[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Pages 34128-34131]
[FR Doc No: 2018-15463]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0007; FRL-9980-26]

Pesticide Product Registration; Receipt of Applications for New
Active Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and
opportunity to comment on these applications.

DATES: Comments must be received on or before August 20, 2018.

ADDRESSES: Submit your comments, identified by the Docket
Identification (ID) Number and the File Symbol of interest as shown in
the body of this document, 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 Confidential Business
Information (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.
    FOR FURTHER INFORMATION CONTACT Robert McNally, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), email address:
[email protected]., Anita Pease, Antimicrobials Division (AD)
(7510P), email address: [email protected]. Michael Goodis,
Registration Division (RD) (7505P), email address: [email protected].
The mailing address and phone number for each contact person is: Office
of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number:
(703) 305-7090.

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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4)
(7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications.

New Active Ingredients

    1. File Symbol: 524-ALG. Docket ID number: EPA-HQ-OPP-2018-0245.
Applicant: Monsanto Company, 800 N. Lindbergh Blvd., St. Louis, MO
63167. Product name: LCO Liquid Additive.

Active ingredient: Plant regulator--LCO MOR116 (chemical name: D-
glucose, O-6-deoxy-2-O-methyl-[alpha]-L-galactopyranosyl-(1[rarr]6)-O-
[O-2-deoxy-2-[[(11Z)-1-oxo-11-octadecen-1-yl]amino]-[beta]-D-
glucopyranosyl-(1[rarr]4)-O-2-(acetylamino)-2-deoxy-[beta]-D-
glucopyranosyl-(1[rarr]4)-O-2-(acetylamino)-2-deoxy-[beta]-D-
glucopyranosyl-(1[rarr]4)-2-(acetylamino)-2-deoxy-[beta]-D-
glucopyranosyl-(1[rarr]4)]-2-(acetylamino)-2-deoxy-; and D-glucose, O-
2-deoxy-2-[[(11Z)-1-oxo-11-octadecen-1-yl]amino]-[beta]-D-
glucopyranosyl-(1[rarr]4)-O-2-(acetylamino)-2-deoxy-[beta]-D-
glucopyranosyl-(1[rarr]4)-O-2-(acetylamino)-2-deoxy-[beta]-D-
glucopyranosyl-(1[rarr]4)-O-2-(acetylamino)-2-deoxy-[beta]-D-
glucopyranosyl-(1[rarr]4)-O-[6-deoxy-[alpha]-L-galactopyranosyl-
(1[rarr]6)]-2-(acetylamino)-2-deoxy-) at 0.0000266%. Proposed use: Seed
treatment. Contact: BPPD.
    2. File Symbol: 524-ALU. Docket ID number: EPA-HQ-OPP-2018-0245.
Applicant: Monsanto Company, 800 N. Lindbergh Blvd., St. Louis, MO
63167. Product name: LCO MOR116 MP. Active ingredient: Plant
regulator--LCO MOR116 (chemical name: D-glucose, O-6-deoxy-2-O-methyl-
[alpha]-L-galactopyranosyl-(1[rarr]6)-O-[O-2-deoxy-2-[[(11Z)-1-oxo-11-
octadecen-1-yl]amino]-[beta]-D-glucopyranosyl-(1[rarr]4)-O-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)-O-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)]-2-
(acetylamino)-2-deoxy-; and D-glucose, O-2-deoxy-2-[[(11Z)-1-oxo-11-
octadecen-1-yl]amino]-[beta]-D-glucopyranosyl-(1[rarr]4)-O-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)-O-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)-O-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)-O-[6-deoxy-
[alpha]-L-galactopyranosyl-(1[rarr]6)]-2-(acetylamino)-2-deoxy-) at
0.013%. Proposed use: Manufacturing-use product. Contact: BPPD.
    3. File Symbol: 7969-UEE. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: VediraTM
Cockroach Gel Bait. Active ingredient: Insecticide-Broflanilide at
0.25%. Proposed Use: To kill Asian and German cockroaches in and around
commercial, institutional, and warehousing establishments [including
computer facilities, food/feed processing plants, hospitals, hotels,
housing and containment areas (i.e. arenas, barns, cages, hatcheries,
houses, hutches, kennels, parlors, pens, sheds, shelters, stables) for
animals (i.e. avian, bovine, canine, equine, feline, hircine, leporine,
murine, porcine), laboratories, milk houses, motels, nursing homes, pet
shops, poultry facilities (including hatchery, egg packaging, and
breeding facilities), restaurants, schools, sewers, supermarkets,
warehouses, and zoos], residences, and transportation equipment
(aircraft--cargo areas only, boats, buses, ships, and trains). Contact:
RD.
    4. File Symbol: 7969-UEG. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: NurizmaTM SC
Insecticide. Active ingredient: Insecticide--Broflanilide at 30%.
Proposed Use: For control of soil insects in corn grown for seed, field
corn, popcorn, sweet corn; and tuberous and corm vegetables, Crop
Subgroup 1C. Contact: RD.
    5. File Symbol: 7969-UEN. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: CimegraTM SC
Insecticide. Active ingredient: Insecticide-Broflanilide at 10%.
Proposed Use: For control of soil insects in corn grown for seed, field
corn, popcorn, sweet corn; and tuberous and corm vegetables, Crop
Subgroup 1C. Contact: RD.
    6. File Symbol: (7969-EUP-UT). Applicant: BASF Corporation.
Pesticide Chemical: Broflanilide. Summary of Request: The purpose of
the requested EUP is to generate efficacy data on structural protection
applications using conventional application equipment and the BASF
Corporation-patented HP Unit to protect structures from termites.
Contact: RD.
    7. File Symbol: 7969-UER. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: TerindaTM Foam
Termiticide/Insecticide. Active ingredient: Insecticide-Broflanilide at
0.0045%. Proposed Use: To kill termites (drywood and subterranean) and
foraging carpenter ants in and around apartments, homes, food/feed
handling establishments (non-food/feed areas), restaurants, hospitals
and nursing homes (non-patient areas), hotels and motels, hobby
greenhouses, interiorscapes, mobile homes, office buildings, schools,
transportation equipment (buses, cargo trucks, trailers, and trains),
warehouses and other commercial and industrial buildings in addition to
outdoor spot treatments. Contact: RD.
    8. File Symbol: 7969-UEU. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: VediraTM Ant Gel
Bait. Active ingredient: Insecticide-Broflanilide at 0.02%. Proposed
Use: To kill ants (acrobat, Argentine, bigheaded, black carpenter,
crazy, field, ghost, honey, little black, odorous house, pavement,
rover, and thief) in and around commercial, industrial, and residential
buildings including apartments, garages, food storage areas, homes,
hospitals and nursing homes, hotels, motels, office buildings,
restaurants and other food handling establishments, schools,
supermarkets, transportation equipment (buses, boats, ships, trains,
planes), utilities, and warehouses. Contact: RD.
    9. File Symbol: 7969-URA. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: VediraTM Granular
Ant Bait. Active ingredient: Insecticide-Broflanilide at 0.005%.
Proposed Use: To kill ants (acrobat, Argentine, bigheaded, crazy,
Florida carpenter, foraging fire, ghost, little black, odorous house,
pavement, rover, and thief) and crickets in and around commercial
buildings and other structures, food handling facilities, food
processing plants, food storage areas, golf courses, homes, hotels,
meat packing plants, lawns, motels, restaurants and other food handling
establishments, non-occupied patient areas of hospitals and nursing
homes, parks, residential areas, schools, supermarkets, turf and
warehouses. Contact: RD.
    10. File Symbol: 7969-URG. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: VediraTM Granular
Fly Bait. Active ingredient: Insecticide-Broflanilide at 0.025%.
Proposed Use: To kill flies (blue bottle, house, phorid, and small
fruit or vinegar) in and around Commercial buildings, Industrial
buildings, and Other manmade structures; Garbage or refuse bins and
receptacles; or Other areas where flies may be a nuisance or health
hazard Bakeries; Campgrounds; Carnivals; Circuses; Concert arenas;
Confectionaries; County and state fair facilities; Dairy areas;
Festival grounds, Food handling establishments; Food processing plants;
Food storage areas; Food vending structures; Golf courses; Grain mills;
Granaries; Hospitals; Hotels; Housing and containment areas (i.e.,
Arenas, Barns, Cages, Hatcheries, Houses, Hutches, Kennels, Parlors,
Pens, Sheds, Shelters, Stables) for Animals (i.e., Avian, Bovine,
Canine, Equine, Feline, Hircine, Leporine, Murine, Porcine);
Interiorscapes; Libraries; Marinas; Meat, Poultry and egg processing
facilities; Meat packing plants; Milk houses; Motels; Museums; Nursing
homes; Pavilions; Research facilities; Resorts; Restaurants; Mobile
food vendors; Parking ramps; Poultry facilities (including: Hatchery,
Egg

