[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]
[Page 73940-73941]
[DOCID:fr04de08-44]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0128] (formerly Docket No. 1999D-2013)

Guidance for Industry: Cooperative Manufacturing Arrangements for
Licensed Biologics; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry:
Cooperative Manufacturing Arrangements for Licensed Biologics,'' dated
November 2008. The guidance document provides information concerning
cooperative manufacturing arrangements applicable to biological
products subject to licensure under the U.S. Public Health Service Act
(PHS Act). The guidance describes the licensing strategies for meeting
the increased need for flexible manufacturing arrangements. The
guidance announced in this notice finalizes the draft guidance of the
same title.

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

ADDRESSES:  Submit written requests for single copies of the guidance
to the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and

Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, or the Division of Drug
Information, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>; or
    David Cummings, Center for Drug Evaluation and Research (HFD-354),
Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 21, rm.
3525, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Guidance for Industry: Cooperative Manufacturing Arrangements for
Licensed Biologics'' dated November 2008. The guidance document
provides information concerning the various cooperative manufacturing
arrangements used in the production of biological products subject to
licensure under section 351 of the PHS Act (42 U.S.C. 262). The
guidance describes FDA's current thinking on licensing strategies for
meeting the increased need for planning flexible manufacturing
arrangements. Because cooperative manufacturing arrangements can take a
considerable amount of time to develop, the guidance may also be useful
for planning purposes in the early phases of product development.
Several types of manufacturing arrangements discussed in the guidance
include short supply arrangements, divided manufacturing arrangements,
shared manufacturing arrangements, and contract manufacturing
arrangements. The guidance supersedes ``FDA's Policy Statement
Concerning Cooperative Manufacturing Arrangements for Licensed
Biologics'' published in the Federal Register of November 25, 1992 (57
FR 55544).
    In the Federal Register of August 3, 1999 (64 FR 42136), FDA
announced the availability of the draft guidance of the same title
dated August 1999. FDA received several comments on the draft guidance;
those comments were considered as the guidance was finalized. In
response to public comments, we clarified the document and reformatted
it into plain language. In the Federal Register of July 23, 2007 (72 FR
40157), FDA published a 60-day notice requesting public comment on the
information collections in the draft guidance of the same title dated
July 2007, which revised the draft guidance dated August 1999. The
guidance announced in this notice finalizes the draft guidance dated
July 2007.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in this guidance were approved under OMB control number
0910-0629.

III. Comments

    Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding this guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in the brackets in the heading of this document. A copy of
the guidance and received comments are available for public examination
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cber/guidelines.htm or http://
www.regulations.gov.

    Dated: November 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28693 Filed 12-3-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Proposed Rules]
[Pages 43321-43323]
[FR Doc No: 2017-19637]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Chapter V

[Docket No. NHTSA-2017-0082]

Automated Driving Systems: A Vision for Safety

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

ACTION: Notice of public availability and request for comments.

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SUMMARY: NHTSA is releasing new voluntary guidance on automated driving
systems--Automated Driving Systems: A Vision for Safety. The new
voluntary guidance is based on public comments received on the Federal
Automated Vehicles Policy (FAVP) released in September 2016. The
purpose of this new voluntary guidance is to support industry
innovators, States and other key stakeholders as they consider and
design best practices relative to the testing and deployment of
automated vehicle technologies, while informing and educating the
public and improving roadway safety. NHTSA invites public comment on
the voluntary guidance and additional ways to improve its usefulness.
    This new voluntary guidance is an important part of DOT's multi-
modal efforts to support the introduction of automation technologies
that hold the promise of fulfilling NHTSA's mission of reducing the
number of injuries and fatalities on our roads. As an update to the
FAVP this new voluntary guidance serves as NHTSA's current operating
guidance for Automated Driving Systems (ADSs--SAE International
Automation Levels 3-5). NHTSA intends to continue to revise and refine
the guidance periodically to reflect continued public input,
experience, research, and innovation, and will address significant
comments in preparing future iterations of the guidance. This guidance
supports that effort.

