[Federal Register: February 28, 2008 (Volume 73, Number 40)]
[Rules and Regulations]
[Page 10655-10658]
[DOCID:fr28fe08-7]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0075; Directorate Identifier 2007-NM-171-AD;
Amendment 39-15390; AD 2008-04-18]
RIN 2120-AA64

Airworthiness Directives; EMBRAER Model EMB-120, -120ER, -120FC,
-120QC, and -120RT Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    It has been found that former revisions of the Maintenance
Review Board Report (MRBR) of the EMB-120( ) aircraft do not fully
comply with some Critical Design Configuration Control Limitations
(CDCCL) and Fuel System Limitations (FSL). These limitations are
necessary to preclude ignition sources in the fuel system, as
required by RBHA-E88/SFAR-88 (Special Federal Aviation Regulation
No. 88).

* * * * *
    The potential of ignition sources, in combination with flammable
fuel vapors, could result in fuel tank explosions and consequent loss
of the airplane. We are issuing this AD to require actions to correct
the unsafe condition on these products.

DATES: This AD becomes effective April 3, 2008.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of April 3,
2008.

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

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on October 23, 2007 (72
FR 59967). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    It has been found that former revisions of the Maintenance
Review Board Report (MRBR) of the EMB-120( ) aircraft do not fully
comply with some Critical Design Configuration Control Limitations
(CDCCL) and Fuel System Limitations (FSL). These limitations are
necessary to preclude ignition sources in the fuel system, as
required by RBHA-E88/SFAR-88 (Special Federal Aviation Regulation
No. 88).
    Since this condition affects flight safety, a corrective action
is required. Thus, sufficient reason exists to request compliance
with this AD in the indicated time limit.

The potential of ignition sources, in combination with flammable fuel
vapors, could result in fuel tank explosions and consequent loss of the
airplane. The corrective action is revising the Airworthiness
Limitations Section of the Instructions for Continued Airworthiness to
incorporate new limitations for fuel tank systems. You may obtain
further information by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Changes to This AD

    For standardization purposes, we have revised this AD in the
following ways:
     We revised the language in Note 1 of this AD to correspond
to the language contained in the same note in similar ADs.
     We revised paragraph (f)(4) of this AD to specify that no
alternative inspections, inspection intervals, or CDCCLs may be used
unless they are part of a later approved revision of certain documents
specified in this AD, or unless they are approved as an alternative
method of compliance (AMOC). Inclusion of this paragraph in the AD is
intended to ensure that the AD-mandated airworthiness limitations
changes are treated the same as the airworthiness limitations issued
with the original type certificate.

Conclusion

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

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect about 109 products of U.S.
registry. We also estimate that it will take about 1 work-hour per
product to comply with the basic requirements of this AD. The average
labor rate is $80 per work-hour. Based on these figures, we estimate
the cost of this AD to the U.S. operators to be $8,720, or $80 per
product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify 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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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:

2008-04-18 Empresa Brasileira de Aeronautica S.A. (EMBRAER):
Amendment 39-15390. Docket No. FAA-2007-0075; Directorate Identifier
2007-NM-171-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective April 3,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all EMBRAER Model EMB-120, -120ER, -
120FC, -120QC, and -120RT airplanes; certificated in any category.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (g) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    It has been found that former revisions of the Maintenance
Review Board Report (MRBR) of the EMB-120( ) aircraft do not fully
comply with some Critical Design Configuration Control Limitations
(CDCCL) and Fuel System Limitations (FSL). These limitations are
necessary to preclude ignition sources in the fuel system, as
required by RBHA-E88/SFAR-88 (Special Federal Aviation Regulation
No. 88).
    Since this condition affects flight safety, a corrective action
is required. Thus, sufficient reason exists to request compliance
with this AD in the indicated time limit.

