[Federal Register Volume 77, Number 245 (Thursday, December 20, 2012)]
[Rules and Regulations]
[Pages 75383-75384]
[FR Doc No: 2012-30533]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2009-0805; EPA-HQ-OAR-2009-0491; FRL-9763-3]

Approval and Promulgation of Air Quality Implementation Plans;
Illinois; Infrastructure SIP Requirements for the 2006 PM2.5
NAAQS; Revisions to FIPs To Reduce Interstate Transport of
PM2.5 and Ozone; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correcting amendment.

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SUMMARY: This document corrects errors in the codification of final
rules published on July 13, 2011, August 8, 2011, February 21, 2012,
and October 29, 2012. The July 13, 2011, and October 29, 2012, actions
pertain to State Implementation Plan (SIP) submissions by Illinois
regarding the infrastructure requirements of the Clean Air Act (CAA)
for the 1997 eight-hour ground level ozone national ambient air quality
standards (NAAQS), the 1997 fine particle (PM2.5) NAAQS, and
the 2006 24-hour PM2.5 NAAQS. The August 8, 2011, and
February 21, 2012, actions pertain to Federal Implementation Plans
(FIPs) to reduce interstate transport of PM2.5 and ozone.

DATES: This correcting amendment is effective on December 20, 2012.

FOR FURTHER INFORMATION CONTACT: Christos Panos, Environmental
Engineer, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), U.S. Environmental Protection Agency, Region 5,
Chicago, Illinois 60604,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 8, 2011, (76 FR 48208), EPA
published FIPs to reduce interstate transport of PM2.5 and
ozone. It codified the regulation, ``Interstate pollutant transport
provisions; What are the FIP requirements for decreases in emissions of
nitrogen oxides?'', at 40 CFR 52.745. In so doing, EPA had not realized
that this section had already been reserved by a previous rulemaking
action, titled ``Section 110(a)(2) Infrastructure Requirements,'' and
created on July 13, 2011, (76 FR 41075). EPA attempted to correct this
error on February 21, 2012, (77 FR 10324). What resulted, however, is
that the interstate pollutant transport provision disappeared entirely.
    We are now correcting this error by codifying the provision titled
``Section 110(a)(2) Infrastructure Requirements'' at 40 CFR 52.745; and
codifying the provision titled ``Interstate pollutant transport
provisions; What are the FIP requirements for decreases in emissions of
nitrogen oxides?'' at 40 CFR 52.731. As a result of this correction,
the rulemaking action published on October 29, 2012, (77 FR 65478) is
now codified at 40 CFR 52.745.
    Section 553 of the Administrative Procedure Act, 5 U.S.C.
553(b)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, the agency may issue a rule without providing
notice and an opportunity for public comment. We have determined that
there is good cause for making this rule final without prior proposal
and opportunity for comment because we are merely correcting an
incorrect citation in a previous action. Thus, notice and public
procedure are unnecessary. We find that this constitutes good cause
under 5 U.S.C. 553(b)(B).

Statutory and Executive Order Reviews

    Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993),
this action is not a ``significant regulatory action'' and is therefore
not subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)). Because
the agency has made a ``good cause'' finding that this action is not
subject to notice-and-comment requirements under the Administrative
Procedures Act or any other statute as indicated in the Supplementary
Information section above, it is not subject to the regulatory
flexibility provisions of the Regulatory Flexibility Act (5 U.S.C 601
et seq), or to sections 202 and 205 of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Pub. L. 104-4). In addition, this action does not
significantly or uniquely affect small governments or impose a
significant intergovernmental mandate, as described in sections 203 and
204 of UMRA. This rule also does not have a

substantial direct effect on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it have substantial direct
effects 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 governments, as specified
by Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also
is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997),
because it is not economically significant.
    This correction action does not involve technical standards; thus
the requirements of section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The rule
also does not involve special consideration of environmental justice
related issues as required by Executive Order 12898 (59 FR 7629,
February 16, 1994). In issuing this rule, EPA has taken the necessary
steps to eliminate drafting errors and ambiguity, minimize potential
litigation, and provide a clear legal standard for affected conduct, as
required by section 3 of Executive Order 12988 (61 FR 4729, February 7,
1996). EPA has complied with Executive Order 12630 (53 FR 8859, March
15, 1998) by examining the takings implications of the rule in
accordance with the ``Attorney General's Supplemental Guidelines for
the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued
under the executive order. This rule does not impose an information
collection burden under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq).
    The Congressional Review Act (5 U.S.C. 801 et seq.), as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. This
determination must be supported by a brief statement. 5 U.S.C. 808(2).
As stated previously, EPA had made such a good cause finding, including
the reasons therefore, and established an effective date of December
20, 2012. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This correction to
40 CFR 52 for Illinois is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: December 10, 2012.
Susan Hedman,
Regional Administrator, Region 5.

    For the reasons stated in the preamble, part 52, title 40, chapter
I of the Code of the Federal Regulations is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Sec.  52.731  [Redesignated as Sec.  52.745]

0
2. Redesignate Sec.  52.731 as Sec.  52.745.

0
3. A new Sec.  52.731 is added to read as follows:

Sec.  52.731  Interstate pollutant transport provisions; What are the
FIP requirements for decreases in emissions of nitrogen oxides?

    (a)(1) The owner and operator of each source and each unit located
in the State of Illinois and for which requirements are set forth under
the TR NOX Annual Trading Program in subpart AAAAA of part
97 of this chapter must comply with such requirements. The obligation
to comply with such requirements will be eliminated by the promulgation
of an approval by the Administrator of a revision to Illinois' State
Implementation Plan (SIP) as correcting the SIP's deficiency that is
the basis for the TR Federal Implementation Plan under Sec.  52.38(a),
except to the extent the Administrator's approval is partial or
conditional.
    (2) Notwithstanding the provisions of paragraph (a)(1) of this
section, if, at the time of the approval of Illinois' SIP revision
described in paragraph (a)(1) of this section, the Administrator has
already started recording any allocations of TR NOX Annual
allowances under subpart AAAAA of part 97 of this chapter to units in
the State for a control period in any year, the provisions of subpart
AAAAA of part 97 of this chapter authorizing the Administrator to
complete the allocation and recordation of TR NOX Annual
allowances to units in the State for each such control period shall
continue to apply, unless provided otherwise by such approval of the
State's SIP revision. (b)(1) The owner and operator of each source and
each unit located in the State of Illinois and for which requirements
are set forth under the TR NOX Ozone Season Trading Program
in subpart BBBBB of part 97 of this chapter must comply with such
requirements. The obligation to comply with such requirements will be
eliminated by the promulgation of an approval by the Administrator of a
revision to Illinois' State Implementation Plan (SIP) as correcting the
SIP's deficiency that is the basis for the TR Federal Implementation
Plan under Sec.  52.38(b), except to the extent the Administrator's
approval is partial or conditional.
    (2) Notwithstanding the provisions of paragraph (b)(1) of this
section, if, at the time of the approval of Illinois' SIP revision
described in paragraph (b)(1) of this section, the Administrator has
already started recording any allocations of TR NOX Ozone
Season allowances under subpart BBBBB of part 97 of this chapter to
units in the State for a control period in any year, the provisions of
subpart BBBBB of part 97 of this chapter authorizing the Administrator
to complete the allocation and recordation of TR NOX Ozone
Season allowances to units in the State for each such control period
shall continue to apply, unless provided otherwise by such approval of
the State's SIP revision.

