[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Notices]
[Pages 41122-41124]
[FR Doc No: 2022-14719]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-478-000]

Florida Gas Transmission Company, LLC; Notice of Request Under
Blanket Authorization and Establishing Intervention and Protest
Deadline

    Take notice that on June 24, 2022, Florida Gas Transmission
Company, LLC (Florida Gas), 1300 Main Street, Houston, Texas 77002,
filed in the above referenced docket a prior notice request pursuant to
sections 157.205, 157.208, 157.210, and 157.211 of the Commission's
regulations under the Natural Gas Act (NGA), and Florida Gas' blanket
certificate issued in Docket No. CP82-533-000, for authorization to
increase mainline capacity by approximately 29,850 million British
Thermal Units per day, and make auxiliary facility modifications under
section 2.55(a) on compressor units at the existing Compressor Station
(CS) 15 in Taylor County, CS 16 in Bradford County, CS 17 in Marion
County, and CS 18 in Orange County, all in Florida (Orange County
Project). The Orange County Project will enable Florida Gas to
transport interstate natural gas from three existing receipt points in
George County, Mississippi, and Mobile County, Alabama, to two existing
delivery points in Orange County, Florida for the Orlando Utilities
Commission, an existing customer of Florida Gas. The estimated cost for
the project is $1,364,655 all as more fully

set forth in the request which is on file with the Commission and open
to public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this prior notice request should be
directed to Blair Lichtenwalter, Senior Director of Certificates,
Florida Gas Transmission Company, LLC, 1300 Main Street, Houston, Texas
77002, by phone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, or via email at
[email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on September 3, 2022.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
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    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
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    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is September 3, 2022. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
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    \3\ 18 CFR 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is September 3, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
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    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
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    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before September 3, 2022. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP22-478-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \6\
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    \6\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
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    (2) You can file a paper copy of your submission by mailing it to
the address below.\7\ Your submission must reference the Project docket
number CP22-478-000.
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    \7\ Hand-delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.
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    Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426.
    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: 1300 Main
Street, P.O. Box 4967, Houston, Texas 77210, or
[email protected]. Any subsequent submissions by
an intervenor must be served on the applicant and all other parties to
the proceeding. Contact information for parties can be downloaded from
the service list at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: July 5, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-14719 Filed 7-8-22; 8:45 am]
BILLING CODE 6717-01-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: Sheryl Reilly, Branch Chief,<PHONE_NUMBER>

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

SUBMISSION: E-mail the completed template to<EMAIL_ADDRESS>
TEMPLATE:

AgraQuest, Inc.

[1F7896]

	EPA has received a pesticide petition (insert petition number) from AgraQuest, Inc., 1540 Drew Avenue, Davis, CA 95618 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

(Options (pick one)

	3. to establish an amendment/expansion of an existing tolerance exemption for the

(Options (pick one)

   	1. microbial pesticide  Bacillus subtilis strain QST 713 variant Soil

Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, AgraQuest, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by AgraQuest, Inc. and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

I. AgraQuest, Inc. Petition Summary

   	[1F7896]
A. Product Name and Proposed Use Practices

	Bacillus subtilis strain QST 713 is the active ingredient in the formulated end-use product Serenade[(R)] ASO (EPA Reg. No. 69592-12), with uses as a foliar spray on many agricultural field and greenhouse crops, soil treatment for selected agricultural field corps, foliar and soil drench treatments for ornamentals including turf, in fields, greenhouses and nurseries.  Serenade ASO is also sold under an alternate brand name into the consumer home and garden market for use on a variety of crops for foliar applications.

Bacillus subtilis strain QST 713 variant Soil is the active ingredient in the proposed formulated end-use product Serenade[(R)] Soil DPZ(TM).  The formulated product containing Bacillus subtilis strain QST 713 variant Soil is intended for use as a fungicide for the control or suppression of various soil diseases including Rhizoctonia spp., Pythium spp., Fusarium spp., Verticillium spp., and Phytophthora spp.  Treatment with Serenade Soil DPZ enhances plant growth and plant health.  The end-use product, Serenade Soil DPZ, consists of a 1.57% active ingredient aqueous suspension formulation that is mixed with water and applied as a soil drench or in-furrow spray with conventional application equipment.  It may also be shaked-in or injected into the soil prior to-, at-, or post-planting/transplanting of crops alone or with most types of liquid nutrients.  Serenade Soil DPZ can be mixed with chemical fungicides registered for soil applications.  It may be applied as a water-based slurry alone or with other registered seed treatment insecticides and fungicides through standard slurry or mist commercial seed treatment equipment.  The product would be applied at a maximum application rate of 6 quarts per acre for field applications.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Bacillus subtilis strain QST 713 variant Soil is a microbial pesticide active ingredient.  Serenade Soil DPZ's fermentation and formulation processes and inert ingredients are the same as for Serenade ASO (EPA Reg. No. 69592-12); therefore no new impurities are produced as the strains differ in a single point mutation which results in enhanced root colonization by Bacillus subtilis strain QST 713 variant Soil compared to the parent strain Bacillus subtilis strain QST 713.  Therefore, the active ingredient Bacillus subtilis strain QST 713 and Bacillus subtilis strain QST 713 variant Soil are substantially similar and data supporting the existing registration of Serenade ASO is supportive of the proposed product Serenade Soil DPZ.