The potential of ignition sources, in combination with flammable
fuel vapors, could result in fuel tank explosions and consequent
loss of the airplane. The corrective action is revising the
Airworthiness Limitations Section of the Instructions for Continued
Airworthiness to incorporate new limitations for fuel tank systems.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 1 month after the effective date of this AD, revise
the Airworthiness Limitations Section (ALS) of the Instructions for
Continued Airworthiness to incorporate Tasks 15 to 18 of Section 6--
``Part E--Fuel System Limitations,'' EMBRAER Temporary Revision No.
22-1, dated November 18, 2005, of the EMBRAER EMB-120 Brasilia
Maintenance Review Board Report (MRBR), MRB-HI-200. For all tasks
identified in the MRBR, the initial compliance times start from the
later of the times specified in paragraphs (f)(1)(i) and (f)(1)(ii)
of this AD, and the repetitive inspections must be accomplished
thereafter at the interval specified in the MRBR, except as provided
by paragraphs (f)(3) and (g)(1) of this AD.
    (i) The effective date of this AD.
    (ii) The date of issuance of the original Brazilian standard
airworthiness certificate or the date of issuance of the original
Brazilian export certificate of airworthiness.
    (2) Within 1 month after the effective date of this AD, revise
the ALS of the Instructions for Continued Airworthiness to
incorporate the CDCCLs to include items (1) and (2), dated March 22,
2005, of Section 6--``Part D--Critical Design Configuration Control
Limitation,'' of the EMBRAER EMB-120 Brasilia MRBR, MRB-HI-200.
    (3) For the functional checks and detailed visual inspections,
Tasks 15 to 18 of Section 6--``Part E--Fuel System Limitations,''
EMBRAER Temporary Revision No. 22-1, dated November 18, 2005, of the
EMBRAER EMB-120 Brasilia MRBR, MRB-HI-200: The initial compliance
time is within 4,000 flight hours or 48 months after the effective
date of this AD, whichever occurs first. Thereafter those tasks must
be accomplished at the repetitive interval specified in Section 6--
``Part E--Fuel System Limitations,'' EMBRAER Temporary Revision No.
22-1, dated November 18, 2005, of the EMBRAER EMB-120 Brasilia MRBR,
MRB-HI-200.
    (4) After accomplishing the actions specified in paragraphs
(f)(1) and (f)(2) of this AD, no alternative inspections, inspection
intervals, or CDCCLs may be used unless the inspections, intervals,
or CDCCLs are part of a later revision of EMBRAER EMB-120 Brasilia
MRBR, MRB-HI-200, dated March 22, 2005, that is approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA, or the Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC) (or its delegated agent); or
unless the inspections, intervals, or CDCCLs are approved as an
alternative method of compliance in accordance with the procedures
specified in paragraph (g)(1) of this AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Dan
Rodina, Aerospace Engineer, International Branch, ANM-116, FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
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, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Brazilian Airworthiness Directive 2007-05-02,
effective June 6, 2007; EMBRAER Temporary Revision No. 22-1, dated
November 18, 2005, of the EMBRAER EMB-120 Brasilia MRBR, MRB-HI-200;
and Section 6--``Part D--Critical Design Configuration Control
Limitation,'' of the EMBRAER EMB-120 Brasilia MRBR, MRB-HI-200; for
related information.

Material Incorporated by Reference

    (i) You must use EMBRAER Temporary Revision No. 22-1, dated
November 18, 2005, of the EMBRAER EMB-120 Brasilia Maintenance
Review Board Report, MRB-HI-200; and pages 6.III.1 and 6.III.2,
dated March 22, 2005, of Section 6--``Part D--Critical Design
Configuration Control Limitation,'' of the EMBRAER EMB-120 Brasilia
Maintenance Review Board Report, MRB-HI-200; to do the actions
required by this AD, unless the AD specifies otherwise. EMBRAER EMB-
120 Brasilia Maintenance Review Board Report, MRB-HI-200, contains
the following effective pages:

------------------------------------------------------------------------
                 Page No.                        Date shown on page
------------------------------------------------------------------------
List of Effective Pages:
  Pages III-VII...........................  December 1, 2006.
------------------------------------------------------------------------

    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), P.O. Box 343--CEP
12.225, Sao Jose dos Campos--SP, Brazil.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the

National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Renton, Washington, on February 15, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-3399 Filed 2-27-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: October 22, 2009 (Volume 74, Number 203)]
[Proposed Rules]
[Page 54533-54534]
[DOCID:fr22oc09-22]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 151

46 CFR Part 162

[USCG-2001-10486]
RIN 1625-AA32

Standards for Living Organisms in Ships' Ballast Water Discharged
in U.S. Waters

AGENCY: Coast Guard, DHS.

ACTION: Notice of public meetings.

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

SUMMARY: This notice provides the times and locations of two public
meetings which will be held by the Coast Guard (USCG) regarding the
Notice of Proposed Rulemaking (NPRM) entitled ``Standards for Living
Organisms in Ships' Ballast Water Discharged in U.S. Waters'' that
published in the Federal Register on Friday, August 28, 2009.

DATES: Public meetings will be held in the Oakland, CA (October 27,
2009) and New York, NY (October 29, 2009) areas to provide
opportunities for oral comments. The comment period for the NPRM closes
on December 4, 2009. All comments and related material submitted after
a meeting must either be submitted to our online docket via http://
www.regulations.gov on or before December 4, 2009 or reach the Docket
Management Facility by that date.

ADDRESSES: The public meetings will be held at the Marriott Oakland
City Center, 1001 Broadway, Oakland, CA, 94607, on October 27, 2009,
and the Marriott New York Downtown, 85 West Street at Albany Street,
New York, NY 10006, on October 29, 2009.
    All meetings will be held from 9 a.m. until 4 p.m. local time
unless otherwise noted. The meetings may conclude before the allotted
time if all matters of discussion have been addressed.
    You may submit written comments identified by docket number USCG-
2001-10486 before or after the meeting using any one of the following
methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
Our online docket for this rulemaking is available on the Internet at
http://www.regulations.gov under docket number USCG-2001-10486.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rulemaking, call or e-mail Mr. John Morris, Project Manager,
Environmental Standards Division, U.S. Coast Guard Headquarters,
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Ms.
Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-
9826.

