[Federal Register Volume 86, Number 56 (Thursday, March 25, 2021)]
[Notices]
[Pages 15950-15951]
[FR Doc No: 2021-06210]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-1269, FDA-2020-E-1273, and FDA-2020-E-1272]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BAROSTIM NEO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by May 24, 2021.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by September 21, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 24, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 24, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2020-E-1269, FDA-2020-E-1273, and FDA-2020-E-1272 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; BAROSTIM NEO.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you 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 Sec.  10.20 (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,
240-402-7500.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device BAROSTIM NEO.
BAROSTIM NEO is indicated for the improvement of symptoms of heart
failure, quality of life, six-minute hall walk and functional status,
for patients who remain symptomatic despite treatment with guideline-
directed medical therapy, are New York Heart Association Class III or
Class II (who had a recent history of Class III), have a left
ventricular ejection fraction <=35%, a NT-proBNP <1,600 picograms/
milliliter and excluding patients indicated for Cardiac
Resynchronization Therapy according to American Heart Association/
American College of Cardiology/European Society of Cardiology Committee
guidelines. Subsequent to this approval, the USPTO received patent term
restoration applications for BAROSTIM NEO (U.S. Patent Nos. 8,606,359;
9,044,609; and 9,427,583) from CVRx, Inc., and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In a letter dated July 14, 2020, FDA advised the
USPTO that this medical device had undergone a regulatory review period
and that the approval of BAROSTIM NEO represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
BAROSTIM NEO is 2,550 days. Of this time, 2,310 days occurred during
the testing phase of the regulatory review period, while 240 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption for this device, under section 520(g) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)), became effective: August 24, 2012. The applicant claims that
the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
October 10, 2012. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
August 24, 2012, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): December
20, 2018. The applicant claims December 19, 2018, as the date the
premarket approval application (PMA) for BAROSTIM NEO (PMA 180050) was
initially submitted. However, FDA records indicate that PMA 180050 was
submitted on December 20, 2018.
    3. The date the application was approved: August 16, 2019. FDA has
verified the applicant's claim that PMA 180050 was approved on August
16, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 541 days, 768 days, or 1,038 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06210 Filed 3-24-21; 8:45 am]
BILLING CODE 4164-01-P


EPA Registration Division contact: Andrew Ertman<PHONE_NUMBER>
IR-4
PP# 1E7908

	EPA has received a pesticide petition PP# 1E7908 from Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180. 511 by establishing a tolerance for residues of buprofezin in or on the raw agricultural commodities: bean, succulent (0.02 ppm); brassica, leafy greens, subgroup 5B (55 ppm); turnip, greens (55 pm); vegetable, fruiting, group 8-10 (3.0 ppm); fruit, citrus, group 10-10 (2.5 ppm); fruit, pome, group 11-10 (4.0 ppm); persimmon (1.9 ppm); and tea (20 ppm).  The petition also proposes removing the existing tolerance for non-bell pepper; fruiting vegetable group 8, except non-bell pepper; fruit, citrus, group 10; and fruit, pome, group 11 which will now be covered by the newly requested tolerances.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. This summary has been prepared by Nichino America, Inc., Wilmington, DE 19808, the registrant.

A. Residue Chemistry
	1. Plant metabolism. The metabolic profile of buprofezin has been elucidated in a wide range of crops, including tomatoes, lettuce, cotton, and citrus.   In citrus, although buprofezin was a major component of the residue, a chromatographically well-defined region of radioactivity, clearly associated with polar conjugates, was observed. Mass spectrometry identified the principal polar residue as a hexose conjugate of BF4 (buprofezin hydroxylated in the t-butyl group). Although the conjugate was resistant to enzyme hydrolysis, acid hydrolysis of the polar fraction released predominantly BF26 with minor amounts of BF9 and BF12. The same compounds were observed following acid hydrolysis of a standard of BF4 clearly indicating that BF4 is the conjugated metabolite existing in citrus. Although only limited metabolism was observed in lettuce and cotton, trace levels of similar metabolites, including the conjugate BF4 were observed indicating that the metabolic pathway does not differ with plant species.