[FR Doc. 2012-30533 Filed 12-19-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Rules and Regulations]
[Pages 51088-51090]
[FR Doc No: 2014-19973]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0616; Directorate Identifier 2014-CE-018-AD;
Amendment 39-17954; AD 2014-17-01]
RIN 2120-AA64

Airworthiness Directives; Viking Air Limited Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Viking
Air Limited Model DHC-3 airplanes. This AD results from mandatory
continuing airworthiness information (MCAI) issued by the aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as looseness of the horizontal stabilizer actuator mounting
block in the forward-aft and side-to-side directions. We are issuing
this AD to require actions to address the unsafe condition on these
products.

DATES: This AD is effective September 16, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of September 16,
2014.
    We must receive comments on this AD by October 14, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Viking Air
Limited Technical Support, 1959 De Havilland Way, Sidney, British
Columbia, Canada, V8L 5V5; Fax:<PHONE_NUMBER>; telephone: (North
America) 1-800-663-8444; email<EMAIL_ADDRESS>
Internet: http://www.vikingair.com/content.aspx?id=358. You may view
this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0616; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
(800) 647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Safety Enginer,
FAA, New York Aircraft Certification Office, 1600 Steward Avenue, Suite
410, Westbury, New York 11590; telephone:<PHONE_NUMBER>; fax: (516)
794-5531; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    Transport Canada, which is the aviation authority for Canada, has
issued AD No. CF-2014-14, dated June 5, 2014 (referred to after this as
``the MCAI''), to correct an unsafe condition for Viking Air Limited
Model DHC-3 airplanes. The MCAI states:

    A horizontal stabilizer actuator (trim jack) mounting block,
part number C3FS79-5, was found loose in the forward-aft and side-
to-side directions. The trim jack mounting block fastens the
stabilizer actuator (trim jack) which allows the angle of incidence
of the stabilizer to be varied. The stabilizer actuator (trim jack)
also functions as the rear mounting point for the stabilizer.
    Failure of the mounting block through breakage or detachment may
cause loss of control of the horizontal stabilizer and subsequent
loss of control of the aeroplane. Therefore, this AD mandates a one-
time inspection of the stabilizer actuator (trim jack) mounting
block.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0616.

Relevant Service Information

    Viking Air Limited has issued Viking Service Bulletin No. V3/0005,
Revision `A', dated May 27, 2014. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of the AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are issuing this AD because we
evaluated all information provided by the State of Design Authority and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

Interim Action

    We consider this AD interim action. After the State of Design
reviews and evaluates the reporting data, we may take further
rulemaking action in the future.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
failure of the mounting block through breakage or detachment may cause
loss of control of horizontal stabilizer and subsequent loss of
control. Therefore, we determined that notice and opportunity for
public comment before issuing this AD are impracticable and that good
cause exists for making this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2014-0616; Directorate
Identifier 2014-CE-018-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may

amend this AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD will affect 35 products of U.S. registry.
We also estimate that it would take about 3 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $8,925, or $255 per product.
    The scope of damage found in the inspections could vary from
airplane to airplane. We have no way of determining how much damage may
be found on each airplane or the cost to repair or replace damaged
parts on each airplane or the number of airplanes that may require
repair or replacements.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information
Collection Clearance Officer, AES-200.

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.

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:

2014-17-01. Viking Air Limited: Amendment 39-17954; Docket No. FAA-
2014-0616; Directorate Identifier 2014-CE-018-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective September
16, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Viking Air Limited Models DHC-3 airplanes,
all serial numbers, certificated in any category.

(d) Subject

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

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as looseness of the
horizontal stabilizer actuator mounting block in the forward-aft and
side-to-side directions. We are issuing this AD to prevent breakage
or detachment of the horizontal stabilizer actuator mounting block,
which could lead to failure of the horizontal stabilizer with
subsequent loss of control.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) and (f)(2).
    (1) Within the next 100 hours time-in-service after September
16, 2014 (the effective date of this AD) or within the next 90 days
after September 16, 2014 (the effective date of the this AD),
whichever occurs first, inspect the horizontal stabilizer actuator
(trim jack) for movement or defects following the Accomplishment
Instructions in Viking Service Bulletin No. V3/0005, Revision `A',
dated May 27, 2014.
    (2) If any movement or defects are found during the inspection
required by paragraph (f)(1) of this AD, before further flight, you
must contact Viking Air Limited to obtain FAA-approved repair
instructions approved specifically for compliance with this AD and
incorporate those instructions. You can find contact information for
Viking Air Limited in paragraph (i)(3) of this AD. Use the Service
Bulletin V3/0005--Operator Reply Form found in Viking Service
Bulletin No. V3/0005, Revision `A', dated May 27, 2014, to report
details of the inspection findings.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Cesar Gomez, Aerospace Safety Enginer, FAA, New
York Aircraft Certification Office (ACO), 1600 Steward Avenue, Suite
410, Westbury, New York 11590; telephone:<PHONE_NUMBER>; fax: (516)
794-5531; email<EMAIL_ADDRESS>Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (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.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI, Transport Canada AD No. CF-2014-14, dated June 5,
2014, and Viking Service Bulletin No. V3/0005, Revision `A', dated
May 27, 2014, for related information. You may examine the MCAI on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2014-0616.

(i) 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) Viking Service Bulletin No. V3/0005, Revision `A', dated May
27, 2014.
    (ii) Reserved.
    (3) For Viking Air Limited service information identified in
this AD, contact Viking Air Limited Technical Support, 1959 De
Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; Fax: 250-
656-0673; telephone: (North America) 1-800-663-8444; email:
<EMAIL_ADDRESS>Internet: http://www.vikingair.com/content.aspx?id=358.
    (4) You may view this referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
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 Kansas City, Missouri on August 18, 2014.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2014-19973 Filed 8-26-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 130 (Friday, July 8, 2022)]
[Notices]
[Pages 40872-40873]
[FR Doc No: 2022-14693]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, that the
Securities and Exchange Commission will hold an Open Meeting on
Wednesday, July 13, 2022 at 10:00 a.m.

