[Federal Register Volume 77, Number 32 (Thursday, February 16, 2012)]
[Notices]
[Page 9229]
[FR Doc No: 2012-3631]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13-023]

Green Island Power Authority; Notice of Meeting and
Teleconference

    a. Date and Time of Meeting: Wednesday March 21, 2012, beginning at
10 a.m. EST.
    b. Place: Commission Headquarters, 888 First Street NE.,
Washington, DC 20426, Room 62-26.
    c. FERC Contact: Tom Dean,<PHONE_NUMBER>.
    d. Purpose of Meeting: To discuss authorizations and approvals that
may be needed for, and the U.S. Army Corps of Engineers' (Corps)
position on, proposed modifications to the facilities and operation of
the Corps' Green Island Lock and Dam (see attached agenda for complete
list of topics).
    e. All local, state, and federal agencies, Indian tribes, and other
interested parties are invited to participate either in person or by
phone. Please call Tom Dean at<PHONE_NUMBER> by Wednesday, March 14,
2012, to receive specific instructions on how to participate.
    f. FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an email to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    g. A summary of the teleconference will be placed in the public
record for the project.

    Dated: February 10, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-3631 Filed 2-15-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Notices]
[Page 33074-33076]
[DOCID:fr11jn08-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

June 3, 2008.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC08-95-000.
    Applicants: PDI Stoneman, Inc.; Mid-American Power, LLC; DTE Energy
Services, Inc.
    Description: Joint Application of PDI Stoneman, Inc, Mid-American
Power, LLC and DTE Energy Services, Inc for authorization of proposed
transaction under Section 203 of the Federal Power Act etc.
    Filed Date: 05/29/2008.
    Accession Number: 20080603-0035.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 19, 2008.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER01-3001-020.
    Applicants: New York Independent System Operator, Inc.
    Description: Semi-Annual 2007 Compliance Report of New York
Independent System Operator, Inc. on Demand Response Programs and New
Generation Projects.
    Filed Date: 06/02/2008.
    Accession Number: 20080602-5144.
    Comment Date: 5 p.m. Eastern Time on Monday, June 23, 2008.

    Docket Numbers: ER05-1056-004; ER06-1548-002.
    Applicants: Chehalis Power Generating, L.P.
    Description: Chehalis Power Generating, L.P., Refund Report.
    Filed Date: 05/30/2008.
    Accession Number: 20080530-5143.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-552-001.
    Applicants: Niagara Mohawk Power Corporation.
    Description: Response to Deficiency Letter of April 30, 2008 of
Niagara Mohawk Power Corporation.
    Filed Date: 05/30/2008.
    Accession Number: 20080530-5121.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-837-002.
    Applicants: PJM Interconnection, L.L.C.
    Description: Amendment to Filing of PJM Interconnection, L.L.C.
    Filed Date: 05/30/2008.
    Accession Number: 20080530-5114.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-971-001.
    Applicants: Commonwealth Edison Company, Commonwealth Edison Co. of
Indiana, Inc.
    Description: Commonwealth Edison Company et al. submits redlined
version of the tariff sheets previously submitted on 5/15/08.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0032.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1020-000.
    Applicants: The Toledo Edison Company.
    Description: Toledo Edison Company submits Notice of Cancellation
of the Interconnection and Service Agreement Between The Toledo Edison
Company and American Municipal Power-Ohio, Inc dated 5/1/89 etc.
    Filed Date: 05/29/2008.
    Accession Number: 20080602-0115.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 19, 2008.

    Docket Numbers: ER08-1024-000.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Golden Spread Electric Cooperative, Inc submits its
Eighth Informational Filing setting forth updated fixed costs
associated with rates charged for sales of replacement energy pursuant
to Rate Schedule 35 etc.
    Filed Date: 05/30/2008.
    Accession Number: 20080602-0105.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1025-000.
    Applicants: The Connecticut Light and Power Company.
    Description: Connecticut Light and Power Company submits an Amended
Interconnection and Operation Agreement by and between designated as
Second Revised Service Agreement.
    Filed Date: 05/30/2008.
    Accession Number: 20080602-0104.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1026-000.
    Applicants: FirstEnergy Service Company.
    Description: FirstEnergy Service Company on behalf of The Cleveland
Electric Illuminating Company et al. submits Notices of Cancellation of
Rate Schedule FERC 26 et al.
    Filed Date: 05/30/2008.
    Accession Number: 20080602-0103.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1027-000.
    Applicants: Ameren Services Company.
    Description: Central Illinois Public Service Company submits an
executed service agreement for Wholesale Distribution Service with
Wabash Valley Power Association, Inc as agent for Enerstar Electric
Cooperative et al.
    Filed Date: 05/30/2008.
    Accession Number: 20080602-0102.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1029-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits a Petition for Approval of
Settlement Agreement.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0102.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1031-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits Petition for Approval of
Settlement Agreement.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0101.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1035-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits a Petition for Approval of
Settlement Agreement.

    Filed Date: 05/30/2008.
    Accession Number: 20080603-0099.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1036-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy Inc et al submit Second Revised Sheet 8
and 1 to the Wholesale Electric Service Agreement dated 12/21/87,
designated as First Revised Rate Schedule 250 with the City of
Burlingame KS.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0108.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1037-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy Inc submits Petition for Approval of
Settlement Agreement.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0109.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1039-000.
    Applicants: DPL Energy, LLC.
    Description: DPL Energy, LLC submits its proposed FERC Electric
Tariff, Original Volume 2 and supporting cost data.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0092.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1040-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Operating Companies submits a Notice of
Termination of Service Agreement 2 with Hodge Utility Operating
Company.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0091.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1041-000.
    Applicants: Entergy Services, Inc.
    Description: City of Benton Arkansas et al submit First Revised
Service Agreement 466 et al under FERC Electric Tariff, Third Revised
Volume 3.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0090.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1042-000.
    Applicants: Midwest Independent Transmission System.
    Description: Midwest Independent Transmission System Operator, Inc
submits Notice of Cancellation of the 2006 CRSG Agreement etc.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0088.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1043-000.
    Applicants: Midwest Independent Transmission System.
    Description: Midwest Independent Transmission System Operator Inc
submits proposed revisions to Section 40.2.22 (Emergency Energy
Assistance) and Section 40.3.3.d (Charges and Credits for Midwest ISO
Balancing Authority etc).
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0087.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1044-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits Transmission Service
Agreement between PJM and FirstEnergy Solutions Corp on behalf of
FirstEnergy Nuclear Generation Corp for Firm Point-to-Point
Transmission Service.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0086.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1045-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits Service Agreement
for Network Integration Transmission Service between SPP as
Transmission Provider and Kansas Power Pool as, Network Customer.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0085.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1046-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc and Kansas Gas and Electric Co
submit their Second Revised Sheet 10 and 1 to the Wholesale Electric
Service Agreement commencing 2/1/88.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0089.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1048-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc et al submit revised tariff sheets
to three existing participation power service agreements with Midwest
Energy, Inc etc.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0110.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1049-000.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Company submits a single-issue rate
and transmission revenue requirement adjustment for their Open Access
Transmission Tariff, Schedules 7 and 8 and Attachment H as 2nd Rev
Sheet 137 et al.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0111.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1052-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits Transmission Service
Agreement between PJM and Orion power Midwest, LP for Firm Point-to-
Point Transmission Service pursuant to Part II of the PJM Open Access
Tariff etc.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0113.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1053-000.
    Applicants: California Independent System Operator C.
    Description: California Independent System Operator Corporation
submits proposed amendments to their FERC electric tariffs--both
currently effective tariff and the MRTU Tariff etc.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0114.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1054-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool Inc submits an executed Service
Agreement for Network Integration Transmission Service with
Transmission Provider and Kansas Power Pool as Network Customer.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0115.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1055-000.
    Applicants: Midwest Independent Transmission System.
    Description: Midwest Independent Transmission System Operator Inc
submits an Amended and Restates Midwest Contingency Reserve Sharing
Group Agreement.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0116.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA07-56-003.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Company conform to the Open Access

