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Guidance for FDA
Reviewers and
Sponsors
Content and Review of Chemistry,
Manufacturing, and Control (CMC)
Information for Human Gene Therapy
Investigational New Drug Applications
(INDs)
Additional copies of this guidance are available from the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD
20852-1448, or by calling 1-800-835-4709 or<PHONE_NUMBER>, or from the Internet at
http://www.fda.gov/cber/guidelines.htm.
For questions on the content of this guidance, contact the Office of Cellular, Tissue, and Gene
Therapies at<PHONE_NUMBER>.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
April 2008

Contains Nonbinding Recommendations
Table of Contents
I.
INTRODUCTION............................................................................................................. 1
A.
How will FDA Reviewers and Sponsors Use this Guidance?............................ 2
B.
How is this Guidance Organized? ....................................................................... 2
II.
ADMINISTRATIVE INFORMATION TO BE DOCUMENTED BY FDA
REVIEWERS .................................................................................................................... 3
III.
PRODUCT MANUFACTURING AND CHARACTERIZATION INFORMATION
TO BE SUBMITTED BY SPONSORS AND DOCUMENTED BY FDA
REVIEWERS .................................................................................................................... 4
A.
Product Manufacturing – Components and Materials ..................................... 4
1.
Vector.......................................................................................................... 4
2.
Cells ............................................................................................................ 5
3.
Reagents...................................................................................................... 9
4.
Excipients.................................................................................................. 12
5.
Additional Considerations ........................................................................ 12
B.
Product Manufacturing – Procedures .............................................................. 14
1.
Vector Production/Purification .................................................................. 14
2.
Preparation of ex Vivo Gene-Modified Autologous or Allogeneic Cells ... 15
3.
Process Timing and Intermediate Storage ................................................ 16
4.
Final Formulation ..................................................................................... 16
IV.
PRODUCT TESTING.................................................................................................... 16
A.
Microbiological Testing...................................................................................... 17
1.
Sterility Testing (Bacterial and Fungal Testing) ...................................... 17
2.
Mycoplasma.............................................................................................. 19
3.
Adventitious Agent Testing...................................................................... 19
B.
Identity................................................................................................................. 22
C.
Purity.................................................................................................................... 22
1.
Residual Contaminants ............................................................................. 22
2.
Pyrogenicity/Endotoxin ............................................................................ 23
D.
Potency................................................................................................................. 23
E.
Other .................................................................................................................... 24
1.
General Safety Testing.............................................................................. 24
2.
Viability .................................................................................................... 24
3.
Cell Number/Dose .................................................................................... 24
V.
FINAL PRODUCT RELEASE CRITERIA TESTING.............................................. 24
VI.
PRODUCT STABILITY................................................................................................ 25
VII.
OTHER ISSUES ............................................................................................................. 26
A.
Product Tracking................................................................................................ 26
B.
Labeling ............................................................................................................... 26
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Contains Nonbinding Recommendations
C.
Container/Closure............................................................................................... 27
D.
Environmental Impact ....................................................................................... 27
E.
Qualification of the Manufacturing Process .................................................... 27
F.
Biostatistics.......................................................................................................... 28
VIII.
PRECLINICAL STUDIES TO BE DOCUMENTED BY FDA REVIEWERS........ 29
A.
Summary of Concept Studies............................................................................. 29
B.
Gonadal Distribution.......................................................................................... 29
IX.
CLINICAL STUDIES TO BE DOCUMENTED BY FDA REVIEWERS................ 29
A.
Protocol Title....................................................................................................... 29
B.
Subject Population.............................................................................................. 29
C.
Route of Administration..................................................................................... 30
D.
Dose ...................................................................................................................... 30
E.
Frequency ............................................................................................................ 30
F.
Genetic, Biochemical, and Immunological Testing.......................................... 30
G.
Informed Consent ............................................................................................... 30
H.
Recombinant DNA Advisory Committee (RAC) Review................................ 30
X.
RECOMMENDATION TO BE DETERMINDED BY FDA REVIEWERS ............ 30
XI.
COMMENTS TO SPONSOR GENERATED BY FDA REVIEWERS .................... 31
A.
Clinical Hold........................................................................................................ 31
B.
Non-Clinical Hold ............................................................................................... 31
XII.
REFERENCES................................................................................................................ 32
APPENDIX A – PRODUCT REVIEW TEMPLATE (GENE THERAPY).......................... 35
APPENDIX B – CONSIDERATIONS FOR DEVELOPMENT OF FINAL PRODUCT
RELEASE CRITERIA SPECIFICATIONS AND STABILITY PROTOCOLS ..... 40
A.
Development of Release Acceptance Criteria .................................................. 40
B.
Development of Acceptance Criteria Analytical Procedures ......................... 40
C.
Development of Stability Protocols ................................................................... 41
ii

Contains Nonbinding Recommendations
Guidance for FDA Reviewers and Sponsors
Content and Review of Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene Therapy Investigational New
Drug Applications (INDs)
This guidance represents the Food and Drug Administration’s (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.  You can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations.  If you want to discuss an alternative
approach, contact the appropriate FDA staff.  If you cannot identify the appropriate FDA staff,
call the appropriate number listed on the title page of this guidance.
I.
INTRODUCTION
This guidance document provides to you, sponsors of a human gene therapy investigational new
drug application (IND), recommendations on the chemistry, manufacturing, and control (CMC)
information to include in an original IND.  This guidance also applies to combination products
that contain a human gene therapy biological product in combination with a drug or device as
part of the final product.  Also, this guidance instructs FDA CMC reviewers about the
information to record and assess as part of an IND review, taking into consideration the various
manufacturing challenges for these products.
In order to deliver a safe and effective product, human gene therapies present many
manufacturing challenges.  Some of these challenges include the variability and complexity
inherent in the components used to generate the final product, such as the source of cells (i.e.,
autologous or allogeneic), the potential for adventitious agent contamination, the need for aseptic
processing, and in the case of ex vivo genetically modified cell therapies the inability to
“sterilize” the final product because it contains living cells.  Distribution of these products can
also be a challenge due to stability issues and the frequently short dating period of many ex vivo
genetically modified cell products, which may necessitate release of the final product for
administration to a patient before certain test results are available.
This guidance finalizes the draft guidance entitled, “Guidance for FDA Review Staff and
Sponsors:  Content and Review of Chemistry, Manufacturing, and Control (CMC) Information
for Human Gene Therapy Investigational New Drug Applications (INDs)” dated November 2004
(69 FR 64958; November 9, 2004).
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities.  Instead, guidances describe the FDA’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in FDA’s guidances means that something is suggested or
recommended, but not required.
1