packaging, Breeding facilities); Public picnic areas; Public restrooms;
Recreational rest areas; Schools; Supermarkets; Temporary shelters;
Theme parks; Terminals; Transportation equipment (Barges, Ships,
Trailers, Trains, Trucks); Utilities; Warehouses; Waysides; Wildlife
refuge areas; Zoos. Contact: RD.
    11. File Symbol: 7969-URI. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: TeraxxaTM
Insecticide Seed Treatment. Active ingredient: Insecticide-Broflanilide
at 34.93%. Proposed/Use: Seed treatment for insect control in wheat
(all types), barley, oats, rye, triticale, amaranth grain, buckwheat
(all types), ca[ntilde]ihua, chia, cram-cram, huauzontle, quinoa, and
spelt. Contact: RD.
    12. File Symbol: 7969-URL. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product Name: TerindaTM SC
Termiticide/Insecticide. Active ingredient: Insecticide-Broflanilide at
9.47%. Proposed Use: To kill subterranean termites outdoors around
apartments, homes, restaurants, hospitals and nursing homes (non-
patient areas), hotels and motels, mobile homes, office buildings,
schools, transportation equipment (cargo trucks, trailers, and train
cars ONLY), warehouses and other commercial and industrial buildings
and in transportation equipment. Contact: RD.
    13. File Symbol: 7969-URO. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: TeraxxaTM F4
Insecticide and Fungicide Seed Treatment. Active ingredient:
Insecticide-Broflanilide at 1.55%, Fluxapyroxad at 0.78%,
Pyraclostrobin at 1.55%, Triticonazole at 1.55%, and Metalaxyl at
0.93%. Proposed Use: Seed treatment for insect control in wheat (all
types), barley, oats, rye, triticale, amaranth grain, buckwheat (all
types), ca[ntilde]ihua, chia, cram-cram, huauzontle, quinoa, and spelt.
Contact: RD.
    14. File Symbol: 7969-URT. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: PT VediraTM
Pressurized Insecticide. Active ingredient: Insecticide-Broflanilide at
0.20%. Proposed Use: To kill ants (excluding carpenter), bed bugs,
crickets, Indian meal moths (adult and larvae), millipedes, silverfish,
spiders (including black widow and brown recluse), and stored product
pest beetles; and to control ants (foraging harvester and Pharaoh),
beetles (Asian lady), cockroaches (German), flies (house and stable),
kuzu bugs, and stink bugs (brown marmorated) in and around Apartments,
Campgrounds, Food storage areas, Homes, Hospitals**, Hotels, Meat
packing and food processing plants, Motels, Nursing homes **, Resorts,
Restaurants and other food handling establishments, Schools,
Supermarkets, Transportation equipment (Airplanes--cargo areas only,
Buses, Boats, Ships, Trains, and Trucks), Utilities, Warehouses and
other commercial and industrial buildings. Contact: RD.
    15. File Symbol: 7969-URU. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: BASF Corporation. Product name: VediraTM
Pressurized Fly Bait. Active ingredient: Insecticide-Broflanilide at
0.125%. Proposed Use: To kill flies (blue bottle, filth, flesh, house,
moth, phorid, and small fruit or vinegar flies) and house fly larvae in
and around Commercial, residential, and industrial buildings and other
manmade structures; Garbage or refuse bins and receptacles; or Other
areas where flies may be a nuisance or health hazard: Apartments;
Bakeries; Campgrounds; Carnivals; Circuses; Concert arenas;
Condominiums; Confectionaries; County and state fair facilities; Dairy
areas; Farm houses; Day care facilities; Festival grounds, Food
handling establishments; Food processing plants; Food storage areas;
Food vending structures; Garages; Golf courses; Grain mills; Granaries;
Homes; Hospitals; Hotels; Housing and containment areas (i.e., Arenas,
Barns, Cages, Hatcheries, Houses, Hutches, Kennels, Parlors, Pens,
Sheds, Shelters, Stables) for animals (i.e., Avian, Bovine, Canine,
Equine, Feline, Hircine, Leporine, Murine, Porcine); Interiorscapes;
Libraries; Marinas; Meat, poultry and egg processing facilities; Meat
packing plants; Milk houses; Mobile homes; Motor homes; Motels;
Museums; Nursing homes; Outdoor living areas; Pavilions; Porches;
Research facilities; Resorts; Restaurants; Mobile food vendors; Parking
ramps; Poultry facilities (including: Hatchery, Egg packaging, Breeding
facilities, Houses); Public picnic areas; Public restrooms;
Recreational rest areas; Residential backyards; Schools; Supermarkets;
Tents or temporary shelters; Theme parks; Terminals; Transportation
equipment (Buses, Barges, Boats, Ships, Trailers, Trains, Trucks);
Utilities; Warehouses; Waysides; Wildlife refuge areas; Zoos. Contact:
RD.
    16. File Symbol: 86203-EI. Docket ID number: EPA-HQ-OPP-2018-0053.
Applicant: Mitsui Chemicals Agro, Inc. (MCAG). Product name:
Broflanilide Technical. Active ingredient: Insecticide-Broflanilide at
99.68%. Proposed Use: For formulation into insecticides for 1)
terrestrial food crops and crop groups: Brassica (Cole) Leafy
Vegetables (Crop Group 5), Canola, Corn, Cotton, Fruiting Vegetables
(Except Cucurbits) (Crop Group 8), Herbs and Spices (Crop Group 19),
Leafy Vegetables (Except Brassica Vegetables) (Crop Group 4), Legume
Vegetables (Succulent or Dried) (Crop Group 6), Soybean, Tea, and
Tuberous and Corm Vegetables (Crop Subgroup 1C); and the following seed
treatment uses: Cereal Grains (Crop Group 15), Tuberous and Corm
Vegetables (Crop Subgroup 1), and Soybeans. 2) Non-crop uses: Food-
handling establishments; indoor and outdoor residential and commercial
as well as termiticide applications. Contact: RD
    17. File Symbol: 80286-EI. Docket ID number: EPA-HQ-OPP-2018-0370.
Applicant: ISCA Technologies, Inc., 1230 W. Spring St., Riverside, CA
92507. Product name: SPLAT FAW GL3. Active ingredients: Straight Chain
Lepidopteran Pheromone--(Z)-7-Dodecenyl Acetate at 0.09%, (Z)-9-
tetradecenyl acetate at 2.55%, and (Z)-11-hexadecenyl acetate at 0.36%.
Proposed use: End-use product to be used as mating distruptant for
lepidopteran species. Contact: BPPD.
    18. File Symbol: 80286-E.O.. Docket ID number: EPA-HQ-OPP-2018-
0370. Applicant: ISCA Technologies, Inc., 1230 W. Spring St.,
Riverside, CA 92507. Product name: SPLAT FAW GL4. Active ingredients:
Straight Chain Lepidopteran Pheromone--(Z)-7-Dodecenyl Acetate at
0.12%, (Z)-9-tetradecenyl acetate at 3.40%, and (Z)-11-hexadecenyl
acetate at 0.48%. Proposed use: End-use product to be used as mating
distruptant for lepidopteran species. Contact: BPPD.
    19. File Symbol: 80286-ET. Docket ID number: EPA-HQ-OPP-2018-0370.
Applicant: ISCA Technologies, Inc., 1230 W. Spring St., Riverside, CA
92507. Product name: ISCA FAW MP. Active ingredients: Straight Chain
Lepidopteran Pheromone--(Z)-7-Dodecenyl Acetate at 2.86%, (Z)-9-
tetradecenyl acetate at 81.00%, and (Z)-11-hexadecenyl acetate at
11.44%. Proposed use: Manufacturing-use product for formulation into
end-use products to be used as mating distruptants for lepidopteran
species. Contact: BPPD.
    20. File Symbol: 80286-GN. Docket ID number: EPA-HQ-OPP-2018-0370.
Applicant: ISCA Technologies, Inc., 1230 W. Spring St., Riverside, CA
92507. Product name: SPLAT FAW GL5. Active ingredients: Straight Chain
Lepidopteran Pheromone--(Z)-7-

