    \8\ The Exchange uses reports from OCC when assessing and
collecting the ORF.
    \9\ CMTA or Clearing Member Trade Assignment is a form of
``give-up'' whereby the position will be assigned to a specific
clearing firm at OCC.
    \10\ By way of example, if Broker A, a Phlx member organization,
routes a customer order to CBOE and the transaction executes on CBOE
and clears in Broker A's OCC Clearing account, ORF will be collected
by Phlx from Broker A's clearing account at OCC via direct debit.
While this transaction was executed on a market other than Phlx, it
was cleared by a Phlx member organization in the member
organization's OCC clearing account in the customer range, therefore
there is a regulatory nexus between Phlx and the transaction. If
Broker A was not a Phlx member organization, then no ORF should be
assessed and collected because there is no nexus; the transaction
did not execute on Phlx nor was it cleared by a Phlx member
organization.
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    In the case where a member organization both executes a transaction
and clears the transaction, the ORF will be assessed to and collected
from that member organization. In the case where a member organization
executes a transaction and a different member organization clears the
transaction, the ORF will be assessed to and collected from the member
organization who clears the transaction and not the member organization
who executes the transaction. In the case where a non-member
organization executes a transaction at an away market and a member
organization clears the transaction, the ORF will be assessed to and
collected from the member organization who clears the transaction. In
the case where a member executes a transaction on Phlx and a non-member
organization clears the transaction, the ORF will be assessed to the
member organization that executed the transaction on Phlx and collected
from the non-member organization who cleared the transaction. In the
case where a member organization executes a transaction at an away
market and a non-member organization clears the transaction, the ORF
will not be assessed to the member organization who executed the
transaction or collected from the non-member organization who cleared
the transaction because the Exchange does not have access to the data
to make absolutely certain that ORF should apply. Further, the data
does not allow the Exchange to identify the member organization
executing the trade at an away market.
ORF Revenue and Monitoring of ORF
    The Exchange monitors the amount of revenue collected from the ORF
to ensure that it, in combination with other regulatory fees and fines,
does not exceed regulatory costs. In determining whether an expense is
considered a regulatory cost, the Exchange reviews all costs and makes
determinations if there is a nexus between the expense and a regulatory
function. The Exchange notes that fines collected by the Exchange in
connection with a disciplinary matter offset ORF.
    Revenue generated from ORF, when combined with all of the
Exchange's other regulatory fees and fines, is designed to recover a
material portion of the regulatory costs to the Exchange of the
supervision and regulation of member \11\ and member organization
customer options business including

performing routine surveillances, investigations, examinations,
financial monitoring, and policy, rulemaking, interpretive, and
enforcement activities. Regulatory costs include direct regulatory
expenses and certain indirect expenses in support of the regulatory
function. The direct expenses include in-house and third-party service
provider costs to support the day-to-day regulatory work such as
surveillances, investigations and examinations. The indirect expenses
include support from such areas as Office of the General Counsel,
technology, and internal audit. Indirect expenses were approximately
38% of the total regulatory costs for 2021. Thus, direct expenses were
approximately 62% of total regulatory costs for 2021.\12\
---------------------------------------------------------------------------

    \11\ The term ``member'' means a permit holder which has not
been terminated in accordance with the By-Laws and these Rules of
the Exchange. A member is a natural person and must be a person
associated with a member organization. Any references in the rules
of the Exchange to the rights or obligations of an associated person
or person associated with a member organization also includes a
member. See General 1, Section 1(16).
    \12\ The Exchange will set a 2022 Regulatory Budget in the first
quarter of 2022.
---------------------------------------------------------------------------

    The ORF is designed to recover a material portion of the costs to
the Exchange of the supervision and regulation of its members and
member organizations, including performing routine surveillances,
investigations, examinations, financial monitoring, and policy,
rulemaking, interpretive, and enforcement activities.
Proposal
    Based on the Exchange's most recent review, the Exchange is
proposing to reduce the amount of ORF that will be collected by the
Exchange from $0.0042 per contract side to $0.0034 per contract side.
The Exchange issued an Options Trader Alert on December 31, 2021
indicating the proposed rate change for February 1, 2022.\13\
---------------------------------------------------------------------------

    \13\ See Options Trader Alert 2021-63.
---------------------------------------------------------------------------

    The proposed reduction is based on a sustained high level of
options volume in 2021. The below table displays average daily volume
for 2021.\14\
---------------------------------------------------------------------------

    \14\ The OCC data from December 2021 numbers reflect only 13
trading days as this information is through December 17, 2021.
Volume data in the table represents numbers of contracts; each
contract has two sides.
[GRAPHIC] [TIFF OMITTED] TN01FE22.000