The parent strain Bacillus subtilis strain QST 713 is a EPA- registered microbial pesticide active ingredient and has an exemption from tolerance (40 CFR §180.1209).  Bacillus subtilis strain QST 713 variant Soil has the same active component and has been shown to have the same activity spectrum as Bacillus subtilis strain QST 713 with enhanced plant growth and promotion of plant health when applied in the soil prior to-, at-, or post-planting/transplanting of crops or as a seed treatment.

	2. Magnitude of residues at the time of harvest and method used to determine the residue. Since Bacillus subtilis is a ubiquitous organism, it is commonly recovered from soil, water and decomposing plant residue.  It is found at population levels of 10[6] to 10[7] per gram of soil (EPA Risk Assessment of Bacillus subtilis, February, 1997); therefore, any residues of Bacillus subtilis strain QST 713 variant Soil on crops at the time of harvest are not of concern due to the low toxicity and non-pathogenic nature of these strains, and the long history of human exposure to Bacillus subtilis spores including use of the strain as a probiotic.  In addition, common food handling practices would further reduce human exposure.  It would be difficult to routinely determine if any Bacillus subtilis strain QST 713 variant Soil residue on crops were from the natural environment or from applications of the microbial pest control agent.  Studies indicate that the MPCA concentration is elevated directly after foliar application to crops but then declines rapidly, though Bacillus spores may persist at low levels on the plant surfaces and in the soil community.  Environmental factors can reduce populations on plant surfaces due to UV radiation, excess moisture, and competition for nutrients from other microbes.  Bacillus subtilis strain QST 713 variant Soil applied to the soil would be expected to become part of the soil community and have no negative effect on the indigenous soil community.

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed.
      An analytical method for detecting Bacillus subtilis strain QST 713 variant Soil is not applicable.  It is expected that, when used as proposed, Bacillus subtilis strain QST 713 variant Soil would not result in residues that are of toxicological concern.

C. Mammalian Toxicological Profile

	Bacillus subtilis strain QST 713 and Bacillus subtilis strain QST 713 variant Soil are produced under the same conditions; therefore, the resulting products are substantially similar.  It is not unreasonable to conclude, based on the similarity in product composition and production, measured physical/chemical, and pathogenicity / infectivity toxicity data that data generated for Bacillus subtilis strain QST 713 can be used to bridge any data gaps for which there are no corresponding Bacillus subtilis strain QST 713 variant Soil toxicity data.  (This concept was proposed to and accepted by BPPD at a December 14, 2010 pre-registration meeting with AgraQuest.)  At the request of the Agency a study to evaluate the safety to mammals and demonstrate equivalence of the strains has been conducted with the Bacillus subtilis strain QST 713 variant Soil and compared to the same study conducted Bacillus subtilis strain QST 713, and is summarized as follows:
There was no mortality in any group during the study.  During observations for clinical signs, all animals appeared normal for the duration of the study.  The gross necropsy conducted at termination of the study revealed no observable abnormalities with the exception of two enlarged and/or discoloured spleens from the test group.  The test organism had cleared completely from treatment group blood and brains by Day 21 and showed a pattern of clearance for the lungs, liver, spleen, kidneys mesenteric lymph nodes and cecum contents.

The test substance was determined to be non-toxic, non-infective and non-pathogenic to rats when injected intravenously at a dose of 6.6 x 108 cfu/rat.

Due to the similarity of the results for both Intravenous Toxicity / Pathogenicity Study in Rats conducted with Bacillus subtilis strain QST 713 and Bacillus subtilis strain QST 713 variant Soil, it is not unreasonable to conclude, that data generated for Bacillus subtilis strain QST 713 can be used to bridge any data gaps for which there are no corresponding Bacillus subtilis strain QST 713 variant Soil data.  Therefore, the battery of OPPTS series 885 studies that were conducted on Bacillus subtilis strain QST 713 technical powder to determine the potential detrimental effects to humans by the strain are representative of the toxicological / pathogenicity profile of the strain Bacillus subtilis strain QST 713 variant Soil.  Results from studies on file with Agency are summarized below.