Transmission Tariff to Order Nos. 890 and 890-A regarding rollover
rights as required by paragraph 46 of Order issued April 3, 2008.
    Filed Date: 06/02/2008.
    Accession Number: 20080602-5150.
    Comment Date: 5 p.m. Eastern Time on Monday, June 23, 2008.

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

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-13035 Filed 6-10-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Page 77158]
[FR Doc No: 2022-27300]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FRA-2022-1712]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Flight
Attendant Fatigue Risk Management Plan

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection involves submission of Fatigue Risk
Management Plans (FRMP) for flight attendants of certificate holders
operating under Title 14 of the Code of Federal Regulations (CFR) part
121. The certificate holders will submit the information to be
collected to the FAA for review and acceptance as required by the FAA
Reauthorization Act of 2018.

DATES: Written comments should be submitted by February 14, 2023.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Sandra Ray, Federal Aviation Administration, Voluntary
Programs and Rulemaking Section AFS-260, 1187 Thorn Run Road, Suite
200, Coraopolis, PA 15108.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sandra L. Ray by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0789.
    Title: Flight Attendant Fatigue Risk Management Plan.
    Form Numbers: None.
    Type of Review: Renewal of an information collection.
    Background: On October 5, 2018, Congress enacted Public Law 115-
254, the FAA Reauthorization Act of 2018 (``the Act''). Section 335(b)
of the Act required each certificate holder operating under 14 CFR part
121 to submit to the FAA for review and acceptance a Fatigue Risk
Management Plan (FRMP) for each certificate holder's flight attendants.
Section 335(b) contains the required contents of the FRMP, including a
rest scheme consistent with current flight time and duty period
limitations and development and use of methodology to continually
assess the effectiveness of the ability of the plan to improve
alertness and mitigate performance errors. Section 335(b) requires that
each certificate holder operating under 14 CFR part 121 shall update
its FRMP every two years and submit the update to the FAA for review
and acceptance. Further, section 335(b) of the Act requires each
certificate holder operating under 14 CFR part 121 to comply with its
FRMP that is accepted by the FAA.
    Respondents: 55 Part 121 Air Carriers and 2 new entrants
    Frequency: 1 initial submission and then updates every 2 years
    Estimated Average Burden per Response: 20 Hours for Initial
Submission, 5 Hours for Updates.
    Estimated Total Annual Burden: 40 Hours per year for Initial
Submission, 275 Hours per year for updates.

    Issued in Washington, DC on December 14, 2022.
Sandra L. Ray,
Aviation Safety Inspector, AFS-260.
[FR Doc. 2022-27300 Filed 12-15-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 62 (Monday, April 3, 2017)]
[Notices]
[Pages 16245-16247]
[FR Doc No: 2017-06442]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80321; File No. SR-FINRA-2017-008]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to the Private Placement Filer Form Under
FINRA Rules 5122 and 5123

March 28, 2017.
    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 March 17, 2017, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested
persons.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6). FINRA has given the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
    \4\ The text of the proposed rule change is available at the
principal office of FINRA, on FINRA's Web site at http://www.finra.org, and at the Commission's Public Reference Room.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing changes to the Private Placement Filer Form
(``Filer Form'') that members complete when submitting private
placement filings under FINRA Rules 5122 (Private Placements of
Securities Issued by Members) or 5123 (Private Placements of
Securities). The proposal does not make any changes to the text of
FINRA rules.