	2. Analytical method. The proposed analytical method involves extraction, partition, clean-up and detection of residues by gas chromatography using nitrogen phosphorous detection.

      3. Magnitude of residues. Field trials were conducted on mustard greens with buprofezin, the principal residue of concern, in the required geographic regions in the United States at the maximum rate and minimum application and the minimum pre-harvest interval.  The highest average residue value for mustard greens was 34.9 parts per million (ppm).   A tolerance on Brassica, leafy greens, subgroup 5B is being proposed at 55 ppm.   The requested proposed tolerance is adequately supported.
The residue of buprofezin (the principal residue of concern) on tea was evaluated from studies conducted in China, Japan and India.   A tolerance on tea is being proposed at 20 ppm.   The data support the proposed tolerance.
A tolerance on persimmon is requested to be translated from established tolerances on stone fruit, crop group 12 (except apricot and peach) at 1.9 ppm.
A tolerance on bean, succulent is requested to be established from data on snap bean and is being proposed at 0.02 ppm.  The tolerance for snap bean is currently established at 0.02 ppm.

B. Toxicological Profile
	1. An extensive battery of toxicology studies has been conducted with buprofezin.  EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk  The nature of the toxic effects caused by buprofezin is discussed in Unit III.A. of the Final Rule on Buprofezin Pesticide Tolerance published in the Federal Register on September 5, 2001 (66 FR 46381) (FRL-6796-6).   An assessment of toxic effects caused by buprofezin including the toxicological endpoints of concern is also discussed in Unit III.A. and Unit III B. of the Federal Register dated June 25, 2003   (FRL-7310-7) (68 FR 37765).
      2. Animal metabolism. The metabolism of buprofezin has been extensively studied in various species of animals and fish. Buprofezin has several groups that can metabolize in a variety of ways thus potentially producing a very large number of metabolites. Extensive metabolism to many minor metabolites was observed in all the animal species. Metabolism in fish was, however, much more limited and clearly defined. Although not all metabolic intermediates have been detected in all the species, the major routes of metabolism have been identified in animals and fish and a consistent pattern is observed throughout these species. The proposed metabolic pathway was provided in the tolerance petition, PP 0F6087. For convenience, degradates are referred to by an internal code: BF 1 through 13. Corresponding chemical structures were provided in the tolerance petition, PP 0F6087.

	3. Metabolite toxicology.
	i. Metabolism in rats.  The major metabolite found in rat excreta was parent buprofezin in addition to several compounds formed after extensive metabolism. Whereas plant metabolism appeared restricted mainly to oxidation of the tertiary butyl group, oxidation of the butyl group and hydroxylation of the phenyl ring were both observed in rats. Oxidation of the t-butyl group proceeded beyond an alcohol to an acid and was accompanied by ring opening. The most extensively metabolized compound identified in rats was BF23 (acetylated p-aminophenol).
	ii. Metabolism in ruminants and hens. Residue levels were low (0.05 ppm) in all ruminant and poultry tissues and commodities, following treatment at exaggerated rates (approximately 20x and 7,500x the anticipated dietary burden, respectively). The only exceptions were cow liver (1.21 ppm), cow kidney (0.41 ppm), hen liver (0.15 ppm), and egg yolk (0.11 ppm). Extensive metabolism was observed in both species with a large number of minor metabolites being produced.  The principal metabolites identified in the cow were BF2 and BF23, indicating that the major pathway of degradation in ruminants is hydroxylation of the phenyl ring followed by opening and degradation of the heterocyclic ring. The identification of trace levels of BF13 confirms this pathway. As in rats, BF23 was the most extensively metabolized compound identified. Trace levels of BF12 were also detected. This indicates that the parallel pathway of heterocyclic ring opening without hydroxylation of the phenyl ring is also in operation. Similarly in hens, the identified metabolites were derived from degradation of the heterocyclic ring either with (BF13) or without (BF9 and BF12) phenyl ring hydroxylation.  No single unidentified compound accounted for more than 6% of the total residue in any animal tissue or commodity, with the exception of a component comprising 8.7% of egg white. The total residue in egg white was, however, only 0.02 ppm even at this highly exaggerated dose rate.
	 iii. Metabolism in fish. Analysis of fish tissues, following a bioaccumulation study, found a much simpler metabolic profile. Buprofezin was present in both edible and non-edible tissues, but the principle metabolites were polar conjugates of BF4. Trace levels of BF12 were also detected.