    To date, fourth quarter options average daily volume in 2021 has
been higher than options average daily volume in any of the prior three
quarters of 2021. With respect to customer options volume across the
industry, total customer options contract average daily volume, to
date, in 2021 is 36,565,398 as compared to total customer options
contract average daily volume in 2020 which was 27,002,511.\15\
---------------------------------------------------------------------------

    \15\ See data from OCC at: https://www.theocc.com/Market-Data/Market-Data-Reports/Volume-and-Open-Interest/Volume-by-Account-Type.
---------------------------------------------------------------------------

    There can be no assurance that the Exchange's costs for 2022 will
not differ materially from these expectations and prior practice, nor
can the Exchange predict with certainty whether options volume will
remain at the current level going forward. The Exchange notes however,
that when combined with regulatory fees and fines, the revenue that may
be generated utilizing an ORF rate of $0.0042 per contract side may
result in revenue which exceeds the Exchange's estimated regulatory
costs for 2022 if options volume persists. In 2021, options volume
remained high, due in large part to the extreme volatility in the
marketplace as a result of the COVID-19 pandemic. The Exchange
therefore proposes to reduce its ORF to $0.0034 per contract side to
ensure that revenue does not exceed the Exchange's estimated regulatory
costs in 2022. Particularly, the Exchange believes that reducing the
ORF when combined with all of the Exchange's other regulatory fees and
fines, would allow the Exchange to continue covering a material portion
of its regulatory costs, while lessening the potential for generating
excess revenue that may otherwise occur using the rate of $0.0042 per
contract side.\16\
---------------------------------------------------------------------------

    \16\ The Exchange notes that its regulatory responsibilities
with respect to member and member organization compliance with
options sales practice rules have largely been allocated to FINRA
under a 17d-2 agreement. The ORF is not designed to cover the cost
of that options sales practice regulation.
---------------------------------------------------------------------------

    The Exchange will continue to monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed regulatory costs. If the
Exchange determines regulatory revenues exceed regulatory costs, the
Exchange will adjust the ORF by submitting a fee change filing to the
Commission and notifying \17\ its members and member organizations via
an Options Trader Alert.\18\
---------------------------------------------------------------------------

    \17\ The Exchange will provide members and member organizations
with such notice at least 30 calendar days prior to the effective
date of the change.
    \18\ The Exchange notes that in connection with this proposal,
it provided the Commission confidential details regarding the
Exchange's projected regulatory revenue, including projected revenue
from ORF, along with a projected regulatory expenses.
---------------------------------------------------------------------------

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.\19\ Specifically, the
Exchange believes the proposed rule change is consistent with Section
6(b)(4) of the Act \20\, which provides that Exchange rules may provide
for the equitable allocation of reasonable dues, fees, and other
charges among its

members, member organizations, and other persons using its facilities.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \21\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(4).
    \21\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed fee change is reasonable because
customer transactions will be subject to a lower ORF fee than the rate
that would otherwise be in effect on February 1, 2022. Moreover, the
proposed reduction is necessary for the Exchange to avoid collecting
revenue, in combination with other regulatory fees and fines, that
would be in excess of its anticipated regulatory costs which is
consistent with the Exchange's practices.
    The Exchange had designed the ORF to generate revenues that would
be less than the amount of the Exchange's regulatory costs to ensure
that it, in combination with its other regulatory fees and fines, does
not exceed regulatory costs, which is consistent with the view of the
Commission that regulatory fees be used for regulatory purposes and not
to support the Exchange's business operations. As discussed above,
however, after review of its regulatory costs and regulatory revenues,
which includes revenues from ORF and other regulatory fees and fines,
the Exchange determined that absent a reduction in ORF, it may collect
revenue which would exceed its regulatory costs. Indeed, the Exchange
notes that when taking into account the potential that recent options
volume persists, it estimates the ORF may generate revenues that would
cover more than the approximated Exchange's projected regulatory costs.
As such, the Exchange believes it's reasonable and appropriate to
reduce the ORF amount from $0.0042 to $0.0034 per contract side.
    The Exchange also believes the proposed fee change is equitable and
not unfairly discriminatory in that it is charged to all member
organizations on all their transactions that clear in the customer
range at OCC.\22\ The Exchange believes the ORF ensures fairness by
assessing higher fees to those member organizations that require more
Exchange regulatory services based on the amount of customer options
business they conduct. Regulating customer trading activity is much
more labor intensive and requires greater expenditure of human and
technical resources than regulating non-customer trading activity,
which tends to be more automated and less labor-intensive. For example,
there are costs associated with main office and branch office
examinations (e.g., staff expenses), as well as investigations into
customer complaints and the terminations of registered persons. As a
result, the costs associated with administering the customer component
of the Exchange's overall regulatory program are materially higher than
the costs associated with administering the non-customer component
(e.g., member and member organization proprietary transactions) of its
regulatory program. Moreover, the Exchange notes that it has broad
regulatory responsibilities with respect to activities of its members
and member organizations, irrespective of where their transactions take
place. Many of the Exchange's surveillance programs for customer
trading activity may require the Exchange to look at activity across
all markets, such as reviews related to position limit violations and
manipulation. Indeed, the Exchange cannot effectively review for such
conduct without looking at and evaluating activity regardless of where
it transpires. In addition to its own surveillance programs, the
Exchange also works with other SROs and exchanges on intermarket
surveillance related issues. Through its participation in the
Intermarket Surveillance Group (``ISG'') \23\ the Exchange shares
information and coordinates inquiries and investigations with other
exchanges designed to address potential intermarket manipulation and
trading abuses. Accordingly, there is a strong nexus between the ORF
and the Exchange's regulatory activities with respect to customer
trading activity of its members and member organizations.
---------------------------------------------------------------------------