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
    Rules 5122 and 5123 require a FINRA member to file information
regarding private placements in which the member participates.\5\ When
Rule 5123 became effective on December 3, 2012,\6\ FINRA required
members to use the Filer Form for filings under both rules.\7\ Members
submit the Filer Form and relevant offering documents to FINRA through
the FINRA Firm Gateway.\8\ On July 1, 2013, FINRA amended Rule 5123 to
require members to file the requisite information ``in a manner
prescribed by FINRA'' and also began using an updated version of the
Filer Form.\9\ The changes proposed herein would further update the
version of the Filer Form that has been in use since 2013 for filings
made pursuant to Rule 5122 and Rule 5123.
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    \5\ Both Rules 5122 and 5123 provide exemptions from the filing
requirement when certain types of securities are sold or securities
are sold to certain types of investors. See Rules 5122(c) and
5123(b).
    \6\ See Securities Exchange Act Release No. 67157 (June 7,
2012), 77 FR 35457 (June 13, 2012) (Notice of Filing of Amendments
No. 2 and No. 3 and Order Granting Accelerated Approval of File No.
SR-FINRA-2011-057); Regulatory Notice 12-40 (September 2012).
    \7\ See Regulatory Notice 12-40 (September 2012). See also
Regulatory Notice 13-26 (August 2013); Securities Exchange Act
Release No. 69843 (June 25, 2013), 78 FR 39367 (July 1, 2013)
(Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change Relating to Members' Filing Obligations under FINRA Rule 5123
(Private Placements of Securities) File No. SR-FINRA-2013-026).
    \8\ FINRA Firm Gateway is an online compliance tool that
provides consolidated access to FINRA applications and allows
members to submit required filings electronically to meet their
compliance and regulatory obligations.
    \9\ See Securities Exchange Act Release No. 69843 (June 25,
2013), 78 FR 39367 (July 1, 2013) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change Relating to Members' Filing
Obligations under FINRA Rule 5123 (Private Placements of Securities)
File No. SR-FINRA-2013-026).
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    The Filer Form has three main components: (1) The ``Participating
Member Information'' section, which seeks information about the members
that are selling the private placement; (2) the ``Issuer Information''
section, which captures basic information about the issuer; and (3) the
``Offering Information'' section, which seeks information about the
offering. FINRA proposes changes to the Filer Form that will add,
clarify and eliminate questions or other information requested in each
section. Members may respond ``unknown'' for all new requests for
information. Therefore, the Filer Form, as proposed to be modified,
would not impose any new obligation on broker-dealers to seek out
information that they do not already have. FINRA describes these
proposed changes below.
    The Participating Member section of the Filer Form would add
questions regarding whether the member making the filing (``filing
member'') is the exclusive selling agent in the private placement and
whether there is any affiliation between the issuer or sponsor of the
private placement with any member participating in the offering upon
whose behalf the filing member is submitting the Filer Form. This
section would no longer require the title and email address for the
contact person of the filing member or the contact name, title and
telephone number for other members identified in the filing.
    The Issuer Information section of the Filer Form would add a
question asking whether the issuer is a reporting company. This section
would no longer require the filing member to enter the name, title and
email address of the issuer's contact person.
    The Offering Information section would add questions regarding:
     The type of security the issuer is offering;
     whether the issuer raised capital within the preceding 12
months from any source (excluding loans or investments by affiliates);
     minimum investment amount that the issuer will accept and
whether the issuer can waive that minimum;
     whether the filing member sold or will sell the offering
to any non-accredited investors;
     the exemption from the Securities Act of 1933 that the
issuer is relying upon; \10\ and
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    \10\ FINRA notes that one of the exemptions listed on the Filer
Form is Rule 505 of Regulation D. The SEC has recently repealed Rule
505, with a stated effective date of May 22, 2017, in connection
with its amendments to exemptions to facilitate intrastate and
regional securities offerings. See Securities Exchange Act Release
No. 79161, 81 FR 83494 (November 21, 2016). FINRA will modify the
Filer Form to remove the reference to Rule 505 following the
effective date of the repeal of that rule.

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     for contingency offerings, whether a contingency has been
met as of the date of the filing.
    The Offering Information section would also request the date on
which the filing member first offered or sold the private placement and
allow the filing member to indicate that sales have yet to commence.
The Offering Information section would no longer include the
requirements to provide the aggregate amount of non-commission
compensation and the offering's conclusion date. This section also
would no longer include the questions asking whether the member used a
term sheet, whether the issuer has any independently audited financial
statements and whether the issuer's directors are independent. In
addition, the Offering Information section would clarify that the
requirement to provide the stated or target rate of return is relevant,
only if an offering document provides an actual or target rate of
return to investors. Finally, this section also would clarify that the
question regarding general solicitation only seeks information
regarding whether the filing member or the issuer has, in fact, engaged
in general solicitation in connection with the private placement at or
before the time of filing.
    FINRA believes that these revisions will assist it in fulfilling
its regulatory responsibilities by improving the information about the
nature of the private placement and members' role in offering the
securities. Specifically, FINRA proposes to eliminate questions or data
fields that were not as useful as anticipated, clarify questions that
may have raised questions with members, and add other questions that,
with the benefit of experience, FINRA believes will help it better
understand the issues and potential risks associated with a private
placement (e.g., an offering with an unmet contingency).\11\
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    \11\ FINRA published Regulatory Notice 16-08 (February 2016) to
highlight issues that FINRA has observed concerning members'
compliance with SEA Rules 10b-9 and 15c2-4.
---------------------------------------------------------------------------

    FINRA has filed the proposed changes for immediate effectiveness.
FINRA anticipates that the implementation date will be May 22, 2017.
2. Statutory Basis
    FINRA believes that the proposed changes to the Filer Form are
consistent with the provisions of Section 15A(b)(6) of the Act,\12\
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, in that it will assist in FINRA's
efforts to detect and prevent fraud in connection with specified
private placements. In addition, the proposed changes will assist FINRA
in evaluating the specified private placement activities of members and
assess whether members are conducting a reasonable investigation for
specified private placement offerings in which they participate.
---------------------------------------------------------------------------

    \12\ 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 changes to the Filer Form
will result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. FINRA notes that
all members that participate in specified private placements will have
to file electronically (or have another member that is participating in
the specified private placement file on its behalf) a Filer Form in
connection with the rules. In addition, all of the new questions
proposed herein permit members to respond ``unknown.''
    Because the proposed Filer Form does not impose an affirmative duty
on members to obtain answers, but only requires the member to provide
the information on the Filer Form if known, FINRA believes that the
proposed changes present no new burden upon filing members. In light of
the role of the rules and the accompanying Filer Form in assisting
FINRA in its efforts to detect and prevent fraudulent and manipulative
acts and practices and enhance the protection of investors, FINRA does
not believe that the proposed changes 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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2017-008 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2017-008. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of

10:00 a.m. and 3:00 p.m. Copies of 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 available publicly.
    All submissions should refer to File Number SR-FINRA-2017-008 and
should be submitted on or before April 24, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-06442 Filed 3-31-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Rules and Regulations]
[Pages 12083-12088]
[FR Doc No: 2019-06026]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2011-N-0103]
RIN 0910-AH98

Microbiology Devices; Classification of In Vitro Diagnostic
Devices for Bacillus Species Detection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to classify in vitro diagnostic devices for
Bacillus species (spp.) detection into class II (special controls) and
to continue to require a premarket notification (510(k)) to provide a
reasonable assurance of safety and effectiveness of the device. FDA is
also establishing special controls in a special controls guideline in
addition to restricting use and distribution of the devices. An in
vitro diagnostic device for Bacillus spp. detection is a prescription
device used to detect and differentiate among Bacillus spp. and
presumptively identify B. anthracis and other Bacillus spp. from
cultured isolates or clinical specimens as an aid in the diagnosis of
anthrax and other diseases caused by Bacillus spp.