                    OPPTS Guideline Number     (OPP Number)
                                  Study Title
                                Test Substance
                                 Study Result
                                   Tox. Cat.
                                    MRID #
                                   885.3100
Acute Dermal Toxicity / Pathology Rabbits
QST 713 Technical Powder
LD50 >2000 mg/kg;
Doses: 2.3E +11  -  1.73E+11 cfu  /animal
no deaths occurred;
no signs of systemic  toxicity
                                      III
                                   44651907
                                   885.3200
Acute Intravenous (Injection) Toxicity / Pathogenicity  Rats
QST 713 Technical Powder
LD50 >9.4E+06 cfu/animal
not toxic or pathogenic;
no mortality and no adverse clinical signs
                                      N/A
                                   44651908
                                   885.3150
Acute (Intratracheal) Pulmonary Toxicity / Pathogenicity
Rats
QST 713 Technical Powder
LD50 >1.2E+08 cfu/animal
in 0.1 ml
not toxic or pathogenic;
no mortality and no adverse effects
                                      N/A
                                   44651909
                                   885.3400
Hypersensitivity Incidents
QST 713 Technical Powder
none reported
                                      N/A

                               885.3050
(152-30)
Acute Oral Toxicity / Pathogenicity
Rats
QST 713 Technical Powder
LD50 >1.13E+08 cfu/animal
not toxic or pathogenic
                                      IV
                                   44651906
                                   870.2400
Acute Eye Irritation Rabbits
QST 713 Technical Powder
mild or slight irritant
                                      III
                                   44664602
                                   870.2500
Acute Dermal Irritation Rabbits
QST 713 Technical Powder
slight irritant
                                      IV
                                   44664601
Toxicity Data on End-Use Product
Both Serenade ASO (EPA Reg. No. 69592-12), Serenade AS (EPA Reg. No. 695925-8) and Serenade Soil DPZ (EPA Reg. No. 69592-EI) contain the same amount of active ingredient, and based on the similarity in product composition and production, measured physical/chemical, and pathogenicity / infectivity toxicity data, it is not unreasonable to conclude that the end-use product toxicity data for Serenade AS, non-organic formulation and Serenade ASO, eligible for organic production under NOP regulations, support Serenade Soil DPZ acute toxicity Tier 1 870 series data requirements.  Results for the currently registered products to support Serenade Soil DPZ are as follows:
OPPTS Guideline Number
Study Title
Test Substance
Study Result
                               Toxicity Category
                                    MRID #
OPPTS 870.1100
Acute Oral Toxicity
Serenade AS
LD50 >5000 mg/kg
                                      IV
                                   45385304
OPPTS 870.1200
Acute Dermal Toxicity
Serenade AS
LD50 >5000 mg/kg
                                      IV
                                   45385305
OPPTS 870.1300
Acute Inhalation Toxicity
Serenade AS
LC50 >1.45 mg/L
                                      III
                                   45385306
OPPTS 870.2400
Acute Eye Irritation
Serenade AS
nonirritant
                                      IV
                                   45385307
OPPTS 870.2500
Acute Dermal Irritation
Serenade AS
mild or slight irritant
                                      IV
                                   45385308
OPPTS 870.2600
Dermal Sensitization
Serenade AS
not a sensitizer
                                      N/A
                                   45385309

Serenade ASO contains the same certified limits of active ingredient as Serenade AS.  All of the inert ingredients in Serenade ASO are from EPA's Inert List, 4(a) or 4(b).  Under the USDA's National Organic Program the active ingredient also qualifies as an organic material, thus Serenade ASO is labeled in the USA for use in organic agriculture.  Serenade ASO should be considered even more toxicologically benign and environmentally sound than Serenade AS.  A comparison of the additives for the two products is located in MRID 46012201.  By extension the data generated on Serenade AS is supportive of Serenade Soil DPZ.

The results of toxicity testing with Bacillus subtilis strain QST 713 and Bacillus subtilis strain QST 713 variant Soil and information found in published literature, and EPA Bacillus subtilis Case 6012, Final Registration Review Decision (March 2010) on this strain and other strains of Bacillus subtilis indicate that no foreseeable risks to human health are to be expected by Bacillus subtilis strain QST 713 variant Soil.