    \22\ If the OCC clearing member is a Phlx member organization,
ORF will be assessed and collected on all cleared customer contracts
(after adjustment for CMTA); and (2) if the OCC clearing member is
not a Phlx member organization, ORF will be collected only on the
cleared customer contracts executed at Phlx, taking into account any
CMTA instructions which may result in collecting the ORF from a non-
member organization.
    \23\ ISG is an industry organization formed in 1983 to
coordinate intermarket surveillance among the SROs by cooperatively
sharing regulatory information pursuant to a written agreement
between the parties. The goal of the ISG's information sharing is to
coordinate regulatory efforts to address potential intermarket
trading abuses and manipulations.
---------------------------------------------------------------------------

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 not necessary or appropriate in
furtherance of the purposes of the Act. This proposal does not create
an unnecessary or inappropriate intra-market burden on competition
because the ORF applies to all customer activity, thereby raising
regulatory revenue to offset regulatory expenses. It also supplements
the regulatory revenue derived from non-customer activity. The Exchange
notes, however, the proposed change is not designed to address any
competitive issues. Indeed, this proposal does not create an
unnecessary or inappropriate inter-market burden on competition because
it is a regulatory fee that supports regulation in furtherance of the
purposes of the Act. The Exchange is obligated to ensure that the
amount of regulatory revenue collected from the ORF, in combination
with its other regulatory fees and fines, does not exceed regulatory
costs.

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

    No written comments were either solicited or received.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \24\ of the Act and subparagraph (f)(2) of Rule
19b-4 \25\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78s(b)(3)(A).
    \25\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \26\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File No. SR-Phlx-2022-03 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-Phlx-2022-03. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File No. SR-Phlx-2022-03, and should be submitted on or
before February 22, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-01973 Filed 1-31-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Page 10138]
[FR Doc No: 2015-03838]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2014-0031; OMB No. 1660-0069]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; National Fire Incident Reporting System
(NFIRS) v5.0

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before March 27, 2015.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Room 7NE, Washington, DC
20472, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 10, 2014, FEMA published in the
Federal Register at 79 FR 64610 a 60 day Federal Register notice
requesting comment on FEMA's proposed revision to the National Fire
Incident Reporting System (NFIRS) v5.0 informaton collection. FEMA
subsquently received 8 comments providing positive and constructive
feedback regarding the information collected by NFIRS. The cost and
hour burden of the NFIRS to users was not addressed directly in any of
the comments received. All comments received regarding the content of
information collected, the suggested combination of the NFIRS with
other data collection systems, the suggested enhancements to the user
interface experience of some specific systems (which would impact
average time burden in reporting), the suggested ``mandatory
reporting'' by all fire agencies (including Wildland), and the
capability for fire departments to review other fire department and
regional fire incident data were provided to the program office for
their consideration when updating or modifiying the NFIRS.

Collection of Information

    Title: National Fire Incident Reporting System (NFIRS) v5.0.
    Type of information collection: Revision of a currently approved
information collection.
    Form Titles and Numbers: FEMA Form The National Fire Incident
Reporting System (NFIRS) v5.0.
    Abstract: NFIRS was established in 1975 by the USFA as a
cooperative effort of local, State, and Federal authorities to improve
uniformity in fire incident reporting and to ensure that data are
useable for fire protection planning and management. The program
provides a well-established mechanism, using standardized reporting
methods, to collect and analyze fire incident data at the Federal,
State, and local levels with a myriad of life and property saving uses
and benefits.
    Affected Public: State, Local or Tribal, and Federal Governments.
    Estimated Number of Respondents: 23,856. The number of respondents
has increased by 856 since FEMA published the 60 day Federal Register
notice on October 30, 2014 because of a clerical error.
    Estimated Total Annual Burden Hours: 13,500,230. The annual burden
hours decreased by 204,670 hours from the previous inventory due to
discontinuation of use of NFIRS paper forms and a small decrease in the
number of students receiving the NFIRS Program Management Training and
Orientation.
    Estimated Cost: The estimated annual operations and maintenance
costs to respondents or record keepers resulting from the collection of
information is $13,915,000. The estimated annual cost to the Federal
Government is $2,416,255.