Contains Nonbinding Recommendations
A.
How will FDA Reviewers and Sponsors Use this Guidance?
FDA’s primary objectives in the review of INDs are to help ensure the safety and rights
of human subjects in all phases of an investigation and, in Phases 2 and 3, to help ensure
that the quality of the scientific evaluation of the investigational product is adequate to
permit an evaluation of its safety and effectiveness (21 CFR 312.22(a)).  This guidance
will help sponsors and FDA reviewers to assess, given the phase of the investigation,
whether sufficient information is provided to assure the proper identification (identity
testing), quality, purity, and strength (one aspect of potency) of the investigational
product (21 CFR 312.23(a)(7)(i)).  These principles apply to investigational biological
products and drugs; however, specific terms, such as safety, identity, purity, and potency,
are generally understood to be applicable to biological products and are used throughout
this document.
If you are a FDA reviewer, you will use this guidance as you assess the safety, identity,
purity, and potency of an investigational product and you will use the format of the
human gene therapy CMC review template (Appendix A) in preparing your reviews.
Because of the wide variability of the contents of IND amendments, you are only
expected to use the attached template during review of original IND submissions.
However, you should consult this document for guidance throughout the investigational
new drug development process.
The human gene therapies CMC review instructions and template described in this
guidance are tools to assist FDA in the review of human gene therapy INDs.  They are
designed to serve as a guide to help ensure that all applicable regulatory requirements are
reviewed at the appropriate stage of product development.  In addition to the CMC
review instructions and template, some general considerations are discussed in Appendix
B that should be helpful in assessing proposed release criteria testing and specifications.
Section 10.70 (21 CFR 10.70) provides further instruction to FDA reviewers regarding
documentation of review decisions.
If you are a sponsor of a human gene therapy IND, you may use this guidance in
developing an IND submission that will be adequate to permit FDA reviewers to make an
assessment of the safety, identity, purity, and potency of your investigational product.
Other regulatory documents that may be relevant are listed in the references (see Section
XII below).
B.
How is this Guidance Organized?
This guidance is organized in a format that generally corresponds to the sections in the
CMC review template provided in Appendix A.  In each section, where necessary, we
(FDA) provide recommendations as to the information you may submit in your original
IND submission.  As necessary throughout this document, we give specific instructions
to FDA reviewers concerning their documentation and assessment of an IND submission
during the CMC review.  Many of the instructions for FDA reviewers provided in this
guidance are distinguished by the designation “Note to FDA Reviewers.”
2

Contains Nonbinding Recommendations
II.
ADMINISTRATIVE INFORMATION TO BE DOCUMENTED BY FDA
REVIEWERS
Note to FDA Reviewers:  Document in your review all of the IND information listed below.
Most of this information should be available on Form FDA 1571, the sponsor’s cover letter, or
the reviewer assignment notice from the Regulatory Project Manager (RPM) of the application
division.
x
BB-IND Number (assigned by Center for Biologics Evaluation and Research (CBER)
after receipt);
x
Date of submission;
x
30-day review due date;
x
Sponsor – name, address, title, phone, fax;
x
Sponsor point of contact (sponsor’s authorized representative) – name, address, title,
phone, fax;
x
Title of IND;
x
Proposed use;
x
Product description;
x
Phase of study;
x
Cross-referenced INDs, investigational device exemptions (IDEs), and master files
(MFs):  List all regulatory files (IND, IDE, MF) that the sponsor has obtained permission
to cross-reference in support of this file.  The file under review must contain a letter
signed by the person who submitted the cross-referenced file (21 CFR 312.23(b)), giving
FDA permission to cross-reference the file.  This letter should identify the nature of the
information being cross-referenced (e.g., pre-clinical, product manufacturing, and/or
clinical) and where it is located within the file being cross-referenced.  You should verify
that the cross-referenced information satisfies the IND requirement for which the
information is cited.  If the letter of cross-reference is absent or inadequate, or the cross-
referenced information is inadequate for the purpose cited, the RPM or the reviewer
should notify the sponsor to obtain additional information;
x
Key words:  Include three to four words that can be used to identify the product,
indication, and any materials, components, or devices that may be part of the final
product or used in the manufacturing process.  These key words should be general
enough to be used in a database search;
x
Introduction/rationale:  Summarize relevant information on the development of the
product if the sponsor provides this information.  In addition, document and assess, as
appropriate, the sponsor’s scientific rationale and justification for using the product for
the indication under review; and
x
Study objectives.
3

Contains Nonbinding Recommendations
III.
PRODUCT MANUFACTURING AND CHARACTERIZATION INFORMATION
TO BE SUBMITTED BY SPONSORS AND DOCUMENTED BY FDA
REVIEWERS
As described in the following sections, you should provide a detailed description of where and
how the gene therapy product is manufactured.  You should include all of the components and
materials used during the manufacture of the gene therapy product, such as the vector, cells, cell
bank systems, and any reagents or excipients.  In addition, you should describe all procedures
used during the manufacturing process.  Examples of these procedures may include vector
derivation, purification, preparation of cell banks systems and testing, including final
formulation of the product.  This information will allow us to assess the identity, quality, purity,
and potency of your product.  For further information, refer to the guidance on “Content and
Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
Including Well-Characterized, Therapeutic, Biotechnology-Derived Products” (Ref. 1).  In
addition, you may refer to the other documents listed in the references (see Section XII below).
We also encourage sponsors to use the format and headings described in Appendix A to facilitate
an efficient review by FDA.
Note to FDA Reviewers:  Document and assess product manufacturing and characterization
information in your IND reviews.  Organize the CMC review using the format and headings
described in Appendix A and below, as appropriate.
A.
Product Manufacturing – Components and Materials
Note to FDA Reviewers:  Document the source of all materials and components and
summarize the testing performed on those materials and components, and review the
specific instructions and recommendations set out below.
Your IND must include a list of all components used in manufacturing of your product
(21 CFR 312.23(a)(7)(iv)(b)).  The sections below detail the information on
manufacturing components that we recommend you submit in an IND, and that FDA
reviewers will document and assess.
1. Vector
You should provide the following information about your vector:
a.
Gene Therapy Vector Construct
A description of the history and detailed derivation of the gene therapy vector
including:
x
The gene map, with relevant restriction sites, and any vector constructs
used during generation of the final vector and their sources;
x
The gene insert;
4

Contains Nonbinding Recommendations
x
Regulatory elements, such as promoter, enhancer, and poly-adenylation
signal; and
x
Selection markers.
b.
Vector  Diagram
A diagram of the vector identifying the gene insert and regulatory regions, and any
other relevant elements, such as pertinent restriction endonuclease sites:
Note to FDA Reviewers:  Document the vector diagram by scanning it into the
review document.
c.
Sequence  Analysis
Vectors 40 kilobases (kb) or less:  We recommend that you fully sequence all
vectors under 40 kb, perform sequence analysis, and submit an annotated sequence
of the entire vector.  You should provide a summary of the sequence analysis,
indicating the origin and function of each component of the vector that accounts for
all nucleotides such as promoters, known coding sequences, polyadenylation
signals, origins of replication and restriction sites used during construction of the
vector or for diagnostic tests.  You should provide an evaluation of the significance
of all discrepancies between the expected sequence and the experimentally
determined sequence and an evaluation of the significance of any unexpected
sequence elements, including open reading frames.  We recommend viral vectors be
sequenced from the master viral bank (MVB) when appropriate.  Plasmid sequence
should be obtained from the master cell bank (MCB), and retroviral vector sequence
should be obtained from the MVB/packaging cell line or from DNA obtained after
transduction of a stable cell line.
Vectors greater than 40 kb:  You should summarize the extent and results of
sequence analysis that you have performed including any testing performed by
restriction endonuclease analysis.  We recommend that you perform sequence
analysis of the gene insert, flanking regions, and any regions of the vector that are
modified.
2. Cells
a.
Allogeneic and/or Autologous Cell Components
You should describe the following information in your IND:
x
Cell source:  tissue and cell type (e.g., colon, hematopoietic, neuronal, T-
cells);
x
Mobilization protocol:  document whether or not donor cells are mobilized
or activated in vivo in the donor;
5