DATES: This rule is effective May 1, 2019. See further discussion in
section V ``Implementation Strategy''.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule 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: Beena Puri, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4502, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
V. Implementation Strategy
VI. Electronic Access
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Final Rule

    FDA is classifying in vitro diagnostic devices for Bacillus species
(spp.) detection (product codes NVQ, NPO, NRL, NHT, and NWZ) into class
II (special controls), establishing special controls in a special
controls guideline entitled ``Class II Special Controls Guideline: In
Vitro Diagnostic Devices for Bacillus spp. Detection,'' restricting the
device to prescription use, and restricting distribution of these
devices to laboratories that follow public health guidelines that
address appropriate biosafety conditions, interpretation of test
results, and coordination of findings with public health authorities.
    This decision is based upon the recommendations from the
Microbiology Devices Advisory Panel (the Panel), public comments
received following the publication of the proposed rule, FDA's
experience with these devices. FDA believes that the special controls
established and imposed by this final rule and special controls
guideline, together with the general controls, will provide a
reasonable assurance of safety and effectiveness of the device.
Further, FDA believes that the restrictions on use and distribution are
required for the safe and effective use of the device.

B. Summary of the Major Provisions of the Final Rule

    This final rule classifies in vitro diagnostic devices for Bacillus
spp. detection into class II (special controls), and establishes
special controls in a special controls guideline entitled ``Class II
Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus
spp. Detection'' which address: (1) Specific information relating to
the devices' intended use, components, testing procedures, specimen
storage/shipping conditions, and interpretation/reporting; (2) detailed
descriptive information regarding the studies required to demonstrate
appropriate performance and control against assays that may otherwise
fail to perform to acceptable standards; (3) specific labeling
requirements; and (4) certain information that must be submitted for in
vitro diagnostic devices for Bacillus spp. detection that use nucleic
acid amplification.
    This rule also restricts the use and distribution of these devices.
Because handling the quality control organisms and those potentially
present in the specimen may pose a risk to laboratory workers, FDA is
finalizing a restriction on distribution of these products to
laboratories that follow public health guidelines that address
appropriate biosafety conditions, interpretation of test results, and
coordination of findings with public health authorities. Further, FDA
is restricting use of these devices to be a prescription device under
the terms set forth in 21 CFR 866.3045(d).

C. Legal Authority

    FDA is issuing this rule under the authority of the provisions of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to
medical devices (21 U.S.C. 301 et seq.), including section 513(a)
regarding device classes (21 U.S.C. 360c(a)), sections 513(b) and (c)
regarding device classification panels (21 U.S.C. 360c(b) and (c)),
section 513(d) regarding device classification (21 U.S.C. 360c(d)), and
section 520(e) regarding restrictions on the sale, distribution, or use
of a device (21 U.S.C. 360j(e)).

D. Costs and Benefits

    Quantifiable benefits of this rule are annual cost savings
resulting from a reduction in the time burden of inquiries
manufacturers submit to FDA. The primary present value of the benefits,
over a 20-year time horizon from 2018 to 2038 are estimated to be
$258,054, at a 7 percent discount rate and $353,393, at a 3 percent
discount rate. The primary estimate of the annual benefits is $22,258 a
year.
    This rule has a one-time upfront cost for current manufacturers of
these devices as they will need to spend time reading the rule and may
need to develop new labeling. There is also an annual cost of reading
the rule to firms who may submit inquiries in the future. The primary
present value of the costs, over a 20-year time horizon, are estimated
to be $12,659 at a 7 percent discount rate and $14,081 at a 3 percent
discount rate. The primary annualized costs are $1,092 at a 7 percent
discount rate and $887 at a 3 percent discount rate. The total net
benefit of the rule is estimated to be $245,395 at a 7 percent discount
rate and $339,312 at a 3 percent discount rate. The annualized net
benefits of this rule are estimated to be $21,166 at a 7 percent
discount rate and $21,371 at a 3 percent discount rate.

II. Background

A. History of This Rulemaking

    In the Federal Register of November 17, 2015 (80 FR 71756), FDA
issued a proposed rule to classify in vitro diagnostic devices for
Bacillus spp. detection as class II with special controls, and proposed
the draft special controls guideline entitled ``Class II Special
Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp.
Detection; Draft Guideline for Industry and Food and Drug
Administration Staff'' (Ref. 1) and certain restrictions on its use and
distribution. The proposed special controls and restrictions were
based, in part, upon feedback received from the Panel on March 7, 2002
(Ref. 2). FDA invited interested persons to comment on the proposed
regulation and the special controls guideline by February 16, 2016.

B. Summary of Comments to the Proposed Rule

    FDA received one comment requesting an exclusive 510(k). This
comment is outside the scope of the rule. No comments opposed the
proposed classification for in vitro diagnostic devices for Bacillus
spp. detection.

III. Legal Authority

    The FD&C Act (21 U.S.C. 301 et seq.), as amended, established a
comprehensive system for the regulation of medical devices intended for
human use. The FD&C Act establishes three categories (classes) of
devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness (section 513(a)
of the FD&C Act). The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Class I devices are those devices for which the general controls of
the FD&C Act (controls authorized by or under the general controls
sections of the FD&C Act (sections 501, 502, 510, 516, 518, 519, or 520
(21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j), or any
combination of such sections) are sufficient to provide a reasonable
assurance of the safety and effectiveness of the device; or those
devices for which insufficient information exists to determine that
general controls are

sufficient to provide reasonable assurance of the safety and
effectiveness of the device or to establish special controls to provide
such assurance, but because the devices are not purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury, are to be regulated by general controls (section
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for
which general controls by themselves are insufficient to provide
reasonable assurance of the safety and effectiveness, and for which
there is sufficient information to establish special controls to
provide such assurance, including the promulgation of performance
standards, postmarket surveillance, patient registries, development and
dissemination of guidelines, recommendations, and other appropriate
actions as the Agency deems necessary to provide such assurance
(section 513(a)(1)(B) of the FD&C Act). Class III devices are those
devices for which insufficient information exists to determine that
general controls and special controls would provide a reasonable
assurance of safety and effectiveness, and are purported or represented
for a use in supporting or sustaining human life or for a use which is
of substantial importance in preventing impairment of human health, or
present a potential unreasonable risk of illness or injury (section
513(a)(1)(C) of the FD&C Act).
    FDA refers to devices that were in commercial distribution before
May 28, 1976 (the date of enactment of the Medical Device Amendments of
1976), as ``preamendments devices.'' Pursuant to section 513(d)(1) of
the FD&C Act, FDA classifies these devices after FDA: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device (section 513(d)(1) of the FD&C
Act). FDA has classified most preamendments devices under these
procedures and has followed these procedures to classify in vitro
diagnostic devices for Bacillus spp. detection.
    Section 520(e) of the FD&C Act authorizes FDA to issue regulations
imposing restrictions on the sale, distribution, or use of a device, if
because of its potentiality for harmful effect or the collateral
measures necessary to its use, FDA determines that absent such
restrictions, there cannot be a reasonable assurance of its safety and
effectiveness. Certain provisions of the FD&C Act related specifically
to FDA's authority over restricted devices. For example, section 502(q)
and (r) of the FD&C Act provide that a restricted device distributed or
offered for sale in any state shall be deemed to be misbranded if its
advertising is false or misleading or fails to include certain
information regarding the device, or it is sold, distributed, or used
in violation of regulations prescribed under section 520(e) of the FD&C
Act, and section 704(a) of the FD&C Act (21 U.S.C. 374(a)) authorizes
FDA to inspect certain records relating to restricted devices. FDA
continues to believe that the restrictions as provided in the final
rule related to distribution and use are required for the safe and
effective use of the device.