	4. Endocrine disruption. No special studies have been conducted to investigate the potential of buprofezin to induce estrogenic or other endocrine effects. The standard battery of required toxicity studies has been completed. These studies include an evaluation of the potential effects on reproduction and development and an evaluation of the pathology of the endocrine organs following repeated or long-term exposure. These studies are generally considered to be sufficient to detect any endocrine effects. The only effect noted on endocrine organs was an increased incidence of follicular cell hypertrophy and C-cell hyperplasia of the thyroid gland in rats administered buprofezin.  Buprofezin also caused mild to moderate hepatotoxic effects at this dietary concentration.  The effect on the thyroid is consistent with an increased turnover of T3/T4 in the liver with a resultant rise in TSH secretion (due to the hepatotoxicity). The rat is known to be much more susceptible than humans to these effects due to the very rapid turnover of thyroxine in the blood in rats (12 hours vs. about 5-9 days in humans). Therefore, the thyroid pathological  changes which have been noted following administration of high doses of buprofezin are considered to be of minimal relevance to human risk assessment, particularly considering the low levels of buprofezin to which humans are likely to be exposed.

C. Aggregate Exposure

	1. Dietary exposure. Acute and chronic dietary risk analyses were conducted by the Agency to estimate the potential buprofezin residues in/on the following crops with established tolerances: almond, avocado, banana, bell and non-bell peppers, Brassica, head and stem, subgroup 5A [broccoli; broccoli, Chinese; Brussels sprouts; cabbage; cabbage, Chinese (napa); cabbage, Chinese mustard; cauliflower; cavalo broccoli; kohlrabi], Brassica, leafy greens, subgroup 5B [broccoli raab; cabbage, Chinese (bok choy); collards; kale; mizuna; mustard greens; mustard spinach; rape greens], canistel, celery, coffee, spinach, cotton, grape, grape raisin, longan, lychee, mamey sapote, mango, papaya, persimmons, pomegranates, Spanish lime, head lettuce, leaf lettuce, snap bean, fruiting vegetables, cucurbit vegetables, citrus fruits (crop group 10-10), pome fruits (crop group 11-10), stone fruits, almond, pistachio, olive, and strawberry, tea, turnip greens, and meat and milk, using DEEM(TM) (ver. 7.76).   Residue estimates for water consumption were based on PRZM3/EXAMs and SCIGROW models and incremental exposure assessments for Brassica, leafy greens, persimmon, and tea using LifeLine[TM] version 5.0. Vegetable, fruiting, group 8-10, except nonbell pepper; Fruit, citrus, group 10-10; and Fruit, pome, group 11-10 were modeled in the previous assessment.
	i. Food. The Hazard Identification Assessment Review Committee (HIARC) met on 15-February-2000 and determined the endpoint selection for buprofezin (HED Doc. No. 014093) and subsequently on 22-October-2002 to evaluate the potential for increased susceptibility of infants and children from exposure to buprofezin.  Based on toxicological considerations, the special FQPA safety factor was set at 1X when assessing acute and chronic dietary exposures.  The acute dietary aPAD (acute population adjusted dose) was set at 2.0 mg/kg/day for females aged 13-50 years old based on a developmental toxicity study in rats that had an oral NOEL of 200 mg/kg/day.  The chronic dietary cPAD (chronic Population Adjusted Dose) was determined to be 0.01 mg/kg/day for the general population based on a oral NOAEL of 1.0 mg/kg/day in the two-year rat chronic/oncogenicity study.  The uncertainty factor of 30 was used to account for interspecies and intraspecies variations.  An additional 10x database uncertainty factor was applied.  The resultant safety factor used to establish the cPAD was 300.  The cPAD was set at 0.0033 mg/kg/day.