Contains Nonbinding Recommendations
x
Collection or recovery method:  state the procedure used to obtain cells
(e.g., surgery or leukapheresis indicating the device used if possible), the
name and location of the collection facility, and transport conditions if
shipped to a processing facility for further manufacturing; and
x
Donor screening and testing:  the donor screening and testing that is
performed to determine donor eligibility.  Requirements for screening and
testing donors of human cells and tissues are described in 21 CFR Part
1271 (see final rule, “Eligibility Determination for Donors of Human
Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)”) (Ref.
2).  When appropriate, you should document the donor safety testing that
is performed.  In addition, FDA has published a final “Guidance for
Industry:  Eligibility Determination for Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT/Ps)” (Ref. 3).  We
recommend that you review this guidance to ensure that the donor
qualification criteria described in your IND are consistent with current
recommendations.
1) Autologous
You are not required to make a donor eligibility determination or to perform
donor screening for cells and tissues for autologous use (21 CFR
1271.90(a)(1)).  However, you should determine whether your manufacturing
procedures increase the risk of propagation of pathogenic agents that may be
present in the donor.  If so, you should document whether the donor is
reactive for specific pathogens.  Also, you should describe precautions to
prevent the spread of viruses or other adventitious agents to persons other
than the autologous recipient (see Ref. 2).
2) Allogeneic
You must perform donor screening and testing as required in 21 CFR Part
1271 for all allogeneic cells or tissues except those that meet the exceptions
in 21 CFR 1271.90(a).  Donors of all types of cells and tissues must be
screened and tested for HIV-1, HIV-2, hepatitis B virus (HBV, surface and
core antigen), hepatitis C virus (HCV), Treponema pallidum (syphilis), and
CJD (screening only).  Donors of viable leukocyte-rich cells or tissues should
be screened and tested for human T-lymphotropic virus types 1 and 2
(HTLV-1, HTLV-2) and CMV.  In addition, you should document whether
FDA-licensed, cleared, or approved test kits are used in these detection
assays and document which tests are used.  Include a description of the type
of serological, diagnostic, and clinical history data obtained from the donor.
You should consider other issues such as typing for polymorphisms and
6

Contains Nonbinding Recommendations
human leukocyte antigen (HLA) matching, where appropriate.  If cord blood
or other maternally derived tissue is used, you should describe testing and
screening performed on birth mothers.
Note to FDA Reviewers:  Communicate with the clinical reviewer regarding any
issues or concerns relating to the screening or testing of the donor cells.
b.
Cell Bank System
You should describe pertinent information, as described in Sections 1) through 3)
below, relating to the cell bank system (i.e., master cell bank (MCB), and working
cell bank (WCB)) used in product manufacture.  In addition, you should describe
the history, source, derivation, characterization of each cell bank (both MCB and
WCB), and the frequency at which testing is performed.  For further information,
refer to the document on “Points to Consider in the Characterization of Cell Lines
Used to Produce Biologicals” (Ref. 4).  See also ICH document Q5D, “Derivation
and Characterization of Cell Substrates Used for Production of
Biotechnological/Biological Products” (Ref. 5), and, where applicable, “Guidance
for Industry:  Source Animal, Product, Preclinical, and Clinical Issues Concerning
the Use of Xenotransplantation Products in Humans” (Ref. 6) and the “PHS
Guideline on Infectious Disease Issues in Xenotransplantation” (Ref. 7).
1


[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11814-11815]
[FR Doc No: 2018-05309]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2018-0004]

Petition for Waiver of Compliance

    Under part 211 of Title 49 of the Code of Federal Regulations
(CFR), this document provides the public notice that on November 11,
2017, Brightline (BLF) has petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR part
229, Railroad Locomotive Safety Standards. FRA assigned the petition
docket number FRA-2018-0004.
    BLF has purchased ten Siemens SCB-40 locomotives to power
Brightline trains between Miami and Orlando, Florida. BLF requests
relief from the requirements of 49 CFR 229.61, Draft system, with
respect to the daily inspection procedure for the front coupler. The
locomotives are equipped

with a streamlined front coupler cover for improved aerodynamic and
esthetic purposes. BLF will use the front coupler for rescue purposes
only, and proposes to remove the coupler cover at 184-day inspection
intervals as required by 49 CFR 229.23 (b)(1). During the daily
inspection the front coupler will be visually inspected as best as
possible from the bottom. The nose cone will not be removed unless the
bottom visual inspection warrants further investigation based on the
requirements of 49 CFR 229.61. If the front coupler is used in
operations prior to the next daily inspection, the coupler will be
completely inspected before the coupler cover is replaced.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by April 30, 2018 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2018-05309 Filed 3-15-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31745-31746]
[FR Doc No: 2018-14568]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2905-033]

Village of Enosburg Falls, Municipal Water and Light Department;
Notice of Intent To File License Application, Filing of Pre-Application
Document, and Approving Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 2905-033.
    c. Date Filed: April 30, 2018.
    d. Submitted by: Village of Enosburg Falls, Vermont (Enosburg
Falls).
    e. Name of Project: Enosburg Falls Hydroelectric Project.
    f. Location: On the Missisquoi River in the Village of Enosburg
Falls, Franklin County, Vermont. No federal lands are occupied by the
project works or located within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 and 5.5 of the Commission's
regulations.
    h. Potential Applicant Contact: Paul V. Nolan, Representative of
Village of Enosburg Falls, 5515 North 17th Street, Arlington, VA 22205-
2722;<PHONE_NUMBER>; email at [email protected].
    i. FERC Contact: John Ramer at<PHONE_NUMBER>; or email at
[email protected].
    j. Enosburg Falls filed its request to use the Traditional
Licensing Process on

April 30, 2018 on behalf of the Village of Enosburg Falls Municipal
Water and Light Department, and provided public notice of the request
on April 27, 2018. In a letter dated June 28, 2018, the Director of the
Division of Hydropower Licensing approved Enosburg Falls' request to
use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7
of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the Vermont State Historic Preservation Officer, as
required by section 106 of the National Historic Preservation Act, and
the implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Enosburg Falls as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act; and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. Enosburg Falls filed a Pre-Application Document (PAD; including
a proposed process plan and schedule) with the Commission on behalf of
the Village of Enosburg Falls Municipal Water and Light Department,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's website
(http://www.ferc.gov), using the eLibrary link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
42 Village Drive, Enosburg Falls, VT 05450.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 2905. Pursuant to 18 CFR
16.8, 16.9, and 16.10, each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by April 30,
2021.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: June 28, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-14568 Filed 7-6-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58533-58535]
[FR Doc No: 2016-20358]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2016-0002]

Federal Advisory Council on Occupational Safety and Health
(FACOSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of FACOSH meeting.