D. Aggregate Exposure

	1. Dietary exposure. Due to the ubiquitous nature of the organism, the concentrations of Bacillus subtilis and other closely related Bacillus species that already exist in the environment, the likelihood of increased risk to humans or animals from the use of Serenade Soil DPZ is low.  EPA in its registration review decision concluded "the risk posed to adults, infants, and children is likely to be minimal because of the low acute oral toxicity/Pathogenicity potential of Bacillus subtilis strain QST 713."  Common food handling practices such as washing and peeling would also reduce any residues on crops.  It is not unreasonable to conclude, based on the similarity in product composition and production, measured physical/chemical, and pathogenicity / infectivity toxicity data, that the risk from any potential exposure to Bacillus subtilis strain QST 713 variant Soil in Serenade Soil DPZ would be minimal.

	i. Food. Due to the ubiquitous nature of the organism, the concentrations of Bacillus subtilis and other closely related Bacillus species that already exist in the environment, the likelihood of increased risk to humans or animals from the use of Serenade Soil DPZ is low.  EPA in its registration review decision concluded "the risk posed to adults, infants, and children is likely to be minimal because of the low acute oral toxicity/Pathogenicity potential of Bacillus subtilis strain QST 713."  It is not unreasonable to conclude, based on the similarity in product composition and production, measured physical/chemical, and pathogenicity / infectivity toxicity data, that the risk from any potential exposure to Bacillus subtilis strain QST 713 variant Soil in Serenade Soil DPZ would be minimal.

	ii. Drinking water.  As discussed in literature and EPA Bacillus subtilis Case 6012, Final Registration Review Decision (March 2010), intake of low levels of ubiquitous Bacillus subtilis in drinking water may occur but exposure would represent a minimal risk due to the low toxicity of the strain.  Similarly exposure to other strains of Bacillus subtilis would not represent a greater risk.  It is not unreasonable to conclude, based on the similarity in product composition and production, measured physical/chemical, pathogenicity / infectivity toxicity data, that the risk from any potential exposure to Bacillus subtilis strain QST 713 variant Soil in Serenade Soil DPZ would be minimal and equivalent to the risk from exposure to Bacillus subtilis strain QST 713.
	2. Non-dietary exposure. The use sites for Serenade Soil DPZ containing Bacillus subtilis strain QST 713 variant Soil include both agricultural and residential garden sites.  Based on the toxicity information on file with the Agency, aggregate exposure to Bacillus subtilis strain QST 713 variant Soil would be below the levels in the safety testing conducted on Bacillus subtilis strain QST 713 and would not represent an undue risk due to the lack of residues of toxicological concern and the low toxicity of the product and active ingredient.  Therefore, the non-dietary exposures to the general population, including infants and children would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.  Serenade Soil DPZ in the manufacturing plant (fermentation facility) will be minimal due to rigorous Good Manufacturing Practices and quality controls put in place to minimize contamination, cross contamination, and exposure to the workers, and also due to protective equipment worn by manufacturing plant workers.  Therefore, inadvertent releases in the workplace would not be expected to increase the risk to workers, especially since high levels of the organism already exist in this environment.  The EPA Risk Assessment of Bacillus subtilis (February, 1997) concludes that ``human health and environmental hazards of Bacillus subtilis are low'' and ``the number of microorganisms released from the fermentation facility is low''.  Furthermore exposure to Bacillus subtilis strain QST 713 variant Soil would be minimized by use of required personal protection equipment by applicators, handlers and manufacturing workers.  It is not unreasonable to conclude, based on the similarity in product composition and production, measured physical/chemical, and pathogenicity / infectivity toxicity data, that the risk from any potential exposure to Bacillus subtilis strain QST 713 variant Soil in Serenade Soil DPZ would be minimal and equivalent to the risk from exposure to Bacillus subtilis strain QST 713 which has been fully assessed by the Agency.

E. Cumulative Effects

	According the EPA Bacillus subtilis Case 6012, Final Registration Review Decision (March 2010), no toxic mechanism has been associated with the mode of action of Bacillus subtilis strain QST 713; therefore, no cumulative toxic effect would be expected for this strain or with other related strains of Bacillus subtilis.  Therefore, it is not unreasonable to conclude, based on the similarity in product composition and production, measured physical/chemical, and pathogenicity / infectivity toxicity data that no cumulative toxic effect would result from exposure to Bacillus subtilis strain QST 713 variant Soil in Serenade Soil DPZ.  Therefore, the likely hood of adverse dietary effects is expected to be minimal for the general population and to infants and children.

F. Safety Determination

	1. U.S. population. Bacillus subtilis strain QST 713 is not pathogenic or infective to mammals.  There have been no reports of toxins associated with the organism and acute toxicity/pathogenicity data demonstrate that Bacillus subtilis strain QST 713 is non-toxic, non-pathogenic, and non-irritating or slightly irritating to the skin and eyes depending on the formulation type.  Therefore, it is not unreasonable to conclude, based on the similarity in product composition and production, measured physical/chemical, and pathogenicity / infectivity toxicity data for Bacillus subtilis strain QST 713 and Bacillus subtilis strain QST 713 variant Soil that there is reasonable certainty of no harm to the general US population from exposure to residues of the substantially similar active ingredient Bacillus subtilis strain QST 713 variant Soil in Serenade Soil DPZ, when used as proposed.