The acute dietary exposure was based on the following assumptions: residues at tolerance levels, 100% crop treated, and DEEM(TM) (ver. 7.76) default processing factors for all registered/proposed commodities (Tier 1).  For all currently registered crops and commodities, the acute risk was assessed as 7% of the aPAD for the population group females 13-49 years old.  No other population groups were identified based on the lack of adverse effects resulting from a single exposure  (Federal Register vol 74 No. 131 p 33157, July 19, 2009). The chronic dietary exposure assessment for all currently registered crops for food and water resulted in a risk estimate of  80% of the cPAD of 80% for the population groups receiving the greatest exposure (all infants <1 year old and children 1-2 years old) (Federal Register vol 74 No. 131 p 33157, July 19, 2009).

An incremental exposure assessment for the petitioned tolerances was performed using LifeLine(TM) version 5.0.  Tolerance values were used for exposure and a default value of 100% crop treated. Expanded crops in the citrus and pome crop groupings were already modeled in the Agency's previous assessments.  The resulting incremental food exposure estimate for females 13-49 years old was < 0.1% of the acute RfD bringing the total acute risk to 7% of the aPAD. No acute endpoint was identified for the remaining population subgroups.

The incremental chronic dietary exposure used 100% crop treated for Brassica, leafy greens, persimmons and tea. Proposed tolerance values were assumed for all crop residues. The food exposure estimates from residues of buprofezin for the U.S. population for the petitioned crops was 6.3 % of the chronic population adjusted dose (cPAD) and 5.5% for children 3-5 years old. The total estimated risk from chronic exposure does not exceed 86% of the cPAD for the most sensitive population group, children 3-5 years old.  These can be considered conservative values.

Since the only evidence of carcinogenicity was `suggestive', EPA regards the carcinogenic potential as very low.  Therefore, an exposure assessment for evaluating cancer risk was not deemed relevant to this assessment and was not conducted.

	ii. Drinking water. The residue of concern in drinking water was determined to be buprofezin.  There are no established maximum contaminant levels or health advisory levels for residues of buprofezin in drinking water.  In the absence of comprehensive water monitoring data, the Agency uses the FQPA Index Reservoir Screening Tool or the Pesticide Root ZoneModel/Exposure Analysis Modeling System (PRZM/EXAMS) to produce estimates of pesticide concentrations in an index resevoir.   The SCI-GROW model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.
The estimated drinking water concentrations (EDWCs) in surface water were determined using the Tier II PRZM (Pesticide Root Zone Model) and EXAMS (Exposure Analysis Modeling System (PE4-PL, version 01).  PRZM is used to simulate pesticide transport as a result of runoff and erosion and spray drift from an agricultural field and EXAMS estimates environmental fate and transport of pesticides in surface water. The acute EDWCs estimated for buprofezin acute exposure are 57.4 ppb for surface water and 0.09 ppb for ground water.  The chronic EECs are estimated to be 18.6 ppb for surface water and 0.09 ppb for ground water (Federal Register Vol. 74 No. 131 p 33157, July 19, 2009).

	2. Non-dietary exposure. The term residential exposure is used in this document to refer to non-occupational, non-dietary exposure (e.g. for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Buprofezin is not registered for use on any sites that would result in residential exposure.