PLACE: The meeting will be webcast on the Commission's website at
www.sec.gov.

STATUS: This meeting will begin at 10:00 a.m. (ET) and will be open to
the public via webcast on the Commission's website at www.sec.gov.

MATTERS TO BE CONSIDERED:
    1. The Commission will consider whether to adopt amendments to the
proxy rules governing proxy voting advice.
    2. The Commission will consider whether to propose amendments to
update certain substantive bases for exclusion of shareholder proposals
under the Commission's shareholder proposal rule (Rule 14a-8).

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Vanessa A. Countryman from the Office of the Secretary
at<PHONE_NUMBER>.
    Authority: 5 U.S.C. 552b.

    Dated: July 6, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-14693 Filed 7-6-22; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]
[Page 73103-73104]
[DOCID:fr29no10-101]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0600]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Drug User Fee Cover Sheet, Form 3546

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 burden hours necessary to
complete FDA Form 3546, Animal Drug User Fee Act (ADUFA) Cover Sheet.

DATES: Submit either electronic or written comments on the collection
of information by January 28, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
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.

Animal Drug User Fee Cover Sheet; FDA Form 3546 (OMB Control Number
0910-0539)--Extension

    Under section 740 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 379j-12), as amended by ADUFA, FDA has the
authority to assess and collect for certain animal drug user fees.
Because the submission of user fees concurrently with applications and
supplements is required, review of an application cannot begin until
the fee is submitted. The types of fees that require a cover sheet are
certain animal drug application fees and certain supplemental animal
drug application fees. The cover sheet (FDA Form 3546) is designed to
provide the minimum necessary information to determine whether a fee is
required for the review of an application or supplement, to determine
the amount of the fee required, and to assure that each animal drug
user fee payment and each animal drug application for which payment is
made is appropriately linked to the payment that is made. The form,
when completed electronically, will result in the generation of a
unique payment identification number used in tracking the payment. FDA
will use the information collected to initiate administrative screening
of new animal drug applications and supplements to determine if payment
has been received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
   Section of the FD&C Act as        Number of     frequency per   Total annual      Hours per      Total hours
        amended by ADUFA            respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
740(a)(1), FDA Form 3546 (Cover               76               1              76               1              76
 Sheet).........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              76
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents to this collection of information are new animal drug
applicants or manufacturers. Based on FDA's database system, there are
an estimated 140 manufacturers of products or sponsors of new animal
drugs potentially subject to ADUFA. However, not all manufacturers or
sponsors will have any submissions in a given year and some may have
multiple submissions. The total number of annual responses is based on
the number of submissions received by FDA in fiscal year 2008. The
estimated hours per response are based on past FDA experience with the
various submissions. The hours per response are based on the average of
these estimates.

    Dated: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29820 Filed 11-26-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Page 71189]
[FR Doc No: 2012-28872]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ13-3-000]

City of Vernon, California; Notice of Filing

    Take notice that on November 16, 2012, City of Vernon, California
submitted its tariff filing per 35.28(e): Filing 2013 TRR and TRBAA to
be effective 1/1/2013.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on December 7, 2012.

    Dated: November 21, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-28872 Filed 11-28-12; 8:45 am]
BILLING CODE 6717-01-P


FILE NAME: company. wpt ( 7/ 1/ 2004)

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

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE ( 7/ 1/ 2004)

EPA Registration Division contact: [ insert name and telephone number with area code]

INSTRUCTIONS: Please utilize this outline in preparing tolerance petition documents. In cases where the outline element does not apply please insert " NA Remove" and maintain the outline. The comment notes that appear on the left margin represent hidden typesetting codes designed to expedite the processing of the Federal Register document. Please do not remove or alter these comment notes or change the margins, font, or format in your document. Simply replace the instructions that appear in italics and brackets, i. e., "[ insert company name]," with the information specific to your action.

[ Insert petition number]

Summary of Petitions EPA has received a pesticide petition ([ insert petition number]) from [ Bayer CropScience], [ P. O. Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709] proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.

Options ( pick one)

by establishing a tolerance for residues of [ trifloxystrobin] in or on the raw agricultural commodities [ corn, sweet, kernel plus cob with husks removed] at [ 0.04] parts per million ( ppm), [ corn, sweet, forage] at [ 0.6] ppm, and [ corn, sweet, stover] at [ 0.25] ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 2 1. Plant metabolism. [ The metabolism of trifloxystrobin in plants ( cucumbers, apples, wheat, sugar beets and peanuts) is well understood. Identified metabolic pathways are substantially similar in plants and animals ( goat, rat and hen). EPA has determined that trifloxystrobin parent and its metabolite CGA 321113 are the residue of concern for tolerance setting purposes.]

2. Analytical method. [ A practical analytical methodology for detecting and measuring levels of trifloxystrobin in or on raw agricultural commodities has been submitted. The limit of detection ( LOD) for each analyte of this method is 0.08 ng injected, and the limit of quantitation ( LOQ) is 0.02 ppm. The method is based on crop specific cleanup procedures and determination by gas chromatography with nitrogen phosphorus detection.]

3. Magnitude of residues. [ Twelve field trials were conducted in major sweet corn growing areas of the United States. No trifloxystrobin equivalent residues were found in sweet corn ear ( kernels plus cob with husks removed) samples. The maximum trifloxystrobin equivalent residues in forage without ears and stover were 0.54 ppm and 0.19 ppm, respectively, at the target 14 day PHI. ]

B. Toxicological Profile 1. Acute toxicity. [ Studies conducted with the technical material of trifloxystrobin:

rat acute oral toxicity study with a LD50 > 5000 mg/ kg mouse acute oral toxicity study with a LD50 > 5000 mg/ kg rabbit acute dermal toxicity study with a LD50 > 2000 mg/ kg rat acute dermal toxicity study with a LD50 > 2000 mg/ kg rat acute inhalation toxicity study with a LC50 > 4.65 mg/ L rabbit eye irritation study showing slight irritation ( Category III) rabbit dermal irritation study showing slight irritation ( Category IV) Guinea pig dermal sensitization study with the Buehler's method showing negative findings Guinea pig dermal sensitization study with the Maximization method showing some positive findings.]

