[Federal Register: October 3, 2008 (Volume 73, Number 193)]
[Notices]
[Page 57693-57695]
[DOCID:fr03oc08-112]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 28420; 812-13533]

Forward Funds and Forward Management, LLC; Notice of Application

September 29, 2008.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act.

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Summary of Application: Applicants request an order that would
supersede an existing order that permits them to enter into and
materially amend subadvisory agreements without shareholder approval
(``Existing Order'').\1\
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    \1\ Forward Funds, et al., Investment Company Act Release Nos.
27777 (April 5, 2007) (notice) and 27814 (May 1, 2007) (order).

Applicants: Forward Funds (the ``Trust'') and Forward Management, LLC
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(``Forward Management'').

DATES: Filing Dates: The application was filed on May 19, 2008 and
amended on September 25, 2008.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on October 24, 2008, and should be accompanied by proof of service
on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
St., NE., Washington, DC 20549-1090; Applicants, 433 California Street,
11th Floor, San Francisco, CA 94104.

FOR FURTHER INFORMATION CONTACT: Mary Kay Frech, Branch Chief, or
Michael W. Mundt, Assistant Director, at<PHONE_NUMBER> (Division of
Investment Management, Office of Investment Company Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Desk, 100 F St., NE., Washington, DC
20549-1520 (telephone<PHONE_NUMBER>).

Applicants' Representations

    1. The Trust is organized as a Delaware statutory trust and is
registered under the Act as an open-end management investment company.
The Trust currently offers sixteen series (the ``Funds''), each with
its own investment objectives, policies, and restrictions. Applicants
request that the order apply to: (a) The Funds; and (b) any future
series of the Trust and any other registered open-end management
investment companies or series thereof that (1) use the ``manager-of-
managers'' arrangement described in the application, (2) comply with
the terms and conditions of the application, and (3) are advised by a
Manager (as defined below) (the investment companies and their series,
as well as the Funds, the ``Sub-Advised Funds'').\2\
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    \2\ All existing entities that currently intend to rely on the
order are named as applicants. Any entity that relies on the order
in the future will do so only in accordance with the terms and
conditions of the application. If the name of any Sub-Advised Fund
contains the name of a Sub-Adviser (as defined below), the name of
the Manager that serves as the primary adviser to the Sub-Advised
Fund will precede the name of the Sub-Adviser.
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    2. Forward Management is registered as an investment adviser under
the Investment Advisers Act of 1940 (the ``Advisers Act'') and serves
as investment adviser to the Funds pursuant to an investment advisory
agreement with the Trust, on behalf of the Funds (``Advisory
Agreement''). The Advisory Agreement has been approved by the Trust's
board of trustees (``Board''), including a majority of the trustees who
are not ``interested persons,'' as defined in section 2(a)(19) of the
Act, of the Trust (the ``Independent Trustees''), as well as by the
shareholders of the Funds. The term ``Manager'' refers to Forward
Management and any existing or future entity controlling, controlled
by, or under common control with Forward Management that is an
investment adviser registered under the Advisers Act and any successor
in interest thereto.\3\
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    \3\ A successor in interest is limited to entities that result
from a reorganization into another jurisdiction or a change in the
type of business organization.
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    3. Under the terms of the Advisory Agreement, the Manager provides
investment advisory services to each Sub-Advised Fund and has the
authority, subject to Board approval, to enter into investment
subadvisory agreements (``Sub-Advisory Agreements'') with one or more
subadvisers (``Sub-Advisers''). Each Sub-Adviser is registered under
the Advisers Act. The Manager will monitor and evaluate the Sub-
Advisers and recommend to the Board their hiring, retention or
termination. Sub-Advisers recommended to the Board by the Manager are
selected and approved by the Board, including a majority of the
Independent Trustees. Each Sub-Adviser has discretionary authority to
invest the assets or a portion of the assets of the relevant Sub-
Advised Fund. For its services, the Manager receives a fee from the
Sub-Advised Fund computed as a percentage of the Sub-Advised Fund's net
assets.
    4. Applicants request an order that would permit the Manager to
hire Sub-Advisers and materially amend Sub-Advisory Agreements without
obtaining