DATES: You should submit your comments early enough to ensure that
Docket Management receives them no later than November 14, 2017.

ADDRESSES: Comments should refer to the docket number above and be
submitted by one of the following methods:
     Federal Rulemaking Portal: Please submit one copy to
http://www.regulations.gov. Follow the online instructions for
submitting comments.
     Mail: Please submit two copies to Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001.
     Hand Delivery: Please submit two copies to 1200 New Jersey
Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC,
between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal
Holidays.
     Instructions: For detailed instructions on submitting
comments and additional information on the rulemaking process, see the
Public Participation heading of the SUPPLEMENTARY INFORMATION section
of this document. Note that all comments received will be posted
without change to http://www.regulations.gov, including any personal
information provided.
     Privacy Act: Anyone is able to search the electronic form
of all comments received into any of our dockets by the name of the
individual submitting the comment (or signing the comment, if submitted
on behalf of an association, business, labor union, etc.). You may
review DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477-78) or at https://www.transportation.gov/privacy.
     Docket: For access to the docket to read background
documents or comments received, go to http://www.regulations.gov or to
the street address listed above. Follow the online instructions for
accessing the dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical issues related to the Voluntary Guidance: Ms. Dee
Williams of NHTSA's Office of Vehicle Safety Research at<PHONE_NUMBER>
or by email at<EMAIL_ADDRESS>    For legal issues: Mr. Steve Wood of NHTSA's Office of Chief
Counsel, at<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The National Highway Traffic Safety Administration (NHTSA), under
the U.S. Department of Transportation, was established by the Highway
Safety Act of 1970, to carry out safety programs under the National
Traffic and Motor Vehicle Safety Act of 1966 and the Highway Safety Act
of 1966. NHTSA is responsible for reducing deaths, injuries, and
economic losses resulting from motor vehicle crashes on our nation's
roadways. It accomplishes these tasks by conducting research, setting
and enforcing safety performance standards for motor vehicles and motor