	2. Infants and children. As stated above, it is not expected that, when used as proposed, Bacillus subtilis strain QST 713 variant Soil would result in residues of toxicological concern.  This conclusion is supported by the data on the substantially similar strain Bacillus subtilis strain QST 713, public literature and EPA's Bacillus subtilis Case 6012, Final Registration Review Decision (March 2010).  There is reasonable certainly of no harm to infants and children from exposure to Bacillus subtilis strain QST 713 variant Soil from the proposed uses.

G. Effects on the Immune and Endocrine Systems

	Bacillus subtilis strain QST 713 and Bacillus subtilis strain QST 713 variant Soil are naturally occurring, non-pathogenic organisms.  There is no evidence to suggest that Bacillus subtilis strain QST 713 or the substantially similar Bacillus subtilis strain QST 713 variant Soil will compromise the immune or endocrine systems, or that it functions in a manner similar to any known hormone or endocrine disruptor.

H. Existing Tolerances

	While there are no existing tolerances for Bacillus subtilis strain QST 713 variant Soil, there is an exemption from tolerance for the substantially similar Bacillus subtilis strain QST 713.  On July 5, 2000, EPA established an exemption from the requirement of a tolerance for residues of the Bacillus subtilis strain QST 713 in or on all raw agricultural commodities when applied/used according to label instructions in 40 CFR §180.1209 which reads as follows;

An exemption from the requirement of a tolerance is established for residues of the microbial pesticide Bacillus subtilis strain QST 713 when used in or on all food commodities.

FR Doc. 00-16803 Filed 7-3-00; 8:45 am
BILLING CODE 6560-50-F.

I. International Tolerances

	There is no Codex alimentarius commission maximum residue level for Bacillus subtilis strain QST 713.
EU - Maximum Residue Levels (Reg. (EC) No 396/2005) (MRLs) as amended by Commission Regulation (EC) No 839/2008 of 31 July 2008 to include in Annex IV Bacillus subtilis strain QST 713 as an active substance for which no maximum residue levels (MRLs) in or on food and feed of plant and animal origin are required.


[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Page 49832]
[FR Doc No: 2014-19931]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-56]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before September 11, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0519 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20951.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 18, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2014-0519.
    Petitioner: Burnz Eye View, Inc.
    Section of 14 CFR: parts 21 Subpart H, 45.23(b), 61.113(a) and (b),
91.7(a), 91.9(b)(2), 91.103, 91.109, 91.119, 91.121, 91.151(a),
91.203(a) and (b), 91.405(a), 91.407(a)(1), 91.409(a)(2), and 91.417(a)
and (b).
    Description of Relief Sought: The petitioner is seeking an
exemption to commercially operate Small Unmanned Aerial Vehicles
equipped to conduct aerial photography and inspection.

[FR Doc. 2014-19931 Filed 8-21-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 65 (Tuesday, April 5, 2011)]
[Notices]
[Pages 18816-18817]
[FR Doc No: 2011-7980]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64152; File No. SR-CFE-2011-001]

Self-Regulatory Organizations; CBOE Futures Exchange, LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend Certain Rules Relating to Listing and Trading Security Futures

March 30, 2011.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on March 18, 2011, CBOE
Futures Exchange, LLC. (``CFE'' or ``Exchange'') filed with the
Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change described in Items I, II, and III below, which
Items have been prepared by CFE. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons. CFE also filed this proposed rule change concurrently with the
Commodity Futures Trading Commission (``CFTC''). CFE filed a written
certification with the CFTC under Section 5c(c) of the Commodity
Exchange Act (``CEA'') \2\ on March 18, 2011.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(7).
    \2\ 7 U.S.C. 7a-2(c).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Description of the Proposed Rule
Change

    The Exchange proposes to amend certain rules relating to the
listing and trading of security futures on the Exchange. The changes
are being proposed to conform certain CFE rules to current parallel
rules of OneChicago, LLC (``OCX''). The text of the proposed rule
change is available on the Exchange's Web site at http://www.cfe.cboe.com, on the Commission's Web site at http://www.sec.gov,
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, CFE 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. CFE 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 purpose of this proposed rule is to amend certain rules
governing the listing and trading of security futures on the Exchange.
The changes are being made to conform certain CFE rules to current
parallel rules of OCX.
Regulatory Halt Amendments
    CFE is proposing to amend Rule 417 by adding provisions for
regulatory halts. OCX made a similar rule change to make clear that a
``regulatory halt'' applies not only to the suspending of all trading
in equity securities on the underlying national securities exchange but
also to a trading pause on an individual underlying equity security
that has been imposed by the rules of the national securities
exchange.\3\ CFE is also proposing to amend CFE Policy and Procedure
III by adding a cross-reference to Rule 417 and setting forth the
ability of the help desk to bust any trade in a Single Stock Future or
in a Narrow-Based Index Future that occurs after the time a regulatory
halt is instituted and before trading has been resumed in the affected
Single Stock Future or Narrow-Based Index Future.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 62582 (July 28,
2010), 75 FR 47039 (August 4, 2010) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change by OneChicago, Amending Rule
419(a), Regulatory Halts) (SR-OC-2010-03).
---------------------------------------------------------------------------