2. Genotoxicty. [ No genotoxic activity is expected of trifloxystrobin under in vivo or physiological conditions. The compound has been tested for its potential to induce gene mutation and chromosomal changes in five different test systems. The only positive finding was seen in the in vitro test system ( Chinese hamster V79 cells) as a slight increase in 3 mutant frequency at a very narrow range ( 250  278 µ g/ ml) of cytotoxic and precipitating concentrations ( compound solubility in water was reported to be 0.61 µ g/ ml; precipitate was visually noted in culture medium at 150 µ g/ ml). The chemical was found to be non mutagenic in the in vivo system or all other in vitro systems. Consequently, the limited gene mutation activity in the V79 cell line is considered a nonspecific effect under non physiological in vitro conditions and not indicative of a real mutagenic hazard.]

3. Reproductive and developmental toxicity. [ FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for pre and post natal toxicity and the completeness of the database. Based on the current toxicological data requirements, the database on trifloxystrobin relative to pre and post natal effects for children is complete.

In assessing the potential for additional sensitivity of infants and children to residues of trifloxystrobin, data were considered from teratogenicity studies in the rat and the rabbit and a 2 generation reproduction studies in the rat. The teratogenicity studies are designed to evaluate adverse effects on the developing embryo as a result of chemical exposure during the period of organogenesis. Reproduction studies provide information on effects from chemical exposure on the reproductive capability of mating animals and systemic and developmental toxicity from in utero exposure.

In the rat teratology study, reductions in body weight gain and food consumption were observed in the dam at $ 100 mg/ kg. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increased incidence of enlarged thymus, which is a type of variation, at 1000 mg/ kg. The developmental NOEL was 100 mg/ kg.

In the rabbit teratology study, body weight loss and dramatically reduced food consumption were observed in the dam at $ 250 mg/ kg. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increase in skeletal anomaly of fused sternebrae 3 and  4 at the top dose level of 500 mg/ kg. This finding is regarded as a marginal effect on skeletal development that could have resulted from the 40 65% lower food intake during treatment at this dose level. The developmental NOEL was 250 mg/ kg.

In the 2 generation rat reproduction study, body weight gain and food consumption were decreased at $ 750 ppm, especially in females during lactation. Consequently, the reduced pup weight gain during lactation ($ 750 ppm) and the slight delay in eye opening ( 1500 ppm) are judged to be a secondary effect of maternal toxicity. No other fetal effects or any reproductive changes were noted. The low developmental NOEL, 50 ppm ( 5 mg/ kg), seen in this study was probably due to the lack of intermediate dose levels between 50 and 750 ppm. Based on an evaluation of the dose response 4 relationship for pup weight at 750 ppm and 1500 ppm, the NOEL should have been nearly ten fold higher if such a dose was available.

Based on all these teratology and reproduction studies, the lowest NOEL for developmental toxicity is 5 mg/ kg while the lowest NOEL in the subchronic and chronic studies is 2.5 mg/ kg/ day ( from the rat chronic study). Therefore, no additional sensitivity for infants and children to trifloxystrobin is suggested by the data base.]

4. Subchronic toxicity. [ In subchronic studies, several mortality related changes were reported for the top dose in dogs ( 500 mg/ kg) and rats ( 800 mg/ kg). At these dose levels, excessive toxicity has resulted in body weight loss and mortality with the associated and nonspecific changes in several organs ( such as atrophy in the thymus, pancreas, bone marrow, lymph node, and spleen) which are not considered specific target organs for the test compound. In the dog, specific effects were limited to hepatocellular hypertrophy at $ 150 mg/ kg and hyperplasia of the epithelium of the gall bladder at 500 mg/ kg. Target organ effects in the rat were noted as hepatocellular hypertrophy ($ 200 mg/ kg) and the related liver weight increase ( $ 50 mg/ kg). In the mouse, target organ effects included single cell necrosis ( $ 300 mg/ kg) and hypertrophy ( 1050 mg/ kg) in the liver and extramedullary hematopoiesis ( $ 300 mg/ kg) and hemosiderosis in the spleen ( 1050 mg/ kg).

In general, definitive target organ toxicity, mostly in the liver, was seen at high feeding levels of over 100 mg/ kg for an extended treatment period. At LOEL, no serious toxicity was observed other than mostly non specific effects including a reduction in body weight and food consumption or liver hypertrophy.]

5. Chronic toxicity. [ The liver appears to be the major primary target organ based on the chronic studies conducted in mice, rats, and dogs. It was identified as a target organ in both the mouse and the dog studies with trifloxystrobin. However, no liver effect was seen in the chronic rat study which produced the lowest NOEL of 2.5 mg/ kg based on reduced body weight gain and food consumption seen at higher dose levels.

The compound did not cause any treatment related increase in general tumor incidence, any elevated incidence of rare tumors, or shortened time to the development of palpable or rapidly lethal tumors in the 18 month mouse and the 24 month rat studies. Dosages in both studies were sufficient for identifying a cancer risk. In the absence of carcinogenicity, a Reference Dose approach is appropriate for quantitation of human risks.]

6. Animal metabolism. [ Trifloxystrobin is moderately absorbed from the gastrointestinal tract of rats and is rapidly distributed. Subsequent to a single oral dose, the half life of 5 elimination is about 2 days and excretion is primarily via bile. Trifloxystrobin is extensively metabolized by the rat into about 35 metabolites, but the primary actions are on the methyl ester ( hydrolysis into an acid), the methoxyimino group ( O demethylation), and the methyl side chain ( oxidation to a primary alcohol). Metabolism is dose dependent as it was almost complete at low doses but only about 60% complete at high doses.

In the goat, elimination of orally administered trifloxystrobin is primarily via the feces. The major residues were the parent compound and the acid metabolite ( CGA 321113) plus its conjugates. In the hen, trifloxystrobin is found as the major compound in tissues and in the excreta, but hydroxylation of the trifluormethyl phenyl moiety and other transformations, including methyl ester hydrolysis and demethylation of the methoxyimino group, are also seen. In conclusion, the major pathways of metabolism in the rat, goat, and hen are the same.]

7. Metabolite toxicology. [ Metabolism of trifloxystrobin has been well characterized in plants, soil, and animals. In plants and soil, photolytically induced isomerization results in a few minor metabolites not seen in the rat; however, most of the applied materials remained as parent compound as shown in the apple and cucumber studies. All quantitatively major plant and/ or soil metabolites were also seen in the rat. The toxicity of the major acid metabolite, CGA 321113 ( formed by hydrolysis of the methyl ester), has been evaluated in cultured rat hepatocytes and found to be 20 times less cytotoxic than the parent compound. Additional toxicity studies were conducted for several minor metabolites seen uniquely in plants and/ or soil. The studies indicate that these metabolites, including CGA 357261, CGA 373466, and NOA 414412, are not mutagenic to bacteria and are of low acute toxicity ( LD50 > 2000 mg/ kg). In conclusion, the metabolism and toxicity profiles support the use of an analytical enforcement method that accounts for parent trifloxystrobin.]