vehicle equipment, generating and disseminating comparative safety
performance information to encourage the production and purchase of
advanced safety features, requiring the recalling and remedying of
defective and noncompliant vehicles and equipment, and by distributing
highway safety formula grants to state governments to enable them to
conduct effective highway safety programs. Additionally, NHTSA issues
guidance regarding motor vehicle safety issues.
    On September 20, 2016, NHTSA developed and published for comment
the Federal Automated Vehicles Policy (FAVP). The comment period
officially closed on November 22, 2016, but NHTSA continued to receive
and consider comments through February 16, 2017. The public docket
received 160 unique comments in response to the FAVP representing the
traditional motor vehicle industry, the technology sector, public
agencies, special interest groups, and private citizens. The agency
also held public meetings to seek additional comment.
    NHTSA analyzed the docket comments, public meeting proceedings and
other stakeholder discussions, recent Congressional hearings, and State
activities and used this analysis as the foundation for improvements
and refinements to develop NHTSA's new voluntary guidance--Automated
Driving Systems: A Vision for Safety.
    In Section 1: Voluntary Guidance for Automated Driving Systems
(Voluntary Guidance), NHTSA offers a nonregulatory approach to
Automated Driving System (ADS) safety. This Voluntary Guidance supports
the automotive industry and other key stakeholders as they consider and
design best practices for the testing and safe deployment of ADSs (SAE
International Automation Levels 3 through 5--Conditional, High, and
Full Automation Systems). Section 1 contains 12 priority safety design
elements for consideration, including vehicle cybersecurity, human
machine interface, crashworthiness, consumer education and training,
and post-crash ADS behavior. Given the developing state of the
technology, this Voluntary Guidance provides a flexible framework for
industry to use in choosing how to address a given safety design
element. In addition, to help support public trust and confidence, the
Voluntary Guidance encourages entities engaged in testing to publicly
disclose Voluntary Safety Self-Assessments of their systems
demonstrating their varied approaches to achieving safety.
    Vehicles operating on public roads are subject to both Federal and
State jurisdictions, and States are continuing to draft legislation to
safely deploy emerging ADSs. To support the State work, NHTSA offers
Section 2: Technical Assistance to States, Best Practices for
Legislatures Regarding Automated Driving Systems (Best Practices). The
section clarifies and delineates Federal and State roles in the
regulation of ADSs. NHTSA remains responsible for regulating the safety
design and performance aspects of motor vehicles and motor vehicle
equipment; States continue to be responsible for regulating the human
driver and vehicle operations.
    The section also provides Best Practices for Legislatures, which
incorporates common safety-related components and significant elements
regarding ADSs that States should consider incorporating in
legislation. In addition, the section provides Best Practices for State
Highway Safety Officials, which offers a framework for States to
develop procedures and conditions for ADS' safe operation on public
roadways. It includes considerations in such areas as applications and
permissions to test, registration and titling, working with public
safety officials, and liability and insurance.
    NHTSA emphasizes the importance of Automated Driving Systems: A
Vision for Safety as new voluntary guidance in its entirety--a cohesive
package that represents the Agency's current position on Automated
Driving Systems. As the new voluntary guidance is a result of
improvements based on public comments and new information, in the
future, it too will be updated to reflect input by the public, advances
in technology, increased presence of ADSs on public roadways, new
research, and any regulatory action or statutory changes that could
occur at both the Federal and State levels. NHTSA encourages
collaboration and communication between all government entities and the
private sector as the technology evolves, and the Agency will continue
to coordinate dialogue among all stakeholders. The Department and NHTSA
recognize that regulatory efforts in this arena must promote safety,
remove any existing unnecessary barriers, remain technology neutral,
and enable a pathway for innovation that has the potential to save
lives. Any initiative in the regulatory realm will seek to remove
regulatory barriers and burdens that could unnecessarily hinder the
safe and efficient implementation of ADSs.
    The new guidance is available at https://www.nhtsa.gov/technology-innovation/automated-vehicles, which will also serve as a central
repository of associated references to this and other NHTSA ADS
resources, including new frequently asked questions. Additionally, to
support manufacturers and other entities looking to request regulatory
action from NHTSA, companies can find an informational resource,
Understanding NHTSA's Regulatory Tools: Instructions, Practical
Guidance, and Assistance for Entities Seeking to Employ NHTSA's
Regulatory Tools. The new guidance is also available in the public
docket at http://www.regulations.gov (search Docket No. NHTSA-2017-
0082).

Public Comment

    NHTSA is seeking written public comments on the new voluntary
guidance--Automated Driving Systems: A Vision for Safety and additional
ways to improve its usefulness. The Agency expects and intends the
voluntary guidance to continue to be updated based on public comment;
the experience of the agency, manufacturers, suppliers, consumers, and
others; and further research findings and technological innovations. To
inform the next iteration of the voluntary guidance, the Agency may
hold public meetings and workshops associated with specific items
relevant to the guidance. Once the timing of those meetings has been
finalized, the Agency will publish Federal Register notices for those
meetings. Given that not all interested persons may have an opportunity
to attend such meetings, the Agency's solicitation of written comments
will ensure that all persons have a chance to participate. When
possible, NHTSA will also arrange for the meetings to be webcast and
for written transcripts of the meetings. When available, webcast videos
and transcripts will be at https://www.nhtsa.gov/technology-innovation/automated-vehicles.

Public Participation

How do I prepare and submit comments?

    Your comments must be written and in English. To ensure that your
comments are filed correctly in the docket, please include the docket
number of this document in your comments.
    Your comments must not be more than 15 pages long (49 CFR 553.21).
NHTSA established this limit to encourage you to write your primary
comments in a concise fashion. However, you may attach necessary
additional documents to your

comments. There is no limit on the length of the attachments.
    Please submit one copy (two copies if submitting by mail or hand
delivery) of your comments, including the attachments, to the docket
following the instructions given above under ADDRESSES. Please note, if
you are submitting comments electronically as a PDF (Adobe) file, we
ask that the documents submitted be scanned using an Optical Character
Recognition (OCR) process, thus allowing the agency to search and copy
certain portions of your submissions.