IV. Comments on the Proposed Rule and FDA Response

    FDA received one comment on the proposed rule by the close of the
comment period, requesting an exclusive 510(k). This comment is outside
of the scope of the rule. No comments opposed the proposed
classification for in vitro diagnostic devices for Bacillus spp.
detection. In this final rule, FDA is adopting the classification,
special controls and the restrictions on use and distribution from its
proposed rule published on November 17, 2015 (80 FR 71756).

V. Implementation Strategy

    This final rule will become effective 30 days after its date of
publication in the Federal Register.
    The implementation strategy is set forth below for these devices.
     Devices that have not been legally marketed prior to the
date of publication of this final rule, or devices that have been
legally marketed, but are required to submit a new 510(k) under 21 CFR
807.81(a)(3) because the device is about to be significantly changed or
modified: Manufacturers must obtain 510(k) clearance and comply with
special controls before marketing the new or changed device.
     Devices that have been legally marketed prior to the date
of publication of this final rule, and devices for which 510(k)
submissions have been submitted before the date of publication of this
final rule: Manufacturers are not required to submit a 510(k) to
demonstrate compliance with the special controls set forth in sections
VI, VII, and IX of the special controls guideline. FDA had proposed
that manufacturers of such devices must comply with the underlying
requirements for those special controls, as well as the labeling
special controls set forth in section VIII of the special controls
guideline. FDA is finalizing our classification and is clarifying that
for such devices, FDA does not expect submission of documentation to
FDA demonstrating compliance with the special controls set forth in
sections VI, VII, and IX of the special controls guideline. Further,
FDA does not intend to enforce compliance with the labeling special
controls set forth in section VIII of the special controls guideline
until April 1, 2020. If a manufacturer markets such a device after
April 1, 2020, and that device does not comply with the labeling
special controls set forth in section VIII of the special controls
guideline, then FDA would consider taking action against such a
manufacturer under its usual enforcement policies. FDA believes that a
period of 1 year from the publication date of this final rule is
appropriate for manufacturers to come into compliance with such
requirements. FDA believes this approach will help ensure the efficient
and effective implementation of this final rule.

VI. Electronic Access

    Persons interested in obtaining a copy of the final special
controls guideline may do so by using the internet. A search capability
for all Center for Devices and Radiological Health guidelines and
guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumentsdefault.htm. The final
special controls guideline is also available at https://www.regulations.gov. Persons unable to download an electronic copy of
``Class II Special Controls Guideline: In Vitro Diagnostic Devices for
Bacillus spp. Detection,'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1400038 to identify the special controls
guideline you are requesting.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety,

and other advantages; distributive impacts; and equity). Executive
Order 13771 requires that the costs associated with significant new
regulations ``shall, to the extent permitted by law, be offset by the
elimination of existing costs associated with at least two prior
regulations.'' We believe that this final rule is not a significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because of the small impact expected from this rule, we
certify that the final rule will not have a significant economic impact
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This final rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    Quantifiable benefits of this rule are cost savings resulting from
a reduction in the time burden of inquiries manufacturers submit to
FDA. The cost savings involve manufacturers, who no longer need to
submit as many inquiries related to submissions for these devices,
because much of the necessary information is provided by this rule and
guideline, and FDA, who no longer needs to use resources to respond to
these inquiries. A 20-year time horizon was chosen for this analysis
because this industry has been stable and there is no reason to expect
disruptions for the foreseeable future. The primary present value of
the benefits, over a 20-year time horizon from 2018 to 2038 are
estimated to be $258,054, at a 7 percent discount rate and $353,393, at
a 3 percent discount rate. The primary estimate of the annual benefits,
over a 20-year time horizon from 2018 to 2038, are estimated to be
$22,258 a year.

              Table 1--Summary of Benefits, Costs, and Distributional Effects of the Final Rule in 2017 Dollars Over a 20-Year Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                     Primary                                    ------------------------------------------------
            Category                estimate      Low estimate    High estimate                   Discount rate                           Notes
                                                                                Year dollars         (%)       Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $/year         $22,258          $7,419         $37,096            2017               7              20
                                         22,258           7,419          37,096            2017               3  ..............
    Annualized Quantified......  ..............  ..............  ..............  ..............               7  ..............
                                 ..............  ..............  ..............  ..............               3  ..............
    Qualitative.
Costs:
    Annualized Monetized $/year           1,092             733           1,455            2017               7              20
                                            887             595           1,183            2017               3              20
    Annualized Quantified......  ..............  ..............  ..............  ..............               7  ..............
                                 ..............  ..............  ..............  ..............               3  ..............
    Qualitative.
Transfers:
    Federal Annualized           ..............  ..............  ..............  ..............               7  ..............
     Monetized $/year.           ..............  ..............  ..............  ..............               3  ..............
                                ------------------------------------------------------------------------------------------------------------------------
    From/To....................  From:
                                 To:
                                ------------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized   ..............  ..............  ..............  ..............               7  ..............
     $/year.                     ..............  ..............  ..............  ..............               3  ..............
                                ------------------------------------------------------------------------------------------------------------------------
    From/To....................  From:
                                 To:
                                ------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:
    Small Business:
    Wages:
    Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    This rule has a one-time upfront cost for current manufacturers of
these devices as they may need to develop new labeling. There are seven
total products on the market and each labeling redesign is estimated to
cost $1,096. We estimate the total labeling cost to be $7,674. The six
existing manufacturers (one firm has two products) also face a one-time
upfront cost of having to read the rule and guideline which we estimate
to be $1,138 for the manufacturers. Finally, there is an annual cost of
reading the rule to firms who may submit inquiries in the future. We
estimate this annual cost to be $332. The primary present value of the
costs, over a 20-year time horizon from 2018 to 2038, are estimated to
be $12,659 at a 7 percent discount rate and $14,081 at a 3 percent
discount rate. The primary annualized costs, over a 20-year time
horizon from 2018 to 2038, are estimated to be $1,092 at a 7 percent
discount rate and $887 at a 3 percent discount rate. The total net
benefit of the rule is estimated to be $245,395 at a 7 percent discount
rate and $339,312 at a 3 percent discount rate. The annualized net
benefits of this rule are estimated to be $21,166 at a 7 percent
discount rate and $21,371 at a 3 percent discount rate.
    In line with Executive Order 13771, in table 2 we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. Based on these cost savings this final rule would be
considered a deregulatory action under Executive Order 13771. Our
primary estimate for the present value of the net costs is -$319,974
(or a cost savings of $319,974) at a 7 percent discount rate and -
$729,462 at a 3 percent discount rate in 2016 dollars.