SUPPLEMENTARY INFORMATION:
    The Coast Guard published a Notice of Proposed Rulemaking (NPRM) in
the Federal Register on Friday, August 28, 2009 (74 FR 44632), entitled
``Standards for Living Organisms in Ships' Ballast Water Discharged in
U.S. Waters.'' In it, we stated our intention to hold public meetings,
and to publish a notice with additional details regarding those public
meetings as soon as the information was available (74 FR 44632).
    On Monday, September 14, 2009, we published a Notice of Public
Meeting to inform the public of the date for each public meeting, as
well as the city in which those meetings will be held (74 FR 46964).
That notice also stated that additional notice(s) would be published in
the Federal Register as specific locations and details for these
meetings were finalized.
    On Tuesday, September 22, 2009, we published a Notice of Public
Meeting with the specific locations and details for the first two of
the six public meetings (74 FR 48190). Then, on Monday, September 28,
2009, we published a Notice of Public Meeting providing the same
information for the second two public meetings and restating the
details for the first two public meetings (74 FR 49355). This notice
provides those details for the final two public meetings.
    On Thursday, October 15, 2009, we published a Notice to extend the
periods of public comment on the Notice of Proposed Rulemaking (NPRM)
and the Draft Programmatic Environmental Impact Statement (DPEIS) to
December 4, 2009 (74 FR 52941).
    The October 27, 2009 meeting will be held at the Marriott Oakland
City Center, 1001 Broadway, Oakland, CA, 94607. The phone number for
the location is<PHONE_NUMBER>.
    The October 29, 2009 meeting will be held at the Marriott New York
Downtown, 85 West Street at Albany Street, New York, NY 10006. The
phone number for the location is<PHONE_NUMBER>.
    Live webcasts (audio and video) of the public meetings will also be
broadcast online at http://ballastwater.us/.
    Written comments and related material may also be submitted to
Coast Guard personnel specified at those meetings for inclusion in the
official docket for this rulemaking.

Information on Service for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meetings,
contact Mr. John Morris at the telephone number or e-mail address
indicated under the FOR FURTHER INFORMATION CONTACT section of this
notice.

    Dated: October 19, 2009.
F.J. Sturm,
Acting Director of Commercial Regulations and Standards, U.S. Coast
Guard.
[FR Doc. E9-25558 Filed 10-20-09; 4:15 pm]

BILLING CODE 4910-15-P


[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Rules and Regulations]
[Pages 34145-34147]
[FR Doc No: 2021-13806]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0475; FRL-10025-21]

Bacillus velezensis Strain RTI301; Exemption From the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Bacillus velezensis strain RTI301 in or
on all food commodities when used in accordance with label directions
and good agricultural practices. FMC Corporation submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of Bacillus velezensis strain RTI301 under FFDCA when used
in accordance with this exemption.

DATES: This regulation is effective June 29, 2021. Objections and
requests for hearings must be received on or before August 30, 2021 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0475, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0475 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
August 30, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although EPA
strongly encourages those interested in submitting objections or a
hearing request, to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal delivery,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system, at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at<PHONE_NUMBER>. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The

address for mailing documents is U.S. Environmental Protection Agency,
Office of Administrative Law Judges, Mail Code 1900R, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0475, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of February 4, 2020 (85 FR 6129) (FRL-
10003-17), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
exemption petition (PP 9F8750) by FMC Corporation, 2929 Walnut St.,
Philadelphia, PA 19104. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of the fungicide Bacillus velezensis strain
RTI301 in or on all food commodities. That notice referenced a summary
of the petition prepared by the petitioner FMC Corporation and
available in the docket via http://www.regulations.gov. Although one
comment was submitted to the docket for this notice of filing, it was
unrelated to this tolerance exemption rulemaking.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue . . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on
Bacillus velezensis strain RTI301 and considered their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
EPA relied and its risk assessment based on those data can be found
within the document entitled ``Human Health Risk Assessment for the New
Active Ingredients Bacillus subtilis strain RTI477 and Bacillus
velezensis strain RTI301 in the Proposed Manufacturing-use Products
279-OAUT, 279-OAUI and End-use Products 279-OAUO, 279-OALN and 279-OALR
for FIFRA Section 3 Registration with Tolerance Exemption Petitions''
(Bacillus subtilis strain RTI477 and Bacillus velezensis strain RTI301
Human Health Assessment). This document, as well as other relevant
information, is available in docket for this action as described under
ADDRESSES.
    The available data demonstrated that, with regard to humans,
Bacillus velezensis strain RTI301 is not toxic via the pulmonary, oral,
or dermal routes of exposure and is not pathogenic or infective via the
pulmonary or oral routes of exposure. Although there may be some
dietary and non-occupational exposures to residues of Bacillus
velezensis strain RTI301 when used in accordance with label directions
and good agricultural practices, there is not a concern due to the lack
of potential for adverse effects. Because there are no threshold levels
of concern with the toxicity, pathogenicity, or infectivity of Bacillus
velezensis strain RTI301, EPA determined that no additional margin of
safety is necessary to protect infants and children as part of the
qualitative assessment conducted. Based upon its evaluation in the
Bacillus subtilis strain RTI477 and Bacillus velezensis strain RTI301
Human Health Assessment, which concludes that there are no risks of
concern from aggregate exposure to Bacillus velezensis strain RTI301,
EPA concludes that there is a reasonable certainty that no harm will
result to the U.S. population, including infants and children, from
aggregate exposure to residues of Bacillus velezensis strain RTI301.

B. Analytical Enforcement Methodology

    An analytical method is not required for Bacillus velezensis strain
RTI301 because EPA is establishing an exemption from the requirement of
a tolerance without any numerical limitation.

C. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of Bacillus velezensis strain RTI301 in or on
all food commodities when used in accordance with label directions and
good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act, 44 U.S.C.