How do I submit confidential business information?

    If you wish to submit any information under a claim of
confidentiality, you should submit three copies of your complete
submission, including the information you claim to be confidential
business information, to the Office of the Chief Counsel, NHTSA, at the
address given above under FOR FURTHER INFORMATION CONTACT. In addition,
you may submit a copy (two copies if submitting by mail or hand
delivery), from which you have deleted the claimed confidential
business information, to the docket by one of the methods given above
under ADDRESSES. When you send a comment containing information claimed
to be confidential business information, you should include a cover
letter setting forth the information specified in NHTSA's confidential
business information regulation (49 CFR part 512).

Will the agency consider late comments?

    NHTSA will consider all comments received before the close of
business on the comment closing date indicated above under DATES. To
the extent possible, the Agency will also consider comments received
after that date. Given that we intend for the policy document to be a
living document and to be developed in an iterative fashion, subsequent
opportunities to comment will also be provided periodically.

How can I read the comments submitted by other people?

    You may read the comments received at the address given above under
COMMENTS. The hours of the docket are indicated above in the same
location. You may also see the comments on the Internet, identified by
the docket number at the heading of this notice, at http://www.regulations.gov.
    Please note that, even after the comment closing date, NHTSA will
continue to file relevant information in the docket as it becomes
available. Further, some people may submit late comments. Accordingly,
the agency recommends that you periodically check the docket for new
material.

    Issued in Washington, DC, under authority delegated by 49 CFR
1.95.
Nathaniel Beuse,
Associate Administrator for Vehicle Safety Research.
[FR Doc. 2017-19637 Filed 9-14-17; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Page 34564]
[FR Doc No: 2018-15563]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC18-122-000.
    Applicants: GridLiance High Plains LLC.
    Description: Application for Authorization to Acquire Transmission
Facilities Pursuant to Section 203 of the FPA and Request for Expedited
Action and Certain Waivers of GridLiance High Plains LLC.
    Filed Date: 7/13/18.
    Accession Number: 20180713-5202.
    Comments Due: 5 p.m. ET 8/3/18.

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

    Docket Numbers: ER12-164-019.
    Applicants: Bishop Hill Energy III LLC.
    Description: Notification of Change in Facts under Market-Based
Rate Authority of Bishop Hill Energy III LLC.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5063.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER17-1414-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Midcontinent Independent System Operator, Inc. submits
tariff filing per 35.19a(b): Refund Report to be effective N/A.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5052.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-836-001.
    Applicants: Energia Sierra Juarez 2 U.S., LLC.
    Description: Compliance filing: Energia Sierra Juarez 2 U.S., LLC
Compliance Filing to be effective 7/16/2018.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5105.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-1344-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2018-07-16 Congestion Revenue
Rights Auction Efficiency Track 1A Compliance to be effective 7/1/2018.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5112.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-1915-001.
    Applicants: Bowfin KeyCon Energy, LLC.
    Description: Tariff Amendment: Bowfin Energy FERC Electric Tariff
Supplement to be effective 8/13/2018.
    Filed Date: 7/13/18.
    Accession Number: 20180713-5181.
    Comments Due: 5 p.m. ET 8/3/18.

    Docket Numbers: ER18-1917-001.
    Applicants: Bowfin KeyCon Power, LLC.
    Description: Tariff Amendment: Bowfin Power FERC Electric Tariff
Supplement to be effective 8/13/2018.
    Filed Date: 7/13/18.
    Accession Number: 20180713-5183.
    Comments Due: 5 p.m. ET 8/3/18.

    Docket Numbers: ER18-2018-000.
    Applicants: PacifiCorp.
    Description: Notice of termination of Electric Rate Schedule (No.
378) of PacifiCorp.
    Filed Date: 7/13/18.
    Accession Number: 20180713-5191.
    Comments Due: 5 p.m. ET 8/3/18.