8. Endocrine disruption. [ Trifloxystrobin does not belong to a class of chemicals known for having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that trifloxystrobin might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long term effect related to the endocrine system.]

C. Aggregate Exposure 1. Dietary exposure. [ Assessments, using the DEEM FCID Version 2.0, 1994 1996,98 CSFII 6 software, were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U. S. population and selected population subgroups to residues of trifloxystrobin. These analyses cover all registered crops plus the pending uses on barley, oats sweet corn and grasses grown for seed.

The EPA has established an acute Population Adjusted Dose ( aPAD) of 2.5 mg/ kg/ day for acute dietary risk assessments based on a NOAEL of 250 mg/ kg bwt/ day from a rabbit developmental toxicity study and an uncertainty factor or 100. For chronic dietary analyses, the EPA established a chronic Population Adjusted Dose ( cPAD) of 0.038 based on a NOAEL of 3.8 from a rat reproductive toxicity study and and uncertainty factor of 100.

Results from the acute and chronic dietary exposure analyses described below demonstrate a reasonable certainty that no harm to the overall U. S. population or any population subgroup will result from the use of trifloxystrobin on currently registered uses plus the pending uses on barley, oats, sweet corn, and grasses grown for seed.]

i. Food. [ For food, a Tier 1 acute and a Tier 2 chronic dietary exposure assessments were performed. Acute exposure, expressed at the 95th percentile of exposure, was 0.53% of the aPAD for females 13 49 years old ( only population subgroup of concern). The chronic exposure was 2.5% cPAD for the total US population and 13.7% cPAD for the most sensitive population, children 1 2 years old.]

ii. Drinking water. [ The DEEM software was also used to calculate acute and chronic drinking water levels of concern ( aDWLOC and cDWLOC). The aDWLOC was 74,599 and the cDWLOC was 1,296 for the total US population and 328 for the most sensitive population subgroup, children 1 2 years old. These values are above realistic estimated concentrations of trifloxystrobin and its metabolites in drinking water as published in the Federal Register ( 68 FR 53297). Therefore, there is reasonable certainty that exposure from trifloxystrobin will not result in harm to the adult U. S. population, females 13 49, or infants and children.]

2. Non dietary exposure. [ As published in the Federal Register ( 68 FR 53297), the EPA considered chronic, short term and intermediate term risk from residential uses of tebuconazole. The EPA determined that the risk did not exceed the Agency's level of concern.]

D. Cumulative Effects [ EPA has determined, as published in the Federal Register ( 68 FR 53297), that unlike other pesticides for which EPA has followed a cumulative risk approach based on a common 7 mechanism of toxicity, trifloxystrobin does not appear to produce a toxic metabolite produced by other substances. Therefore EPA has not assumed that trifloxystrobin has a common mechanism of toxicity with other substances.]

E. Safety Determination 1. U. S. population. [ Based on the information supplied under Aggregate Exposure describe above, there is reasonable certainty that exposure from trifloxystrobin will not result in harm to the adult U. S. population.]

2. Infants and children. [ Based on the information supplied under Aggregate Exposure describe above, there is reasonable certainty that exposure from trifloxystrobin will not result in harm to infants and children.]

F. International Tolerances [ Brazil and Spain have establisheed MRLs for trifloxystrobin on sweet corn. No Codex MRLs have been established for trifloxystrobin.]


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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

Electronic cigarettes have become critical to my personal health. Prior to adopting e-cigarettes, I smoked 2-3 cigars and approximately 15 cigarettes per day. Despite trying a variety of methods to quit, including patches, gum and medication all supported by counseling, I was not successful in quitting smoking. However, with e-cigarettes I’ve been smoke free for over two years and have been “vaping” only nicotine free juice for over one year. The rich ecosystem of small business producing a wide variety of devices and liquids was critical to the success I’ve had and continue to have. I’ve been saved from fates both of my parents - COPD, cancer and early death.

The Proposed Rule raises numerous issues which I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I wish to provide you with my personal story, as well as science and evidence based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 81, Number 197 (Wednesday, October 12, 2016)]
[Notices]
[Pages 70447-70449]
[FR Doc No: 2016-24572]

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

[Release No. 34-79047; File No. SR-Phlx-2016-96]

Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options
Floor Procedure Advice F-1, Entitled ``Use of Identification Letters
and Numbers.''

October 5, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 23, 2016, NASDAQ PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend Options Floor Procedure Advice F-1,
entitled ``Use of Identification Letters and Numbers.''
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Options Floor Procedure Advice
(``OFPA'') F-1, entitled ``Use of Identification Letters and Numbers''
to eliminate the current fine schedule. Pursuant to this OFPA F-1,
today, all Specialists, ROTs, and Floor Brokers must use the complete
alpha/numeric identification assigned by the Exchange. Specifically,
all Floor Brokers or their employees must indicate their complete
alpha/numeric identifiers on the Options Floor Broker Management System
(``FBMS'') for each order they receive and represent in the trading
crowd. The FMBS system is automated and requires this field to be
completed before the transaction may be submitted. These numbers are
important because they represent the parties to the particular
transaction for purposes of audit trail, clearance and settlement of
that transaction. This information is submitted to The Options Clearing
Corporation at the end of the day to complete the back-office portion
of the transaction. The information is available to and reviewed by
both parties to the transaction. The Exchange currently has a fine
schedule for violations of OFPA F-1 as follows:

                              Fine Schedule
           [Implemented on a two-year running calendar basis]
------------------------------------------------------------------------

------------------------------------------------------------------------
1st Occurrence.........................  $250.00.
2nd Occurrence.........................  $500.00.
3rd Occurrence.........................  $1,000.00.
4th Occurrence and Thereafter..........  Sanction is discretionary with
                                          Business Conduct Committee.
------------------------------------------------------------------------

    The Exchange notes that the violations of this rule today consist
of inadvertent failures to include the requisite alpha/numeric
identification.\3\ These errors are corrected post-trade, by end of day
by the party in error. The Floor Brokers receive inter-day reports
which allow them to review this information and determine if any errors
occurred. Also, the contra-party to the transaction may alert the Floor
Broker that an error occurred. The Exchange notes that where errors
have been identified through surveillance, it has not witnessed any
manipulative conduct, rather the error was an inadvertent data entry
error, which was subsequently corrected.
---------------------------------------------------------------------------