Change Quoting Requirements for Market Makers
    CFE is proposing to amend Rule 517 and CFE Policy and Procedure VII
to change the quoting requirements for Market Makers. Presently, a
market maker, when providing quotations, quotes with a maximum bid/ask
spread of no more than the greater of $0.20 (the ``20 Cent Spread'') of
150 percent of the bid/ask spread in the primary market for the
security underlying the Security Future. The proposed rule change will
raise the 20 Cent Spread to $5. This change will be affected by
amending subparagraph (n) to Rule 517 and subparagraph C to CFE Policy
and Procedure VII. OCX made a similar rule change raising its 20 Cent
Spread to $5, which was nearly identical to one approved by the SEC for
security options.\4\
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    \4\ See Securities Exchange Act Release No. 60143 (June 19,
2009), 74 FR 30345 (June 25, 2009) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change Widening the Bid/Ask Spread
for Quoting Market-Makers) (SR-OC-2009-02).
---------------------------------------------------------------------------

Maintenance Standard Amendments
    First, CFE is proposing to amend CFE Policy and Procedure VIII by
eliminating the $3 market price maintenance standard. This change will
be affected by deleting subparagraph B.1.(v) to CFE Policy and
Procedure VIII. OCX made a similar rule change eliminating the $3
market price per share requirement, which was nearly identical to one
approved by the SEC for security options.\5\
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    \5\ See Securities Exchange Act Release No. 59744 (April 9,
2009), 74 FR 17706 (April 16, 2009) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change Eliminating the $3 Market
Price Maintenance Standard) (SR-OC-2009-01).
---------------------------------------------------------------------------

    Second, CFE is proposing to eliminate the prohibition against
opening trading in a Single Stock Future with a new delivery month
unless the issuer of the underlying satisfies applicable Exchange Act
reporting requirements, or corrects any failure within 30 days after
the date the report was due to be filed. This change will be affected
by deleting subparagraph B.2.(i) to CFE Policy and Procedure VIII. OCX
made a similar rule change eliminating this maintenance requirement,
which was nearly identical to one approved by the SEC for security
options.\6\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 54454 (September 15,
2006), 71 FR 5539 (September 22, 2006) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change Relating to
Listing Standards of Security Futures Products) (SR-OC-2006-02).

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

New Listing Standard Conforming With Joint Order
    CFE is proposing to conform its listing standards to those approved
by the SEC and the Commodity Futures Trading Commission in their Joint
Order dated November 19, 2009.\7\ To affect this change, CFE is
proposing to add new paragraph E to CFE Policy and Procedure VIII that
references the Joint Order and provides that, ``the Exchange may list
security futures on any security that is eligible to underlie options
on a national securities exchange.'' CFE notes that OCX made a similar
change conforming its listing standards to those set forth in the Joint
Order.\8\
---------------------------------------------------------------------------

    \7\ 74 FR 61380 (November 24, 2009).
    \8\ See Securities Exchange Act Release No. 61346 (January 13,
2010), 75 FR 3515 (January 21, 2010) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change, as Modified by Amendment
No. 1, Changing Its Listing Standards in Conformance with the
November 9, 2009 Joint Order Modifying the Listing Standards
Requirements under Section 6(h) of the Securities Exchange Act of
1934 and the Criteria under Section 2(a)(1) of the Commodity
Exchange Act) (SR-OC-2009-04).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) \9\ of the Securities Exchange Act (the ``Act''), in
general, and furthers the objectives of Section 6(b)(5) \10\ in
particular in that it is 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 facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. The proposed rule change updates
certain CFE listing and trading rules for security futures and conforms
them to ones previously changed by OCX for security futures.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

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

    The proposed rule change has become effective on March 22, 2011.
    At any time within 60 days of the date of effectiveness of the
proposed rule change, the Commission, after consultation with the CFTC,
may summarily abrogate the proposed rule change and require that the
proposed rule change be refiled in accordance with the provisions of
Section 19(b)(1) of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CFE-2011-001 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CFE-2011-001. This file
number should be included on the subject line if e-mail 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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CFE-2011-001 and should be
submitted on or before April 26, 2011.