D. Cumulative Effects
	A determination has not been made that buprofezin has a common mechanism of toxicity with other substances. Buprofezin does not appear to produce a common toxic metabolite with other substances. A cumulative risk assessment was, therefore, not performed for this analysis. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to buprofezin and any other substances and buprofezin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that buprofezin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at  http://www.epa.gov/ pesticides/cumulative/.

E. Safety Determination

	1. U.S. population.
i. Acute risk.  Using the conservative assumptions discussed above, based on the completeness and reliability of the toxicity data, it is concluded that aggregate exposure to the proposed uses of buprofezin are estimated at most 7.1 % of the acute reference dose of females (13-49).  This estimate is likely to be much less, as more realistic data and models are developed.  Drinking water and other water consumption scenarios were included in the dietary risk assessment modeling.

ii. Chronic Risk.  Based on the toxicology data base and available information on anticipated residues, the chronic dietary exposure to the U.S. Population (total) was estimated to utilize no more than 86.3 % of the estimated chronic population adjusted dose (cPAD). Drinking water and other potential water consumption scenarios were included in the dietary risk assessment modeling. Based on these assessments, it can be concluded that there is reasonable certainty of no harm to the U.S. Population or any population subgroup from exposure to buprofezin.

	2. Infants and children. Chronic exposure to food and water to children ages 3-5, the highest exposed population subgroup, (85.5 % of the cPAD).  EPA has determined that reliable data support the uncertainty factor (300 for combined interspecies and intraspecies variability and a data base uncertainty factor) for buprofezin.  EPA deemed an additional FQPA safety factor is not necessary to be protective of infants and children.  EPA generally has no concern for exposures below 100% of the cPAD. The Agency has considered the potential aggregate exposure from food, water and non-occupational exposure routes and has concluded aggregate exposure is not expected to exceed 100% of the chronic reference dose, and consequently, has determined there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure to residues of buprofezin.

F. International Tolerances

Canada, Codex, and Mexico do not have maximum residue limits for residues of buprofezin in/on the proposed crops.  Therefore, harmonization is not an issue.


[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Proposed Rules]
[Pages 57545-57546]
[FR Doc No: 2012-23014]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 142

[FRL-9727-9]

Long Term 2 Enhanced Surface Water Treatment Rule: Public Meeting
on Monitoring Data Analysis, Occurrence Forecasts, Binning, and the
Microbial Toolbox

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is hosting a
public meeting on November 15, 2012, concerning monitoring, binning and
microbial toolbox information as part of the regulatory review of the
Long Term 2 Enhanced Surface Water Treatment Rule (LT2 rule). At this
meeting, EPA plans to discuss and solicit public input on data and
information related to several topics. The first topic is the results
of the first round of LT2 Cryptosporidium monitoring that are used to
determine which one of the four categories (i.e., bins) a public
drinking water system (PWS) should be placed. The second topic is the
implications of predicted occurrence and bin category placement that
may result from a second round of Cryptosporidium monitoring using the
existing or enhanced analytical methods. The third topic is the
effectiveness of Escherichia coli as a screen to identify small
filtered PWSs that need to perform Cryptosporidium monitoring for bin
placement. The fourth topic is the determination of the potential
credits assigned to different risk mitigation tools. EPA will also
provide background information on the LT2 rule's monitoring and binning
requirements, microbial toolbox options for risk management, and the
agency's Six Year Review process. EPA will consider the data and/or
information discussed at this meeting during the agency's review of the
LT2 rule, which the agency has announced as part of both the
Retrospective Review Plan under Executive Order (E.O.) 13563 and the
third Six-Year Review under the Safe Drinking Water Act.