    Dated: February 5, 2015.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2015-03838 Filed 2-24-15; 8:45 am]
BILLING CODE 9111-76-P


[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55723-55726]
[FR Doc No: 2018-24321]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3758]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Individual Patient Expanded Access Applications: Form
FDA 3926

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on individual patient expanded
access applications.

DATES: Submit either electronic or written comments on the collection
of information by January 7, 2019.

ADDRESSES: 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 January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 7, 2019. 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-2018-N-3758 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry on
Individual Patient Expanded Access Applications: Form FDA 3926.''
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.gpo.gov/fdsys/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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Individual Patient Expanded Access
Applications: Form FDA 3926

OMB Control Number 0910-0814--Extension

    This information collection supports Agency regulations, associated
guidance, and Form FDA 3926 concerning individual patient expanded
access. Individual patient expanded access allows an individual patient
who has a serious or immediately life-threatening disease or condition
and there is no comparable or satisfactory alternative therapy to
diagnose, monitor, or treat the disease or condition, the use of an
investigational new drug (IND) outside of a clinical investigation, or
the use of an approved drug where availability is limited by a risk
evaluation and mitigation strategy. When applicable criteria in Sec.
312.305(a) (21 CFR 312.305(a)) (which apply to all types of expanded
access) and the criteria in Sec.  312.310(a) (21 CFR 312.310(a)) (which
apply specifically to individual patient expanded access, including for
emergency use) are met, FDA may permit expanded access.
    Section 312.305(b) sets forth the submission requirements for all
types of expanded access requests. To assist respondents with
requirements in Sec.  312.305 we developed Form FDA 3926 (Individual
Patient Expanded Access Investigational New Drug Application) and the
guidance document entitled, ``Individual Patient Expanded Access
Applications: Form FDA 3926.''
    The physician may satisfy some of the submission requirements by
referring to information in an existing IND, ordinarily the one held by
the investigational drug's manufacturer, if the physician obtains
permission from that IND holder. If permission is obtained, the
physician should then provide to FDA a letter of authorization (LOA)
from the existing IND holder that permits FDA to reference that IND.
    One of the requirements under Sec.  312.305(b)(2) is that a ``cover
sheet'' must be included ``meeting the requirements of Sec.
312.23(a).'' This provision applies to several types of submissions
under part 312 (21 CFR part 312), ranging from commercial INDs under
Sec.  312.23 that involve large groups of patients enrolled in clinical
trials to requests from physicians to use an investigational drug for
an individual