Dodecenyl Acetate at 0.15%, (Z)-9-tetradecenyl acetate at 4.25%, and
(Z)-11-hexadecenyl acetate at 0.60%. Proposed use: End-use product to
be used as mating distruptant for lepidopteran species. Contact: BPPD.

    Authority:  7 U.S.C. 136 et seq.

    Dated: June 27, 2018.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2018-15463 Filed 7-18-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Notices]
[Pages 62781-62783]
[FR Doc No: 2016-21800]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78771; File No. SR-BatsEDGX-2016-49]

Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change to Fees
for Use of Bats EDGX Exchange, Inc.

September 6, 2016.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 22, 2016, Bats EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to EDGX Rules
15.1(a) and (c).
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    \5\ The term ``Member'' is defined as ``any registered broker or
dealer that has been admitted to membership in the Exchange.'' See
Exchange Rule 1.5(n).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to amend its marketing fee program to
institute a monthly cap of $250,000 on undisbursed funds and reimburse
excess funds on a pro-rata basis, as further described below.
    The Exchange assesses a marketing fee to all Market Makers for
contracts they execute in their assigned classes when the contra-party
to the execution is a Customer.\6\ The marketing fee is charged only in
a Market Maker's assigned classes because it is in these classes that
the Market Maker has the general obligation to attract order flow to
the Exchange. Each Primary Market Maker (``PMM'') \7\ and Directed
Market Maker (``DMM'') \8\ has a marketing fee pool into which the
Exchange will deposit the applicable per-contract marketing fee. For
orders directed to DMMs, the applicable marketing fees are allocated to
the DMM pool. For non-directed orders, the applicable marketing fees
are allocated to the PMM pool. All Market Makers that participated in
such transaction will pay the applicable marketing fees to the
Exchange, which allocates such funds to the Market Maker that controls
the distribution of the marketing fee pool. Each month the Market Maker
provides instruction to the Exchange describing how the Exchange is to
distribute the marketing fees in the pool to the order flow provider,
who submit as agent, Customer orders to the Exchange.
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    \6\ The amount of the marketing fee depends upon whether the
affected option class is a Penny Pilot Security. A marketing fee of
$0.25 per contract is assessed to Market Makers for transactions in
Penny Pilot Securities. A Marketing Fee of $0.70 per contract is
assessed to Market Makers for transactions in Non-Penny Pilot
Securities. A list of option classes included in the Penny Pilot
Program is available on the Exchange's Web site.
    \7\ See Exchange Rule 21.8(g).
    \8\ See Exchange Rule 21.8(f).
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    The Exchange proposes to now require that the total balance of the
undisbursed marketing fees for a PMM pool and DMM pool cannot exceed
$250,000. When the pool balance exceeds this threshold level, the
Exchange will rebate funds proportionately to those who have paid the
marketing fee during the preceding month. Today, undisbursed marketing
fees are reimbursed to the Market Makers that contributed to the pool
based upon their pro-rata portion of the entire amount of marketing fee
collected. As proposed, each month, undisbursed marketing fees in
excess of $250,000 will be reimbursed to the Market Makers that
contributed to the pool based upon a one month look back and their pro-
rata portion of the entire amount of marketing fee collected during
that month. The Exchange will closely monitor the levels of the cap to
ensure that there are adequate funds available to Market Makers to be
competitive. The Exchange believes the proposed cap and reimbursement
process would assist Market Makers in better managing their respective
marketing fee pools and incentivize them to allocate those funds to
order flow providers accordingly on a monthly basis.

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of section 6 of the Act.\9\
Specifically, the Exchange believes that the proposed rule change is
consistent with section 6(b)(4) of the Act,\10\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
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    The Exchange notes that the U.S. options markets are highly
competitive, and the marketing fee is intended to provide an incentive
for Market Makers to enter into marketing agreements with Members so
that they will provide order flow to the Exchange. The marketing fee is
charged only in a Market Maker's assigned classes because it is in
these classes that the Market Maker has the general obligation to
attract order flow to the Exchange.
    The Exchange believes that the proposed amendments to its marketing
fee program, which is similar to marketing fee programs that have
previously been implemented on other options exchanges,\11\ will
enhance the Exchange's competitive position and will result in
increased liquidity on the Exchange, thereby providing more of an
opportunity for customers to receive best executions. In addition, the
proposed cap and reimbursement process would assist Market Makers in
better managing their respective marketing fee pools and incentivize
them to allocate those funds to order flow providers accordingly on a
monthly basis. The Exchange notes that most options exchange's that
administer a marketing fee program do not cap the monthly
contributions,\12\ thereby allowing their market makers to roll over
monies from month to month without making the disbursements provided
for by their respective programs. Therefore, the Exchange believes that
providing a cap of $250,000 is equitable and reasonable as it would
allow the Exchange to monitor the impact of the cap on a Market Maker's
allocation of marketing fees without inappropriately limiting a Market
Maker's ability to carry over funds from month to month.
---------------------------------------------------------------------------

    \11\ See International Securities Exchange, Inc. (``ISE'') fee
schedule available at http://www.ise.com/assets/documents/OptionsExchange/legal/fee/ISE_fee_schedule.pdf (implementing a cap
of $100,000); ISE Mercury LLC (``ISE Mercury'') fee schedule
available at http://www.ise.com/assets/mercury/documents/OptionsExchange/legal/fee/Mercury_Fee_Schedule.pdf (implementing a
marketing fee cap of $100,000); and Chicago Board Options Exchange,
Incorporated (``CBOE'') fee schedule available at http://www.cboe.com/framed/pdfframed.aspx?content=/publish/feeschedule/CBOEFeeSchedule.pdf§ion=SEC_RESOURCES&title=CBOE%20Fee%20Schedule
 (implementing a marketing fee cap of $100,000).
    \12\ See e.g., Nasdaq PHLX LLC (``PHLX'') price list available
at http://www.nasdaqtrader.com/Micro.aspx?id=PHLXPricing; Miami
International Securities Exchange LLC (``MIAX'') available at http://www.miaxoptions.com/sites/default/files/MIAX_Options_Fee_Schedule_08012016C.pdf.
---------------------------------------------------------------------------

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

    The Exchange believes its proposed amendments to its fee schedule
would not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
does not believe that the proposed change represents a significant
departure from previous pricing offered by the Exchange or its
competitors. Additionally, Members may opt to disfavor the Exchange's
pricing if they believe that alternatives offer them better value. The
Exchange believes that its proposed marketing fee cap, which is similar
to marketing fee caps in place on other options exchanges,\13\ will
enhance the Exchange's competitive position by resulting in increased
liquidity on the Exchange, thereby providing more of an opportunity for
customers to receive best executions.
---------------------------------------------------------------------------

    \13\ See supra note 10.
---------------------------------------------------------------------------

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A) of the Act \14\ and paragraph (f) of Rule 19b-4
thereunder.\15\ 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
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 No. SR-BatsEDGX-2016-49 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-BatsEDGX-2016-49. 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 will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BatsEDGX-2016-49 and should be
submitted on or before October 3, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-21800 Filed 9-9-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 10, 2009 (Volume 74, Number 236)]
[Notices]
[Page 65591-65592]
[DOCID:fr10de09-103]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2009-0285]

Pipeline Safety: Requests for Special Permit

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

ACTION: Notice.