    \3\ For example in 2016, the Exchange statistically had .00004%
of violations of this minor rule. In 2015, the Exchange
statistically had .00003% of violations of this minor rule.
---------------------------------------------------------------------------

    By way of background, the Exchange notes that when the floor
operated with more manual procedures and inter-day reports were not
available, these types of error occurred with more frequency. The
Exchange at that time employed a greater number of staff employees on
the Exchange floor when the population on the floor was also at greater
numbers. The amount of time that staff was devoted to assisting with
these types of errors placed an administrative burden on the Exchange
and presented an administrative cost to the Exchange to employ staff to
assist with clerical errors. The fine at that time was justified to
prevent a greater number of violations and also to support the amount
of regulatory resources that were required to surveil for such
violations and assist in the correction of errors.
    Today, the automated processes and inter-day reports alleviate many
of the issues that previously existed, including the burden on staff to
correct errors. The Exchange does not believe that a single error
necessitates the imposition of a $250.00 fine, for example, where a
data entry error occurred and was corrected by the firm.
    The Exchange proposes to eliminate the current fine schedule and
instead

review for patterns and practices of manipulative conduct. The Exchange
will continue to review, as it does today, for instances where a party
to a trade did not enter the complete or an accurate identifier. Also,
the Exchange would continue to bring violations of this rule before the
Business Conduct Committee and suggest appropriate fines given the
facts and circumstances surrounding current and previous violations of
the minor rule. Today, the Exchange has the ability to bring any
violations before the Business Conduct Committee.\4\ The disciplinary
rules provide for a process by which the Exchange will discipline
members for violations of its rules and the process for hearings.\5\
The Exchange's focus is to prevent abusive or manipulative patterns and
practices of violations of OFPA F-1 and also prevent repeated abuse of
this rule. The Exchange intends to continue to surveil and discipline
its members for violations of this rule.
---------------------------------------------------------------------------

    \4\ Any member, member organization, or any partner, officer,
director or person employed by or associated with any member or
member organization (the Respondent) who is alleged to have violated
or aided and abetted a violation of the Securities Exchange Act of
1934 (Exchange Act), the rules and regulations thereunder, the by-
laws and Rules of the Exchange or any interpretation thereof, and
the Rules, Regulations, resolutions and stated policies of the Board
of Directors or any Committee of the Exchange, shall be subject to
the disciplinary jurisdiction of the Exchange, and after notice and
opportunity for a hearing may be appropriately disciplined by
expulsion, suspension, fine, censure, limitation or termination as
to activities, functions, operations, or association with a member
or member organization, or any other fitting sanction in accordance
with the provisions of these disciplinary Rules. See Phlx Rule
960.1(a). Further, whenever the staff of the Exchange has a
reasonable basis to believe that a violation within the disciplinary
jurisdiction of the Exchange has occurred, a written report shall be
submitted to the Business Conduct Committee specifying the
violations which are believed to have occurred and those facts which
gave rise to these violations. See Phlx Rule 960.2(d).
    \5\ See Phlx Rules 960-970.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by continuing to enforce violations of rules governing the marking of
orders.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Proper identification of orders protects investors and the public
interest. In cases where human error occurred and a member failed to
include the requisite alpha/numeric identification or submitted an
incorrect alpha/numeric identification, such information may be
corrected post-trade. The Exchange will continue to enforce the proper
identification on each trade. Regulatory staff will monitor violations
of such rule and bring cases before the Business Conduct Committee
where a pattern or practice of violation of such rule exists and
suggest appropriate fines given the facts and circumstances surrounding
current and previous violations of the minor rule. Today, the Exchange
has the ability to bring any violations before the Business Conduct
Committee.\8\
---------------------------------------------------------------------------

    \8\ See note 4 above.
---------------------------------------------------------------------------

    The Exchange is concerned with the entry of accurate trading
information which identifies counter-parties to each trade. The trading
system requires such information for each transaction. The automated
process combined with the surveillance of such information, as well as
counter-party transparency to the information, ensure that the audit
trail is accurate and complete. The Exchange understands that human
error may occur from time to time and that members have the ability to
and do correct such information prior to the end of the day. Given all
of these circumstances, the proposal is consistent with the Act because
it will continue to ensure that the information is maintained
accurately and also discipline members that fail to consistently abide
by this rule.
    The Exchange believes it is consistent with the Act and protects
investors and the general public to amend the rule to bring
disciplinary actions where a pattern or practice of violating OFPA F-1
exists versus multiple fines for each individual violation. The
Exchange notes that it has not observed a large number of these
violations. Where a number of violations have occurred or where there
has been manipulative activity in the entry of such trade information,
these actions will be brought by the Regulatory group to the Business
Conduct Committee for further action. The Exchange will enumerate the
facts and circumstances surrounding the violations and present an
appropriate sanction in light of the circumstances to the Business
Conduct Committee.
    This filing is non-controversial because the Exchange will continue
to regulate members for violations of Rule OFPA F-1, albeit in a
slightly different matter. The result may be the imposition of the same
fines by the Business Conduct Committee.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes that no
undue burden on competition arises with this rule change as the rule
will be uniformly applied to all members. The Exchange will continue to
monitor the activity of all members, and where a number of violations
has occurred or where there has been manipulative activity in the entry
of such trade information, these actions will be brought by the
Regulatory group to the Business Conduct Committee for further action.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \9\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing,

including whether the proposed rule change is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2016-96 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2016-96. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; 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-Phlx-2016-96 and should be
submitted on or before November 2, 2016.

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

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

Brent J. Fields,
Secretary.
[FR Doc. 2016-24572 Filed 10-11-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Page 34632]
[FR Doc No: 2015-14870]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meeting related to the transmission planning activities of ISO New
England Inc.
    ISO New England Inc. Planning Advisory Committee Meeting.
    June 17, 2015, 9:30 a.m.-4:00 p.m. (Eastern Standard Time)
    The above-referenced meeting will be held at: Doubletree Hotel,
5400 Computer Drive, Westborough, MA 01581.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.iso-ne.com/committees/planning/planning-advisory.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket No. ER13-193, ISO New England Inc.
Docket No. ER13-196, ISO New England Inc.
Docket No. ER13-1957, ISO New England Inc. et al.
Docket No. ER13-1960, ISO New England Inc. et al.

    For more information, contact Michael Cackoski, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (202) 502-
6169 or<EMAIL_ADDRESS>
    Dated: June 11, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-14870 Filed 6-16-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Proposed Rules]
[Pages 27932-27933]
[FR Doc No: 2018-12910]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket Number USCG-2018-0388]

Anchorage Ground; Sabine Pass, TX

AGENCY: Coast Guard, DHS.