patient. Sponsors currently use Form FDA 1571 for all types of IND
submissions to meet the requirements in Sec.  312.23(a).
    Concerned that physicians requesting expanded access for an
individual patient may encounter difficulty in completing Form FDA 1571
and the associated documents because the form is not tailored to
requests for individual patient expanded access, we developed Form FDA
3926 to comply with the IND submission requirements in Sec. Sec.
312.23, 312.305(b), and 312.310(b). Form FDA 3926 provides a
streamlined means to request expanded access and is available for
licensed physicians. FDA considers a completed Form FDA 3926 with the
box in Field 10 checked and the form signed by the physician to be a
request in accordance with Sec.  312.10 for a waiver of any additional
requirements in part 312 for an IND submission, including additional
information currently provided in Form FDA 1571 and Form FDA 1572
(Statement of Investigator, which provides the identity and
qualifications of the investigator conducting the clinical
investigation).
    Under Sec.  312.310(d), in an emergency situation that requires the
patient to be treated before a written submission can be made, the
request to use the investigational drug for individual patient expanded
access may be made by telephone (or other rapid means of communication)
to the appropriate FDA review division. Authorization of the emergency
use may be given by an FDA official over the telephone, provided the
physician explains how the expanded access use will meet the
requirements of Sec. Sec.  312.305 and 312.310 and agrees to submit an
expanded access application within 15 working days of FDA's initial
authorization of the expanded access use (Sec.  312.310(d)). The
physician may choose to use Form FDA 3926 for the expanded access
application.
    As explained in the instructions for Form FDA 3926 and discussed in
the guidance document, the following information is submitted to FDA:
     Initials for the patient and date of submission.
     Type of submission (initial or follow-up submission).
     Clinical information, including indication, brief clinical
history of the patient (age, gender, weight, allergies, diagnosis,
prior therapy, response to prior therapy), and the reason for
requesting the proposed treatment, including an explanation of why the
patient lacks other therapeutic options.
     Treatment information, including the investigational
drug's name and the name of the entity supplying the drug (generally
the manufacturer), the applicable FDA review division (if known), and
the treatment plan. This should include the planned dose, route and
schedule of administration, planned duration of treatment, monitoring
procedures, and planned modifications to the treatment plan in the
event of toxicity.
     LOA, generally obtained from the entity that is the
sponsor of the IND (e.g., commercial sponsor/drug manufacturer) being
referenced, if applicable.
     Physician's qualification statement. An appropriate
statement includes medical school attended, year of graduation, medical
specialty, State medical license number, current employment, and job
title. Alternatively, the relevant portion of the physician's
curriculum vitae may be attached.
     Physician's contact information, including name, physical
address, email address, telephone number, facsimile number, and
physician's IND number, if previously issued by FDA.
     Contents of submission (for follow-up/additional
submissions), including the type of submission being made. FDA accepts
Form FDA 3926 for certain follow-up/additional submissions, which
include the following: Initial Written IND Safety Report (Sec.
312.32(c)); Followup to a Written IND Safety Report (Sec.  312.32(d));
Annual Report (Sec.  312.33); Summary of Expanded Access Use (treatment
completed) (Sec.  312.310(c)(2)); Change in Treatment Plan (Sec.
312.30); General Correspondence or Response to FDA Request for
Information (Sec.  312.41); and Response to Clinical Hold (Sec.
312.42(e)).
     Request for authorization to use Form FDA 3926 for
individual patient expanded access application.
     Signature of the physician certifying that treatment will
not begin until 30 days after FDA receives the completed application
and all required material unless the submitting physician receives
earlier notification from FDA that the treatment may proceed. The
physician agrees not to begin or continue clinical investigations
covered by the IND if those studies are placed on clinical hold. The
physician also certifies that informed consent will be obtained in
compliance with Federal requirements (including FDA's regulations in 21
CFR part 50) and that an institutional review board (IRB) that complies
with all Federal requirements (including FDA's regulations in 21 CFR
part 56) will be responsible for initial and continuing review and
approval of the expanded access use. The physician also acknowledges
that in the case of an emergency request, treatment may begin without
prior IRB approval, provided the IRB is notified of the emergency
treatment within 5 working days of treatment. The physician agrees to
conduct the investigation in accordance with all other applicable
regulatory requirements.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
   Guidance on Individual Patient  Expanded       Number of     responses per   Total annual         Average  burden per  response          Total hours
     Access  Applications: Form FDA 3926         respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expanded access submission elements included              790            3.03           2,394  0.75 (45 mins.)..........................           1,795
 in Form FDA 3926.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection, we are retaining
the currently approved burden estimate. The estimates for ``number of
respondents,'' ``number of responses per respondent,'' and ``total
annual responses'' were obtained from reports and data management
systems from the Center for Drug Evaluation and Research (CDER) and
from other sources familiar with the number of submissions received for
individual patient expanded access use under part 312. The estimates
for ``average burden per response'' were based on information CDER
provided and personnel of the U.S. Department of Health and Human
Services familiar with preparing and reviewing expanded access
submissions by practicing physicians.

    Based on data from the Document Archiving, Reporting and Regulatory
Tracking System for the number of submissions to FDA using FDA Form
3926 during fiscal years 2015, 2016, and 2017, we estimate that
approximately 790 licensed physicians would use FDA Form 3926 to submit
1.46 requests per physician (respondent) for individual patient
expanded access, for a total of 1,153 responses annually. Based on
these estimates, FDA calculates the total annual responses to be 2,394
(1,153 requests for individual patient expanded access and 1,241
follow-up submissions) by 790 physicians for an average of 3.03
responses per respondent. FDA estimates the average burden per response
to be 45 minutes (0.75 hour). Based on this estimate, FDA calculates
the total burden to be 1,795 hours.

    Dated: October 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24321 Filed 11-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 73 (Friday, April 15, 2022)]
[Notices]
[Pages 22619-22620]
[FR Doc No: 2022-08132]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2010-0032]

Metro-North Commuter Railroad's Request To Amend Its Positive
Train Control Safety Plan and Positive Train Control System

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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

SUMMARY: This document provides the public with notice that, on April
4, 2022, Metro-North Commuter Railroad (MNR) submitted a request for
amendment (RFA) to its FRA-approved Positive Train Control Safety Plan
(PTCSP). As this RFA may involve a request for FRA's approval of
proposed material modifications to an FRA-certified positive train
control (PTC) system, FRA is publishing this notice and inviting public
comment on the railroad's RFA to its PTCSP.