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SUMMARY: The Federal Advisory Council on Occupational Safety and Health
(FACOSH) will meet Thursday, September 8, 2016, in Washington, DC.

DATES: FACOSH meeting: FACOSH will meet from 1 to 4 p.m., Thursday,
September 8, 2016.
    Submission of comments, requests to speak, speaker presentations,
and requests for special accommodations: You must submit (postmark,
send, transmit, deliver) comments, requests to speak at the FACOSH
meeting, speaker presentations, and requests for special accommodations
to attend the meeting by September 1, 2016.

ADDRESSES:
    FACOSH meeting: FACOSH will meet in Room N-3437, U.S. Department of
Labor, 200 Constitution Avenue NW., Washington, DC 20210.
    Submission of comments, requests to speak, and speaker
presentations: You may submit comments, requests to speak at the FACOSH
meeting, and speaker presentations using one of the following methods:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the online instructions for making submissions;
    Facsimile: If your submission, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648; or
    Mail, express delivery, hand delivery, or messenger/courier
service: You may submit materials to the OSHA Docket Office, Docket No.
OSHA-2016-0002, Room N-2625, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER> (OSHA TTY
(877) 889-5627). Deliveries (hand, express mail, messenger/courier
service) are accepted during the Department's and the OSHA Docket
Office's normal business hours, 8:15 a.m.--4:45 p.m., weekdays.
    Requests for special accommodations to attend the FACOSH meeting:
You may submit requests for special accommodations by hard copy, email,
or telephone to Ms. Frances Owens, OSHA Office of Communications, Room
N-3647, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; email<EMAIL_ADDRESS>telephone (202) 693-
1904.
    Instructions: All submissions must include the agency name and
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significant delay. Please contact the OSHA Docket Office for
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additional information making submissions, see Public Participation in
the SUPPLEMENTARY INFORMATION section of this notice.

    OSHA will post comments, requests to speak, and speaker
presentations, including any personal information provided, without
change in the FACOSH public docket and submissions may be available
online at http://www.regulations.gov. Therefore, OSHA cautions
individuals about submitting certain personal information, such as
Social Security numbers and birthdates.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    For general information: Mr. Francis Yebesi, Director, OSHA Office
of Federal Agency Programs, Room N-3622, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2122; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    FACOSH will meet September 8, 2016, in Washington, DC. The meeting
is open to the public. Some FACOSH members may attend the meeting
electronically.
    The tentative agenda for the FACOSH meeting includes:
     An update on federal agencies' efforts on improving
workplace safety and health and return-to-work outcomes for federal
workers who sustain injuries or illnesses in the performance of duty;
     Updates from the FACOSH subcommittee reviewing the status
of Federal Field Safety and Health Councils;
     The U.S. Department of Labor's 2015 data collection of
federal agency injuries and illnesses;
     OSHA activities to protect workers from the Zika Virus;
     The U.S. Department of Defense's Implementation of a
Safety and Health Management System;
     The status of the OSHA Safety and Health Program
Management Guidelines; and
     Developing guidelines for training senior federal agency
management on occupational safety and health issues.
    FACOSH is authorized by 5 U.S.C. 7902; section 19 of the
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 668);
and Executive Order 11612, as amended, to advise the Secretary of Labor
(Secretary) on all matters relating to the occupational safety and
health of federal employees. This includes providing advice on how to
reduce and keep to a minimum the number of injuries and illnesses in
the federal workforce, and how to encourage each federal Executive
Branch department and agency to establish and maintain effective
occupational safety and health programs. FACOSH operates in accordance
with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and
its implementing regulations (41 CFR part 102-3).
    OSHA transcribes and prepares detailed minutes of FACOSH meetings.
The Agency posts meeting transcripts and minutes plus other materials
presented at the FACOSH meeting in the public record of the meeting.

Public Participation, Submissions, and Access to Public Record

    FACOSH meeting: FACOSH meetings are open to the public. Individuals
attending FACOSH meetings at the U.S. Department of Labor must enter at
the Visitors' Entrance, 3rd and C Streets NW., and pass through
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security measures, and requests for special accommodations for
attending the FACOSH meeting, please contact Ms. Owens (see ADDRESSES
section).
    Submission of comments. You may submit comments, including data and
other information, using one of the methods listed in the ADDRESSES
section. Your submissions, including attachments and other materials,
must identify the agency name and the OSHA docket number for this
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supplementary materials electronically. If, instead, you wish to submit
hard copies of supplementary materials, you must submit them to the
OSHA Docket Office following the instructions in the ADDRESSES section.
The additional materials must clearly identify your electronic
submission by name, date, and docket number. OSHA will provide copies
of submissions to FACOSH members.
    Because of security-related procedures, receipt of submissions by
regular mail may result a significant delay. For information about
security procedures concerning submissions by hand, express delivery,
and messenger/courier service, please contact the OSHA Docket Office
(see ADDRESSES section).
    Submission of requests to speak and speaker presentations. You may
submit a request to speak to FACOSH and speaker presentations in
advance by one of the methods listed in the ADDRESSES section or sign
up at the FACOSH meeting to speak. Your request must state:
     The amount of time you request to speak;
     The interest you represent (e.g., organization name), if
any; and,
     A brief outline of your presentation.
    PowerPoint speaker presentations and other electronic materials
must be compatible with Microsoft Office 2010 formats. The FACOSH chair
may grant requests to address FACOSH at his discretion, and as time and
circumstances permit.
    Access to submissions and public record. OSHA places comments,
requests to speak, speaker presentations, meeting transcripts and
minutes, and other documents presented at the FACOSH meeting in the
public record without change. Those documents also may be available
online at http://www.regulations.gov. Therefore, OSHA cautions
individuals about submitting certain personal information, such as
Social Security numbers and birthdates.
    To read or download documents in the public record, go to Docket
No. OSHA-2016-0002 at http://www.regulations.gov. Although all meeting
documents are listed in the index of that Web page, some documents
(e.g., copyrighted materials) are not publicly available to read or
download. All meeting documents, including copyrighted materials, are
available at the OSHA Docket Office.
    Information about using http://www.regualtions.gov to make
submissions and access the record of FACOSH meetings is available at
that Web page. Please contact the OSHA Docket Office for assistance
with making submissions and obtaining documents in the FACOSH record,
and for information about materials that not available on http://www.regulations.gov.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information about FACOSH, also is available at OSHA's
Web page at http://www.osha.gov/.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this notice
pursuant to 5 U.S.C. 7902; 5 U.S.C. App. 2; 29 U.S.C. 668; Executive
Order 12196 (45 CFR 12629 (2/27/1980)), as amended; 41 CFR part 102-3;
and Secretary of Labor's Order No. 1-2012 (77 FR 3912).

    Signed at Washington, DC, on August 19, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-20358 Filed 8-24-16; 8:45 am]
 BILLING CODE 4510-26-P


SEQ CHAPTER \h \r 1 FILE NAME:   company.wpt   (7/1/2005) (xml)

Template Number P25

Metiram import crop October 2005 (wine and banana)

ATTENTION:

	All commodity terms must comply with the Food and Feed Commodity Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

	All text in blue font (instructions for preparing the document), should be removed prior to sending the document to the Federal Register Staff.  Instructional text and prompts in green font should also be removed.