ACTION: Notice of inquiry; request for comments.

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

SUMMARY: We are requesting your comments on a request we received from
Sabine Pass LNG, L.P. for the disestablishment of the Sabine Pass
Channel Anchorage Ground in Sabine, TX. The request indicates that deep
draft ships do not use the anchorage and that disestablishment of the
anchorage would not pose a concern for ship traffic. We seek your
comments on whether we should consider a proposed rulemaking
disestablishing the Sabine Pass Anchorage Ground based on this request
or if other actions, such as reducing the size of the anchorage, should
be considered.

DATES: Your comments and related material must reach the Coast Guard on
or before July 16, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0388 using the Federal portal at http://www.regulations.gov. See
the ``Public Participation and Request for Comments'' portion of the
SUPPLEMENTARY INFORMATION section for further instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of inquiry, call or email Mr. Scott K. Whalen, Marine Safety
Unit Port Arthur, U.S. Coast Guard; telephone<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
U.S.C. United States Code

II. Background and Purpose

    In 1967, the Secretary of the Army transferred responsibility for
certain functions, power, and duties to the Secretary of
Transportation. Among the responsibilities transferred to the Secretary
of Transportation was establishment and administration of water vessel
anchorages. On December 12, 1967, the regulations for the Sabine Pass
Anchorage Ground were republished in 33 CFR part 110, without change,
under this new authority (32 FR 17726). The regulations for the Sabine
Pass Channel Anchorage Ground in Sabine, TX are contained in 33 CFR
110.196.
    The legal basis and authorities for this notice of inquiry are
found in 33 U.S.C. 471, 1221 through 1236; 33 CFR 1.05-1, and
Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to propose, establish, and
define regulatory anchorages. As reflected in title 33 CFR 109.05, the
Commandant of the U.S. Coast Guard has delegated the authority to
establish anchorage grounds to U.S. Coast Guard District Commanders.
The Coast Guard is now requesting comments on considering a proposed
rulemaking based on Sabine Pass LNG L.P.'s request for disestablishing
the Sabine Pass Anchorage Ground, or if other actions, such as reducing
the size of the anchorage, should also be considered.
    As discussed earlier, administration of the Sabine Pass Anchorage
Ground was originally transferred to the Coast Guard in 1967. Under 33
CFR 110.196, the anchorage ground is ``for the temporary use of vessels
of all types, but especially for naval and merchant vessels awaiting
weather and tidal conditions favorable to the resumption of their
voyages.'' In 2006, Cheniere Energy began construction of a liquefied
natural gas terminal on the eastern waterfront of the Sabine Pass
Channel, immediately north and adjacent to the Sabine Pass Channel
Anchorage Ground. On October 3, 2006, the Coast Guard published a
notice of proposed rulemaking proposing to reduce the area of the
Sabine Pass Anchorage Ground by 800 feet on the north end of the
anchorage in order to reduce the risk of collision between anchored
vessels and berthing and unberthing vessels at Cheniere's terminal, as
well as to reduce the risk of grounding by providing a larger
maneuvering area for vessels calling Cheniere's terminal (71 FR 58330).
Both comments we received during that rulemaking process supported the
proposed reduction on the basis of enhancing navigation safety. One
commenter noted that ``the anchorage was infrequently used and would
have minimal impact on the economy.'' On January 5, 2007, the Coast
Guard published the final rule reducing the overall size of the
anchorage consistent with the proposal (72 FR 463).
    On November 8, 2017, we received a request from Sabine Pass LNG
L.P. to disestablish the Sabine Pass Anchorage Ground in its entirety.
The request states that the anchorage is rarely used and its
disestablishment would not significantly impact vessels that use the
area. A copy of this request is available in the docket where indicated
under ADDRESSES.
    A review of Vessel Traffic Service transit reports shows that deep
draft ships have not made use of this anchorage during the last decade.
It is estimated that the anchorage area is utilized an average of 27
times each year by shallow draft vessels (for example, tows, dredges,
and work boats) for shortening tow or for use as a staging area for
local work projects such as dredging.

III. Information Requested

    We seek your comments on whether we should consider a proposed
rulemaking to disestablish or otherwise modify the Sabine Pass
Anchorage Ground. In particular, the Coast Guard requests your input to
determine if there remains a need for a regulated anchorage in this
area, and if so, to what extent and for what purpose; if a reduction in
size of the anchorage would meet current and anticipated industry
needs; or if other options should be considered. Recent U.S. Army Corps
of Engineers survey data of the anchorage is available in the docket
where indicated under ADDRESSES.

IV. Public Participation and Request for Comments

    We encourage you to submit comments through the Federal portal at
http://www.regulations.gov. If your material cannot be submitted using
http://www.regulations.gov, contact the person in the FOR FURTHER
INFORMATION CONTACT section of this document for alternate
instructions. In your submission, please include the docket number for
this notice of inquiry and provide a reason for each suggestion or
recommendation.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this notice of inquiry as being available in
the docket, and all public comments, will be in our online docket at
http://www.regulations.gov and can be viewed by following that
website's instructions.

    Dated: June 12, 2018.
Paul F. Thomas,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2018-12910 Filed 6-14-18; 8:45 am]
 BILLING CODE 9110-04-P


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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they have saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your time and consideration of my request and am happy to discuss this issue with you further.

Sincerely,

Mr. E-cig consumer and former smoker


[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71040-71041]
[FR Doc No: 2011-29478]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0781]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Record Retention Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health Claim

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 record retention
requirements for the soy protein and coronary heart disease health
claim.

DATES: Submit either electronic or written comments on the collection
of information by January 17, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

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.