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

SUMMARY: PHMSA is publishing this notice of special permit requests we
have received from several pipeline operators, seeking relief from
compliance with certain requirements in the Federal pipeline safety
regulations. This notice seeks public comments on these requests,
including comments on any safety or environmental impacts. At the
conclusion of the 30-day comment period, PHMSA will evaluate each
request and determine whether to grant or deny a special permit.

DATES: Submit any comments regarding these special permit requests by
January 11, 2010.

ADDRESSES: Comments should reference the docket numbers for the
specific special permit request and may be submitted in the following
ways:
     E-Gov Web Site: http://www.Regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency.
     Fax: 1-202-493-2251.
     Mail: Docket Management System: U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: DOT Docket Management System: U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Instructions: You should identify the docket number for the special
permit request you are commenting on at the beginning of your comments.
If you submit your comments by mail, please submit two copies. To
receive confirmation that PHMSA has received your comments, please
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.Regulations.gov.

    Note:  Comments are posted without changes or edits to http://
www.Regulations.gov, including any personal information provided.

    Privacy Act Statement: Anyone may search the electronic form of all
comments received for any docket. DOT's complete Privacy Act Statement
was published in the Federal Register on April 11, 2000 (65 FR 19477)
and is available on http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: General: Kay McIver by telephone at
(202) 366-0113; or, e-mail at<EMAIL_ADDRESS>    Technical: Steve Nanney by telephone at<PHONE_NUMBER>; or, e-mail
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: PHMSA has received several requests for
special permits from pipeline operators who seek relief from compliance
with certain pipeline safety regulations. Each request is filed in the
Federal Docket Management System (FDMS) and has been assigned a
separate docket number in the FDMS. Each docket includes any technical
analysis or other supporting documentation provided by the requestor,
including a description of any alternative measures the operator
proposes to take in lieu of compliance. We invite interested persons to
participate by reviewing these special permit requests at http://
www.Regulations.gov, and by submitting written comments, data or other
views. Please include any comments on potential environmental impacts
that may result if these special permits are granted.
    Before acting on these special permit requests, PHMSA will evaluate
all comments received on or before the comments closing date. Comments
will be evaluated after this date if it is possible to do so without
incurring additional expense or delay. PHMSA will consider each
relevant comment we receive in making our decision to grant or deny a
request and what terms and conditions are appropriate.
    PHMSA has received the following special permit requests:

----------------------------------------------------------------------------------------------------------------
                                                     Regulation(s)
         Docket Number              Requester           affected               Nature of special permit
----------------------------------------------------------------------------------------------------------------
PHMSA-2009-0266...............  CountryMark        49 CFR             CountryMark Pipeline, LLC requested relief
                                 Cooperative, LLP.  195.452(h)(4)(ii   from certain federal regulations for its
                                                    )(A),.             178 mile Intrastate, Mount Vernon,
                                                   49 CFR              Indiana to Jolietville, Indiana pipeline.
                                                    195.452(h)(4)(ii   CountryMark requests that the special
                                                    i)(B).             permit conditions be in accordance with
                                                                       the guidelines from ASME B31.4 and the
                                                                       PRCI Pipeline Repair Manual, which states
                                                                       that:
                                                                       Dents deeper than 6% should be
                                                                       repaired.
                                                                       In pipe NPS 4 and smaller, dents
                                                                       are allowed up to \1/4\ inch and
                                                                       Dents larger than 2% should be
                                                                       analyzed for fatigue.
                                                                      The pipeline runs through the counties of
                                                                       Posey, Gibson, Knox, Green, Owen, Putnam,
                                                                       Morgan, Hendricks, Boone and Hamilton in
                                                                       Indiana. The pipeline has two segments;
                                                                       (1) Mount Vernon to Switz City; and (2)
                                                                       Switz City to Jolietville.
                                                                      This intrastate pipeline was constructed
                                                                       in 1952 and 1953 (8\5/8\-inch, 0.322''
                                                                       wall thickness, Grade B steel, seamless
                                                                       pipe) and follows a largely rural route
                                                                       as it passes through 13 (11 Ecological
                                                                       and 2 Drinking Water) Unusually Sensitive
                                                                       Areas. The pipeline operates at a MOP of
                                                                       800 psig.
PHMSA-2009-0273...............  Vintage            49 CFR 192.53,     Vintage Production California LLC
                                 Production         192.55, 492.105,   requested relief from certain federal
                                 California LLC.    192.107,           regulations for the use of flexible steel
                                                    192.109,           pipe. The flexible steel pipe that
                                                    192.111,           Vintage proposes to use was designed and
                                                    192.113, 192.221   manufactured in accordance with API 17J,
                                                    192.455,           Specification for Un-bonded Flexible
                                                    192.503(b)(3),     Pipe. Vintage proposes to install
                                                    192.619.           approximately 46,300 feet of 6-inch Flex
                                                                       Steel \TM\ pipe in Ventura County,
                                                                       California.
PHMSA-2009-0319...............  Kern River Gas     49 CFR 192.625...  Kern River Gas Transmission Company
                                 Transmission                          requested relief from federal regulations
                                 Company.                              require odorization of natural gas in its
                                                                       Centennial Lateral Line. This line is
                                                                       located in Clark County, Las Vegas,
                                                                       Nevada. The lateral begins at the Kern
                                                                       River 36-inch main line (mile post
                                                                       519.68) and runs to a meter station that
                                                                       supplies natural gas to the Southwest Gas
                                                                       Corporation. The lateral is 1,083 feet in
                                                                       length and has a 10.750-inch diameter tap
                                                                       valve that transitions into a 12.75-inch,
                                                                       0.250'' wall thickness, Grade API 5L-X65
                                                                       pipe line. The current MAOP is 1,200 psig
                                                                       with plans to operate at 1,333 psig in
                                                                       the future per special permit, PHMSA-2007-
                                                                       29078.
----------------------------------------------------------------------------------------------------------------

    Authority:  49 U.S.C. 60118 (c)(1) and 49 CFR 1.53.

    Issued in Washington, DC on December 3, 2009.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. E9-29400 Filed 12-9-09; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 85, Number 97 (Tuesday, May 19, 2020)]
[Notices]
[Pages 29949-29951]
[FR Doc No: 2020-10635]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1370]

COVID-19: Developing Drugs and Biological Products for Treatment
or Prevention; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``COVID-19:
Developing Drugs and Biological Products for Treatment or Prevention.''
This guidance describes FDA's current recommendations regarding phase 2
or phase 3 trials for drugs or biological products under development
for the treatment or prevention of COVID-19. Given the public health
emergency presented by COVID-19, this guidance document is being
implemented without prior public comment because FDA has determined
that prior public participation is not feasible or appropriate, but it
remains subject to comment in accordance with the Agency's good
guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on May 19, 2020. The guidance document is immediately in
effect, but it remains subject to comment in accordance with the
Agency's good guidance practices.