shareholder approval. The requested order would supersede the Existing
Order to allow a Sub-Adviser to be compensated either (a) by the
Manager out of the advisory fees it receives from the Sub-Advised Fund,
or (b) directly by the Sub-Advised Fund out of its assets.\4\ The
conditions of the requested order are identical to the conditions in
the Existing Order, except for the addition of condition 10, which
addresses Sub-Adviser compensation paid directly by a Sub-Advised Fund.
The requested relief will not extend to any Sub-Adviser that is an
affiliated person, as defined in section 2(a)(3) of the Act, of a Sub-
Advised Fund or the Manager, other than by reason of serving as a Sub-
Adviser to one or more of the Sub-Advised Funds (``Affiliated Sub-
Adviser'').
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    \4\ Under the Existing Order, the Manager compensates each Sub-
Adviser out of the fees paid to the Manager under the Advisory
Agreement.
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Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that it is
unlawful for any person to act as an investment adviser to a registered
investment company except under a written contract that has been
approved by the vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series company affected by a matter must approve such
matter if the Act requires shareholder approval.
    2. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
from any rule under the Act, if such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policy and
provisions of the Act. Applicants state that their requested relief
meets this standard for the reasons discussed below.
    3. Applicants assert that the Sub-Advised Funds' shareholders are
relying on the Manager's experience to select one or more Sub-Advisers
best suited to achieve a Sub-Advised Fund's investment objectives.
Applicants assert that, from the perspective of an investor in the Sub-
Advised Fund, the role of the Sub-Advisers is comparable to that of the
individual portfolio managers employed by traditional investment
company advisory firms. Applicants state that requiring shareholder
approval of each Sub-Advisory Agreement would impose costs and
unnecessary delays on the Sub-Advised Funds, and may preclude the
Manager from acting promptly in a manner considered advisable by the
Board. Applicants note that the Advisory Agreement and any Sub-Advisory
Agreement with an Affiliated Sub-Adviser will remain subject to section
15(a) of the Act and rule 18f-2 under the Act.
    4. Applicants state that for tax or other reasons as may be
determined by the Board and the Manager to be relevant from time to
time, certain Sub-Advised Funds may pay fees directly to the Sub-
Adviser rather than having the Manager pay the Sub-Adviser out of its
advisory fees. With respect to the Sub-Advised Funds that pay Sub-
Advisers directly, any change to a Sub-Advisory Agreement that results
in an increase in the total management and advisory fees payable by a
Sub-Advised Fund will be required to be approved by the shareholders of
the Sub-Advised Fund.
    5. Applicants note that the Commission has proposed rule 15a-5
under the Act and agree that the requested order will expire on the
effective date of rule 15a-5 under the Act, if adopted.\5\
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    \5\ Investment Company Act Release No. 26230 (Oct. 23, 2003).
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Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Sub-Advised Fund may rely on the requested order, the
operation of the Sub-Advised Fund in the manner described in the
application will be approved by a majority of the Sub-Advised Fund's
outstanding voting securities, as defined in the Act, or in the case of
a Sub-Advised Fund whose public shareholders purchase shares on the
basis of a prospectus containing the disclosure contemplated by
condition 2 below, by the initial shareholder(s) before offering shares
of that Sub-Advised Fund to the public.
    2. Each Sub-Advised Fund will disclose in its prospectus the
existence, substance and effect of the order. In addition, each Sub-
Advised Fund will hold itself out to the public as employing the
manager-of-managers arrangement described in the application. The
prospectus relating to each Sub-Advised Fund will prominently disclose
that the Manager has ultimate responsibility (subject to oversight by
the Board) to oversee Sub-Advisers and to recommend their hiring,
termination, and replacement.
    3. Within 90 days of the hiring of a new Sub-Adviser, the Manager
will furnish shareholders of the applicable Sub-Advised Fund all
information about the new Sub-Adviser that would be included in a proxy
statement. To meet this condition, the Manager will provide
shareholders of the applicable Sub-Advised Fund with an information
statement meeting the requirements of Regulation 14C, Schedule 14C and
Item 22 of Schedule 14A under the Securities Exchange Act of 1934.
    4. The Manager will not enter into a Sub-Advisory Agreement with
any Affiliated Sub-Adviser unless such agreement, including the
compensation to be paid thereunder, has been approved by the
shareholders of the applicable Sub-Advised Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the nomination of new or additional
Independent Trustees will be placed within the discretion of the then-
existing Independent Trustees.
    6. When a change of Sub-Adviser is proposed for a Sub-Advised Fund
with an Affiliated Sub-Adviser, the Board, including a majority of the
Independent Trustees, will make a separate finding, reflected in the
Board minutes, that such change is in the best interests of such Sub-
Advised Fund and its shareholders and does not involve a conflict of
interest from which the Manager or an Affiliated Sub-Adviser derives an
inappropriate advantage.
    7. The Manager will provide general investment management services
to each Sub-Advised Fund, including overall supervisory responsibility
for the general management and investment of each Sub-Advised Fund's
assets and, subject to review and approval by the Board, will: (a) Set
the Sub-Advised Fund's overall investment strategies; (b) evaluate,
select, and recommend Sub-Advisers to manage all or a part of the Sub-
Advised Fund's assets; (c) when appropriate, allocate and reallocate
the Sub-Advised Fund's assets among multiple Sub-Advisers; (d) monitor
and evaluate the Sub-Advisers' investment performance; and (e)
implement procedures reasonably designed to ensure compliance by the
Sub-Adviser(s) with the Sub-Advised Fund's investment objectives,
policies and restrictions.
    8. No trustee or officer of the Trust, or director or officer of
the Manager, will own directly or indirectly (other than through a
pooled investment vehicle that is not controlled by such person) any
interest in a Sub-Adviser, except for (a) ownership of interests in the
Manager or any entity that controls, is controlled by, or is under
common control with the Manager, or (b) ownership of less than 1% of
the

outstanding securities of any class of equity or debt of a publicly-
traded company that is either a Sub-Adviser or an entity that controls,
is controlled by or is under common control with a Sub-Adviser.
    9. The requested order will expire on the effective date of rule
15a-5 under the Act, if adopted.
    10. For Sub-Advised Funds that pay a Sub-Adviser's fees directly
from Fund assets, any changes to a Sub-Advisory Agreement that would
result in an increase in the total management and advisory fees payable
by a Sub-Advised Fund will be required to be approved by the
shareholders of the Sub-Advised Fund.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-23365 Filed 10-2-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: September 26, 2008 (Volume 73, Number 188)]
[Notices]
[Page 55893-55894]
[DOCID:fr26se08-107]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of Draft Environmental Impact Statement
(DEIS) Containing a Notice of Public Comment Period and Schedule for a
Public Information Workshop and Public Hearing for Proposed New Air
Carrier Runway 9R/27L and Associated Developments at Palm Beach
International Airport (PBIA)

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of availability, notice of comment period, notice of
Public Information Workshop and Public Hearing.

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SUMMARY: The Federal Aviation Administration (FAA) is issuing this

notice to advise the public that a Draft Environmental Impact Statement
(DEIS) for the Proposed New Runway and Associated Development at Palm
Beach International Airport, has been prepared and is available for
public review and comment. Your written comments on the DEIS and
related documents can be sent to the individual listed in the section
FOR FURTHER INFORMATION CONTACT. A Public Information Workshop and
Public Hearing will be held on November 12, 2008. The public comment
period will commence on September 26, 2008 and will close on November
24, 2008.
    Public Comment and Information Workshop/Public Hearing: The start
of the public comment period on the DEIS and associated studies will
start on September 26, 2008 and will close on November 24, 2008. A
Public Information Workshop and Public Hearing will be held on November
12, 2008 in West Palm Beach. The purpose of the Public Information
Workshop and Public Hearing and the public comment period is to comply
with NEPA requirements to provide public disclosure and involvement
concerning the scope and content of the DEIS, and to afford the public
and other interested parties the opportunity to comment on the
economic, social, and environmental effects of the proposed project and
its consistency with the objectives of any planning that the community
has carried out. The Public Information Workshop will begin at 4 p.m.
(EST) and will end at 7 p.m. (EST). The Public Hearing will begin at 6
p.m. (EST) and run concurrently with the Public Information Workshop.
The Public Information Workshop/Public Hearing will be held at the Palm
Beach County Convention Center, Second Floor, 650 Okeechobee Boulevard,
West Palm Beach, FL 33401.
    You can review copies of the DEIS and related documents may be
viewed during regular business hours at the following locations:
    1. PBC Library Main Branch, 3650 Summit Boulevard, West Palm Beach,
FL 33406.
    2. PBC Library Greenacres Branch, 3750 Jog Road, Greenacres, FL
33467.
    3. PBC Library Okeechobee Boulevard Branch, 5689 West Okeechobee
Boulevard, West Palm Beach, FL 33417.
    4. WPB Public Library, 100 Clematis Street, West Palm Beach, FL
33401.
    Copies of the DEIS and related documents will also be available for
review by appointment only at the following FAA and Palm Beach County
Department of Airports offices: Federal Aviation Administration,
Orlando Airports District Office, 5950 Hazeltine National Drive,
Citadel International Building, Suite 400, Orlando, FL,<PHONE_NUMBER>;
Palm Beach International Airport, Palm Beach County Department of
Airports Office, 846 Palm Beach International Airport, West Palm Beach,
FL,<PHONE_NUMBER>. Please schedule an appointment to review the DEIS
in advance. A copy of the DEIS will also be available September 26,
2008 on the project Web site at http://www.pbia-eis.com.