3501 et seq., nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or Tribal
Governments, on the relationship between the National Government and
the States or Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 21, 2021.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1383 to subpart D to read as follows:

Sec.  180.1383  Bacillus velezensis strain RTI301; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Bacillus velezensis strain RTI301 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2021-13806 Filed 6-28-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 1 (Friday, January 2, 2015)]
[Notices]
[Pages 69-71]
[FR Doc No: 2014-30702]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73943; File No. SR-NASDAQ-2014-123]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change to
Rules 4751(h) and 4754(b) Relating to the Closing Process

December 24, 2014.
    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 December 16, 2014, The NASDAQ Stock Market LLC (``NASDAQ'' 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 make changes to Rules 4751(h) and 4754(b)
relating to the closing process.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.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 is proposing to adopt changes related to the close of
Regular Market Session \3\ on NASDAQ, which are designed to bring
consistency and stability to the processing of securities in the NASDAQ
Closing Cross.\4\ Each trading day, NASDAQ accepts orders designated to
participate in the Closing Cross.\5\ The Closing Cross is the process
by which NASDAQ determines the price at which orders will be executed
at market close. Beginning at 3:50 p.m. Eastern Time, NASDAQ
disseminates an Order Imbalance Indicator \6\ every five seconds until
market close, which allows market participants to see the nature of
interest in a security and make investment decisions accordingly. The
NASDAQ closing process is initiated at 4:00 p.m. Eastern Time.\7\
During the brief period between the initiation of the closing process
and the conclusion of the last Closing Cross,\8\ the continuous order
book is open to accept orders and cancellations in a security until the
Closing Cross for that security is complete. These orders can affect
the ultimate closing price of the security. Although accepting orders
and cancellations through the completion of a security's Closing Cross
allows the greatest interest to participate in the Closing Cross, the
Exchange has observed that in cases where there is aberrant volatility
in a security due to an error,\9\ accepting such order activity may
also significantly alter the closing price. In normal trading, NASDAQ
has observed that allowing order entry and cancellation in a security
up to the completion of a security's Closing Cross provides little
additional price discovery to offset the greater risk in allowing such
order activity. Accordingly, NASDAQ is proposing to close the order
book for participation in the Closing Cross once the closing process is
initiated at 4:00 p.m. Eastern Time (the ``Lockdown Period''). As a
consequence of closing the order book, orders entered for participation
in the continuous market after the Lockdown Period has begun, but prior
to completion of the Closing Cross, will not be accepted by the System.
---------------------------------------------------------------------------

    \3\ As defined by Rule 4120(b)(4)(D).
    \4\ See Rule 4754.
    \5\ See Rule 4754(a)(1) for a description of quotes and orders
eligible for participation in the Closing Cross.
    \6\ The Order Imbalance Indicator provides information about
orders eligible to participate in the Closing Cross and the price at
which those orders would execute at the time of dissemination.
    \7\ Once the closing process is initiated, the System will
execute crosses in each individual security traded on NASDAQ one by
one. The order in which each security is processed is random and
differs day by day.
    \8\ This brief period is normally well under one second.
    \9\ For example, a member firm that enters an order that is
erroneous in price and/or size may cause significant order
imbalances, which may cause the closing price of the security to be
significantly different from what is anticipated.
---------------------------------------------------------------------------

    Under the proposed process, at 4:00 p.m. Eastern Time, when the
closing process is initiated, the Lockdown Period is triggered at which
point the order book will no longer accept new orders for execution,
and will cease to process order cancellation requests for resting
orders. New orders received for participation in the Closing Cross
after initiation of the Lockdown Period will be cancelled back to the
member firm, and cancellations of resting orders will be processed
after the Closing Cross is complete.\10\ NASDAQ notes that the
processing and calculation of the Closing Cross will remain
unchanged.\11\ Moreover, in proposing the Lockdown Period, NASDAQ is
not altering how orders are processed prior to the Closing Cross, and
after it is completed. Rather, NASDAQ is merely providing a precise
time at which orders will not participate in the Closing Cross, in lieu
of the uncertain, albeit brief, time under the current process. In
addition to amending Rule 4754(b) to reflect the changes discussed
above, NASDAQ is making a clarifying change to the rule text to make it
clear that the Closing Cross begins at 4:00:00 p.m.. [sic]
---------------------------------------------------------------------------

    \10\ A member firm that sends a cancellation request during the
Lockdown Period will receive an execution message for that order if
it is executed in the Closing Cross.
    \11\ The closing process will still be initiated at 4:00 p.m.
Eastern Time, and the order in which securities enter into their
individual Closing Crosses will continue to be random.
---------------------------------------------------------------------------

    In a related change, the Exchange is also proposing to harmonize
the processing of Market Hours Day (``MDAY'') orders \12\ in the
Closing Cross. MDAY is a time-in-force characteristic of orders, which
allows the order to be executed during the Regular Market Session.
Under NASDAQ rules, MDAY-designated orders are available from 4:00 a.m.
to 4:00 p.m. Eastern Time.\13\ Currently, an order designated as MDAY
entered after completion of the Closing Cross in a particular security
may be rejected, cancelled, or modified to an order with a time-in-
force of Immediate or Cancel,