DATES: FRA will consider comments received by May 5, 2022. FRA may
consider comments received after that date to the extent practicable
and without delaying implementation of valuable or necessary
modifications to a PTC system.

ADDRESSES:
    Comments: Comments may be submitted by going to https://www.regulations.gov and following the online instructions for
submitting comments.
    Instructions: All submissions must include the agency name and the
applicable docket number. The relevant PTC docket number for this host
railroad is Docket No. FRA-2010-0032. For convenience, all active PTC
dockets are hyperlinked on FRA's website at https://railroads.dot.gov/train-control/ptc/ptc-annual-and-quarterly-reports. All comments
received will be posted without change to https://www.regulations.gov;
this includes any personal information.

FOR FURTHER INFORMATION CONTACT: Gabe Neal, Staff Director, Signal,
Train Control, and Crossings Division, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: In general, Title 49 United States Code
(U.S.C.) section 20157(h) requires FRA to certify that a host
railroad's PTC system complies with 49 CFR part 236, subpart I, before
the technology may be operated in revenue service. Before making
certain changes to an FRA-certified PTC system or the associated FRA-
approved PTCSP, a host railroad must submit, and obtain FRA's approval
of, an RFA to its PTCSP under Title 49 Code of Federal Regulations
(CFR) Section 236.1021.
    Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will
publish a notice in the Federal Register and invite public comment in
accordance with 49 CFR part 211, if an RFA includes a request for
approval of a material modification of a signal and train control
system. Accordingly, this notice informs the public that, on April 4,
2022, MNR submitted an RFA to its PTCSP for its Advanced Civil Speed
Enforcement System II (ACSES II) and that RFA is available in Docket
No. FRA-2010-0032.
    Interested parties are invited to comment on MNR's RFA to its PTCSP
by submitting written comments or data. During FRA's review of this
railroad's RFA, FRA will consider any comments or data submitted within
the timeline specified in this notice and to the extent practicable,
without delaying implementation of valuable or necessary modifications
to a PTC system. See 49 CFR 236.1021; see also 49 CFR 236.1011(e).
Under 49 CFR 236.1021, FRA maintains the authority to approve, approve
with conditions, or deny a

railroad's RFA to its PTCSP at FRA's sole discretion.

Privacy Act Notice

    In accordance with 49 CFR 211.3, FRA solicits comments from the
public to better inform its decisions. DOT posts these comments,
without edit, including any personal information the commenter
provides, to https://www.regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov. To facilitate
comment tracking, we encourage commenters to provide their name, or the
name of their organization; however, submission of names is completely
optional. If you wish to provide comments containing proprietary or
confidential information, please contact FRA for alternate submission
instructions.

    Issued in Washington, DC.
Carolyn R. Hayward-Williams,
Director, Office of Railroad Systems and Technology.
[FR Doc. 2022-08132 Filed 4-14-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Notices]
[Page 49631]
[FR Doc No: 2022-17217]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34665; File No. 812-15320]

MSD Investment Corp., et al.

August 5, 2022.
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice.

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

    Notice of application for an order (``Order'') under sections 17(d)
and 57(i) of the Investment Company Act of 1940 (the ``Act'') and rule
17d-1 under the Act to permit certain joint transactions otherwise
prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1
under the Act.

Summary of Application:  Applicants request an order to amend a
previous order granted by the Commission that permits certain business
development companies (``BDCs'') and closed-end management investment
companies to co-invest in portfolio companies with each other and with
certain affiliated investment entities.