FOR FURTHER INFORMATION CONTACT: Lindy McDowell, Environmental
Specialist, Federal Aviation Administration, Orlando Airports District
Office, 5950 Hazeltine National Drive, Citadel International Building,
Suite 400, Orlando, FL. You can contact Ms. McDowell at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Aviation Administration (FAA) is
issuing this Notice of Availability to advise the public that a DEIS
will be available for public review beginning September 26, 2008. The
DEIS details the proposed development of a new air carrier runway,
modification of existing runways and taxiways, relocation of general
aviation support facilities, installation of navigational aids
(NAVAIDS), implementation of Global Positioning System (GPS)
approaches, relocation of a Very-High Frequency Omni-directional Radio
Range (VOR) antenna, land acquisition, drainage canal relocation, and
other connected actions at Palm Beach International Airport (PBIA),
West Palm Beach, Florida.
    The DEIS presents the purpose and need for the proposed project, a
comprehensive analysis of the alternatives to the proposed project,
including the No-Action alternative and potential environmental impacts
associated with the proposed development of the new air carrier runway
and related improvements at PBIA.
    The FAA encourages the public to comment on the scope and content
of the DEIS. Comments should be as specific as possible and address the
analysis of potential environmental impacts and the adequacy of the
proposed action or merits of alternatives and the proposed mitigation.
Reviewers should organize their comments so they are meaningful and
make the FAA aware of the viewer's interests and concerns using
quotations and other specific references to the text of the DEIS and
related documents. Specific comments not given during the DEIS comment
period may not be considered if they are raised later in the decision
making process. This commenting procedure is intended to ensure that
substantive comments and concerns are made available to the FAA in a
timely manner so that the FAA has an opportunity to address them.
    We encourage the public to comment on the DEIS and related
documents. You can submit your comments verbally or in writing at the
Public Information Workshop and/or Public Hearing or you can also
submit your comments in writing to the FAA at the address listed in the
section entitled FOR FURTHER INFORMATION CONTACT. The comment period
will close on November 24, 2008.
    In addition to the Public Information Workshop and Public Hearing
being conducted to provide public involvement concerning the scope and
content of the DEIS, they are also being conducted to provide public
involvement and input in regard to historic resources in compliance
with Section 106 of the National Historic Preservation Act of 1966--36
CFR 800.

    Issued in Orlando, FL, on September 22, 2008.
W. Dean Stringer,
Manager, FAA, Orlando Airports District Office.
[FR Doc. E8-22631 Filed 9-25-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58082-58083]
[FR Doc No: 2011-23819]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Notice of Application for
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of Applications for Special Permits.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before October 19, 2011.
    Address Comments To: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue Southeast, Washington DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with Part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC on September 09, 2011.
Donald Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature of special permits
    Application No.       Docket No.         Applicant        Regulation(s) affected            thereof
----------------------------------------------------------------------------------------------------------------
                                               New Special Permits
----------------------------------------------------------------------------------------------------------------
15429-N................  ...........  Demex International     49 CFR 176.144(e).....   To authorize the
                                       Inc. Picayune, MS.                              ransportation in commerce
                                                                                of certain explosives by
                                                                                vessel in an alternative
                                                                                stowage configuration.
                                                                                (mode 3).
15440-N................  ...........  Mountain Air            49 CFR 172.101, Column  To authorize the
                                       Helicopters, Inc. Los   (9B), 172.204(c)(3),    transportation in
                                       Lunas, NM.              173.27(b)(2),           commerce of certain
                                                               175.30(a)(1).           hazardous materials by
                                                                                cargo aircraft including
                                                                                by external load in
                                                                                remote areas of the US
                                                                                without being subject to
                                                                                hazard communication
                                                                                requirements and quantity
                                                                                limitations where no
                                                                                other means of
                                                                                transportation is
                                                                                available. (mode 4).

15443-N................  ...........  Iliamna Air Guides,     49 CFR 172.101 Column   To authorize the
                                       DBA Soloy               (9B), 172.204(c)(3),    transportation in
                                       Helicopters, LLC        173.27(b)(2),           commerce of certain Class
                                       Wasilla, AK.            175.30(a)(1),           1 hazardous materials by
                                                               172.200, 172.300 and    cargo aircraft including
                                                               172.400.                by external load in
                                                                                remote areas of the US
                                                                                without being subject to
                                                                                hazard communication
                                                                                requirements and quantity
                                                                                limitations where no
                                                                                other means of
                                                                                transportation is
                                                                                available. (mode 3).
15446-N................  ...........  Arkema, Inc. King of    49 CFR 172.427........  To authorize the
                                       Prussia, PA.                                    transportation in
                                                                                commerce of organic
                                                                                peroxides in packaging
                                                                                with labeling allowed
                                                                                prior to changes
                                                                                promulgated under HM-
                                                                                2151. (mode 1).
15451-N................  ...........  NK CO., LTD Gangseo-    49 CFR 180.209(a) and   To authorize the
                                       Gu, Busan.              (b).                    transportation in
                                                                                commerce of certain DOT
                                                                                3AA, 3AAX and 3T
                                                                                cylinders in Multiple
                                                                                Element Gas Containers
                                                                                that have been retested
                                                                                every ten (10) years
                                                                                instead of every five (5)
                                                                                years by acoustic
                                                                                emission and ultrasonic
                                                                                examination (AE/UE) in
                                                                                place of the internal
                                                                                visual inspection and the
                                                                                hydrostatic retest
                                                                                required by Sec.
                                                                                180.205 (modes 1, 2, 3).
15452-N................  ...........  BE Aerospace Lenexa,    49 CFR 173.302(f)       To authorize the
                                       KS.                     (2)(i).                 transportation in
                                                                                commerce of certain DOT
                                                                                Specification 39
                                                                                cylinders containing
                                                                                oxygen that have their
                                                                                pressure relief devices
                                                                                set to an alternative
                                                                                burst at pressure range.
                                                                                (modes 4, 5).
15453-N................  ...........  HRD Aero Systems Inc.   49 CFR 173.302a and     To authorize the
                                       Valencia, CA.           173.304a.               transportation in
                                                                                commerce of certain
                                                                                cylinders manufactured
                                                                                under DOT-SP 7971 which
                                                                                contain bromochlorodi-
                                                                                fluoromethane and
                                                                                nitrogen. (modes 1, 2, 3,
                                                                                4, 5).
15454-N................  ...........  Hoke, Inc.              49 CFR 178.39.........  To authorize the re-
                                       Spartanburg, SC.                                manufacturing of specific
                                                                                DOT Specification 3BN
                                                                                cylinders by reducing the
                                                                                volume from 4500 cc to
                                                                                3000 cc. (mode 1)
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-23819 Filed 9-16-11; 8:45 am]
BILLING CODE 4909-60-M