ADDRESSES: You may submit electronic or written comments on Agency
guidances at any time 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-2020-D-1370 for ``COVID-19: Developing Drugs and Biological
Products for Treatment or Prevention.'' 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 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Eithu Lwin, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``COVID-19: Developing Drugs and Biological Products for
Treatment or Prevention.'' There is currently an outbreak of
respiratory disease caused by a novel coronavirus. The virus has been
named SARS-CoV-2, and the disease it causes has been named Coronavirus
Disease 2019 (COVID-19). On January 31, 2020, the Department of Health
and Human Services (HHS) issued a declaration of a public health
emergency related to COVID-19 and mobilized the Operating Divisions of
HHS. The public health emergency declaration was renewed on April 21,
2020. In addition, on March 13, 2020, the President declared a national
emergency in response to COVID-19.
    This guidance describes FDA's current recommendations regarding
phase 2 or phase 3 trials for drugs under development to treat or
prevent COVID-19. This guidance focuses on the patient population,
trial design, efficacy endpoints, safety considerations, and
statistical considerations for such trials. Drugs should have undergone
sufficient development before their evaluation in phase 2 or phase 3.
    This guidance focuses on the development of drugs with direct
antiviral activity or immunomodulatory activity. However, the
recommendations in this guidance may be applicable to development plans
for drugs for COVID-19 with other mechanisms of action. The mechanism
of action of the drug may impact key study design elements (e.g.,
population, endpoints, safety assessments, duration of followup, etc.).
    Preventative vaccines are not within the scope of this guidance.
Nor does this guidance provide general recommendations on early drug
development in COVID-19, such as use of animal models.
    In light of the public health emergency related to COVID-19
declared by the Secretary of HHS, FDA has determined that prior public
participation for this guidance is not feasible or appropriate and is
issuing this guidance without prior public comment (see section
701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately,
but it remains subject to comment in accordance with the Agency's good
guidance practice statute and regulation.
    This guidance is intended to remain in effect for the duration of
the public health emergency related to COVID-19 declared by HHS,
including any renewals made by the Secretary in accordance with section
319(a)(2) of the Public Health Service Act (42 U.S.C.

247d(a)(2)). However, the recommendations and processes described in
the guidance are expected to assist the Agency more broadly in its
continued efforts to assist sponsors in the clinical development of
drugs for the treatment of COVID-19 beyond the termination of the
COVID-19 public health emergency and reflect the Agency's current
thinking on this issue. Therefore, within 60 days following the
termination of the public health emergency, FDA intends to revise and
replace this guidance with any appropriate changes based on comments
received on this guidance and the Agency's experience with
implementation.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``COVID-19: Developing Drugs and Biological
Products for Treatment or Prevention.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). Under
the PRA, Federal Agencies must obtain approval from OMB for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
OMB under the PRA. The collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR parts 312 and 320 have been approved under OMB
control number 0910-0014; the collections of information in 21 CFR part
58 regarding good laboratory practice for nonclinical laboratory
studies have been approved under OMB control number 0910-0119; the
collections of information in 21 CFR parts 50 and 56 have been approved
under OMB control number 0910-0130; the collections of information in
21 CFR part 320 have been approved under OMB control number 0910-0291;
the collections of information in 21 CFR part 601 have been approved
under OMB control number 0910-0338; the collections of information in
FDA's draft guidance for industry entitled ``Formal Meetings Between
FDA and Sponsors and Applicants of Prescription Drug User Fee Act
Products'' have been approved under OMB control number 0910-0429; the
collections of information in FDA's final guidance for clinical trial
sponsors entitled ``Establishment and Operation of Clinical Trial Data
Monitoring Committees'' have been approved under OMB control number
0910-0581; and the collections of information in FDA's final guidance
for industry entitled ``Oversight of Clinical Investigations--A Risk-
Based Approach to Monitoring'' have been approved under OMB control
number 0910-0733.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or
https://www.regulations.gov.

    Dated: May 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10635 Filed 5-18-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 71 (Friday, April 14, 2017)]
[Notices]
[Pages 18058-18061]
[FR Doc No: 2017-07598]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80427; File No. SR-NYSEArca-2016-173]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a
Proposed Rule Change, as Modified by Amendments No. 2 and No. 3
Thereto, To List and Trade Shares of the United States 3x Oil Fund and
United States 3x Short Oil Fund Under NYSE Arca Equities Rule 8.200,
Commentary .02

April 11, 2017.

I. Introduction

    On December 23, 2016, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) \1\ of the Securities
Exchange Act of 1934 (``Act'' or ``Exchange Act'') \2\ and Rule 19b-4
thereunder,\3\ a proposed rule change to list and trade shares
(``Shares'') of the United States 3x Oil Fund (``Oil Fund'') and United
States 3x Short Oil Fund (``Short Oil Fund,'' and together with the Oil
Fund, ``Funds'') under NYSE Arca Equities Rule 8.200, Commentary .02.
The proposed rule change was published for comment in the Federal
Register on January 11, 2017.\4\ On February 22, 2017, the Commission
designated a longer period within which to approve the proposed rule
change, disapprove the proposed rule change, or institute proceedings
to determine whether to disapprove the proposed rule change,\5\
pursuant to Section 19(b)(2) of the Act.\6\ On March 13, 2017, the
Exchange filed Amendment No. 1 to the proposed rule change. On March
29, 2017, the Exchange filed Amendment No. 2 to the proposed rule
change, which replaced and superseded the proposed rule change as
modified by Amendment No. 1.\7\ On April 7, 2017, the Exchange filed
Amendment No. 3 to the proposed rule change.\8\ The Commission received
no comments on the proposed rule change. This order approves the
proposed rule change, as modified by Amendments No. 2 and No. 3.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ See Securities Exchange Act Release No. 79742 (January 5,
2017), 82 FR 3366.
    \5\ See Securities Exchange Act Release No. 80079 (February 27,
2017), 82 FR 11955 (designating April 11, 2017 as the date by which
the Commission would approve the proposal, disapprove the proposal,
or institute proceedings to approve or disapprove the proposal).
    \6\ 15 U.S.C. 78s(b)(2).
    \7\ In Amendment No. 2, the Exchange: (1) Provided additional
detail regarding the Funds' Benchmark Oil Futures Contract; (2)
stated that the CME Group, Inc. (``CME'') is a member of the
Intermarket Surveillance Group; (3) provided additional
clarification regarding the timing of the daily rebalancing of the
Funds' holdings; (4) provided additional clarification and
specificity regarding the instruments in which the Funds may invest;
(5) provided additional information regarding accountability level
requirements applicable to the Funds; (6) supplemented the
description of how certain investments will be valued for computing
a Fund's net asset value (``NAV''); (7) provided additional
clarification regarding the calculation of the Indicative Fund Value
(``IFV'') for a Fund; (8) represented that certain aspects of the
Funds' creation and redemption procedures will not impact market
maker arbitrage opportunities; (9) provided information regarding
the availability of the Benchmark Oil Futures Contract trading
prices prior to the New York Mercantile Exchange closing time and
end of day settlement price once published by the New York
Mercantile Exchange after its closing; (10) removed statements
regarding the rejection or suspension of redemption orders; (11)
provided additional detail regarding the availability of information
regarding the Funds and their portfolio holdings; (12) represented
that the applicability of Exchange listing rules specified in the
proposed rule change shall constitute continued listing requirements
for listing the Shares on the Exchange; (13) supplemented its
description of the information that the Exchange will provide to
Equity Trading Permit Holders in an Information Bulletin; and (14)
made other technical amendments. The amendments to the proposed rule
change are available at: https://www.sec.gov/comments/sr-nysearca-2016-173/nysearca2016173.htm. Amendment No. 2 is not subject to
notice and comment because it is a technical amendment that does not
materially alter the substance of the proposed rule change or raise
any novel regulatory issues.
    \8\ In Amendment No. 3, the Exchange: (1) Clarified that the
futures contracts that trade under the symbol ``CL'' are WTI Crude
Oil futures; and (2) stated that the contents of each Fund's
portfolio would be disclosed to all market participants at the same
time. Amendment No. 3 is not subject to notice and comment because
it is a technical amendment that does not materially alter the
substance of the proposed rule change or raise any novel regulatory
issues.
---------------------------------------------------------------------------