Date and Location:
    The public meeting will be held on Thursday, November 15, 2012
(8:00 a.m. to 5:00 p.m., Eastern Time). The public meeting will be held
at the EPA East Building, Room 1153, 1201 Constitution Avenue NW.,
Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: For technical inquiries, contact
C[eacute]sar Cordero, Standards and Risk Management Division, Office of
Ground Water and Drinking Water (MC 4607M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460 at (202) 564-
3716 or<EMAIL_ADDRESS>For more information about the LT2 rule
or the Six-Year Review process, visit: http://water.epa.gov/lawsregs/rulesregs/sdwa/lt2/ or http://water.epa.gov/lawsregs/rulesregs/regulatingcontaminants/sixyearreview/index.cfm, respectively.

SUPPLEMENTARY INFORMATION:
    Registration: Individuals planning to participate in the public
meeting must register at this Web site  https://www.surveymonkey.com/s/LT2NovemberRegistration no later than November 9, 2012.
Teleconferencing will be available for individuals unable to attend the
meeting in person. EPA will do its best to include all those
interested, but may have to limit attendance due to room and/or
teleconference size limitations and therefore urges people to register
early. Teleconference information will be emailed to registered
participants in advance of the meeting. If you have any difficulty
registering or have questions, please send an email to Morgan Hoenig

of Ross Strategic at<EMAIL_ADDRESS>    Special Accommodations: For information on access or accommodations
for individuals with disabilities, please contact Jini Mohanty at (202)
564-5269 or by email at<EMAIL_ADDRESS>Please allow at least
five business days prior to the meeting to give EPA time to process
your request.
    This meeting will be open to the public. EPA encourages public
input and will allocate time on the agenda to receive verbal
statements. EPA requests that participants limit statements to the
topics described in the agenda and in the SUMMARY section of this
notice. Participants will be provided with a set time frame for their
statements. EPA also requests that only one person present a statement
on behalf of a group or organization. Individuals or organizations
interested in presenting a statement should notify Cesar Cordero by
email at<EMAIL_ADDRESS>no later than November 9, 2012.
Individuals that have scientific data that they would like EPA to
consider during the regulatory review of the LT2 rule are encouraged to
email their data to Cesar Cordero at the email address listed in the
FOR FURTHER INFORMATION CONTACT section by December 31, 2012.
    The LT2 Rule: The purpose of the LT2 rule, promulgated in 2006 (71
FR 654; January 5, 2006), is to reduce disease incidence associated
with Cryptosporidium and other disease-causing microorganisms in
drinking water. The rule includes requirements for PWSs that provide
filtration to be classified in one of four categories (bins) for
additional Cryptosporidium treatment that may be needed based on the
occurrence of Cryptosporidium or E. coli in their source waters.
Systems that are placed into the first bin require no additional
treatment, while systems that are placed into bins 2, 3 or 4 will need
to conduct additional treatment but will be able to select from a range
of treatment and management strategies (i.e. microbial toolbox options)
to meet their treatment requirements.
    EPA Reviews: The Safe Drinking Water Act (SDWA) requires EPA to
review each existing national primary drinking water regulation (NPDWR)
every six years and revise the regulation if appropriate (see SDWA
Section 1412(b)(9)). Section 1412(b)(9) of SDWA specifies that any
revision to a NPDWR ``shall maintain, or provide for greater,
protection of the health of persons.'' In addition to reviewing the LT2
rule under the third Six-Year Review, EPA announced in the August 2011
document, Improving Our Regulations: Final Plan for Periodic Review
Retrospective Reviews of Existing Regulations, that the agency would
review the LT2 rule in response to E.O. 13563, which requires agencies
to review regulations to determine where the agencies could streamline
or eliminate ineffective, overly burdensome, and outdated rules. As
part of these reviews, EPA plans to assess and analyze information and
data regarding occurrence, analytical methods, and treatment to
evaluate whether there are new or additional ways to manage risk.
    The public meeting announced in this notice will be the third
meeting hosted by the agency for the purpose of reviewing the LT2 rule
in response to SDWA Section 1412(b)(9) and E.O. 13563. The first
meeting occurred on December 7, 2011, and focused on the analytical
methods for Cryptosporidium and the preliminary drinking water source
monitoring results from samples collected under the LT2 rule. The
second meeting occurred on April 24, 2012, and focused on the uncovered
finished water reservoirs requirement of the LT2 rule.