                                                      Table 2--Executive Order 13771 Summary Table
                                                    [In 2016 dollars, over an infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................         $13,614          $9,133         $18,094         $19,812         $13,265         $26,358
Present Value of Cost Savings...........................         333,588          77,548         555,938         749,273         174,181       1,248,789
Present Value of Net Costs..............................       (319,974)        (68,415)       (537,843)       (729,462)       (160,916)     (1,222,430)
Annualized Costs........................................             891             597           1,184             577             386             768
Annualized Cost Savings.................................          21,823           5,073          36,370          21,823           5,073          36,372
Annualized Net Costs....................................        (20,933)         (4,476)        (35,186)        (21,246)         (4,687)        (35,605)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 3) and at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final rule establishes special controls and restrictions that
refer to currently approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections
of information in 21 CFR part 807, subpart E, have been approved under
OMB control number 0910-0120 and the collections of information in 21
CFR parts 801 and 809 have been approved under OMB control number 0910-
0485.
    The labeling referenced in sections VI(A), VIII(A), and VIII(C) of
the final special controls guideline do not constitute a ``collection
of information'' under the PRA because the labeling is a ``public
disclosure of information originally supplied by the Federal government
to the recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

XI. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have a copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

*1. Final Special Controls Guideline for Industry and Food and Drug
Administration Staff, ``Class II Special Controls Guideline: In
Vitro Diagnostic Devices for Bacillus spp. Detection,'' issued April
1, 2019, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM470760.pdf.
*2. Transcript of the FDA Microbiology Devices Panel meeting, March
7, 2002 (available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=348).
*3. ``Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for
Microbiology Devices; Classification of In Vitro Diagnostic Device
for Bacillus Species Detection,'' available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM477856.pdf.
4. Abshire, T.G., J.E. Brown, and J.W. Ezzell, ``Validation of the
Use of Gamma Phage for Identifying Bacillus anthracis,'' 102nd
American Society for Microbiology Annual Meeting (poster #C122),
2001.
*5. Abshire, T.G., et al., ``Production and Validation of the Use of
Gamma Phage for the Identification of Bacillus anthracis,'' Journal
of Clinical Microbiology, vol. 43(9), pp. 4780-8, 2005, available at
https://www.ncbi.nlm.nih.gov/pubmed/16145141.
* 6. Brown, E.R. and W.B. Cherry, ``Specific Identification of
Bacillus anthracis by Means of a Variant Bacteriophage,'' Journal of
Infectious Diseases, vol. 96, p. 34, 1955, available at https://jid.oxfordjournals.org/content/96/1/34.long.
* 7. Brown, E.R. et al., ``Differential Diagnosis of Bacillus
cereus, Bacillus anthracis, and Bacillus cereus var. mycoides,''
Journal of Bacteriology, vol. 75, p. 499, 1958, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC290100/pdf/jbacter00512-0024.pdf.
* 8. Buck C.A., R.L. Anacker, F.S. Newman, et al., ``Phage Isolated
from Lysogenic Bacillus anthracis,'' Journal of Bacteriology, vol.
85, p. 423, 1963, available at https://jb.asm.org/content/85/6/1423.full.pdf+html?sid=c14df35d-1d7b-4cac-b55b-2097931a4623.
9. Parry, J.M., P.C.B. Turnbull, and J.R. Gibson, ``A Colour Atlas
of Bacillus Species,'' Wolfe Medical Publications Ltd., London,
1983.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 866.3045 is added to subpart D to read as follows:

Sec.  866.3045   In vitro diagnostic device for Bacillus spp.
detection.

    (a) Identification. An in vitro diagnostic device for Bacillus
species (spp.) detection is a prescription device used to detect and
differentiate among Bacillus spp. and presumptively identify B.
anthracis and other Bacillus spp. from cultured isolates or clinical
specimens as an aid in the diagnosis of anthrax and other diseases
caused by Bacillus spp. This device may consist of Bacillus spp.
antisera conjugated with a fluorescent dye (immunofluorescent reagents)
used to presumptively identify bacillus-like organisms in clinical
specimens; bacteriophage used for differentiating B. anthracis from
other Bacillus spp. based on susceptibility to lysis by the phage; or
antigens used to identify antibodies to B. anthracis (anti-toxin and
anti-capsular) in serum. Bacillus infections include anthrax
(cutaneous, inhalational, or gastrointestinal) caused by B. anthracis,
and gastrointestinal disease and non-gastrointestinal infections caused
by B. cereus.
    (b) Classification. Class II (special controls). The special
controls are set forth in FDA's special controls guideline document
entitled ``In Vitro Diagnostic Devices for Bacillus spp. Detection;
Class II Special Controls Guideline for Industry and Food and Drug
Administration Staff.'' For availability of the guideline document, see
Sec.  866.1(e).
    (c) Restriction on Distribution. The distribution of these devices
is limited to laboratories that follow public health guidelines that
address appropriate biosafety conditions, interpretation of test
results, and coordination of findings with public health authorities.
    (d) Restriction on Use. The use of this device is restricted to
prescription use and must comply with the following:
    (1) The device must be in the possession of:
    (i)(A) A person, or his agents or employees, regularly and lawfully
engaged in the manufacture, transportation, storage, or wholesale or
retail distribution of such device; or
    (B) A practitioner, such as a physician, licensed by law to use or
order the use of such device; and
    (ii) The device must be sold only to or on the prescription or
other order of such practitioner for use in the course of his
professional practice.
    (2) The label of the device shall bear the statement ``Caution:
Federal law restricts this device to sale by or on the order of a __'',
the blank to be filled with the word ``physician'' or with the
descriptive designation of any other practitioner licensed by the law
of the State in which he practices to use or order the use of the
device.
    (3) Any labeling, as defined in section 201(m) of the Federal Food,
Drug, and Cosmetic Act, whether or not it is on or within a package
from which the device is to be dispensed, distributed by, or on behalf
of the manufacturer, packer, or distributor of the device, that
furnishes or purports to furnish information for use of the device
contains adequate information for such use, including indications,
effects, routes, methods, and frequency and duration of administration
and any relevant hazards, contraindications, side effects, and
precautions, under which practitioners licensed by law to employ the
device can use the device safely and for the purposes for which it is
intended, including all purposes for which it is advertised or
represented. This information will not be required on so-called
reminder-piece labeling which calls attention to the name of the device
but does not include indications or other use information.
    (4) All labeling, except labels and cartons, bearing information
for use of the device also bears the date of the issuance or the date
of the latest revision of such labeling.