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(7/1/2005)

EPA Registration Division contact: [Mary Waller, Product Manager (PM) 21, Telephone Number:<PHONE_NUMBER>]

TEMPLATE:

by establishing tolerances for residues of [metiram: a mixture of 5.2 parts by weight of ammoniates of [ethylenebis(dithiocarbamato)) zinc with 1part by weight ethylenebis (dithiocarbamic acid) bimolecular and trimolecular cyclic anhydrosulfides and disulfides, calculated as zinc ethylenebisdithiocarbamate] in or on the raw agricultural commodity [grapes] at [7.0] parts per million (ppm) and in or on the raw agricultural commodity [bananas (whole fruit)] at [5.0] parts per million (ppm).. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition.  Additional data may be needed before EPA rules on the petition.

. [Residue and processing studies on grapes were conducted in Germany, France, Spain and Italy, in support of a metiram tolerance on grapes for the purpose of importing wine into the United States.  Thirty-five (35) field residue trials in Germany were conducted on grapes treated with Polyram 80 DF fungicide.  Fifteen (15) residue trials in Germany, France and Spain were conducted with a solo formulation of metiram (5 trials), a formulation of metiram and pyraclostrobin (5 trials), or a solo formulation of pyraclostrobin (5 trials).  An additional seven (7) residue trials were conducted with a formulation of metiram and pyraclostrobin.  Four (4) residue studies in Italy were conducted with a formulation of metiram and cymoxanil.  Three grape processing studies, consisting of a total of 10 trials, were preformed in Germany (4 trials), France (4 trials) and Spain (2 trials).  These studies are considered suitable for deriving processing factors.

.  [A developmental toxicity study in rats tested metiram via oral gavage at doses of 0, 40, 80 and 160 mg/kg/day.  At 160 mg/kg/day, a slightly decreased body weight gain was observed in the dams.  Also at 160 mg/kg/day, increased pre- and post-implantation losses, decreased litter size, and decreased litter weight was observed.  Metiram was not teratogenic.  The NOAEL for both maternal and developmental toxicity was 80 mg/kg/day.  A developmental toxicity study in rabbits tested metiram at doses of 0, 10, 40 and 120 mg/kg/day. The NOAEL for maternal toxicity was 10 mg/kg/day based on abortions at 40 and 120 mg/kg/day.  The NOAEL for developmental toxicity was 40 mg/kg/day based on slightly reduced fetal weights at 120 mg/kg/day.

. [Ethylenethiourea (ETU) is a metabolite of Metiram.

		i. Acute toxicity of ETU.  Based on available acute toxicity data, ETU does not pose an acute risk.  The acute toxicity studies place ETU in acute toxicity category III for acute dermal; and in category IV for acute inhalation, eye irritation and skin sensitization.  An acute oral toxicity study has not been performed.

		ii. Genotoxicity of ETU.  ETU was tested in a series of in vitro and in vivo genotoxicity assays.  ETU induced a variety of genotoxic endpoints, including gene mutation assays (Ames and mouse lymphoma assays), structural chromosomal assays (aberrations in cultured mammalian cells, dominant lethal assay), and other genotoxic effects (bacterial recombination assay, yeast conversion assay).  Although ETU induced a variety of genotoxic endpoints, it does not appear to be a potent genotoxic agent.

		iii.  Reproductive and developmental toxicity of ETU.  Developmental defects in ETU rat studies included hydrocephalus and related CNS lesions, skeletal malformations and various soft tissue malformations.  Of the three rat studies conducted, the lowest NOAEL was 5 mg/kg/day based on developmental defects of the brain (exencephaly, dilated ventricles and hypoplastic cerebellum) at 10 mg/kg/day.

	iv.  Subchronic toxicity of ETU.  The short-term toxicity of ETU was investigated in 13-week studies in rat, mouse and dog.  The signs of toxicity observed were overall similar with the thyroid as the target organ.  The effects observed typically included changes in thyroid hormone and TSH levels as well as increased thyroid weights.

	v.  Chronic toxicity of ETU.  The chronic toxicity of ETU was investigated in rat, mouse and dog studies.  The signs of toxicity observed were thyroid hyperplasia, increased thyroid weight and changes in thyroid hormone and TSH levels.  The lowest NOAEL for chronic effects was determined to be 2 mg/kg/day observed in the chronic dog study.

. [Metiram: The Environmental Protection agency has evaluated the dietary exposure from metiram for apples, potatoes, and imported wine (Metiram Acute, Chronic, and Cancer Dietary Exposure Assessments for the Reregistration Eligibility Decision. United States Environmental Protection Agency, PC Code:  014601, DP Barcode D290039,  October 21, 2003).  EPA has determined that for acute dietary exposure to metiram, females ages 13-49 are the only population of concern.  EPA determined that acute dietary exposure and risk assessment for all the general population and all other sub-populations is not required based on results from toxicological studies.  BASF utilized the exposure assessments for metiram determined by the EPA and included the additional dietary exposure for metiram from imported bananas.  The acute dietary exposure and %aPAD utilized are shown in the table below.

Results for Metiram Acute Dietary Assessment Using the 99.9th Percentile Exposure Value:

Population Subgroup	aPAD

(mg/kg bw/day)	99.9th Percentile

Exposure

(mg/kg bw/day)	% aPAD

Females

13-49 yrs old	0.01	0.001264	12.64

The acute dietary exposure assessment demonstrates that there is no safety concern from the acute exposure to metiram.

The chronic dietary metiram exposure and %cPAD utilized are shown in the table below.

Results for Metiram Chronic Dietary Assessment:

Population Subgroup	cPAD

(mg/kg bw/day)	Exposure

(mg/kg bw/day)	% cPAD

US Population	0.0004	0.00001677	4.19

Infants < 1 yr	0.0004	0.00005402	13.51

Children 1-2 years old	0.0004	0.00007882	19.71

Children 3-5 years old	0.0004	0.00004771	11.93

Children 6–12 years old	0.0004	0.00001942	4.86

Youth 13-19 years old	0.0004	0.000006	1.50

Adults 20-49 years old	0.0004	0.00000974	2.44

Females 13-49 years old	0.0004	0.00001567	3.92

Adults 50+ years old	0.0004	0.00000852	2.13

The chronic dietary exposure assessment demonstrates that there is no safety concern from the chronic exposure to metiram.

	ETU: Ethylenethiourea (ETU) is a metabolite of metiram and other EBDC fungicides.  The U.S. EPA conducted an acute, chronic, and cancer dietary exposure assessment for ETU to determine the exposure and risk estimates that may result from the use of metiram on crops included in the reregistration eligibility decision (RED) (Metiram Acute, Chronic, and Cancer Dietary Exposure Assessments for the Reregistration Eligibility Decision. United States Environmental Protection Agency, PC Code:  014601, DP Barcode D305909,  October 13, 2004).