depending on the means of entry. Member firms may enter MDAY-designated
orders through OUCH, FLITE, RASH, INET FIX, QIX or SUMO FIX ports.\14\
These various means of connecting to the Exchange for order entry
provide member firms with differing functionality. The Exchange notes
that a MDAY-designated order entered after the conclusion of the
Regular Market Session through an OUCH, FLITE or RASH port will be
modified to an order with a time-in-force of Immediate or Cancel. A
MDAY-designated order entered after the conclusion of Regular Market
Session through an INET FIX port will be modified to a System Hours Day
order.\15\ Lastly, a MDAY-designated order entered after the conclusion
of the Regular Market Session through a QIX or SUMO FIX port will be
rejected. The Exchange notes that the vast majority of such orders are
[sic] entered near the end of the Regular Market Session by member
firms seeking to execute prior to the conclusion of the session. In an
effort to simplify the treatment of order handling on the Exchange,
NASDAQ is proposing to harmonize how MDAY orders entered after the
closing cross is initiated are handled. Specifically, NASDAQ is
proposing to no longer accept orders with a time-in-force of MDAY that
are entered after initiation of the Lockdown Period. The Exchange notes
that not accepting orders after the Closing Cross is initiated will
simplify market participant processing and avoid confusion concerning
how such orders are handled upon conclusion of the Regular Market
Session. Lastly, with the proposed implementation of the Lockdown
Period, such simplification will also aid NASDAQ in operating the
Closing Cross by reducing the logical steps necessary to process MDAY-
designated orders. As a consequence, NASDAQ is adding language to the
rule to reflect that such orders will not be accepted after 4:00 p.m.
---------------------------------------------------------------------------

    \12\ See Rule 4751(h)(6).
    \13\ Id.
    \14\ See http://www.nasdaqtrader.com/Trader.aspx?id=TradingSpecs
for a description of the various order entry port specifications.
    \15\ A System Hours Day order remains available for potential
display and/or execution from 4:00 a.m. until 8:00 p.m. Eastern Time
on the day it was submitted unless cancelled by the entering party.
See Rule 4751(h)(2).
---------------------------------------------------------------------------

    Similarly, NASDAQ is proposing to modify the processing of Good-
til-market close orders (``GTMC'').\16\ GTMC is a time-in-force
characteristic of orders, which allows the order to be executed from
4:00 a.m. to 8:00 p.m. Eastern Time. GTMC orders entered after the
Closing Cross are converted to a time-in-force of System Hours
Immediate or Cancel. In lieu of converting such orders, NASDAQ is
proposing to no longer accept GTMC orders after initiation of the
Lockdown Period at 4:00 p.m. Eastern Time. As a consequence, NASDAQ is
amending language in the rule concerning acceptance of GTMC orders up
to 8:00 p.m. Eastern Time to reflect that such orders will not be
accepted after 4:00 p.m., and is deleting text concerning conversion of
the order. NASDAQ is also making a technical change to the rule text to
harmonize the terminology used under the other time-in-force
designations under Rule 4751(h). Specifically, NASDAQ is replacing the
word ``and'' with ``until.''
---------------------------------------------------------------------------

    \16\ See Rule 4751(h)(8).
---------------------------------------------------------------------------

    The Exchange plans on implementing the proposed changes in mid-
February 2015, and will provide at least 30 days prior notice of the
implementation date and testing opportunities for member firms via an
Equity Trader Alert.
2. Statutory Basis
    The Exchange believes that the proposed rule changes [sic] are
consistent with Section 6 of the Act, in general, and further the
objectives of Section 6(b)(5) of the Act, in particular, in that they
are designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, 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;
and are not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers. Specifically, the proposed changes
promote just and equitable principles of trade and perfect the
mechanisms of a free and open market and the national market system by
providing greater clarity concerning the System's operation during the
closing process and how orders with certain time-in-force
characteristics are processed at the market close. In addition, the
proposed changes will contribute to the protection of investors and the
public interest by making the Exchange's rules easier to understand.
The proposed change to implement the Lockdown Period is designed to
promote a stable closing process and avoid the impact of erroneous
order activity on the market close process. Closing the order book to
new orders and cancellations during the very brief period between the
initiation of the closing process at 4:00 p.m. Eastern Time and the
completion of the last Closing Cross will ensure that the System is
able to cross all securities without impact from erroneous order
activity in a single security. Accordingly, the proposed change
promotes a fair and orderly market during the closing process, and
thereby further perfects the mechanism of a free and open market. The
proposed changes to the processing of MDAY-designated orders further
these objectives because they simplify processing of orders, thereby
avoiding any market participant confusion on how such orders are
treated when entered after the Regular Market Session has ended.
Uniformly rejecting such orders, which are designed to execute during
Regular Market Session, is consistent with a market participant's
intent to execute during Regular Market Session and will remove
complication in the handling of such orders. To the extent a member
firm would like to participate in post-market hours trading, it may
enter a new order eligible to participate in post-market trading.
Likewise, the proposed changes to the processing of GTMC-designated
orders further these objectives because the changes simplify processing
of such orders when entered after the Closing Cross process has begun.
Rather than converting GTMC-designated orders to an order with a
different time-in-force if entered after the market close, NASDAQ will
no longer accept them once the Closing Cross has been initiated, which
is consistent with a market participant's intent to execute during the
period from 4:00 a.m. and 4:00 p.m. As noted above, to the extent a
member firm would like to participate in post-market hours trading, it
may enter a new order eligible to participate in post-market trading.
Moreover, simplifying the processing of both MDAY- and GTMC-designated
orders will remove complication in the handling of such orders, thereby
further improving the operation of the market.