Applicants:  MSD Investment Corp., MSD Partners, L.P., MSD Credit
Opportunity Master Fund, L.P., MSD Credit Opportunity Master Fund II,
L.P., MSD Credit Opportunity Fund, L.P., MSD Credit Opportunity Fund
(Cayman), L.P., MSD Credit Opportunity Fund, Ltd., MSD Debt REIT
Holdings, L.P., MSDC EIV, LLC, MSD EIV Private, LLC, MSD RCOF TRS, LLC,
MSD RCOF TRS (Cayman) LTD., MSD Real Estate Credit Opportunity Fund
L.P., MSD Real Estate Credit Opportunity Fund-C L.P., RCOF-C
Intermediate (Cayman), L.P., RCOF-C Intermediate, L.P., MSD Special
Investments Fund, L.P., MSD SIF Holdings, L.P., MSD Special Investments
Fund (Cayman), L.P., MSD SIF (Cayman), L.P., MSD Alpine Credit
Opportunity Fund, LP, MSD SBAFLA Fund, L.P., MSD UK Holdings Limited,
MSD UK Holdings Ltd, MSD UK Aggregator Fund, LLC, MSD PCOF SMA 1, LLC,
MSD PCOF SMA 2, LLC, MSD RCOF SMA 1, LLC, MSD RCOF SMA 2, LLC, MSD
Private Credit Opportunity Master (ECI) Fund 2, L.P., MSD Private
Credit Opportunity Master Fund 2, L.P., MSD Private Credit Opportunity
Fund 2, L.P., MSD Private Credit Opportunity Fund (Cayman) 2, L.P., MSD
Private Credit Opportunity Fund (Cayman) II, L.P., Intermediate Fund
PCOF 2, LLC, MSD PCOF Fund 2, Ltd, Onshore Intermediate Fund PCOF 2,
LLC, MSD Onshore PCOF Fund 2, Ltd, MSD Private Credit Opportunity
Master (ECI) Fund, L.P., MSD Private Credit Opportunity Master (ECI)
Fund II, L.P., MSD Private Credit Opportunity Master Fund, L.P., MSD
Private Credit Opportunity Fund, L.P., MSD Private Credit Opportunity
Fund (Cayman), L.P., MSD Private Credit Opportunity Fund II, L.P., MSD
BDC SPV I, LLC, MSD Real Estate Credit Opportunity Fund II-C, L.P., MSD
Real Estate Credit Opportunity Fund II, L.P., MSD Credit REIT Holdings
II, L.P., MSD Special Investments Fund (Cayman) II, L.P., and MSD
Special Investments Fund II, L.P.

Filing Dates:  The application was filed on April 14, 2022, and amended
on July 8, 2022.

Hearing or Notification of Hearing:  An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the SEC's Secretary at [email protected] and serving the
Applicants with a copy of the request by email, if an email address is
listed for the relevant Applicant below, or personally or by mail, if a
physical address is listed for the relevant Applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on, August
30, 2022, and should be accompanied by proof of service on applicants,
in the form of an affidavit or, for lawyers, a certificate of service.
Pursuant to rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary at
[email protected].

ADDRESSES: The Commission: [email protected]. Applicants:
Robert Simonds, MSD Partners, L.P., at [email protected], and
Steven B. Boehm, Esq., Anne G. Oberndorf, Esq., and Payam Siadatpour,
Esq., Eversheds Sutherland (US) LLP, at [email protected].

FOR FURTHER INFORMATION CONTACT: Kieran G. Brown, Senior Counsel, or
Terri Jordan, Branch Chief, at<PHONE_NUMBER> (Division of Investment
Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal
analysis, and conditions, please refer to Applicants' first amended and
restated application, dated July 8, 2022, which may be obtained via the
Commission's website by searching for the file number at the top of
this document, or for an Applicant using the Company name search field,
on the SEC's EDGAR system. The SEC's EDGAR system may be searched at,
http://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may
also call the SEC's Public Reference Room at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-17217 Filed 8-10-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 17, 2010 (Volume 75, Number 94)]
[Notices]
[Page 27616-27617]
[DOCID:fr17my10-114]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2009-0322]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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

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

DATES: Effective date: The exemptions are effective May 17, 2010.
Expiration date: The exemptions expire on Thursday, May 17, 2012.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<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:

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 complete Privacy Act Statement in the
Federal Register (65 FR 19477, Apr. 11, 2000). This statement is also
available at http://www.regulations.gov.

Background

    On March 22, 2010, FMCSA published a Notice of receipt of Federal
diabetes exemption applications from fifty-three individuals and
requested comments from the public (75 FR 13647). The public comment
period closed on April 21, 2010, and one comment was received.
    FMCSA has evaluated the eligibility of the fifty-three 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).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current standard for diabetes in 1970
because several risk studies indicated that diabetic drivers 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 fifty-three applicants have had ITDM over a range of 1 to 53
years. These applicants report no

hypoglycemic reaction that resulted in loss of consciousness or
seizure, that required the assistance of another person, or resulted in
impaired cognitive function without warning symptoms in the past 5
years (with one year of stability following any such episode). In each
case, an endocrinologist has verified that the driver has demonstrated
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 standard at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the March 22, 2010 Federal Register
Notice, and they will not be repeated in this Notice.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard 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 standard in 49 CFR 391.41(b)(3) is likely
to achieve a level of safety equal to that existing without the
exemption.

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.