The EPA has determined that for acute dietary exposure to ETU, females ages 13-50 are the only population of concern.  The EPA determined that acute dietary exposure and risk assessment for all the general population and all other sub-populations is not required based on results from toxicological studies.  The results presented in this risk assessment include EPA and higher tiered assessments conducted by BASF (Metiram-Based Total ETU in Imported Wine: Dietary Exposure and Risk Analysis. BASF Registration Document Number 2005/7001320, May 25, 2005). The acute dietary exposure and %aPAD utilized are shown in the table below.

Results for ETU Acute Dietary Assessment Using the 99.9th Percentile Exposure Value:

Population Subgroup	aPAD

(mg/kg bw/day)	99.9th Percentile

Exposure

(mg/kg bw/day)	% aPAD

Females

13-49 yrs old	0.005	0.0015016	30.03

The acute dietary exposure assessment demonstrates that there is no safety concern from the acute exposure to ETU.

The chronic dietary ETU exposure and %cPAD utilized are shown in the table below.

Results for ETU Chronic Dietary Assessment :

Population Subgroup	cPAD

(mg/kg bw/day)	Exposure

(mg/kg bw/day)	% cPAD

US Population	0.0002	0.00001157	6.43

Infants < 1 yr	0.0002	0.00001035	5.75

Children 1-2 years old	0.0002	0.00001808	10.04

Children 3-5 years old	0.0002	0.00001094	6.08

Children 6–12 years old	0.0002	0.00000378	2.10

Youth 13-19 years old	0.0002	0.00000187	1.04

Adults 20-49 years old	0.0002	0.00001052	5.84

Females 13-49 years old	0.0002	0.00001001	5.56

Adults 50+ years old	0.0002	0.00001164	6.47

The chronic dietary exposure assessment demonstrates that there is no safety concern from the chronic exposure to ETU.

The cancer dietary ETU exposure and risk are shown in the table below.  The Q1* value used in for the cancer risk assessment was 0.0601 (mg/kg bw/day)-1.

Results for ETU Cancer Dietary Assessment :

Population Subgroup	Exposure

(mg/kg bw/day)	Estimated Cancer Risk

US Population	0.00001157	6.95 x 10-7

. [The Environmental Protection Agency (EPA) has evaluated the human exposure of metiram from drinking water and concluded that metiram will not be present in surface or ground water because metiram is rapidly degraded in soil and water (Metiram: Health Effects Division (HED) Human Health Risk Assessments to support Reregistration. United States Environmental Protection Agency, DP Barcode No. D305906, October 14, 2004).  Therefore, human exposure of metiram in drinking water is not included in this risk assessment.  Ethylenethiourea (ETU) is a degradate of metiram and the other Ethylenebisdithio carbamate (EBDC) fungicides (maneb, mancozeb).  ETU may reach surface and ground water under certain conditions.  The EPA has determined the Estimated Drinking Water Concentrations (EDWCs) for ETU (Revised Estimated Drinking Water Concentrations of Ethylenebisdithio carbamate(EBDC) Degradate Ethylenethiourea (ETU) for Use in Human Health Risk Assessments. United States Environmental Protection Agency, DP Barcode D290057, February 5, 2004).  The surface water concentrations for ETU are 1.33 ppb (ug/L) for acute (peak) exposure, 0.1 ppb for chronic/non-cancer, and 0.08 for chronic cancer.  The ground water concentration for ETU is 0.21 ppb.

Aggregate exposure includes exposure from food, drinking water, and residential uses.  The exposure from residential uses is included in the short and intermediate-term aggregate exposure assessments.  Metiram is not registered for any residential use and therefore, a short-term or intermediate-term aggregate risk was not conducted.  The acute and chronic aggregate exposure assessment includes exposure from food and water.  Metiram residues will not be present in drinking water and therefore, the acute and chronic aggregate assessments include only food exposure.  The metiram food exposure assessment conducted shows that the aggregate exposure from apples, potatoes, and wine is not of concern.

Drinking water exposure for ETU was calculated using DEEM-FCID commodities “Water, direct, all sources” and “water, indirect, all sources”.  The chronic and cancer exposure was calculated using a Estimated Drinking Water Concentration (EDWC) of 0.21 ppb.  The acute water exposure was calculated using a EDWC value of 1.33 ppb.

The acute aggregate exposure for ETU including food exposure shown above with the additional exposure from drinking water is shown below.

Population Subgroup	aPAD (mg/kg/day)	Food Exp (mg/kg/day)	Water Exp (mg/kg/day)	Aggregate Total Exposure (food + water)	% aPAD

Females 13-49 years	0.005	0.0015016	0.000065	0.0015666	31.332

The results demonstrate that there are no acute exposure safety concerns for females 13-49 based on established and new uses, and that the results clearly meet the FQPA standard of reasonable certainty of no harm.

The chronic aggregate exposures for ETU including food exposure shown above with the additional exposure from drinking water are shown in the table below.

Population Subgroup	cPAD (mg/kg/day)	Food Exp (mg/kg/day)	Water Exp (mg/kg/day)	Aggregate Exposure (food + water) 	% cPAD

US Population	0.0002	0.00001157	0.000004	0.00001557	8.65

Infants < 1 yr	0.0002	0.00001035	0.000015	0.00002535	14.08

Children 1-2 years old	0.0002	0.00001808	0.000006	0.00002408	13.38

Children 3-5 years old	0.0002	0.00001094	0.000006	0.00001694	9.41

Children 6–12 years old	0.0002	0.00000378	0.000004	0.00000778	4.32

Youth 13-19 years old	0.0002	0.00000187	0.000003	0.00000487	2.71

Adults 20-49 years old	0.0002	0.00001052	0.000004	0.00001452	8.07

Females 13-49 years old	0.0002	0.00001001	0.000004	0.00001401	7.78

Adults 50+ years old	0.0002	0.00001164	0.000004	0.00001564	8.69

The results demonstrate that there are no chronic exposure safety concerns for any subpopulation based on established and new uses, and that the results clearly meet the FQPA standard of reasonable certainty of no harm.

The cancer dietary exposure and calculated Drinking Water Levels of Comparison for ETU are shown in the table below.

Population Subgroup	Q1* (mg/kg/day)	Food Exp (mg/kg/day)	Water Exp (mg/kg/day)	Aggregate Exposure (food + water) 	Cancer Risk

US Population	0.0601	0.00001157	0.000004	0.00001557	9.36 x 10-7

	[Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the EPA must consider available information concerning the cumulative effects of a particular pesticide’s residues and other substances that have a common mechanism of toxicity.

The EPA has concluded that the N-methyl carbamates subgroup should be designated as a common mechanism group based on their shared ability to inhibit acetylcholinesterase.  Dithiocarbamates, which includes the EBDC fungicides, are not included in the cumulative assessment because they do not share cholinesterase inhibition as a common principal mechanism of toxicity.

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[Federal Register: March 18, 2010 (Volume 75, Number 52)]
[Notices]
[Page 13174]
[DOCID:fr18mr10-111]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61696; File No. SR-CBOE-2010-005]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Approving Proposed Rule Change To Establish Strike
Price Intervals and Trading Hours for Options on Index-Linked
Securities

March 12, 2010.