    Docket Numbers: ER18-2019-000.
    Applicants: AEP Appalachian Transmission Company, Inc., AEP Indiana
Michigan Transmission Company Inc., AEP Kentucky Transmission Company,
Inc., AEP Ohio Transmission Company, Inc., AEP West Virginia
Transmission Company, Inc., PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: AEP Transco submits
revisions to OATT, Schedule 1A to be effective 1/1/2017.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5036.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-2020-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: MAIT submits IA SA No. 4578
and ECSA Nos. 4971, 4972, 5012 to be effective 9/14/2018.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5057.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-2021-000.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ATSI submits OIA SA No. 2852
& CA SA No. 4715 to be effective 9/14/2018.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5066.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-2022-000.
    Applicants: New York Independent System Operator, Inc., Niagara
Mohawk Power Corporation.
    Description: Sec.  205(d) Rate Filing: NYISO & National Grid--
amended/restated LGIA no. 2356 with Arkwright to be effective 6/28/
2018.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5085.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-2023-000.
    Applicants: Whiting Clean Energy, Inc.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 9/15/2018.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5096.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-2024-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2018-07-16_SA 3084 St.
Joseph Phase II-NIPSCO GIA 1st Rev (J351) to be effective 6/27/2018.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5120.
    Comments Due: 5 p.m. ET 8/6/18.

    Docket Numbers: ER18-2025-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Sec.  205(d) Rate Filing: DEC-Central Electric Power
Cooperative, Inc PPSA (RS-508) to be effective 9/1/2018.
    Filed Date: 7/16/18.
    Accession Number: 20180716-5124.
    Comments Due: 5 p.m. ET 8/6/18.

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

    Dated: July 16, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-15563 Filed 7-19-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Page 63700]
[FR Doc No: 2019-24870]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87508; File No. SR-CboeEDGX-2019-051]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Withdrawal of Proposed Rule Change To Amend the Cboe EDGX Exchange,
Inc. Fee Schedule To Modify the Options Regulatory Fee

November 12, 2019.
    On August 1, 2019, Cboe EDGX Exchange, Inc. (``EDGX'' or
``Exchange'') filed with the Securities and Exchange Commission (the
``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 (File No. SR-CboeEDGX-2019-051) to modify the
amount of its Options Regulatory Fee (``ORF'').\3\ The proposed rule
change was immediately effective upon filing with the Commission
pursuant to Section 19(b)(3)(A) of the Act.\4\ The proposed rule change
was published for comment in the Federal Register on August 14,
2019.\5\ The Commission received one comment letter on the proposal.\6\
On September 30, 2019, pursuant to Section 19(b)(3)(C) of the Act, the
Commission temporarily suspended the proposed rule change and
instituted proceedings under Section 19(b)(2)(B) of the Act to
determine whether to approve or disapprove the proposed rule change.\7\
On November 7, 2019, the Exchange withdrew the proposed rule change
(SR-CboeEDGX-2019-051).
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 86611 (August 8,
2019), 84 FR 40447 (August 14, 2019) (``Notice'').
    \4\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ See Notice, supra note 3.
    \6\ See Letter to Vanessa Countryman, Secretary, Commission,
from Ellen Greene, Managing Director, Securities Industry and
Financial Markets Association (``SIFMA''), dated August 27, 2019
(``SIFMA Letter'').
    \7\ See Securities Exchange Act Release No. 87172, 84 FR 53192
(October 4, 2019).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-24870 Filed 11-15-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 137 (Wednesday, July 17, 2013)]
[Proposed Rules]
[Pages 42727-42730]
[FR Doc No: 2013-17139]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0544; Directorate Identifier 2012-NM-057-AD]
RIN 2120-AA64

Airworthiness Directives; the Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain the Boeing Company Model 777-200 series airplanes. This
proposed AD was prompted by reports of smoke or flames in the passenger
cabin of various transport category airplanes, related to the wiring
for the passenger cabin in-flight entertainment (IFE) system, cabin
lighting, and passenger seats. This proposed AD would require, for
certain airplanes, doing an inspection of the electrical power control
panel for a certain part number, and corrective action if necessary;
and for certain other airplanes, installing a new electrical power
control panel, and making changes to the wiring and certain electrical
load management system (ELMS) panels. We are proposing this AD to
ensure that the flightcrew is able to turn off electrical power to the
IFE systems and other non-essential electrical systems through a switch
in the flight compartment in the event of smoke or flames. In the event
of smoke or flames in the airplane flight deck or passenger cabin, the
flightcrew's inability to turn off electrical power to the IFE system
and other non-essential electrical systems could result in the
inability to control smoke or flames in the airplane flight deck or
passenger cabin during a non-normal or emergency situation, and
consequent loss of control of the airplane.