Record Retention Requirements for the Soy Protein and Risk of Coronary
Heart Disease Health Claim--21 CFR 101.82(c)(2)(ii)(B) (OMB Control
Number 0910-0428)--Extension

    Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343(r)(3)(A)) provides for the use of food label statements
characterizing a relationship of any nutrient of the type required to
be in the label or labeling of the food to a disease or a health-
related condition only where that statement meets the requirements of
the regulations promulgated by the Secretary of Health and Human
Services to authorize the use of such a health claim. Section 101.82
(21 CFR 101.82) of FDA's regulations authorizes a health claim for food
labels about soy protein and the risk of coronary heart disease (CHD).
To bear the soy protein and CHD health claim, foods must contain at
least 6.25 grams of soy protein per reference amount customarily
consumed. Analytical methods for measuring total protein can be used to
quantify the amount of soy protein in foods that contain soy as the
sole source of protein. However, at the present time there is no
validated analytical methodology available to quantify the amount of
soy protein in foods that contain other sources of protein. For these
latter foods, FDA must rely on information known only to the
manufacturer to assess compliance with the requirement that the food
contain the qualifying amount of soy protein. Thus, FDA requires
manufacturers to have and keep records to substantiate the amount of
soy protein in a food that bears the health claim and contains sources
of protein other than soy, and to make such records available to
appropriate regulatory officials upon written request. The information
collected includes nutrient databases or analyses, recipes or
formulations, purchase orders for ingredients, or any other information
that reasonably substantiates the ratio of soy protein to total
protein.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                No. of records                   Average  burden
                           21 CFR section                                 No. of            per          Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.82(c)(2)(ii)(B)................................................              25                1               25                1               25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based upon the Agency's experience with the use of health claims,
FDA estimates that only about 25 firms would be likely to market
products bearing a soy protein/coronary heart disease health claim and
that only, perhaps, one of each firm's products might contain non-soy
sources of protein along with soy protein. The records required to be
retained by Sec.  101.82(c)(2)(ii)(B) are the records, e.g., the
formulation or recipe, that a

manufacturer has and maintains as a normal course of its doing
business. Thus, the burden to the food manufacturer is limited to
assembling and retaining the records, which FDA estimates will take 1
hour annually.

    Dated: November 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29478 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Pages 475-476]
[FR Doc No: 2015-33224]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER10-2265-009; ER12-21-019; ER11-2211-008; ER11-
2209-008; ER11-2210-008; ER11-2207-008; ER11-2206-008; ER13-1150-006;
ER13-1151-006; ER10-2783-013; ER10-2784-013; ER11-2855-019; ER10-2791-
014; ER10-2333-007; ER10-2792-014; ER14-1818-009; ER12-1238-006; ER10-
2260-006; ER10-2261-006; ER10-2337-008; ER14-1668-005; ER14-1669-005;
ER14-1674-005; ER14-1670-005; ER14-1671-005; ER14-1675-005; ER14-1673-
005; ER14-1676-005; ER14-1677-005; ER14-1678-005; ER14-1679-005; ER14-
1672-005; ER10-2795-013; ER10-2798-013; ER10-1575-012; ER10-2338-011;
ER10-2340-011; ER12-1239-006; ER10-2336-007; ER10-2335-007; ER13-1991-
007; ER13-1992-007.
    Applicants: NRG Power Marketing LLC, Agua Caliente Solar, LLC, Alta
Wind I, LLC, Alta Wind II, LLC, Alta Wind III, LLC, Alta Wind IV, LLC,
Alta Wind V, LLC, Alta Wind X, LLC, Alta Wind XI, LLC, Arthur Kill
Power LLC, Astoria Gas Turbine Power LLC, Avenal Park LLC, Bayou Cove
Peaking Power, LLC, Bendwind, LLC, Big Cajun I Peaking Power LLC,
Boston Energy Trading and Marketing LLC, Broken Bow Wind, LLC, Cabrillo
Power I LLC, Cabrillo Power II LLC, CL Power Sales Eight, L.L.C.,
Community Wind North 1 LLC, Community Wind North 2 LLC, Community Wind
North 3 LLC, Community Wind North 5 LLC, Community Wind North 6 LLC,
Community Wind North 7 LLC, Community Wind North 8 LLC, Community Wind
North 9 LLC, Community Wind North 10 LLC, Community Wind North 11 LLC,
Community Wind North 13 LLC, Community Wind North 15 LLC, Conemaugh
Power LLC, Connecticut Jet Power LLC, Cottonwood Energy Company LP, CP
Power Sales Nineteen, L.L.C., CP Power Sales Twenty, L.L.C., Crofton
Bluffs Wind, LLC, DeGreeff DP, LLC, DeGreeffpa, LLC, Desert Sunlight
250, LLC, Desert Sunlight 250, LLC.
    Description: Notice of Change in Status of NRG MBR Sellers [Part 1
of 3].
    Filed Date: 12/30/15.
    Accession Number: 20151230-5304.
    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER10-2794-018; ER14-2672-003; ER12-1825-016.
    Applicants: EDF Trading North America, LLC, EDF Energy Services,
LLC, EDF Industrial Power Services (CA), LLC.
    Description: Updated Market Power Analysis for the Southwest Power
Pool Region of the EDF Sellers.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5191.
    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER10-2794-019; ER14-2672-004; ER12-1825-017.
    Applicants: EDF Trading North America, LLC, EDF Energy Services,
LLC, EDF Industrial Power Services (CA), LLC.
    Description: Updated Market Power Analysis for the Southwest Region
of the EDF Sellers.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5207.
    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER13-1562-005.
    Applicants: Catalina Solar Lessee, LLC.
    Description: Southwest Region Triennial Updated Market Power
Analysis of Catalina Solar Lessee, LLC.
    Filed Date: 12/29/15.
    Accession Number: 20151229-5347.
    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER15-758-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Correction Filing to 2015 Annual
Allocation Update to be effective 1/1/2015.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5141.
    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER15-2205-003.
    Applicants: Prairie Breeze Wind Energy III LLC.

    Description: Triennial Report of Prairie Breeze Wind Energy III
LLC.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5222.
    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER15-2647-001.
    Applicants: Tres Amigas, LLC.
    Description: Compliance filing: Compliance to be effective 12/10/
2015.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5278.
    Comments Due: 5 p.m. ET 1/13/16.

    Docket Numbers: ER16-665-000.
    Applicants: Public Service Company of Colorado.
    Description: Section 205(d) Rate Filing: 2015-12-30_PSC-Brlngtn Mtr
Agrmt-402 0.0.0 to be effective 2/29/2016.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5133.
    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-666-000.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Section 205(d) Rate Filing: NPPC NYPA Amended Service
Agreement No. 2177 to be effective 9/30/2015.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5206.
    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-667-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Section 205(d) Rate Filing: Amendments to SCPSA and
CEPCI NITSA and Metering Agmts to be effective 1/1/2016.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5208.
    Comments Due: 5 p.m. ET 1/20/16.

    Docket Numbers: ER16-668-000.
    Applicants: PJM Interconnection, L.L.C., Ohio Power Company.
    Description: Section 205(d) Rate Filing: AEP submits 46th Revised
Service Agreement No. 1336 to be effective 11/30/2015.
    Filed Date: 12/30/15.
    Accession Number: 20151230-5294.
    Comments Due: 5 p.m. ET 1/20/16.

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

    Dated: December 30, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-33224 Filed 1-5-16; 8:45 am]
 BILLING CODE 6717-01-P