II. Description of the Proposal \9\
---------------------------------------------------------------------------

    \9\ A more detailed description of the Funds, the Shares, and
the Benchmark Oil Futures Contract, as well as investment risks,
creation and redemption procedures, NAV calculation, availability of
values and other information regarding the Funds' portfolio
holdings, and fees, among other things, is included in the
Registration Statements (defined below) and Amendments No. 2 and No.
3, as applicable. See infra note 11, and supra notes 7 and 8,
respectively.
---------------------------------------------------------------------------

    The Exchange proposes to list and trade the Shares under NYSE Arca
Equities Rule 8.200, Commentary .02, which governs the listing and
trading of Trust Issued Receipts.\10\ Each Fund is a series of the USCF
Funds Trust (``Trust''), a Delaware statutory trust.\11\ The Trust and
the Funds are managed and controlled by United States Commodity Funds
LLC (``USCF''). USCF is registered as a commodity pool operator with
the Commodity Futures Trading Commission and is a member of the
National Futures Association. Brown Brothers Harriman & Co. is the
custodian, registrar, transfer agent, and administrator for the Funds.
ALPS Fund Services, Inc. is the marketing agent for the Funds.
---------------------------------------------------------------------------

    \10\ Commentary .02 to NYSE Arca Equities Rule 8.200 applies to
Trust Issued Receipts that invest in ``Financial Instruments.'' The
term ``Financial Instruments,'' as defined in Commentary .02(b)(4)
to NYSE Arca Equities Rule 8.200, means any combination of
investments, including cash; securities; options on securities and
indices; futures contracts; options on futures contracts; forward
contracts; equity caps, collars, and floors; and swap agreements.
    \11\ The Trust is registered under the Securities Act of 1933.
The Trust filed with the Commission a registration statement on Form
S-1 under the Securities Act of 1933 (15 U.S.C. 77a) relating to the
United States 3x Oil Fund (File No. 333-214825) and the United
States 3x Short Oil Fund (File No. 333-214881) (each a
``Registration Statement'' and, collectively, ``Registration
Statements'') on November 29, 2016 and December 2, 2016,
respectively.
---------------------------------------------------------------------------

Overview of the Funds

    The investment objective of the Oil Fund will be for the daily
changes in percentage terms of its Shares' per share NAV to reflect
three times (3x) the daily change in percentage terms of the price

of a specified short-term futures contract on light, sweet crude oil
(``Benchmark Oil Futures Contract''), less the Fund's expenses. The
Benchmark Oil Futures Contract is the futures contract on light, sweet
crude oil as traded on the New York Mercantile Exchange (``NYMEX''),
which is part of the CME, traded under the trading symbol ``CL'' (for
WTI Crude Oil futures), that is the near month contract to expire,
except when the near month contract is within two weeks of expiration,
in which case it will be measured by the futures contract that is the
next month contract to expire.\12\
---------------------------------------------------------------------------

    \12\ See Amendment No. 3, supra note 8. The Exchange represents
that CME is a member of the Intermarket Surveillance Group
(``ISG''). See Amendment No. 2, supra note 7, at 5 n.7.
---------------------------------------------------------------------------

    The investment objective of the Short Oil Fund will be for the
daily changes in percentage terms of its shares' per share NAV to
reflect three times the inverse (-3x) of the daily change in percentage
terms of the price of the Benchmark Oil Futures Contract, less the
Fund's expenses.
    To achieve these objectives, USCF will endeavor to have the
notional value of a Fund's aggregate exposure (in the case of the Oil
Fund) or aggregate short exposure (in the case of the Short Oil Fund)
to the Benchmark Oil Futures Contract at the close of each trading day
approximately equal to 300% of the Fund's NAV. The Funds will not seek
to achieve correlation to the Benchmark Oil Futures Contract over a
period of time greater than one day.\13\
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    \13\ The pursuit of daily leveraged investment goals means that
the return of a Fund for a period longer than a full trading day may
have no resemblance to 300% (in the case of the Oil Fund) or -300%
(in the case of the Short Oil Fund) of the return of the Benchmark
Oil Futures Contract for a period of longer than a full trading day
because the aggregate return of the Fund is the product of the
series of each trading day's daily returns. See Amendment No. 2,
supra note 7, at 5 n.6, 9 n.10.
---------------------------------------------------------------------------

Investments of the Funds

    Each Fund will seek to achieve its investment objective by
investing primarily in futures contracts for light, sweet crude oil
that are traded on the NYMEX, ICE Futures U.S., or other U.S. and
foreign exchanges (collectively, ``Oil Futures Contracts''). The Funds
will, to a lesser extent and in view of regulatory requirements and/or
market conditions:

    (1) Next invest in (a) cleared swaps based on the Benchmark
Futures Contract, (b) non-exchange traded (``over-the-counter'' or
``OTC''), negotiated swap contracts that are based on the Benchmark
Futures Contract, and (c) forward contracts for oil;
    (2) followed by investments in futures contracts for other types
of crude oil, diesel-heating oil, gasoline, natural gas, and other
petroleum-based fuels, each of which that are traded on the NYMEX,
ICE Futures U.S., or other U.S. and foreign exchanges, as well as
cleared swaps and OTC swap contracts valued based on the foregoing;
and
    (3) finally, invest in exchange-traded cash settled options on
Oil Futures Contracts.

    All such other investments are referred to as ``Other Oil-Related
Investments'' (Other Oil-Related Investments, together with Oil Futures
Contracts, are referred to collectively as ``Oil Interests''). The
Exchange states that regulatory requirements, such as accountability
levels or position limits, and market conditions could cause a Fund to
invest in Other Oil-Related Investments.\14\
---------------------------------------------------------------------------

    \14\ See id. at 6-7, 10. The Funds have not limited the size of
their offerings and are committed to utilizing substantially all of
their proceeds to purchase Oil Interests. If a Fund encounters
accountability levels, position limits, or price fluctuation limits
for Oil Futures Contracts on the NYMEX or ICE Futures U.S., it may
then, if permitted under applicable regulatory requirements,
purchase Oil Futures Contracts on other exchanges that trade listed
crude oil futures or invest in Other Oil-Related Investments to meet
its investment objective. See id. at 8, 11.
---------------------------------------------------------------------------

    To satisfy their margin, collateral, and other requirements, the
Funds may hold short-term obligations of the United States of two years
or less (``Treasuries''), cash, and cash equivalents.\15\ The Exchange
states that approximately 15% to 90% of each Fund's assets will be
committed as margin for commodity futures contracts,\16\ but that from
time to time the percentage of assets committed as margin may be
substantially more, or less, than such range. The Funds may hold shares
of money market funds and Treasuries with a maturity date of two years
or less as investments, rather than just as margin or collateral.
---------------------------------------------------------------------------

    \15\ The Exchange states that cash equivalents are short-term
instruments with maturities of less than three months and shall
include the following: (i) Certificates of deposit issued against
funds deposited in a bank or savings and loan association; (ii)
bankers' acceptances, which are short-term credit instruments used
to finance commercial transactions; (iii) repurchase agreements and
reverse repurchase agreements; (iv) bank time deposits, which are
monies kept on deposit with banks or savings and loan associations
for a stated period of time at a fixed rate of interest; (v)
commercial paper, which are short-term unsecured promissory notes;
and (vi) money market funds. See id. at 7 n.9.
    \16\ See id. Ongoing margin and collateral payments will
generally be required for both exchange-traded and OTC contracts
based on changes in the value of the Oil Interests.
---------------------------------------------------------------------------