DATES: We must receive comments on this proposed AD by September 3,
2013.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Ray Mei, Aerospace Engineer, Systems
and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6467; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2013-0544;
Directorate Identifier 2012-NM-057-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports of smoke or flames in the passenger cabin
of various transport category airplanes (the Boeing Company Model MD-11
and DC-9 airplanes and Lockheed Martin Corporation/Lockheed Martin
Aeronautics Company Model L-1011 series airplanes), related to the
wiring for the passenger cabin IFE system, cabin lighting, and
passenger seats. In response to these reports of smoke or flames in the
passenger cabin of various models of transport category airplanes, we
conducted a comprehensive IFE systems review.
    The systems review determined that, in order to minimize the risk
of smoke or flames in the passenger cabin, a switch is needed in the
flight compartment to enable the flightcrew to turn off electrical
power to the IFE system and other non-essential electrical systems. In
the event of smoke or flames in the airplane flight deck or passenger
cabin, the flightcrew's inability to turn off power to the IFE system
and other non-essential electrical systems could result in the
inability to control smoke or flames in the airplane flight deck or
passenger cabin during a non-normal or emergency situation.

Other Relevant Rulemaking

     For certain the Boeing Company Model 777-200 and -300
series airplanes: We have issued an NPRM (78 FR 27310, May 10, 2013),
which proposes to require installing wiring and changing certain
electrical load management system (ELMS) panels and other actions to
ensure that the flightcrew is able to turn off electrical power to the
IFE systems and other non-essential electrical systems through a switch
in the flight compartment in the event of smoke or flames.
     For the Boeing Company Model 757-200 and -300 series
airplanes: AD 2007-16-12, Amendment 39-15151 (72 FR 44740, August 9,
2007), requires changes to existing wiring; installation of new circuit
breakers, relays, relay connectors, and wiring; and replacement of
certain circuit breakers with higher-rated circuit breakers. For
certain airplanes, this AD also requires modification of wiring of the
control module assembly for the electrical systems.
     For the Boeing Company Model 767-200, -300, and -400ER
series airplanes: AD 2008-23-15, Amendment 39-15736 (73 FR 70267,
November 20, 2008), requires installing new relay(s), circuit breakers
as applicable, and wiring to allow the flightcrew to turn off
electrical power to the IFE systems and certain circuit breakers
through a utility bus switch, and doing other specified actions.
     For the Boeing Company Model 737-300, -400, -500, -600, -
700, -700C, -800, and -900 series airplanes: AD 2009-12-06, Amendment
39-15929 (74 FR 27698, June 11, 2009), requires installing a new
circuit breaker, relays, and wiring to allow the flightcrew to turn off
electrical power to the IFE systems and other non-essential electrical
systems through a switch in the flight compartment, and doing other
specified actions.
     For the Boeing Company Model 747-400 and -400D series
airplanes: AD 2009-15-12, Amendment 39-15975 (74 FR 35789, July 21,
2009), requires installing new relays to allow the flightcrew to turn
off electrical power to the IFE system and other non-essential
passenger cabin systems through the left and right utility bus
switches, and other specified actions.
     For certain the Boeing Company Model 777-200 and -300
series airplanes: We have issued an NPRM (78 FR 27310, May 10, 2013),
which proposes to require installing wiring and changing certain
electrical load management system (ELMS) panels and other actions to
ensure that the flightcrew is able to turn off electrical power to the
IFE systems and other non-essential electrical systems through a switch
in the flight compartment in the event of smoke or flames.