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

    The Exchange does not believe that the proposed rule changes will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.
Specifically, the changes are designed to promote consistency and
stability in the closing process and in the handling of orders after
the Regular Market Session has ended. Such changes do not place a
burden on competition between market participants as the changes are
applied consistently to all participants. Moreover, the proposed
changes do not

impose a burden on competition among exchanges as they are done for
regulatory purposes and are therefore irrelevant to competition.

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)(ii) of the Act \17\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\18\ 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.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \18\ 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.
---------------------------------------------------------------------------

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-NASDAQ-2014-123 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.

All submissions should refer to File Number SR-NASDAQ-2014-123. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of 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-NASDAQ-2014-123 and should
be submitted on or before January 2, 2015.

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

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2014-30702 Filed 12-31-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89925-89926]
[FR Doc No: 2016-29787]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP17-214-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Cherokee
AGL--Replacement Shippers--Dec 2016 to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5133.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-215-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Agreements
Filing (Pioneer) to be effective 1/1/2017.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5134.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-216-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: 11.2(a) Inflation Rates to be
effective 1/1/2017.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5159.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-217-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: 2017 Tioga Electric Charge to
be effective 1/1/2017.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5184.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-218-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Non-conforming Neg Rate Agmt
due to Cap Rel (CCI East Texas 35829) to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5187.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-219-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts
(Atlanta 8438 to various eff 12-1-2016) to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5188.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-220-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt
(Petrohawk 41455 to texla 47450) to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5191.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-221-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt (Encana
37663 to texla 47451) to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5192.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-223-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20161130 Remove Non Conforming
to be effective 1/1/2017.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5221.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-224-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmts
(ExGen 43197-3, 43197-5, 43198-4, 43198-6) to be effective 10/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5251.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-225-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing 11-30-
2016 to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5255.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-226-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement--
Plymouth 792668 to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5325.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-227-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement--
Emera 510979 to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5327.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-228-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: CNE Gas Supply Negotiated Rate
to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5329.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-229-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement--
Enhanced Energy--792657 to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5333.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-230-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--BUG Release
to Enhanced--792656 to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5334.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-231-000.
    Applicants: Dominion Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: DTI--November 30, 2016
Negotiated Rate Agreements to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5335.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-232-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Energy America Contract
Consolidation to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5347.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-233-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--ConEd release
to Plymouth--8944211 to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5352.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-234-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--Neg Rate Agmt--
Exelon Generation & Mex Gas Supply to be effective 12/1/2016.
    Filed Date: 11/30/16.
    Accession Number: 20161130-5367.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: RP17-235-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Sec.  4(d) Rate Filing: Rate Schedule S-2 Tracker 12-
1-16 to be effective 12/1/2016.
    Filed Date: 12/1/16.

    Accession Number: 20161201-5080.
    Comments Due: 5 p.m. ET 12/13/16.

    Docket Numbers: RP17-236-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Capacity Release
Agreements--12/1/2016 to be effective 12/1/2016.
    Filed Date: 12/1/16.
    Accession Number: 20161201-5083.
    Comments Due: 5 p.m. ET 12/13/16.

    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.

Filings in Existing Proceedings

    Docket Numbers: RP16-300-004.
    Applicants: Empire Pipeline, Inc.
    Description: Empire Pipeline, Inc. submits Compliance Filing
(Modification to Stipulation and Agreement).
    Filed Date: 11/17/16.
    Accession Number: 20161117-5096.
    Comments Due: 5 p.m. ET 11/29/16.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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 1, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-29787 Filed 12-12-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 124 (Tuesday, June 28, 2016)]
[Proposed Rules]
[Pages 41924-41925]
[FR Doc No: 2016-15047]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2016-0302; FRL-9948-14-Region 7]

Approval and Promulgation of Air Quality Implementation Plans;
State of Missouri; Cross-State Air Pollution Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve portions of a November 20, 2015, State Implementation Plan
(SIP) submittal from Missouri concerning allocations of Cross-State Air
Pollution Rule (CSAPR) emission allowances. Under CSAPR, large
electricity generating units in Missouri are subject to Federal
Implementation Plans (FIPs) requiring the units to participate in
CSAPR's Federal trading program for annual emissions of nitrogen oxides
(NOX) and one of CSAPR's two Federal trading programs for
annual emissions of sulfur dioxide (SO2). This action would
approve Missouri's adoption into its SIP of state regulations
establishing state-determined allocations to replace EPA's default
allocations to Missouri units of CSAPR allowances for annual
NOX emissions and annual SO2 emissions for 2017
and later years. EPA is proposing to approve the SIP revision because
it meets the requirements of the Clean Air Act (CAA) and EPA's
regulations for approval of an abbreviated SIP revision replacing EPA's
default allocations of CSAPR emission allowances with state-determined
allocations. Approval of this SIP revision would not alter any
provision of CSAPR's Federal trading programs for annual NOX
emissions and annual SO2 emissions as applied to Missouri
units other than the allowance allocation provisions, and the FIPs
requiring the units to participate in those trading programs (as
modified by the SIP revision) would remain in place. EPA is not
proposing to act at this time on the portion of Missouri's SIP
submittal concerning allocations of CSAPR allowances for ozone-season
NOX emissions.