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

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

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-7980 Filed 4-4-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Proposed Rules]
[Pages 14960-14961]
[FR Doc No: 2023-04593]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 14 and 1120

[Docket No. FDA-2013-N-0227]

Proposed Requirements for Tobacco Products Manufacturing
Practice; Tobacco Products Scientific Advisory Committee; Notice of
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Tobacco Products Scientific
Advisory Committee (TPSAC). The general function of the committee is to
provide advice and recommendations to FDA on regulatory issues related
to tobacco products. This meeting will be held to discuss and provide
an opportunity for recommendations on the Requirements for Tobacco
Product Manufacturing Practice (TPMP) proposed rule. The meeting will
be open to the public.

DATES: The meeting will be held on May 18, 2023, from 9 a.m. to 2 p.m.
Eastern Time.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room, Silver Spring, MD 20993-0002. For
those unable to attend in person, the meeting will also be webcast and
will be available at the following link: https://fda.zoomgov.com/j/1600966352?pwd=bmRrRlp1MlUrdWVmR095KzN3eWV1UT09; Passcode: Y=Sw4a.
Answers to commonly asked questions including information regarding
special accommodations due to disability, visitor parking, and
transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA has established a docket for public comment (Docket No. FDA-
2013-N-0227). Please note that late, untimely filed comments will not
be considered by the committee. Either electronic or written comments
on this public advisory committee meeting must be submitted by May 11,
2023, for consideration by the committee. The https://www.regulations.gov electronic filing system will accept comments on
this public advisory committee meeting until 11:59 p.m. Eastern Time at
the end of May 11, 2023. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are received on or before that date.
    Comments received on or before May 11, 2023, will be provided to
the committee and become part of the docket. Comments received after
May 11, 2023, and prior to September 6, 2023, will also become part of
the docket, but will not be considered by the committee. In the event
that the meeting is canceled, FDA will continue to evaluate any
relevant information and consider any comments submitted to the docket
for the TPSAC meeting, as appropriate. FDA also reminds the public that
commenters may submit either electronic or written comments on the
proposed rule published elsewhere in this issue of the Federal Register
by September 6, 2023.
    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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0227 and ``Proposed Requirements for Tobacco Products
Manufacturing Practice; Tobacco Products Scientific Advisory Committee;
Notice of Meeting; Request for Comments.''
    Comments on this public advisory committee meeting (see ADDRESSES),
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Eastern Time, Monday through Friday,<PHONE_NUMBER>.
     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 identify as confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for
Tobacco Products, Food and Drug Administration, Document Control
Center, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-
0002, 1-877-287-1373, [email protected]; or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On May 18, 2023, the committee will meet in open session to
discuss and provide recommendations on the TPMP proposed rule (proposed
21 CFR part 1120), published elsewhere in this issue of the Federal
Register.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the time of the
advisory committee meeting, and the background material will be posted
on FDA's website after the meeting. Background material will be
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm and can be accessed by scrolling down to the appropriate
advisory committee meeting link.
    Procedure: On May 18, 2023, from 9 a.m. to 2 p.m. Eastern Time, the
meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. All electronic and written submissions submitted to the
Docket (see ADDRESSES) on or before May 11, 2023, will be provided to
the committee. In the event that the meeting is canceled, FDA will
continue to evaluate any relevant information and consider any comments
submitted to the docket for the TPSAC meeting, as appropriate. FDA also
reminds the public that commenters may submit either electronic or
written comments on the proposed rule by September 6, 2023.
    Oral presentations from the public will be scheduled between
approximately 9:30 a.m. to 10:30 a.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, along with their names,
email addresses, and direct contact phone numbers of proposed
participants, on or before 12 p.m. Eastern Time on May 3, 2023. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by 6 p.m., May 4, 2023.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Serina Hunter-Thomas at [email protected] (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04593 Filed 3-8-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Rules and Regulations]
[Pages 45693-45695]
[FR Doc No: 2011-19321]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0567]
RIN 1625-AA00

Safety Zone; San Diego POPS Fireworks, San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of San Diego Bay in support of the San Diego POPS
Fireworks. This safety zone is necessary to provide for the safety of
the participants, crew, spectators, participating vessels, and other
vessels and users of the waterway during scheduled fireworks events.
Persons and vessels will be prohibited from entering into, transiting
through, or anchoring within this safety zone unless authorized by the
Captain of the Port or his designated representative.

DATES: Effective Date: This rule is effective in the CFR from August 1,
2011 until 10 p.m., September 4, 2011. This rule is effective with
actual notice for purposes of enforcement beginning 9 p.m. July 1,
2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0567 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0567 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the 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, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Petty Officer Shane Jackson, Waterways
Management, U.S. Coast Guard Sector San Diego, CA; telephone (619) 278-
7262, e-mail<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because immediate action is necessary to
ensure the safety of vessels, spectators, participants, and others in
the vicinity of the marine event on the dates and times this rule will
be in effect and delay would be impracticable.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register because delaying the effective date
would be impracticable, since immediate action is needed to ensure the
public's safety.