VIA Email

December 14, 2007

Debbie Edwards, Director

Registration Division

Office of Pesticide Programs

US Environmental Protection Agency (EPA)

One Potomac Yard - South Building

2777 South Crystal Drive

Arlington, Virginia

RE: 	Request for 60-day Extension of Comment Period for Endosulfan Risk
Assessment (EPA-HQ- OPP-2002-0262)

Dear Ms. Edwards:

The undersigned organizations respectfully request a 60-day extension of
the public comment period to respond to the updated human health and
ecological effects risk assessments for the valuable pesticide
endosulfan.

Endosulfan is a very important pesticide for many uses, including many
specialty crops.  EPA seeks comment on these updated risk assessments
as part of EPA’s Post-Reregistration Eligibility Decision (RED)
process for endosulfan. Most importantly, EPA seeks comment on the
agency’s analysis of endosulfan usage information since the 2002 RED,
as well as preliminary determinations regarding the pesticide’s
importance to growers and the availability of alternatives.

Establishing updated use and benefit information on endosulfan is
critically important and requires additional time to properly research
and refine.  A reasonable extension would ensure that the best use
information is provided for review.

Thank you for your timely consideration of this important request.
Please contact the undersigned organizations if you have specific
questions regarding this request.

Sincerely,

American Farm Bureau Federation, Rebeckah Adcock,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
ARIZONIA COTTON GROWERS ASSOCIATION

California Cotton Growers Association

California Cotton Ginners Association

California farm bureau federation, rayne Thompson,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
California Grape and Tree Fruit League, Marcy Martin,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
California Pear Advisory Board, Bob McClain,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
CALIFRONIA SPECIALTY CROPS COUNCIL, Lori Berger,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
FLORIDA FARM BUREAU FEDERATION, Joshua Craft,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
Michigan Blueberry Growers Assoc, Dave Trinka,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
National Cotton CounciL, Don Parker,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>

NORTHWEST HORTICULTURAL COUNCIL, Mike Willett,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
OHIO FARM BUREAU FEDERATION, Adam Sharp,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
TEXAS COTTON GINNERS' ASSOCIATION

TEXAS VEGETABLE ASSOCIATION, Ray Prewett,   HYPERLINK
<EMAIL_ADDRESS>\o<EMAIL_ADDRESS><EMAIL_ADDRESS>

U.S. Apple Association, Jim Cranney,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>


[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Rules and Regulations]
[Pages 58761-58762]
[FR Doc No: 2012-23277]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0638; Directorate Identifier 2011-NM-266-AD;
Amendment 39-17201; AD 2012-19-06]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) all Empresa
Brasileira de Aeronautica S.A. (EMBRAER) Model EMB-135 airplanes, and
Model EMB-145, -145ER, -145MR, -145LR, -145MP, and -145EP airplanes.
This AD was prompted by a report of a lightning strike hitting an
airplane tail boom causing certain rear bulkhead parts to jam an
elevator control rod. This AD requires installing or reworking, as
applicable, metallic diverters and aluminum sheets; modifying the light
assembly on the tail boom rear movable fairing; and replacing the hood
assembly with a new hood assembly and rerouting its electrical harness.
We are issuing this AD to prevent lightning strikes from causing
certain parts to contact the airplane pitch control system, which could
reduce airplane controllability.

DATES: This AD becomes effective October 29, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of October 29,
2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on June 18, 2012 (77 FR
36224). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    [A] lightning strike event hitting the airplane tail boom
[caused certain rear bulkhead parts to jam an elevator control rod]
* * *. The lack of the appropriate protection against lightning
strike effects [could cause certain parts to contact the airplane
pitch control system, which could reduce airplane controllability.]
* * * * *

The required actions include installing or reworking, as applicable,
metallic diverters and aluminum sheets; modifying the light assembly on
the tail boom rear movable fairing; and replacing the hood assembly
with a new hood assembly and rerouting its electrical harness. You may
obtain further information by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 36224, June 18,
2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Costs of Compliance

    Based on the service information, we estimate that this AD will
affect about 668 products of U.S. registry. We also estimate that it
will take about 12 work-hours per product to comply with the basic
requirements of this AD. The average labor rate is $85 per work-hour.
Required parts will cost about $2,507 per product. Where the service
information lists required parts costs that are covered under warranty,
we have assumed that there will be no charge for these parts. As we do
not control warranty coverage for affected parties, some parties may
incur costs higher than estimated here. Based on these figures, we
estimate the cost of the AD on U.S. operators to be $2,356,036, or
$3,527 per product.

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 AD will not have federalism implications
under Executive Order 13132. This AD will 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 that this AD:
    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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 36224, June 18, 2012),
the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 AD:

2012-19-06 Empresa Brasileira de Aeronautica S.A. (EMBRAER):
Amendment 39-17201. Docket No. FAA-2012-0638; Directorate Identifier
2011-NM-266-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective October 29,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model EMB-145, -145ER, -145MR, -145LR, -145MP, and -145EP
airplanes; and Model EMB-135BJ, -135ER, -135KE, -135KL, and -135LR
airplanes; certificated in any category; all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

(e) Reason

    This AD was prompted by a report of a lightning strike hitting
an airplane tail boom causing certain rear bulkhead parts to jam an
elevator control rod. We are issuing this AD to prevent lightning
strikes from causing certain parts to contact the airplane pitch
control system, which could reduce airplane controllability.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Actions

    Within 5,000 flight hours or 48 months after the effective date
of this AD, whichever occurs first: Install or rework, as
applicable, metallic diverters and aluminum sheets; modify the light
assembly on the tail boom rear movable fairing; and replace the hood
assembly with a new hood assembly having part number (P/N) 145-
23046-403 and reroute its electrical harness. Do all the actions in
accordance with the Accomplishment Instructions of EMBRAER Service
Bulletin 145LEG-55-0013, dated September 8, 2011 (for Model EMB-
135BJ airplanes); or EMBRAER Service Bulletin 145-55-0030, Revision
05, dated July 29, 2011 (for Model EMB-145 and EMB-135, except -
135BJ, airplanes).