Relevant Service Information

    We reviewed Boeing Service Bulletin 777-24-0077, Revision 4, dated
October 17, 2012. For information on the procedures and compliance
times, see this service information at http://www.regulations.gov by
searching for Docket No. FAA-2013-0544.

Concurrent Service Information

    Boeing Service Bulletin 777-24-0077, Revision 4, dated October 17,
2012, specifies concurrent or prior accomplishment of Boeing Service
Bulletin 777-23-0176, Revision 2, dated October 26, 2006; and Boeing
Service Bulletin 777-24-0087, Revision 2, dated August 16, 2007. For
information on the procedures, see this service information at http://www.regulations.gov by searching for Docket No. FAA-2013-0544.

Other Service Information

    BAE Systems Service Bulletin 233W3202-24-04, Revision 2, dated
October 2, 2006, specifies identifying the electrical power control
panels 233W3202-12 and 233W3202-13.
    GE Aviation Service Bulletin 6000ELM-24-614, Revision 1, dated
November 9, 2009, specifies putting the P210 power panel back to the
correct standard.
    GE Aviation Service Bulletin 6200ELM-24-616, Revision 1, dated
March 5, 2010, specifies putting the P210 power panel back to the
correct standard.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously.
    The phrase ``related investigative actions'' might be used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that (1) are related to the primary action, and (2) are actions that
further investigate the nature of any condition found. Related
investigative actions in an AD could include, for example, inspections.
    In addition, the phrase ``corrective actions'' might be used in
this proposed AD. ``Corrective actions'' are actions that correct or
address any condition found. Corrective actions in an AD could include,
for example, repairs.

Costs of Compliance

    We estimate that this proposed AD affects 49 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection/installation and        Up to 28 work-hours          $1,436  Up to $3,816.......  Up to $186,984.
 changes.                           x $85 per hour =
                                    $2,380.
Concurrent installation (Boeing    2 work-hours x $85               $0  $170...............  $8,330.
 Service Bulletin 777-23-0176,      per hour = $170.
 Revision 2, dated October 26,
 2006).
Concurrent installation (Boeing    3 work-hours x $85               $0  $255...............  $12,495.
 Service Bulletin 777-24-0087,      per hour = $255.
 Revision 2, dated August 16,
 2007).
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary change that
would be required based on the results of the proposed inspection. We
have no way of determining the number of aircraft that might need this
replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                  Action                                Labor cost                 Parts cost        product
----------------------------------------------------------------------------------------------------------------
Change part number........................  1 work-hour x $85 per hour = $85..              $0              $85
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2013-0544; Directorate Identifier
2012-NM-057-AD.

(a) Comments Due Date

    We must receive comments by September 3, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Boeing Company Model 777-200 series
airplanes, certificated in any category, as specified in Boeing
Service Bulletin 777-24-0077, Revision 4, dated October 17, 2012.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 24, Electrical power.

(e) Unsafe Condition

    This AD was prompted by reports of smoke or flames in the
passenger cabin of various transport category airplanes related to
the wiring for the passenger cabin in-flight entertainment (IFE)
system, cabin lighting, and passenger seats. We are issuing this AD
to ensure that the flightcrew is able to turn off electrical power
to the IFE systems and other non-essential electrical systems
through a switch in the flight compartment in the event of smoke or
flames. In the event of smoke or flames in the airplane flight deck
or passenger cabin, the flightcrew's inability to turn off
electrical power to the IFE system and other non-essential
electrical systems could result in the inability to control smoke or
flames in the airplane flight deck or passenger cabin during a non-
normal or emergency situation, and consequent loss of control of the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Installation

    For Group 1, Configuration 1, airplanes, as identified in Boeing
Service Bulletin 777-24-0077, Revision 4, dated October 17, 2012:
Within 60 months after the effective date of this AD, install a new
electrical power control panel and make changes to the wiring and
certain electrical load management system (ELMS) panels, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 777-24-0077, Revision 4, dated October 17, 2012.