I. Introduction

    On January 27, 2010, the Chicago Board Options Exchange,
Incorporated (``CBOE'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to establish strike price
intervals and trading hours for Index-Linked Securities. The proposed
rule change was published for comment in the Federal Register on
February 8, 2010.\3\ The Commission received no comment letters on the
proposal. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 61466 (February 2,
2010), 75 FR 6243.
---------------------------------------------------------------------------

II. Description of the Proposal

    Prior to the commencement of trading options on Index-Linked
Securities (also known as exchange-traded notes (``ETN'')), CBOE has
proposed to establish strike price intervals and trading hours for
these new products. The Commission has approved CBOE's and other option
exchanges' proposals to enable the listing and trading of options on
Index-Linked Securities.\4\
---------------------------------------------------------------------------

    \4\ See e.g., Securities Exchange Act Release Nos. 58204 (July
22, 2008), 73 FR 43807 (July 28, 2008) (approving SR-CBOE-2008-64);
58203 (July 22, 2008), 73 FR 43812 (July 28, 2008) (approving SR-
NYSEArca-2008-57); 58985 (November 10, 2008), 73 FR 72538 (November
28, 2008) (approving SR-ISE-2008-86).
---------------------------------------------------------------------------

$1 Strikes for ETN Options

    CBOE's proposal would extend the trading conventions applicable to
options on exchange-traded funds (``ETFs'') to options on Index-Linked
Securities. Specifically, under the proposed rule change, strike price
intervals of $1 will be permitted where the strike price is less than
$200. Where the strike price is greater than $200, $5 strikes will be
permitted. These proposed changes are reflected by the proposed
addition of new Interpretation and Policy .09 to Rule 5.5. The proposed
strike price intervals for options on Index-Linked Securities are
consistent with the strike price intervals currently permitted for
options on ETFs.\5\
---------------------------------------------------------------------------

    \5\ See Interpretation and Policy .08 to Rule 5.5. See also
Securities Exchange Act Release No. 46507 (September 17, 2002), 67
FR 60266 (September 25, 2002) (permitting list of options on ETFs at
$1 strike price intervals) (SR-CBOE-2002-54).
---------------------------------------------------------------------------

    In support of its proposal, CBOE stated that it believes the
marketplace and investors will be expecting ETN options to trade in a
similar manner to options on ETFs. Strike prices for ETF options are
permitted in $1 or greater intervals where the strike price is $200 or
less and $5 or greater where the strike price is greater than $200.\6\
Accordingly, the Exchange asserts that the rationale for permitting $1
strikes for ETF options equally applies to permitting $1 strikes for
ETN options and that investors will be better served if $1 strike price
intervals are available for ETN options (where the strike price is less
than $200).
---------------------------------------------------------------------------

    \6\ See id.
---------------------------------------------------------------------------

    CBOE further stated that it has analyzed its capacity and
represents that it believes the Exchange and the Options Price
Reporting Authority have the necessary systems capacity to handle the
additional traffic associated with the listing and trading of $1
strikes (where the strike price is less than $200) for ETN options.

Trading Hours for ETN Options

    Similar to the trading hours for ETF options, the Exchange's
proposal also would amend Interpretation and Policy .03 to Rule 6.1 by:
(1) Adding new subparagraph (b) to provide that options on Index-Linked
Securities, as defined under Interpretation and Policy .13 to Rule 5.3,
may be traded on the Exchange until 3:15 p.m. each business day; and
(2) making a technical change to Interpretation and Policy .03 to Rule
6.1.

III. Discussion

    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.\7\
Specifically, the Commission finds that the proposal is consistent with
Section 6(b)(5) of the Act,\8\ which requires, among other things, that
the rules of a national securities exchange be designed to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission notes that the proposed strike price intervals for
options on Index-Linked Securities are consistent with the strike price
intervals currently permitted for options on ETFs.\9\ Accordingly, the
proposal should provide consistency and predictability for investors
who may view these products as serving similar investment functions in
the marketplace to ETFs and may provide investors with greater
flexibility in achieving their investment objectives.
---------------------------------------------------------------------------

    \9\ See supra note 5.
---------------------------------------------------------------------------

    In addition, the Commission notes that CBOE has represented that it
believes the Exchange and the Options Price Reporting Authority CBOE
and the Options Price Reporting Authority have the necessary systems
capacity to handle the additional traffic associated with the listing
and trading of $1 strikes for options on Index-Linked Securities.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-CBOE-2010-005) be, and
hereby is, approved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-5917 Filed 3-17-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49624-49625]
[FR Doc No: 2019-20378]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0042; Notice 1]

Gillig, LLC, Receipt of Petition for Decision of Inconsequential
Noncompliance

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

ACTION: Receipt of petition.

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

SUMMARY: Gillig LLC, has determined that certain model year (MY) 2013-
2019 Gillig Low Floor buses do not fully comply with Federal Motor
Vehicle Safety Standard (FMVSS) No. 102, Transmission Shift Position
Sequence, Starter Interlock, and Transmission Braking Effect. Gillig
filed a noncompliance report dated April 1, 2019, and later amended
their report on April 23, 2019. Gillig subsequently petitioned NHTSA on
May 8, 2019, for a decision that the subject noncompliance is
inconsequential as it relates to motor vehicle safety. This notice
announces receipt of Gillig's petition.

DATES: Send comments on or before October 21, 2019.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and may be
submitted by any of the following methods:
     Mail: Send comments by mail addressed to the 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 comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000 (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: Gillig has determined that certain MY 2013-2019 Low
Floor buses do not fully comply with paragraph S3.1.3 of FMVSS No. 102,
Transmission Shift Position Sequence, Starter Interlock, and
Transmission Braking Effect (49 CFR 571.102). Gillig filed a
noncompliance report dated April 1, 2019, and later amended their
report on April 23, 2019, pursuant to 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports. and subsequently petitioned
NHTSA on May 8, 2019, for an exemption from the notification and remedy
requirement of 49 U.S.C Chapter 301 on the basis that this
noncompliance is inconsequential as it relates to motor vehicle safety,
pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556,
Exemption for Inconsequential Defect or Noncompliance.
    This notice of receipt of Gillig's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercises of judgment concerning the merits of the petition.
    II. Buses Involved: Approximately 925 MY 2013-2019 Gillig Low Floor
buses, manufactured between December 23, 2013, and February 25, 2019,
are potentially involved.
    III. Noncompliance: Gillig explains that the noncompliance is that
the subject buses are equipped with a starter interlock that is
operational while the transmission shift position is in a forward or
reverse drive position and therefore, does not meet the requirements in
paragraph S3.1.3 of FMVSS No. 102.
    IV. Rule Requirements: Paragraph S3.1.3 of FMVSS No. 102 provides
the requirements relevant to this petition. Except as provided in
paragraphs S<IP_ADDRESS> through S<IP_ADDRESS>, the engine starter shall be
inoperative when the transmission shift position is in a forward or
reverse drive position.