    For a Fund to maintain a consistent 300% (in the case of the Oil
Fund) or -300% (in the case of the Short Oil Fund) return versus the
Benchmark Oil Futures Contract, the Fund's holdings must be rebalanced
on a daily basis by buying additional Oil Interests or by selling Oil
Interests that the Fund holds. Such rebalancing generally will occur
before or at the close of trading of the Shares on the Exchange, at or
as near as possible to that day's settlement price, and will be
disclosed on the Fund's Web site as pending trades before the opening
of trading on the Exchange the next business day and will be taken into
account in the Fund's IFV and reflected in the Fund's end of day NAV on
that business day.\17\
---------------------------------------------------------------------------

    \17\ See id. at 6, 9.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the Exchange's
proposal to list and trade the Shares is consistent with the Exchange
Act and the rules and regulations thereunder applicable to a national
securities exchange.\18\ In particular, the Commission finds that the
proposed rule change, as modified by Amendments No. 2 and No. 3
thereto, is consistent with Section 6(b)(5) of the Exchange Act,\19\
which requires, among other things, that the Exchange's rules be
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \18\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \19\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission finds that the proposal to list and trade the Shares
on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the
Exchange Act,\20\ which sets forth Congress' finding that it is in the
public interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers and investors of information with respect to
quotations for and transactions in securities. According to the
Exchange, quotation and last-sale information regarding the Shares will
be disseminated through the facilities of the Consolidated Tape
Association. The intraday, closing prices, and settlement prices of the
Oil Futures Contracts will be readily available from the applicable
futures exchange Web sites, automated quotation systems, published or
other public sources, or major market data vendors. Complete real-time
data for the Oil Futures Contracts is available by subscription through
on-line information services. ICE Futures U.S. and NYMEX also provide
delayed futures information on current and past trading sessions and
market news free of

charge on their respective Web sites. The specific contract
specifications for Futures Contracts are also available on the Web
sites of those futures exchanges, as well as other financial
informational sources. Information regarding exchange-traded cash-
settled options and cleared swap contracts will be available from the
applicable exchanges and major market data vendors. Information
regarding exchange-traded cash-settled options and cleared swap
contracts will be available from the applicable exchanges and major
market data vendors.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    The Funds' Web site, www.uscfinvestments.com, will display the
applicable end of day closing NAV. The daily holdings of each Fund will
be available on the Fund's Web site before 9:30 a.m. Eastern Time
(``E.T.'') each day. The Web site disclosure of portfolio holdings will
be made daily and will include the following (as applicable): (1) The
composite value of the total portfolio, (2) the quantity and type of
each holding (including the ticker symbol, maturity date or other
identifier, if any) and other descriptive information including, in the
case of a swap, the type of swap, its notional value and the underlying
instrument, index or asset on which the swap is based and, in the case
of an option, its strike price, (3) the value of each Oil Interest (in
U.S. dollars), (4) the type (including maturity, ticker symbol, or
other identifier) and value of each Treasury security and cash
equivalent, and (5) the amount of cash held in each Fund's
portfolio.\21\
---------------------------------------------------------------------------

    \21\ See Amendment No. 2, supra note 7, at 15.
---------------------------------------------------------------------------

    The trading price of the Benchmark Oil Futures Contract will be
disseminated by one or more major market data vendors every 15 seconds
during NYSE Arca's Core Trading Session (9:30 a.m. to 4:00 p.m. E.T.).
An IFV will be disseminated for each Fund on a per Share basis every 15
seconds during the Exchange's Core Trading Session.\22\ The
administrator for the Funds will calculate the NAV of each Fund once
each NYSE trading day. On a normal trading day, the NAV of each Fund's
Shares will be released after 4:00 p.m. E.T. The NAV will be
disseminated daily to all market participants at the same time.
---------------------------------------------------------------------------

    \22\ Each IFV will be calculated by using the prior day's
closing NAV per Share as a base and updating that value throughout
the trading day to reflect changes in the most recently reported
trade price for the active light, sweet Oil Futures Contract on the
NYMEX. See id. at 12.
---------------------------------------------------------------------------

    The Commission believes that the proposal to list and trade the
Shares is reasonably designed to promote fair disclosure of information
that may be necessary to price the Shares appropriately and to prevent
trading when a reasonable degree of transparency cannot be assured. If
the Exchange becomes aware that the NAV with respect to the Shares is
not disseminated to all market participants at the same time, it will
halt trading in the Shares until such time as the NAV is available to
all market participants. Further, the Exchange may halt trading during
the day in which an interruption to the dissemination of the IFV or the
value of the Benchmark Oil Futures Contract occurs. If the interruption
to the dissemination of the IFV or the value of the Benchmark Oil
Futures Contract persists past the trading day in which it occurred,
the Exchange will halt trading no later than the beginning of the
trading day following the interruption. Trading in Shares will also be
halted if the circuit breaker parameters in NYSE Arca Equities Rule
7.12 have been reached. Moreover, trading may be halted because of
market conditions or for reasons that, in the view of the Exchange,
make trading in the Shares inadvisable. The Exchange states that it has
a general policy prohibiting the distribution of material, non-public
information by its employees.\23\ Moreover, trading of the Shares will
be subject to NYSE Arca Equities Rule 8.200, Commentary .02(e), which
sets forth certain requirements to facilitate surveillance of Equity
Trading Permit (``ETP'') Holders acting as registered Market Makers in
Trust Issued Receipts.
---------------------------------------------------------------------------

    \23\ See Amendment No. 2, supra note 7, at 18.
---------------------------------------------------------------------------

    The Commission notes that the Exchange or the Financial Industry
Regulatory Authority (``FINRA''), on behalf of the Exchange, or both,
will communicate as needed regarding trading in the Shares and certain
Oil Futures Contracts with other markets and other entities that are
members of the ISG, and the Exchange or FINRA, on behalf of the
Exchange, or both, may obtain trading information regarding trading in
the Shares and certain Oil Futures Contracts from such markets and
other entities. In addition, the Exchange may obtain information
regarding trading in the Shares and certain Oil Futures Contracts from
markets and other entities that are members of ISG or with which the
Exchange has in place a comprehensive surveillance sharing agreement
(``CSSA'').\24\
---------------------------------------------------------------------------

    \24\ For a list of the current members of ISG, see
www.isgportal.org.
---------------------------------------------------------------------------

    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. In support of this
proposal, the Exchange represented that:
    (1) The Shares will conform to the initial and continued listing
criteria under NYSE Arca Equities Rule 8.200.
    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.
    (3) Trading in the Shares will be subject to the existing trading
surveillances administered by the Exchange, as well as cross-market
surveillances administered by FINRA on behalf of the Exchange, which
are designed to detect violations of Exchange rules and applicable
federal securities laws.
    (4) Prior to the commencement of trading, the Exchange will inform
its ETP Holders in an Information Bulletin of the special
characteristics and risks associated with trading the Shares.
Specifically, the Information Bulletin will discuss the following: (a)
The risks involved in trading the Shares during the Opening and Late
Trading Sessions when an updated IFV will not be calculated or publicly
disseminated; (b) the procedures for purchases and redemptions of
Shares in Creation Baskets and Redemption Baskets (and that Shares are
not individually redeemable); (c) NYSE Arca Equities Rule 9.2(a), which
imposes a duty of due diligence on its ETP Holders to learn the
essential facts relating to every customer prior to trading the Shares;
(d) how information regarding the IFV is disseminated; (e) how
information regarding portfolio holdings is disseminated; (f) the
requirement that ETP Holders deliver a prospectus to investors
purchasing newly issued Shares prior to or concurrently with the
confirmation of a transaction; and (g) trading information.
    (5) For initial and continued listing, the Funds will be in
compliance with Rule 10A-3 under the Act,\25\ as provided by NYSE Arca
Equities Rule 5.3.
---------------------------------------------------------------------------