(h) Inspection

    For Group 1, Configuration 2, airplanes, as identified in Boeing
Service Bulletin 777-24-0077, Revision 4, dated October 17, 2012:
Within 60 months after the effective date of this AD, inspect the
electrical power control panel to determine the part number, and do
all applicable corrective actions, in accordance with the
Accomplishment Instructions of Boeing Service Bulletin 777-24-0077,
Revision 4, dated October 17, 2012. Do all applicable corrective
actions before further flight.

(i) Concurrent Actions

    (1) For Group 1, Configuration 1, airplanes, as identified in
Boeing Service Bulletin 777-24-0077, Revision 4, dated October 17,
2012: Prior to or concurrently with accomplishing the requirements
of paragraph (g) of this AD, install new operational software (OPS)
in the cabin management system to change the operation of the cabin
lighting system when the CABIN/UTILITY switch is installed, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 777-23-0176, Revision 2, dated October 26, 2006.
    (2) For Group 1, Configuration 1, airplanes, as identified in
Boeing Service Bulletin 777-24-0077, Revision 4, dated October 17,
2012: Concurrently with accomplishing the requirements of paragraph
(g) of this AD, change the ELMS OPS and configuration database
software (OPC) to decrease the number of ELMS P110, ELMS P210, and
ELMS P310 panel engine indication and crew alerting system (EICAS)
status messages, in accordance with the Accomplishment Instructions
of Boeing Service Bulletin 777-24-0087, Revision 2, dated August 16,
2007.

(j) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraphs (g) and (h) this AD, if those actions were performed
before the effective date of this AD using Boeing Service Bulletin
777-24-0077, dated

August 21, 2003; Revision 1, dated May 24, 2007; Revision 2, dated
December 17, 2009; or Revision 3, dated December 6, 2011; which are
not incorporated by reference in this AD; provided that, within 60
months after the effective date of this AD, the actions specified in
paragraphs (j)(1)(i) and (j)(1)(ii) of this AD are done, and wire
kit 280W5110-105W is used.
    (i) Identify the electrical power control panels 233W3202-12 and
233W3202-13 in accordance with the Accomplishment Instructions of
BAE Systems Service Bulletin 233W3202-24-04, Revision 2, dated
October 2, 2006. The correct part number for the changed 233W3202-12
panel is 233W3202-18, and the correct part number for the changed
233W3202-13 panel is 233W3202-19.
    (ii) Put back the P210 power panel to the correct standard, in
accordance with the Accomplishment Instructions of GE Aviation
Service Bulletin 6000ELM-24-614, Revision 1, dated November 9, 2009;
or 6200ELM-24-616, Revision 1, dated March 5, 2010.
    (2) This paragraph provides credit for the actions specified in
paragraph (i)(1) of this AD, if those actions were performed before
the effective date of this AD using Boeing Service Bulletin 777-23-
0176, dated January 9, 2003, or Revision 1, dated March 11, 2004;
provided that the actions specified in Boeing Service Bulletin 777-
23-0141, dated June 14, 2001, were done prior to or concurrently
with the actions specified in Boeing Service Bulletin 777-23-0176,
dated January 9, 2003, or Revision 1, dated March 11, 2004, which
are not incorporated by reference in this AD.
    (3) This paragraph provides credit for the actions specified in
paragraph (i)(2) of this AD, if those actions were performed before
the effective date of this AD using Boeing Service Bulletin 777-24-
0087, dated July 24, 2003, or Revision 1, dated December 18, 2003;
provided that the actions specified in Boeing Service Bulletin 777-
24-0087, dated July 24, 2003, or Revision 1, dated December 18,
2003, were done concurrently with the actions specified in Boeing
Service Bulletin 777-24-0077, dated August 21, 2003; Revision 1,
dated May 24, 2007; Revision 2, dated December 17, 2009; Revision 3,
dated December 6, 2011; or Revision 4, dated October 17, 2012.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane and the approval must
specifically refer to this AD.

(l) Related Information

    (1) For more information about this AD, contact Ray Mei,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton,
WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 26, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-17139 Filed 7-16-13; 8:45 am]
BILLING CODE 4910-13-P