Discussion of Comments

    FMCSA received one comment in this proceeding. The comment was
considered and discussed below.
    The Pennsylvania Department of Transportation stated that it had
reviewed the driving records for Dale J. Cleaver, Edgar R. Pole and
Wayne F. Richards and was in favor of granting a Federal diabetes
exemption to each of these individuals.

Conclusion

    Based upon its evaluation of the fifty-three exemption
applications, FMCSA exempts Deanna R. Alvarado, Howard H. Armstrong,
Samuel D. Bentle, Mark S. Boettcher, Steven C. Boudreau, Charles
Boulware, Jr., Roy L. Brokaw, Chris D. Chambers, Charles A. Cinert,
Sr., John D. Clark, IV, Dale J. Cleaver, James H. Collins, William A.
Donais, Lance L. Fuller, Johnny Gardner, Jr., Gregory S. Ghent, Mark D.
Golden, Nathaniel W. Gorham, Younge W. Hooper, Eugene H. Johannes,
Reginald K. Johnson, Sheldon R. Koehn, David L. Kreitzer, Jason R.
Kropp, Joseph A. Laperle, David W. Letto, Robert D. Marquart, Francis
E. Martinez, Stephen A. Miles, Raymond A. Montoya, Adolfo Moreno, Jr.,
Chad D. Morrison, Kevin R. Murphy, Kenneth S. Napieralski, Lowell G.
Neumann, John T. Oliver, Jr., Steven G. Petersen, Edgar R. Polk, Damian
J. Porter, Robert W. Prabucki, Edward R. Ramm, Wayne F. Richards,
George H. Rollins, Jo Ellen Roshak, Gary G. Sironen, Rodney L.
Stoltenberg, David Switala, Stanley C. Tarvidas, Jim D. Thomas,
Florence E. Thompson, Joshua C. Thompson, Phillip M. Vinson and Camella
C. Wilkins from the ITDM standard in 49 CFR 391.41(b)(3), subject to
the conditions listed under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if: (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: May 5, 2010.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. 2010-11706 Filed 5-14-10; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: September 27, 2010 (Volume 75, Number 186)]
[Notices]
[Page 59300-59301]
[DOCID:fr27se10-138]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62953; File No. SR-FINRA-2010-049]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change Relating to
Quotation Requirements on the Alternative Display Facility

September 20, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 17, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. 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.
---------------------------------------------------------------------------

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

    FINRA is proposing to amend FINRA Rule 6272 to enhance quotation
requirements on the Alternative Display Facility (``ADF'').
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, 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, FINRA 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. FINRA 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
    In 2002, FINRA created the ADF to ensure that any FINRA member,
including alternative trading systems, seeking to display quotations
for NMS stocks in the over-the-counter (``OTC'') market, rather than
through an exchange platform, has an alternative venue through which to
post its OTC quotations and report trades.\3\
---------------------------------------------------------------------------

    \3\ Initially, the ADF was limited to quotations and trade
reports in Nasdaq securities. See Securities Exchange Act Release
No. 46249 (July 24, 2002), 67 FR 49822 (July 31, 2002). In 2006, the
ADF was expanded to include all NMS stocks. See Securities Exchange
Act Release No. 54537 (September 28, 2006), 71 FR 59173 (October 6,
2006).
---------------------------------------------------------------------------

    FINRA and numerous exchanges are filing proposed rule changes to
enhance the minimum quotation requirements for market makers by
requiring market makers for each stock in which they are registered to
continuously maintain two-sided quotations within a designated
percentage of the National Best Bid and National Best Offer (or if
there is not a National Best Bid or Offer, the last reported sale).
These proposed rule changes are intended to eliminate trade executions
against market maker ``placeholder'' quotations that are priced far
away from the inside market, commonly known as ``stub quotes.'' Under
these proposed rules, limitations on permissible quotations are
determined by the individual character of the security, the time of day
in which the quote is entered, and any applicable stock trading pause
triggers.
    In order to ensure consistency in quotation requirements across
markets, FINRA is proposing to amend Rule 6272 to impose the same
limitations on a Registered Reporting ADF Market Maker's quotations on
the ADF that will apply to market makers on national securities
exchanges. The proposed rule change would thus require all Registered
Reporting ADF Market Makers to have systems in place to ensure that any
quotations displayed on the ADF met the requirements of Rule 6272.
    FINRA will announce the implementation date on its Web site.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\4\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change will
ensure consistent treatment of quotations across markets and could
prevent the execution of numerous transactions at

stub quote prices, such as those on May 6, 2010.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2010-049 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2010-049. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. 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 publicly available. All
submissions should refer to File Number SR-FINRA-2010-049 and should be
submitted on or before October 18, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-24057 Filed 9-24-10; 8:45 am]
BILLING CODE 8010-01-P