    \25\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    (6) The daily holdings of each Fund will be available on the Funds'
Web site before 9:30 a.m. E.T. each day, and the daily Web site
disclosure of each Fund's portfolio holdings will include the following
(as applicable): (a) The composite value of the total portfolio, (b)
the quantity and type of each holding (including the ticker symbol,
maturity date or other identifier, if any) and other descriptive
information including, in the case of a swap, the type of swap, its
notional value and the underlying instrument, index or asset on which
the swap is based and, in the

case of an option, its strike price, (c) the value of each Oil Interest
(in U.S. dollars), (d) the type (including maturity, ticker symbol, or
other identifier) and value of each Treasury security and cash
equivalent; and (e) the amount of cash held in each Fund's portfolio.
    (7) Not more than 10% of the net assets of a Fund in the aggregate
invested in futures contracts shall consist of futures contracts whose
principal market is not a member of the ISG or is a market with which
the Exchange does not have a CSSA.
    (8) Web site disclosure of each Fund's daily holdings will occur at
the same time as the disclosure by the Trust of the daily holdings to
Authorized Participants so that all market participants are provided
daily holdings information at the same time.\26\
---------------------------------------------------------------------------

    \26\ See Amendment No. 3, supra note 8.
---------------------------------------------------------------------------

    (9) A minimum of 100,000 Shares of each Fund will be outstanding at
the commencement of trading on the Exchange.
    (10) All statements and representations made in the filing
regarding (a) the description of the portfolios of the Funds, (b)
limitations on portfolio holdings or reference assets, or (c)
applicability of Exchange listing rules specified in this filing shall
constitute continued listing requirements for listing the Shares on the
Exchange.
    (11) The issuer has represented to the Exchange that it will advise
the Exchange of any failure by a Fund to comply with the continued
listing requirements.
    (12) Pursuant to its obligations under Section 19(g)(1) of the Act,
the Exchange will monitor for compliance with the continued listing
requirements.\27\
---------------------------------------------------------------------------

    \27\ The Commission notes that certain other proposals for the
listing and trading of exchange traded products include a
representation that the listing exchange will ``surveil'' for
compliance with the continued listing requirements. See, e.g.,
Securities Exchange Act Release No. 77499 (April 1, 2016), 81 FR
20428 (April 7, 2016) (SR-BATS-2016-04). In the context of this
representation, it is the Commission's view that ``monitor'' and
``surveil'' both mean ongoing oversight of the Fund's compliance
with the continued listing requirements. Therefore, the Commission
does not view ``monitor'' as a more or less stringent obligation
than ``surveil'' with respect to the continued listing requirements.
---------------------------------------------------------------------------

    (13) If a Fund is not in compliance with the applicable listing
requirements, the Exchange will commence delisting procedures under
NYSE Arca Equities Rule 5.5(m).
    This approval order is based on all of the Exchange's statements
and representations, including those set forth above and in Amendments
No. 2 and No. 3.
    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendments No. 2 and No. 3 thereto, is
consistent with Section 6(b)(5) of the Act \28\ and the rules and
regulations thereunder applicable to a national securities exchange.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\29\ that the proposed rule change (SR-NYSEArca-2016-173),
as modified by Amendments No. 2 and No. 3 thereto, be, and it hereby
is, approved.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
---------------------------------------------------------------------------

    \30\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-07598 Filed 4-13-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34389-34390]
[FR Doc No: 2019-15264]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0659; FRL-9995-95-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Perchloroethylene Dry Cleaning
Facilities (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Perchloroethylene Dry
Cleaning Facilities (EPA ICR Number 1415.12, OMB Control Number 2060-
0234, to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through
August 31, 2019. Public comments were previously requested, via the
Federal Register, on May 30, 2018 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden

and cost to the public. An agency may neither conduct nor sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before August 19,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0659, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Perchloroethylene Dry Cleaning Facilities (40
CFR part 63, subpart M) were proposed on December 9, 1991, promulgated
on September 22, 1993, and most recently-amended on July 11, 2008.
These regulations apply to existing and new dry-cleaning facilities
that use perchloroethylene (PCE). New facilities include those that
commenced either construction or reconstruction after the date of
proposal. This information is being collected to assure compliance with
40 CFR part 63, subpart M.
    In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NESHAP.
    Form Numbers: None.
    Respondents/affected entities: Dry cleaning facilities that use
perchloroethylene.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart M).
    Estimated number of respondents: 28,020 (total).
    Frequency of response: Initially and occasionally.
    Total estimated burden: 1,590,000 hours (per year). Burden is
defined at 5 CFR 1320.3(b).
    Total estimated cost: $189,000,000 (per year), which includes
$948,000 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the Estimates: There is an adjustment increase in the
total estimated burden as currently identified in the OMB Inventory of
Approved Burdens. This increase is not due to any program changes. The
adjustment increase in burden from the most recently-approved ICR is
due to an increase in the number of existing major sources. The EPA's
records indicate that there are currently 20 major sources subject to
this NESHAP; the previous estimate of 12 major sources was based on the
final amendments to the NESHAP in 2008. There is also an adjustment
increase in operation and maintenance costs due to the increase in the
number of respondents. Finally, there is an adjustment increase in
labor costs to account for costs from major source facilities operated
by Federal employees versus the private sector.

Courtney Kerwin,
 Director, Regulatory Support Division.
[FR Doc. 2019-15264 Filed 7-17-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37379-37380]
[FR Doc No: 2019-16293]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-447, OMB Control No. 3235-0504]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Rule 19b-4(e) and Form 19b-4(e)

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget
(``OMB'') a request for approval of extension of the previously
approved collection of information provided for in Rule 19b-4(e) (17
CFR 240.19b-4(e)) under the Securities Exchange Act of 1934 (15 U.S.C
78a et seq.) (the ``Act'').
    Rule 19b-4(e) permits a self-regulatory organization (``SRO'') to
list and trade a new derivative securities product without submitting a
proposed rule change pursuant to Section 19(b) of the Act (15 U.S.C.
78s(b)), so long as such product meets the criteria of Rule 19b-4(e)
under the Act. However, in order for the Commission to maintain an
accurate record of all new derivative securities products traded on the
SROs, Rule 19b-4(e) requires an SRO to file a summary form, Form 19b-
4(e), to notify the Commission when the SRO begins trading a new
derivative securities product that is not required to be submitted as a
proposed rule change to the Commission. Form 19b-4(e) should be
submitted within five business days after an SRO begins trading a new
derivative securities product that is not required to be submitted as a
proposed rule change. In addition, Rule 19b-4(e) requires an SRO to
maintain, on-site, a copy of Form 19b-4(e) for a prescribed period of
time.
    This collection of information is designed to allow the Commission
to maintain an accurate record of all new derivative securities
products traded on the SROs that are not deemed to be proposed rule
changes and to determine whether an SRO has properly availed itself of
the permission granted by Rule

19b-4(e). The Commission reviews SRO compliance with Rule 19b-4(e)
through its routine inspections of the SROs.
    The respondents to the collection of information are SROs (as
defined by the Act), all of which are national securities exchanges. As
of March 29, 2019 there are twenty-two entities registered as national
securities exchanges with the Commission. The Commission receives an
average total of 5,122 responses per year, which corresponds to an
estimated annual response burden of 5,122 hours. At an average hourly
cost of $71, the aggregate related internal cost of compliance with
Rule 19b-4(e) is $363,662 (5,122 burden hours multiplied by $71/hour).
    Compliance with Rule 19b-4(e) is mandatory. Information received in
response to Rule 19b-4(e) shall not be kept confidential; the
information collected is public information.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website, www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Charles Riddle, Acting Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Candace Kenner, 100 F Street NE, Washington, DC 20549 or by sending an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: July 26, 2019.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-16293 Filed 7-30-19; 8:45 am]
 BILLING CODE 8011-01-P