DATES: Comments must be received by July 28, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2016-0302, to http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Mr. Larry Gonzalez, Air Planning and
Development Branch, Air and Waste Management Division, EPA Region 7,
11201 Renner Boulevard, Lenexa KS 66219; telephone number: (913) 551-
7041; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document proposes to take action on a
revision to the SIP for Missouri concerning allocations of allowances
used in the CSAPR \1\ Federal trading program for annual emissions of
NOX and annual emission of SO2. We have published
a direct final rule approving the State's SIP revision (s) in the Rules
and Regulations section of this Federal Register, because we view this
as a noncontroversial action and anticipate no relevant adverse
comment. We have explained our reasons for this action in the preamble
to the direct final rule. If we receive no adverse comment, we will not
take further action on this proposed rule. If we receive adverse
comment, we will withdraw the direct final rule and it will not take
effect. We would address all public comments in any subsequent final
rule based on this proposed rule. We do not intend to institute a
second comment period on this action. Any parties interested in
commenting must do so at this time. For further information, please see
the information provided in the ADDRESSES section of this document.
---------------------------------------------------------------------------

    \1\ Federal Implementation Plans; Interstate Transport of Fine
Particulate Matter and Ozone and Correction of SIP Approvals, 76 FR
48208 (August 8, 2011), (codified as amended at 40 CFR 52.38 and
52.39 and subparts AAAAA through DDDDD of 40 CFR part 97).
---------------------------------------------------------------------------

    Large electricity generating units in Missouri are subject to CSAPR
FIPs that require the units to participate in the Federal CSAPR
NOX Annual Trading Program and the Federal CSAPR
SO2 Group 1 Trading Program.\2\ Each of CSAPR's Federal
trading programs includes default provisions governing the allocation
among participating units of emission allowances used for compliance
under that program. CSAPR also provides a process for the submission
and approval of SIP revisions to replace EPA's default allocations with
state-determined allocations.
---------------------------------------------------------------------------

    \2\ EPA has proposed to replace the terms ``Transport Rule'' and
``TR'' in the text of the Code of Federal Regulations with the
updated terms ``Cross-State Air Pollution Rule'' and ``CSAPR.'' 80
FR 75706, 75759 (December 3, 2015). EPA uses the updated terms here.
---------------------------------------------------------------------------

    The SIP revision approved in the direct final rule incorporates
into Missouri's SIP state regulations establishing state-determined
allowance allocations to replace EPA's default allocations to Missouri
units of CSAPR NOX Annual allowances and CSAPR
SO2 Group 1 allowances issued for the control periods in
2017 and later years. EPA is approving the SIP revision because it
meets the requirements of the CAA and EPA's regulations for approval of
an abbreviated SIP revision replacing EPA's default allocations of
CSAPR emission allowances with state-determined allocations. Approval
of the SIP revision does not alter any provision of the CSAPR
NOX Annual Trading Program or the CSAPR SO2 Group
1 Trading Program as applied to Missouri units other than the allowance
allocation provisions, and the FIPs requiring the units to participate
in those programs (as modified by the SIP revision) remain in place.
Large electricity generating units in Missouri are also subject to an
additional CSAPR FIP requiring them to participate in the Federal CSAPR
NOX Ozone Season Trading Program. While Missouri's SIP
submittal also seeks to replace the default allocations of CSAPR
NOX Ozone Season allowances to Missouri units, EPA is not
proposing to act on that portion of the SIP submittal at this time.
Approval of this SIP revision concerning other CSAPR trading programs
has no effect on the CSAPR NOX Ozone Season Trading Program
as applied to Missouri units, and the FIP requiring the units to
participate in that program remains in place.

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: June 16, 2016.
Mark Hague,
Regional Administrator, Region 7.
[FR Doc. 2016-15047 Filed 6-27-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 22, 2008 (Volume 73, Number 205)]
[Notices]
[Page 62989-62990]
[DOCID:fr22oc08-58]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2008-0427; FRL-8733-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP Emissions for Polyether
Polyol Production (Renewal), EPA ICR Number 1811.06, OMB Control Number
2060-0415

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR that is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before November 21,
2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2008-0427, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: John Schaefer, Office of Air Quality
Planning and Standards, Sector Policies and Programs Division (D243-
05), Measurement Policy Group, Environmental Protection Agency,
Research Triangle Park, North Carolina 27711; telephone number: (919)
541-0296; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The EPA has submitted the following ICR to
OMB for review and approval according to the procedures prescribed in 5
CFR 1320.12. On May 30, 2008 (73 FR 31088), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    The EPA has established a public docket for this ICR under docket
ID number EPA-HQ-OECA-2008-0427, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER> and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov to submit or view public comments, access the index
listing of the contents of the docket, and to access those documents in
the docket that are available electronically. Once in the system,
select ``docket search,'' then key in the docket ID number identified
above. Please note that EPA's policy is that public comments, whether
submitted electronically or in paper, will be made available for public
viewing at http://www.regulations.gov, as EPA receives them and without
change, unless the comment contains

copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to:
www.regulations.gov.
    Title: NESHAP Emissions for Polyether Polyol Production (Renewal)
    ICR Numbers: EPA ICR Number 1811.06, OMB Control Number 2060-0415.
    ICR Status: This ICR is scheduled to expire on January 31, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emissions Standards for Hazardous Air
Pollutants for Polyether Polyols Production, (40 CFR part 63 subpart
PPP) was proposed on June l, 1999 and published January 30, 2002. These
regulations apply to new and existing facilities that engage in the
manufacture of polyether polyols (which also include polyether mono-
ols) and emit hazardous air pollutants (HAP).
    Owners or operators of polyether polyols production facilities to
which this regulation is applicable must choose one of the compliance
options described in the rule or install and monitor a specific control
system that reduces HAP emissions to the compliance level. Compliance
is assumed through initial performance testing or design analysis, as
appropriate, and ongoing compliance is demonstrated through parametric
monitoring. The respondents are also subject to sections of 40 CFR part
63 subpart A.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 72
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Owners or operators of facilities
that manufacture polyether polyols.
    Estimated Number of Respondents: 82.
    Frequency of Response: Initially, and semi-annually.
    Estimated Total Annual Hour Burden: 13,042.
    Estimated Total Annual Cost: $1,243,954, which includes $1,040,942
in annual labor costs, $203,012 in annualized capital costs, and $0 for
O&M costs.
    Changes in the Estimates: The decrease in burden is due to an
Agency correction in the number of responses from 190 to 180 per year.

    Dated: October 16, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
 [FR Doc. E8-25182 Filed 10-21-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2380-2381]
[FR Doc No: 2017-00108]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1198]

Determination of Regulatory Review Period for Purposes of Patent
Extension; EMPLICITI

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for EMPLICITI and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
10, 2017. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by July 10, 2017. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-1198 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; EMPLICITI.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access

the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product EMPLICITI
(elotuzumab). EMPLICITI is indicated in combination with lenalidomide
and dexamethasone for the treatment of patients with multiple myeloma
who have received one to three prior therapies. Subsequent to this
approval, the USPTO received a patent term restoration application for
EMPLICITI (U.S. Patent No. 7,709,610) from AbbVie Biotherapeutics,
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
July 12, 2016, FDA advised the USPTO that this human biological product
had undergone a regulatory review period and that the approval of
EMPLICITI represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
EMPLICITI is 3,400 days. Of this time, 3,245 days occurred during the
testing phase of the regulatory review period, while 155 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 11,
2006. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on August 11,
2006.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): June 29, 2015. FDA has verified the
applicant's claim that the biologics license application (BLA) for
EMPLICITI (BLA 761035) was initially submitted on June 29, 2015.
    3. The date the application was approved: November 30, 2015. FDA
has verified the applicant's claim that BLA 761035 was approved on
November 30, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,095 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00108 Filed 1-6-17; 8:45 am]
 BILLING CODE 4164-01-P


February 1, 2010

MEMORANDUM

TO: 			Air Docket EPA-HQ-OAR-2005-0161

SUBJECT:	Lifecycle Greenhouse Gas (GHG) Impacts Calculations

This memorandum accompanies spreadsheets placed on the docket that
calculate GHG emissions per british thermal unit of renewable fuel.
These spreadsheets integrate the results from modeling of each stage of
the renewable fuel lifecycle (e.g., feedstock production, domestic and
international agricultural emissions, fuel transport and distribution).
The only piece of the lifecycle analysis not calculated in these
spreadsheets are the emissions from international land use change.  The
results from these impact calculation spreadsheets were used in
spreadsheets that compare the lifecycle GHG emissions of renewable fuels
with the 2005 petroleum baseline, which are docketed separately.

For more information about the calculation of lifecycle GHG emissions
and the data contained in these spreadsheets refer to the RIA Chapter 2.


[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Page 84001]
[FR Doc No: 2023-26547]

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

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 Investor Advisory Committee will
hold a public meeting on Thursday, December 7, 2023. The meeting will
begin at 10:30 a.m. (ET) and will be open to the public.

PLACE: The meeting will be conducted by remote means. Members of the
public may watch the webcast of the meeting on the Commission's website
at www.sec.gov.

STATUS: This Sunshine Act notice is being issued because a majority of
the Commission may attend the meeting.

Public Comment:  The public is invited to submit written statements to
the Committee. Written statements should be received on or before
December 6, 2023.
    Written statements may be submitted by any of the following
methods:

Electronic Statements

     Use the Commission's internet submission form (http://www.sec.gov/rules/other.shtml); or
     Send an email message to [email protected]. Please
include File No. 265-28 on the subject line; or

Paper Electronic Statements

     Paper Statements. Send paper statements to Vanessa A.
Countryman, Secretary, Securities and Exchange Commission, 100 F Street
NE, Washington, DC 20549-1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    The Commission will post all statements on the Commission's
website. Statements also will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Room 1503, Washington, DC 20549, on official business days between the
hours of 10:00 a.m. and 3:00 p.m. Operating conditions may limit access
to the Commission's Public Reference Room. Do not include personal
information in submissions; you should submit only information that you
wish to make available publicly. We may redact in part or withhold
entirely from publication submitted material that is obscene or subject
to copyright.

MATTERS TO BE CONSIDERED: The agenda for the meeting includes: welcome
and introductory remarks; opening remarks; approval of previous meeting
minutes; a panel discussion regarding practical applications for
enhancing financial literacy; a panel discussion examining the use of
complex investment products and strategies by self-directed investors--
is the current approach working; a discussion of a recommendation
regarding digital engagement practices; subcommittee and working group
reports; and a non-public administrative session.

CONTACT PERSON FOR MORE INFORMATION: For further information, please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.
    Authority: 5 U.S.C. 552b.

    Dated: November 29, 2023.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2023-26547 Filed 11-29-23; 4:15 pm]
BILLING CODE 8011-01-P