    V. Summary of Petition: Gillig described the subject noncompliance
and stated its belief that the noncompliance is inconsequential as it
relates to motor vehicle safety. In support of its petition, Gillig
submitted the following reasoning:

    1. The potentially non-compliant condition occurs as follows:
When the ignition switch is in the ON position, the engine is
stopped, the shift selector is in the ``Forward'' or ``Reverse''
position, and the start button is depressed, the starter cranks the
engine, but the transmission does not engage because, according to
ATI, the shifter is in an inhibited state. With the engine running,
the vehicle operator must perform four separate actions in a
specific sequence to engage the transmission and move the vehicle
under power, specifically: (a) place foot on brake (b) select
neutral (c) select a gear, and (d) remove foot from foot brake.
Fortunately, because the transmission controller defaults the
transmission to neutral after an engine start, there is no risk of
unintentional vehicle movement, and thus, no safety risk arises as a
result of the non-compliant condition.

    Gillig concluded that the subject noncompliance is inconsequential
as it relates to motor vehicle safety and that its petition to be
exempted from providing notification of the noncompliance, as required
by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by
49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject buses that Gillig no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve vehicle
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant buses under their control after Gillig
notified them that the subject noncompliance existed.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2019-20378 Filed 9-19-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92964-92966]
[FR Doc No: 2016-30579]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0109; Notice 1]

Mercedes-Benz USA, LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

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

ACTION: Receipt of petition.

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

SUMMARY: Mercedes-Benz USA, LLC (MBUSA), has determined that certain
model year (MY) 2015-2016 Mercedes-Benz CLS-Class motor vehicles do not
fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No.
110, Tire Selection and Rims and Motor Home/Recreation Vehicle Trailer
Load Carrying Capacity Information for Motor Vehicles with a GVWR of
4,536 kilograms (10,000 pounds) or Less. MBUSA filed a Safety Recall
Report dated September 12, 2016. MBUSA also petitioned NHTSA on October
4, 2016, for a decision that the subject noncompliance is
inconsequential as it relates to motor vehicle safety.

DATES: The closing date for comments on the petition is January 19,
2017.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this

notice and submitted by any of the following methods:
     Mail: Send comments by mail addressed to 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 comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) Web site at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the Internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:

I. Overview

    Mercedes-Benz USA, LLC (MBUSA), has determined that certain model
year (MY) 2015-2016 Mercedes-Benz CLS-Class motor vehicles do not fully
comply with paragraph S4.3(a) of Federal Motor Vehicle Safety Standard
(FMVSS) No. 110, Tire Selection and Rims and Motor Home/Recreation
Vehicle Trailer Load Carrying Capacity Information for Motor Vehicles
with a GVWR of 4,536 kilograms (10,000 pounds) or Less. MBUSA filed a
report dated September 12, 2016, pursuant to 49 CFR part 573, Defect
and Noncompliance Responsibility and Reports. MBUSA also petitioned
NHTSA on October 4, 2016, pursuant to 49 U.S.C. 30118(d) and 30120(h)
and 49 CFR part 556, for an exemption from the notification and remedy
requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential as it relates to motor vehicle safety.
    This notice of receipt of MBUSA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.

II. Vehicles Involved

    Approximately 6,678 MY 2015-2016 Mercedes-Benz CLS 400 and
Mercedes-Benz CLS 400 4MATIC motor vehicles manufactured between May
23, 2014 and April 21, 2016, are potentially involved.

III. Noncompliance

    MBUSA explains that the noncompliance is that the subject vehicles
have tire and loading information placards affixed to their B-pillars
that incorrectly identify the maximum combined weight of occupants and
cargo. Specifically, the Mercedes CLS 400 was manufactured with a tire
information placard that identifies a maximum combined weight of 420
kilograms (926 pounds) and the Mercedes CLS 400 4MATIC was manufactured
with a tire information placard that identifies a maximum combined
weight of 355 kilograms (783 pounds). However, the maximum combined
weight of occupants and cargo should be 315 kilograms (694 pounds) for
the Mercedes CLS 400 and 325 kg (717 pounds) for the CLS 400 4MATIC.
Therefore, the vehicles do not comply with paragraph S4.3 of FMVSS No.
110.

IV. Rule Text

    Paragraph S4.3 of FMVSS No. 110 states:

    S4.3 Placard. Each vehicle, except for a trailer or incomplete
vehicle, shall show the information specified in S4.3 (a) through
(g), and may show, at the manufacturer's option, the information
specified in S4.3 (h) and (i), on a placard permanently affixed to
the driver's side B-pillar. . . .
    (a) Vehicle capacity weight expressed as ``The combined weight
of occupants and cargo should never exceed XXX kilograms or XXX
pounds''

V. Summary of MBUSA's Petition

    MBUSA described the subject noncompliance and stated its belief
that the noncompliance is inconsequential as it relates to motor
vehicle safety.
    In support of its petition, MBUSA submitted the following
reasoning:
    (a) The tires originally equipped on the subject vehicles are able
to carry the additional weight indicated on the tire label. Further,
the tire pressure detailed on the label is sufficient to carry those
weights. The maximum tire and vehicle load information detailed in the
table below demonstrates that the tire is designed to carry a higher
load than that which was incorrectly set out on the tire label:

----------------------------------------------------------------------------------------------------------------
                                                                                Maximum vehicle load (per
                                                                                tire)
                         Tire dimension                            Maximum tire  -------------------------------
                                                                    load (lbs)                    CLS 400 4MATIC
                                                                                CLS 400 (lbs)       (lbs)
----------------------------------------------------------------------------------------------------------------
18'' front......................................................            1708            1243            1289
18'' rear.......................................................            1609            1256            1278
19'' front......................................................            1565            1243            1289
19'' rear.......................................................            1653            1256            1278
----------------------------------------------------------------------------------------------------------------

    (b) Should the driver follow the values displayed on the tire
label, motor vehicle safety is not negatively impacted. The vehicle
platform (including chassis and axles) serves other CLS vehicle lines
and is designed for vehicles with a higher gross vehicle weight rating
(``GVWR''). The platform therefore can handle the potential additional
weight.
    (c) Subject vehicles are equipped with the B-pillar certification
information label in accordance with 49 CFR part 567 indicating a GVWR
of 2260 kilograms (4982 pounds) for vehicle type 218.365, the CLS 400,
and a GVWR of 2330 kg (5137 pounds) for vehicle type 218.367, the CLS
400 4MATIC. The information detailed on the B-pillar certification
information label is correct. Therefore, the driver can refer to this
alternative source of information in order to determine the correct
maximum load weight of the vehicle.
    (d) After identifying the potentially incorrect values in the tire
label, Daimler AG (DAG) analyzed potential technical implications,
specifically with respect to the requirements of FMVSS No. 110,
including potential effects on axles, suspension, brakes, driving
dynamic, and crashworthiness. Based on this analysis, an impact on
steering, braking or other vehicle dynamics as a result of the tire
label weight discrepancy can be excluded.
    (e) Moreover, MBUSA is not aware of any customer complaints,
accidents or injuries alleged to have occurred as a result of this non-
compliance. Hence, field data supports the assertion that the issue
described above will have an inconsequential impact on safety.
    MBUSA concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles that MBUSA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve vehicle
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after MBUSA
notified them that the subject noncompliance existed.

    Authority:  (49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8)

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-30579 Filed 12-19-16; 8:45 am]
 BILLING CODE 4910-59-P