Basis and Purpose

    The San Diego Symphony Orchestra and Copley Symphony Hall are
sponsoring the San Diego POPS Fireworks, which will include a fireworks
presentation conducted from a barge in San Diego Bay. The barge will be
located near the navigational channel in the vicinity of North
Embarcadero. The temporary safety zone will be a 400-foot radius around
the firing barge. The sponsor will provide a chase boat to patrol the
safety zone and inform vessels of the safety zone. This temporary
safety zone is necessary to provide for the safety of the crew,
spectators, and other vessels and users of the waterway.

Discussion of Rule

    The Coast Guard is establishing a temporary safety zone that will
be enforced from 9 p.m. to 10 p.m. on the following dates: July 1-3,
July 8-9, July 15-16, July 22-23, July 29-30, August 5-6, August 12-13,
August 19-20, August 26-27, and September 2-4, 2011. The limits of the
safety zone will be a 400-foot radius around the anchored firing barge
in approximate position 32[deg]42.13' N, 117[deg]10.01' W.
    The temporary safety zone is necessary to provide for the safety of
the crews, spectators, and other vessels and users of the waterway.
Persons and vessels will be prohibited from entering into, transiting
through, or anchoring within the safety zone unless authorized by the
Captain of the Port, or his designated representative.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes and executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary.
    This determination is based on the limited duration and size and
location of the safety zone. Recreational vessels will not be allowed
to transit through the designated safety zone during the specified
times. Vessels may transit through the safety zone with permission from
the Captain of the Port San Diego or designated representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
transit or anchor in the specified waters of San Diego Bay within the
safety zone.
    This rule will not have a significant economic impact on a
substantial number of small entities for the following reasons. Vessel
traffic can pass safely around the safety zone. Before the effective
period, the Coast Guard will publish a local notice to mariners (LNM)
and will issue broadcast notice to mariners (BNM) alerts via marine
channel 16 VHF before the safety zone is enforced.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a temporary
safety zone to protect the public from dangers associated with
fireworks display. An environmental analysis checklist and a
categorical exclusion determination are available in the docket where
indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. A new temporary zone Sec.  165.T11-431 to read as follows:

Sec.  165.T11-431;  Safety zone; San Diego POPS Fireworks, San Diego,
CA.

    (a) Location. The limits of the safety zone will be a 400-foot
radius around the anchored firing barge in approximate position
32[deg]42.13' N, 117[deg]10.01' W.
    (b) Enforcement Period. This section will be enforced from 9 p.m.
to 10 p.m. on the following dates: July 1-3, July 8-9, July 15-16, July
22-23, July 29-30, August 5-6, August 12-13, August 19-20, August 26-
27, and September 2-4, 2011.
    (c) Definitions. The following definition applies to this section:
designated representative means any commissioned, warrant, or petty
officer of the Coast Guard on board a Coast Guard, Coast Guard
Auxiliary, or local, state, or federal law enforcement vessel who has
been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated representative on scene.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Sector San Diego
Command Center. The Command Center may be contacted on VHF-FM Channel
16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or his designated representative.
Upon being hailed by U.S. Coast Guard patrol personnel by siren, radio,
flashing light, or other means, the operator of a vessel shall proceed
as directed.
    (4) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: June 27, 2011.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2011-19321 Filed 7-29-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Notices]
[Pages 79720-79721]
[FR Doc No: 2013-31230]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71183; File No. SR-NYSEMKT-2013-86]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change, as Modified by Amendment No. 1 Thereto, To Adopt Commentary .03
to Rule 980NY To Limit the Volume of Complex Orders by a Single ATP
Holder During the Trading Day

December 24, 2013.
    On October 28, 2013, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt Commentary .03 to NYSE MKT Rule 980NY to
limit the volume of complex orders that may be entered by a single ATP
Holder during the trading day. On November 5, 2013, the Exchange
submitted Amendment No. 1 to the proposed rule change. The proposed
rule change, as modified by Amendment No. 1 thereto, was published for
comment in the Federal Register on November 13, 2013.\3\ The Commission
received no comments on the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 70816 (November 6,
2013), 78 FR 68111.
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    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the

proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether the proposed rule change should be
disapproved. The 45th day for this filing is December 28, 2013. The
Commission finds that it is appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Therefore, the
Commission is extending this 45-day time period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates January 3, 2014, as the date by which the Commission
should either approve or disapprove or institute proceedings to
determine whether to disapprove the proposed rule change.
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    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-31230 Filed 12-30-13; 8:45 am]
BILLING CODE 8011-01-P