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Todd
Thompson, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
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. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(i) Related Information

    Refer to MCAI Brazilian Airworthiness Directive 2011-11-01,
dated November 30, 2011, and the following service information, for
related information.
    (1) EMBRAER Service Bulletin 145LEG-55-0013, dated September 8,
2011.
    (2) EMBRAER Service Bulletin 145-55-0030, Revision 05, dated
July 29, 2011.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) EMBRAER Service Bulletin 145LEG-55-0013, dated September 8,
2011.
    (ii) EMBRAER Service Bulletin 145-55-0030, Revision 05, dated
July 29, 2011.
    (3) For service information identified in this AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical
Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170--
Putim--12227-901 S[atilde]o Jose dos Campos--SP--BRASIL; telephone
+55 12 3927-5852 or +55 12 3309-0732; fax +55 12 3927-7546; email
<EMAIL_ADDRESS>Internet http://www.flyembraer.com.
    (4) You may review copies of the 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>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 6, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-23277 Filed 9-21-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 21, 2008 (Volume 73, Number 226)]
[Notices]
[Page 70654-70655]
[DOCID:fr21no08-65]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 16, 2008, from
8 a.m. to 4 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301-977-
8900.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-6793, fax:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: The committee will discuss biologics license application
(BLA) 125084, trade name ERBITUX (cetuximab), ImClone Systems, Inc.,
and BLA 125147, trade name VECTIBIX (panitumumab), Amgen, Inc., in the
context of K-ras as a predictive and/or prognostic biomarker in
oncology drug development.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
December 2, 2008. Oral presentations from the public will be scheduled
between approximately 11:30 a.m. to 12:30 p.m. Those desiring to make
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before November 24, 2008. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine

the speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by November 25, 2008.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-27713 Filed 11-20-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12498-12499]
[FR Doc No: 2015-05348]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0647]

Complexities in Personalized Medicine: Harmonizing Companion
Diagnostics Across a Class of Targeted Therapies; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

    The Food and Drug Administration (FDA), in co-sponsorship with the
American Association for Cancer Research (AACR) and the American
Society of Clinical Oncology (ASCO), is announcing a public workshop
entitled ``Complexities in Personalized Medicine: Harmonizing Companion
Diagnostics Across a Class of Targeted Therapies.'' The objective of
the workshop is to facilitate an in-depth discussion of harmonization
of companion diagnostic devices across a class of targeted therapies.
The workshop aims to foster collaborations in the clinical cancer
research community; provide a deeper understanding of anticancer drug
and device development related to personalized medicine; provide a
unique perspective of personalized medicine; and help incorporate
emerging scientific findings to harmonize companion diagnostics across
a class of targeted therapies.
    Date and Time: The public workshop will be held on March 24, 2015,
from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the Mayflower Hotel,
Grand Ballroom, 1127 Connecticut Ave. NW., Washington, DC 20036, 202-
347-3000.
    Contact Persons: Kaitlyn Antonelli, American Society of Clinical
Oncology, 2318 Mill Rd., suite 800, Alexandria, VA 22314,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Pamela Bradley, Center for Devices and
Radiological Health, Office of In Vitro Diagnostics and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>and
Rasika Kalamegham, American Association for Cancer Research, 1425 K

St. NW., Washington, DC 20005,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending the ``Complexities
in Personalized Medicine: Harmonizing Companion Diagnostics Across a
Class of Targeted Therapies'' public workshop must register online by
March 17, 2015, 5 p.m. Registration will be handled through ASCO. Early
registration is recommended because facilities are limited and,
therefore, we may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please
contact Kaitlyn Antonelli (see Contact Persons),<PHONE_NUMBER>,
<EMAIL_ADDRESS>no later than March 10, 2015.
    To register for the public workshop, please use the following Web
site: https://www.surveymonkey.com/s/FDACompanionDiagnostics2015.
Please provide complete contact information for each attendee,
including name, title, affiliation, email, and telephone number. Those
without Internet access should contact Kaitlyn Antonelli to register.
Registrants will receive confirmation after they have been accepted.
You will be notified if you are on a waiting list.
    Streaming Audiocast of the Public Workshop: This public workshop
will also be audiocast. Persons interested in accessing the audiocast
must register online using the following Web site: https://www.surveymonkey.com/s/FDACompanionDiagnostics2015. FDA has verified
the Web site addresses in this document, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register. Early registration is recommended because
audiocast connections are limited. Organizations are requested to
register all participants but to view using one connection per
location. After registration, participants will be sent technical
system requirements and connection access information after March 19,
2015.
    Comments: FDA is holding this public workshop to obtain information
on harmonization of companion diagnostics across a class of targeted
therapies. To permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the public workshop. The deadline for submitting comments
related to this public workshop is April 23, 2015.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday and will be posted to the docket at http://www.regulations.gov.
    Transcript: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

SUPPLEMENTARY INFORMATION: Multiple manufacturers are developing
therapeutic products that rely on a particular biomarker and that may
require contemporaneous approval/clearance of a companion diagnostic if
biomarker detection or measurement is necessary for the safe and
effective use of the therapeutic product. Therapeutic product
developers working in the same target space can use different methods
and measures for the biomarker, and then partner with various sponsors
to implement distinct companion diagnostics. These development programs
can lead to approval/clearance of multiple therapeutic product-
companion diagnostic pairs for a single class of therapeutic products.
For example, understanding of the Programmed Death Ligand 1 (PD-1)
checkpoint pathway underlies current development of multiple targeted
therapies and potential companion diagnostics targeting and measuring
PD-1 pathway biomarkers. Although the biomarker being detected/measured
is the same (or closely related) within the drug class, there may be
differences between the companion diagnostics in design and
performance, such as use of different antibodies or different cut-off
values leading to designation of different sets of marker-positive and
marker-negative patients.
    Comparison of the results from different tests is not part of the
companies' development program for each drug/test pair. Likewise,
differences in results from distinct tests are typically not examined
for their effect on efficacy of products within the drug class. With no
assurance that all the tests identify the populations most likely to
respond to all of the drugs, problems may arise if various companion
diagnostics for the same biomarker are used in clinical practice to
direct treatment with all the targeted therapies in the drug class.
Using multiple companion diagnostics to determine therapy for each
patient is costly, inefficient, and challenging when dealing with a
limited biological specimen. Even if it were practical, multiple
testing might lead to suboptimal use of the drugs. Likewise, use of one
companion diagnostic might not adequately inform the use of all of the
targeted therapies. In such scenarios, where multiple targeted therapy-
companion diagnostic pairs exist, patients may not be able to receive
optimal care. FDA believes this is an important public health issue
that is not easily resolved. Thus, FDA is convening this workshop in
association with AACR and ASCO to foster a collaborative examination of
the problem as it relates to various stakeholders and to identify
potential solutions or paths to solutions for the problem.

    Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05348 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Notices]
[Pages 63900-63902]
[FR Doc No: 2012-25500]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68036; File No. SR-NYSEMKT-2012-50]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending the NYSE Amex
Options Fee Schedule Relating to Criteria for Rebates to Order Flow
Providers

October 11, 2012.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on September 28, 2012, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend the NYSE Amex Options Fee Schedule
(the ``Fee Schedule'') to establish criteria for Order Flow Providers
(``OFPs'') \4\ to earn rebates based on the average daily volume
(``ADV'') of Customer \5\ electronic equity and exchange-traded fund
(``ETF'') contracts executed by an OFP on the Exchange. The text of the
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.
---------------------------------------------------------------------------

    \4\ An OFP is any ATP Holder that submits, as agent, orders to
the Exchange. See Rule 900.2NY(57).
    \5\ The term ``Customer'' means an individual or organization
that is not a broker-dealer. See Rule 900.2NY(18).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend the Fee Schedule to establish
criteria for OFPs to earn rebates based on the ADV of Customer
electronic equity and ETF contracts executed by an OFP on the Exchange.
The Exchange proposes to implement these changes on October 1, 2012.
    The Exchange proposes to establish a rebate for OFPs based on the
ADV of Customer electronic equity and ETF contracts executed by an OFP
on the Exchange (the ``Tiers'') relative to the overall Total Industry
Customer equity and ETF option ADV.\6\ In order to be eligible for the
rebate, certain criteria must be met. Once all of the criteria have
been met, the highest rebate earned will apply to all eligible volume
for the particular month for the particular OFP. The criteria will be
detailed in new endnote 17 to the Fee Schedule.
---------------------------------------------------------------------------

    \6\ Total Industry Customer equity and ETF option ADV would be
that which is reported for the month by OCC in the month in which
the rebates may apply. For example, October 2012 Total Industry
Customer equity and ETF option ADV will be used in determining what,
if any, rebate an OFP may be eligible for based on the Customer
electronic equity and ETF option ADV it transacts on the Exchange in
October 2012. Total Industry Customer equity and ETF option ADV is
comprised of those equity and ETF option contracts that clear in the
customer account type at OCC and does not include contracts that
clear in either the firm or market maker account type at OCC or
contracts overlying a security other than an equity and ETF
security.
---------------------------------------------------------------------------

    The first criterion is that an OFP must execute Customer electronic
equity and ETF option volume on the Exchange that is equal to or
greater than the percentage of Total Industry Customer equity and ETF
option ADV shown in the table below (e.g., 2.7% of Total Industry
Customer equity and ETF option ADV for the lowest tier). However, no
rebate would be paid on Customer electronic equity and ETF option
volume that is less than 120,000 ADV; thus, in a month where the Total
Industry Customer equity and ETF option ADV as a whole drops
substantially, it is possible that no rebates will be paid.
    Volume from executions of Qualified Contingent Cross (``QCC'')
Orders,\7\

Strategy Executions \8\ and orders that are routed to one or more
exchanges in connection with the Options Order Protection and Locked/
Crossed Market Plan referenced in Rule 991NY (``routed orders'' for
purposes of this proposed rebate) would not count toward either the
120,000 Customer electronic equity and ETF option ADV minimum or any of
the proposed Customer electronic equity and ETF option ADV Tiers.
Volume from executions of Customer Electronic Complex Orders would not
count toward the 120,000 Customer electronic equity and ETF option ADV
minimum, but would count toward any of the Customer electronic equity
and ETF option ADV Tiers. Volume attributable to the execution of QCC
Orders, Strategy Executions, Customer Electronic Complex Orders or
routed orders would not receive a rebate.\9\
---------------------------------------------------------------------------

    \7\ A QCC Order is comprised of an order to buy or sell at least
1,000 contracts that is identified as being part of a qualified
contingent trade, as that term is defined in Commentary .01 to Rule
900.3NY, coupled with a contra-side order to buy or sell an equal
number of contracts. See Rule 900.3NY(y).
    \8\ Strategy Executions are defined in endnote 8 of the Fee
Schedule.
    \9\ The Exchange notes that both QCC Orders and Customer
Electronic Complex Orders are currently eligible to earn rebates and
that Strategy Executions are capped on both a per trade and a
monthly basis. Additionally, the Exchange notes that in complying
with the requirements of the Options Order Protection and Locked/
Crossed Market Plan referenced in Rule 991NY, the Exchange incurs
routing fees and clearing charges when it routes Customer orders to
exchanges that in turn do not charge Customer fees, which the
Exchange does not pass along to OFPs.
---------------------------------------------------------------------------

    The second criterion that must be met in order for an OFP to
qualify for the rebate is that an OFP must execute an ADV of at least
200,000 Customer electronic equity and ETF contracts that specifically
result from posting orders to the Exchange's Consolidated Order Book
(also known as ``making'' liquidity). In calculating the 200,000
Customer electronic equity and ETF option ADV posting requirement, the
Exchange would exclude volume attributable to QCC Orders, Strategy
Executions, Electronic Customer Complex Orders and routed orders.
    The proposed volume tiers and the corresponding per contract rebate
would be as follows:

------------------------------------------------------------------------
                                             Rebate per contract for all
                                             customer electronic equity
                                             and ETF option volume over
 Customer electronic equity and ETF option  120,000 ADV (excludes volume
                 ADV tiers                    from QCC Orders, Strategy
                                             Executions, Complex Orders,
                                                 and routed orders)
------------------------------------------------------------------------
at least 2.7% of Total Industry Customer                           $0.07
 equity and ETF option ADV................
at least 3.6% of Total Industry Customer                            0.08
 equity and ETF option ADV................
at least 4.4% of Total Industry Customer                            0.09
 equity and ETF option ADV................
------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Securities Exchange Act of 1934 (the
``Act''),\10\ in general, and furthers the objectives of Section
6(b)(4) of the Act,\11\ in particular, because it provides for the
equitable allocation of reasonable dues, fees, and other charges among
its members and issuers and other persons using its facilities and does
not unfairly discriminate between customers, issuers, brokers or
dealers.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The proposal to establish a tiered rebate for OFPs that execute the
requisite ADV of Customer electronic equity and ETF contracts on the
Exchange is reasonable because it is designed to attract additional
Customer electronic equity and ETF volume to the Exchange, which would
benefit all participants by offering greater price discovery, increased
transparency and an increased opportunity to trade on the Exchange.
Additionally, the Exchange believes that the proposed rebate is
reasonable because it would incentivize OFPs to submit Customer
electronic equity and ETF option orders to the Exchange and would
result in a rebate that is reasonably related to an exchange's market
quality that is associated with higher volumes. The Exchange also
believes that proposed thresholds for the tiers are reasonable because
they will reward OFPs with a greater rebate when they bring a larger
number of equity and ETF orders to the Exchange. Moreover, the Exchange
believes that the proposed rebate is equitable and not unfairly
discriminatory because it will be available to all OFPs that execute
Customer electronic equity and ETF option orders on the Exchange on an
equal and non-discriminatory basis. The Exchange also believes that the
proposed rebate is not new or novel. Instead, the Exchange understands
that at least two other option exchanges currently offer a rebate
specifically for Customer volume.\12\ Further, the amount of the
proposed per contract rebate is within the range of similar rebates on
other exchanges.\13\
---------------------------------------------------------------------------

    \12\ For example, the Chicago Board Options Exchange (``CBOE'')
has a Volume Incentive Program that pays order flow providers on
CBOE a tiered rebate, from $0.00 to $0.20 per contract, based on the
number of Customer contracts per day that execute electronically on
the exchange. This is described on page 3 of the CBOE fee schedule
dated September 18, 2012, available at http://www.cboe.com/publish/feeschedule/CBOEFeeSchedule.pdf. Additionally, NASDAQ OMX PHLX
(``PHLX'') has a Customer Rebate Program that pays tiered rebates
that range from $0.00 to $0.12 per contract, as described in the
PHLX fee schedule amended September 4, 2012, available at http://nasdaqomxphlx.cchwallstreet.com/NASDAQOMXPHLXTools/PlatformViewer.asp?selectednode=chp%5F1%5F4%5F1&manual=%2Fnasdaqomxphlx%2Fphlx%2Fphlx%2Drulesbrd%2F.
    \13\ See id.
---------------------------------------------------------------------------

    The Exchange believes that the proposal to exclude volume
attributable to QCC Orders, Strategy Executions, Customer Electronic
Complex Orders and routed orders from receiving the rebate is
reasonable, equitable and not unfairly discriminatory for the following
reasons. First, because all OFPs are treated equally in this regard, it
is not unfairly discriminatory. Second, it is reasonable and equitable
to exclude these volumes from receiving the rebate because QCC Orders
and Customer Electronic Complex Orders already are eligible to receive
separate rebates.\14\ It is reasonable and equitable to exclude
Strategy Executions because these transactions are already offered at a
discounted rate of $750 per day and further capped at $25,000 per month
per initiating firm. Additionally, it is reasonable and equitable to
exclude routed orders because the Exchange often incurs a charge for
routing Customer orders to away markets. Accordingly, excluding these
volumes is both reasonable and equitable.
---------------------------------------------------------------------------

    \14\ The Exchange makes a rebate available to Floor Brokers for
the execution of QCC Orders as well as a rebate available to OFPs
for the execution of Customer Electronic Complex Orders, as
described in the Exchange's Fee Schedule, dated September 1, 2012,
available at http://globalderivatives.nyx.com/sites/globalderivatives.nyx.com/files/nyse_amex_options_fee_schedule_09_01_12.pdf.

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

    The Exchange believes that the proposal to only make a rebate
available for Customer electronic equity and ETF option ADV in excess
of 120,000 contracts is reasonable and equitable because it would
reasonably ensure that the Exchange will derive sufficient revenue to
continue to fund the rebates, for the benefit of all participants.
Further this requirement is not unfairly discriminatory because it
applies to all OFPs.
    The Exchange believes that the requirement for an OFP to execute an
ADV of at least 200,000 Customer electronic equity and ETF contracts as
a result of posting orders to the Consolidated Book (i.e., ``making''
liquidity) to be eligible for the rebate is reasonable, equitable and
not unfairly discriminatory for the following reasons. This provision
is designed to encourage OFPs to send orders to the Exchange, which
will contribute to the Exchange's depth of book as well as to the top
of book liquidity. Encouraging the posting of orders is both reasonable
and equitable because it enhances transparency, price discovery and
liquidity for all participants on the Exchange, benefiting all
investors. As the requirement will apply to all OFPs equally, it is
also not unfairly discriminatory.
    For these reasons, the Exchange believes that the entire proposal
is reasonable, equitable and not unfairly discriminatory. Finally, the
Exchange notes that it operates in a highly competitive market in which
market participants can readily favor competing venues if they deem fee
levels at a particular venue to be excessive. In such an environment,
the Exchange must continually review, and consider adjusting, its fees
and credits to remain competitive with other exchanges. For the reasons
described above, the Exchange believes that the proposed rule change
reflects this competitive environment.

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \15\ of the Act and subparagraph (f)(2) of Rule
19b-4 \16\ thereunder, because it establishes a due, fee, or other
charge imposed by the NYSE MKT.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2012-50 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2012-50. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090. Copies of the filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2012-50 and should
be submitted on or before November 7, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-25500 Filed 10-16-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39450-39453]
[FR Doc No: 2018-17024]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2495]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Voluntary Labeling Indicating Whether Foods Have or
Have Not Been Derived From Genetically Engineered Plants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
the guidance to assist manufacturers who wish to voluntarily label
their foods (human and animal) as being made with or without
bioengineering, or the use of bioengineered ingredients, to ensure that
labeling is truthful and not misleading.