    Dated: March 22, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-06026 Filed 3-29-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 71 (Thursday, April 12, 2012)]
[Notices]
[Pages 22032-22034]
[FR Doc No: 2012-8782]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66758; File No. SR-NYSE-2012-05]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Granting Approval of a Proposed Rule Change Amending NYSE Rule 476A To
Update its ``List of Exchange Rule Violations and Fines Applicable
Thereto Pursuant to Rule 476A''

April 6, 2012.

I. Introduction

    On February 7, 2012, New York Stock Exchange LLC (``Exchange'' or
``NYSE'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend NYSE Rule 476A to update its ``List of
Exchange Rule Violations and Fines Applicable Thereto Pursuant to Rule
476A.'' The proposed rule change was published for comment in the
Federal Register on February 24, 2012.\3\ The Commission received no
comment letters on the proposed rule change. This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 66421 (February 17,
2012), 77 FR 11181 (``Notice'').
---------------------------------------------------------------------------

II. Description

    By way of background, NYSE Rule 476 governs disciplinary
proceedings involving charges against members, member organizations,
principal

executives, approved persons, employees, or others for violations of
the federal securities laws, Exchange rules and agreements with the
Exchange, and other offenses listed in the rule.
    NYSE Rule 476A, ``Imposition of Fines for Minor Violation(s) of
Rules,'' provides that, in lieu of commencing a disciplinary proceeding
under Rule 476, the Exchange may (subject to specified requirements)
``impose a fine, not to exceed $5,000, on any member, member
organization, allied member, approved person, or registered or non-
registered employee of a member or member organization, for any
violation of a rule of the Exchange, which violation the Exchange shall
have determined is minor in nature.'' \4\ The provisions of Rule 476A
are known as the Exchange's Minor Rule Violation Plan.
---------------------------------------------------------------------------

    \4\ NYSE Rule 476A(a).
---------------------------------------------------------------------------

    According to the Exchange, the ``summary fines'' under Rule 476A
provide a meaningful sanction for rule violations when the violation
calls for stronger discipline than an admonition or cautionary letter,
but the facts and circumstances of the violation do not warrant
initiation of a formal disciplinary proceeding under Rule 476. A ``List
of Exchange Rule Violations and Fines Applicable Thereto Pursuant to
Rule 476A'' (``Rule 476A List'') is appended as Supplementary Material
to the rule.
    In the instant proposal, the NYSE proposes to amend the Rule 476A
List to: (i) Make technical, non-substantive changes to conform the
list to previously-approved changes in Exchange rules,\5\ (ii) update
the rules relating to conduct by Designated Market Makers (``DMMs''),
and (iii) add rules relating to conduct by DMMs, as follows:
---------------------------------------------------------------------------

    \5\ In addition to these technical changes to the Rule 476A
List, which are described below, the proposed rule change would
amend Rule 476A(a) by replacing the term ``allied member'' with the
term ``principal executive,'' to be consistent with a prior rule
change eliminating the category of ``allied member'' on the
Exchange. See Securities Exchange Act Release No. 58549 (September
15, 2008), 73 FR 54444 (September 19, 2008) (SR-NYSE-2008-80). See
also NYSE Rule 476, which uses the term ``principal executive.''
---------------------------------------------------------------------------

Proposed Non-Substantive Changes to Rule 476A List

    The Exchange proposes to update the Rule 476A List to conform it to
approved changes to Exchange rules by updating the titles of certain
rules, updating references to rules that have been renumbered or
harmonized with a Financial Industry Regulatory Authority (``FINRA'')
rule, deleting references to rules that have been deleted, updating the
descriptions of rules that have been amended, and fixing a
typographical error.\6\
---------------------------------------------------------------------------

    \6\ For a more detailed description of these proposed non-
substantive changes, see Notice, supra note 3.
---------------------------------------------------------------------------

Proposed Updates to Rule 476A List for DMM Conduct Rules

    The current Rule 476A List includes certain specific rules that
govern DMM conduct (e.g., NYSE Rules 104(a)(1)(A) and 104.10), as well
as a category designated as ``Exchange policies regarding procedures to
be followed in delayed opening situations,'' which refers to policies
relating to DMM conduct included in NYSE Rule 123D. The Exchange
proposes generally to update the Rule 476A List with current rules
governing DMM conduct. In particular, under the proposed rule change,
the list would be amended to include, more expansively, ``Rule 104
requirements for the dealings and responsibilities of DMMs'' and ``Rule
123D requirements for DMMs relating to openings, re-openings, delayed
openings, trading halts, and tape indications.'' Thus, additional
elements of Rules 104 and 123D would be included in the Minor Rule
Violation Plan, as further detailed below.

Rule 104

    NYSE Rule 104 requires DMMs registered in one or more securities
traded on the Exchange to engage in a course of dealings for their own
account to assist in the maintenance of a fair and orderly market,
insofar as reasonably practicable, by contributing liquidity when lack
of price continuity and depth, or disparity between supply and demand
exists or is reasonably to be anticipated.\7\
---------------------------------------------------------------------------

    \7\ NYSE Rule 104 currently operates on a pilot basis, set to
end on July 31, 2012. The Exchange stated its belief that the Rule
476A List should reference those rules that are currently
operational, even if operating on a pilot basis.
---------------------------------------------------------------------------

    The Rule 476A List currently includes the following elements of
Rule 104:
     Rule 104(a)(1)(A), which requires DMMs to maintain a bid
or an offer at the National Best Bid and National Best Offer
(``inside'') at least 15% of the trading day for securities in which
the DMM unit is registered that have a consolidated average daily
volume of less than one million shares, and at least 10% for securities
in which the DMM unit is registered that have a consolidated average
daily volume equal to or greater than one million shares; and
     Rule 104.10, which is described in the Rule 476A List as
relating to ``Functions of DMM.'' This description does not relate to
the rule currently denominated as Rule 104.10, which was adopted when
the Exchange adopted the New Market Model,\8\ but to a former rule
relating to certain subject matters that, according to the Exchange,
continue to be covered in the current Rule 104.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 58845 (October 24,
2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46).
---------------------------------------------------------------------------

    The proposed rule change would, instead, include a single reference
in the Rule 476A List identifying ``Rule 104 requirements for the
dealings and responsibilities of DMMs'' as subject to the Minor Rule
Violation Plan. The proposed rule change would have the effect of
adding to the Rule 476A List Rules 104(b), (c), (d), and (e),\9\ as
well as Rule 104(a)(1)(B), the rule that governs the DMM's new pricing
obligations, which were implemented by all equities markets on December
6, 2010.\10\
---------------------------------------------------------------------------

    \9\ See Notice, supra note 3 at 11182-83 for a full description
of the elements of Rule 104 that, under the proposal, would be
included in the Minor Rule Violation Plan. The Exchange states that
other elements of Rule 104 (i.e., Rule 104(j) and supplementary
material .05 and .10) are not related to DMM obligations, but rather
reflect operational aspects of the Exchange. See id. at note 11. The
Exchange notes that, in a separate filing, it has proposed to delete
NYSE Rule 104(a)(6). See Securities Exchange Act Release No. 65736
(November 10, 2011), 76 FR 71399 (November 17, 2011) (SR-NYSE-2011-
56). The Commission instituted proceedings to determine whether to
disapprove SR-NYSE-2011-56. See Securities Exchange Act Release No.
66397 (February 15, 2012), 77 FR 10586 (February 22, 2012).
    \10\ See Securities Exchange Act Release No. 63255 (November 5,
2010), 75 FR 69484 (November 12, 2010) (SR-NYSE-2010-69).
---------------------------------------------------------------------------

Rule 123D

    The Rule 476A List currently provides that ``violations of Exchange
policies regarding procedures to be followed in delayed opening
situations'' are eligible for summary fines under the Minor Rule
Violation Plan. According to the Exchange, such Exchange policies are
codified in Rule 123D. Accordingly, the Exchange proposes to delete
``violations of Exchange policies regarding procedures to be followed
in delayed opening situations'' and replace it with ``Rule 123D
requirements for DMMs relating to openings, re-openings, delayed
openings, trading halts, and tape indications.'' The effect of this
change would be to include other requirements of DMMs set forth in Rule
123D--relating to openings, re-openings, trading halts, and tape
indications--in the Minor Rule Violation Plan.

III. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\11\ In
particular, the Commission believes that the proposed rule change is
consistent with Section 6(b)(5) of the Act \12\ because expanding the
list of DMM obligations that are subject to the Minor Rule Violation
Plan should afford the Exchange increased flexibility in carrying out
its supervisory responsibilities, and, in doing so, help to meet the
aim of protecting investors and the public interest.
---------------------------------------------------------------------------

    \11\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission also believes that the proposed rule change is
consistent with Sections 6(b)(1) and 6(b)(6) of the Act,\13\ which
require that an exchange enforce compliance with, and have rules that
provide appropriate discipline for violations of, the Act, the rules
and regulations thereunder, and Exchange rules. As an initial matter,
the proposed rule change will further these objectives through its
clarification of the list of Exchange rule violations that are subject
to NYSE Rule 476A by updating rule titles and rule references, deleting
references to rules that have been deleted, updating descriptions of
rules that have been amended, and fixing a typographical error.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b)(1) and 15 U.S.C. 78f(b)(6).
---------------------------------------------------------------------------

    Further, the Commission recognizes that the proposed rule change
will render violations of DMM obligations under Rule 104 \14\ and Rule
123D that were not previously on the Rule 476A List as now eligible for
treatment as minor violations. However, the Commission notes that
designating a rule as subject to the Minor Rule Violation Plan does not
signify that violation of the rule will always be deemed a minor
violation. As noted by the Exchange, Rule 476A preserves the Exchange's
discretion to seek formal discipline, as warranted, when transgressions
of rules designated as eligible for the Minor Rule Violation Plan are
found to be more serious. Thus, the Exchange will remain able to
require, on a case-by-case basis, formal disciplinary action for any
particular violation. Therefore, the Commission believes that the
proposed rule change will not compromise the Exchange's ability to seek
more stringent sanctions for the more serious violations of Rules 104
and 123D.
---------------------------------------------------------------------------

    \14\ The Commission believes that it is appropriate to include
in NYSE Rule 476A references to rules that are currently operating
on a pilot basis.
---------------------------------------------------------------------------

    In addition, because NYSE Rule 476A provides procedural rights to a
person fined under the rule, entitling the person to contest the fine
and receive a full disciplinary proceeding,\15\ the Commission believes
that NYSE Rule 476A, as amended by this proposed rule change, will
provide a fair procedure for the disciplining of Exchange members and
persons associated with members, consistent with Sections 6(b)(7) and
6(d)(1) of the Act.\16\
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    \15\ See NYSE Rule 476A(d).
    \16\ 15 U.S.C. 78f(b)(7) and 15 U.S.C. 78f(d)(1).
---------------------------------------------------------------------------

    Finally, the Commission finds that the proposed rule change is
consistent with the public interest, the protection of investors, or is
otherwise in furtherance of the purposes of the Act, as required by
Rule 19d-1(c)(2) under the Act,\17\ which governs minor rule violation
plans. The Commission believes that the proposed changes to NYSE Rule
476A will strengthen the Exchange's ability to carry out its oversight
and enforcement responsibilities as a self-regulatory organization, in
cases where full disciplinary proceedings are unsuitable in view of the
nature of a particular violation.
---------------------------------------------------------------------------

    \17\ 17 CFR 240.19d-1(c)(2).
---------------------------------------------------------------------------

    In approving this proposed rule change, the Commission emphasizes
that in no way should the amendment of the rule be seen as minimizing
the importance of compliance with NYSE rules and all other rules
subject to the imposition of fines under NYSE Rule 476A. The Commission
believes that the violation of any self-regulatory organization's
rules, as well as Commission rules, is a serious matter. However, NYSE
Rule 476A provides a reasonable means of addressing rule violations
that do not rise to the level of requiring formal disciplinary
proceedings, while providing greater flexibility in handling certain
violations. The Commission expects that the Exchange will continue to
conduct surveillance with due diligence and make a determination based
on its findings, on a case by-case basis, of whether a violation
requires formal disciplinary action under Rule 476.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\18\ that the proposed rule change (SR-NYSE-2012-05) be, and hereby
is, approved.
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    \18\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12); 17 CFR 200.30-3(a)(44).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-8782 Filed 4-11-12; 8:45 am]
BILLING CODE 8011-01-P