DATES: Submit either electronic or written comments on the collection
of information by October 9, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 9, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2495 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary Labeling Indicating
Whether Foods Have or Have Not Been Derived from Genetically Engineered
Plants.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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

Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Derived From Genetically Engineered Plants

OMB Control Number 0910-0807--Extension

    This information collection supports Agency guidance. Section 403
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343)
generally governs the labeling of foods. Under section 403(a)(1) of the
FD&C Act, a food is misbranded if its labeling is false or misleading
in any particular. Section 201(n) of the FD&C Act (21 U.S.C. 321(n))
provides that labeling is misleading if, among other things, it fails
to reveal facts that are material in light of representations made or
suggested in the labeling, or material with respect to consequences
that may result from the use of the food to which the labeling relates
under the conditions of use prescribed in the labeling, or

under such conditions of use as are customary or usual.
    In the Federal Register of May 29, 1992 (57 FR 22984), we published
a ``Statement of Policy: Foods Derived from New Plant Varieties'' (the
1992 Policy). The 1992 Policy applies to foods for humans and animals
that are developed from new plant varieties, including varieties that
are developed using recombinant deoxyribonucleic acid (rDNA)
technology, which is often referred to as ``rDNA technology,''
``genetic engineering,'' ``biotechnology,'' or ``bioengineering,'' and
more recently as ``modern biotechnology.'' The 1992 Policy provides
guidance to industry on scientific and regulatory issues related to
bioengineered foods and solicited written comments from interested
persons. It includes guidance on questions to be answered by developers
of foods from new plant varieties to ensure that the new products are
safe and comply with applicable legal requirements.
    The 1992 Policy stated that the method of development of a new
plant variety, including plants developed using bioengineering, is not
information that is material under section 201(n) of the FD&C Act and,
therefore, would not be required in the labeling of food. This
conclusion is consistent with our historic interpretation of section
201(n) of the FD&C Act, in that the method of plant breeding is not
required to be disclosed in labeling. In the 1992 Policy, we addressed,
among other things, the labeling of foods derived from new plant
varieties, including plants developed by bioengineering. In the 1992
Policy, we explained that we were not establishing special labeling
requirements for foods from bioengineered plants as a class of foods
because we did not find any basis for concluding that foods from
bioengineered plants, as a class, differ from other foods in any
meaningful or uniform way, or that foods developed by the new
techniques present any different or greater safety concern than foods
developed by traditional plant breeding.
    The guidance entitled ``Voluntary Labeling Indicating Whether Foods
Have or Have Not Been Derived from Genetically Engineered Plants'' is
intended to assist manufacturers that wish to voluntarily label their
foods (human or animal) as being made with or without genetic
engineering or the use of genetically engineered ingredients, to ensure
that such labeling is truthful and not misleading. The guidance is
available at https://www.fda.gov/FoodGuidances. The information that
the manufacturers will collect is documentation of handling practices
so that they can truthfully label their products to indicate, if they
so choose, whether the food has or has not been developed using genetic
engineering.
    In general, we anticipate that manufacturers that claim that a
product is not developed using bioengineered material would
substantiate the claim. We suggest that manufacturers document
practices and procedures to substantiate a claim that a food was not
developed using genetic engineering. Examples of documentation that we
anticipate will demonstrate practices and procedures are recordkeeping,
and certifications or affidavits from farmers, processors, and others
in the food production and distribution chain. We are neither
suggesting that firms maintain a certain set list of documents nor are
we suggesting that anything less or different would likely be
considered unacceptable. Rather, we are leaving it to each firm's
judgment to maintain appropriate documentation to demonstrate that the
food was produced using traditional methods.
    Description of Respondents: The respondents to the proposed
collection of information are manufacturers of foods that were or were
not derived from genetically engineered plants who wish to voluntarily
label their food products.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping per the Guidance.....................................              85                4              340                1              340
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
    The number of recordkeepers and respondents reflects the number of
food products that are labeled using the terms ``biotechnology'' and
``GMO'' (genetically modified organism). We estimate a recordkeeping
burden to retain paperwork to substantiate that the food or ingredient
is produced without genetic engineering only for products that are not
also already labeled using the term ``organic.'' We did not include
products that are labeled ``organic'' in the estimated annual
recordkeeping burden because, according to a final rule in the Federal
Register of December 21, 2000 (65 FR 80548) issued by the Agriculture
Marketing Service of the U.S. Department of Agriculture, a food labeled
as ``organic'' would not be permitted to contain genetically engineered
materials. Thus, there is no additional paperwork burden to
substantiate a claim that a product is not developed using genetic
engineering for these certified organic products.
    We based our estimates of the recordkeeping burden (table 1 of this
document) on data from Labelbase by FoodEssentials. Labelbase is a
custom online system for accessing consumer-packaged goods product
data; the database contains more than 250,000 product labels that can
be searched by keyword, ingredient, nutrient, allergen, label claim, or
food additive, for example. Using this database, we have identified 540
food manufacturers who produce 2,160 products with the term
``bioengineered'' or ``GMO'' on their labels; this estimate includes
manufacturers of human food and pet food. In addition, the National
Center for Appropriate Technology's National Sustainable Agriculture
Information Center maintains on its website a list of Organic Livestock
Feed Suppliers. Using this list, we have identified 54 livestock feed
suppliers that would be likely to include a statement about
bioengineering on the label of their products and thus would have
documentation to substantiate their claim.
    Of the 2,160 human food and pet food products that we have
identified as using the term ``bioengineered'' or ``GMO'' on their
labels (presumably used in a context to designate foods that are not
bioengineered), 1,140 of these products (285 manufacturers) also use
the term ``organic'' on the label; 1,020 products do not use the term
``organic''

on the label (2,160 - 1,140 = 1,020 products not organics; 540 - 285 =
255 manufacturers of not organic products). In addition, the 54
livestock feed suppliers are also organic producers, thus the 216
products attributed to these manufacturers already are considered to be
labeled ``organic.'' Thus, there are 1,020 products made by 255 human
food and pet food manufacturers that would need to substantiate that
their product or ingredient was not genetically engineered.
    We estimate that the burden of maintaining the documentation is a
one-time burden; the document to substantiate that the product or
ingredient was produced without genetic engineering only needs to be
generated once and then kept on file. To annualize this one-time
burden, we divide by 3 because paperwork burden collections are
approved on a 3-year cycle (255/3 = 85). Thus, we estimate in table 1
that, on average, 85 manufacturers annually will collect and keep
information that substantiates their label claim for four products
(1,020 products/3 = 340 products/85 manufacturers = 4 products per
manufacturer).
    We estimate this one-time recordkeeping burden to be 1 hour per
product that makes use of a labeling claim, which results in a burden
of 1 hour for a total annualized recordkeeping burden of 340 hours (85
manufacturers x 4 records per manufacturer x 1 hour per record).
    We do not estimate any reporting burden or third-party disclosure
burden associated with this information collection. Manufacturers who
want to make use of this voluntary labeling claim option are considered
to be those that already have such wording on their products' labels.
We do not expect that this guidance will cause labels already in the
marketplace to need to be reworded.

    Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17024 Filed 8-8-18; 8:45 am]
 BILLING CODE 4164-01-P