    Dated: September 6, 2012.
Pamela Barr,
Acting Director, Office of Ground Water and Drinking Water.
[FR Doc. 2012-23014 Filed 9-17-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Notices]
[Pages 4290-4291]
[FR Doc No: 2012-1734]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13089-002]

Conway Ranch Hydropower Project; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On July 27, 2011, KC LLC, California, filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the Conway Ranch
Hydropower Project to be located on Virginia Creek, near the city of
Mono, Mono County, California. The project affects federal lands
administered by the Bureau of Land Management. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project would consist of the following new facilities:
(1) A diversion on Virginia Creek (notched weir design); (2) a de
minimus reservoir operated run-of river at approximately 8,800 feet
elevation above mean sea level; (3) a 2-mile-long, 8-inch-diameter
pressurized pipe connecting the reservoir to a powerhouse; (4) a
powerhouse containing a single turbine totaling 500 kilowatts of
generating capacity; and (5) an approximately 360-foot-long
transmission line connecting with the existing Southern California
Edison secondary distribution facilities. The project's annual energy
output would be approximately 2.3 gigawatthours.
    Applicant Contact: Ms. Kelly Sackheim, KC LLC, 5096 Cocoa Palm Way,
Fair Oaks, CA 95628; phone<PHONE_NUMBER>.
    FERC Contact: Carolyn Templeton; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web

site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-(866) 208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13089-002) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: January 20, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-1734 Filed 1-26-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 19, 2009 (Volume 74, Number 117)]
[Notices]
[Page 29249-29250]
[DOCID:fr19jn09-129]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60101; File No. SR-NYSEArca-2009-49]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change, as Modified by Amendment No. 1,
by NYSE Arca, Inc. Implementing Schedule of Fees and Charges for
Exchange Services

June 11, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on June 1, 2009, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. On June 9, 2009, the Exchange filed Amendment No. 1 to
the proposed rule change.\4\ The Commission is publishing this notice
to solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ In Amendment No. 1, the Exchange corrected a typographical
error that occurred on the cover sheet that accompanied the
Exchange's submission on Form 19b-4. Specifically, the Exchange
conformed its categorization of the statutory provision applicable
to the proposed rule change (i.e., Section 19(b)(3)(A) instead of
Section 19(b)(2) of the Act) to make the cover sheet consistent with
the text of the Form 19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend the section of its Schedule of Fees
and Charges for Exchange Services (the ``Schedule''). While changes to
the Schedule pursuant to this proposal will be effective upon filing,
the changes will become operative on June 1, 2009. The text of the
proposed rule change is attached as Ex. 5 to the 19b-4 form. A copy of
this filing is available on the Exchange's Web site at http://
www.nyse.com, at the Exchange's principal office 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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received

on the proposed rule change. The text of those statements may be
examined at the places specified in Item IV below. The Exchange has
prepared summaries, set forth in sections A, B, and C below, of the
most significant parts of such statements.

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

1. Purpose
    The purpose of this proposed rule change is to modify the list of
strategies presently included in the Strategy Execution Fee Pilot
Program (``Pilot Program''). NYSE Arca proposes to add ``Jelly Rolls''
as an eligible strategy execution for inclusion in Pilot Program.
    A Jelly Roll is a long calendar call spread combined with the same
short calendar put spread, or vice versa. This option strategy aims to
profit from a time value spread through the purchase and sale of two
call and two put options, each with different expiration dates. A Jelly
Roll is created by entering into two separate positions simultaneously.
One position involves buying a put and selling a call with the same
strike price and expiration. The second position involves selling a put
and buying a call, with the same strike price, but a different
expiration from the first position. Below is an example of a Jelly Roll
strategy execution.
XYZ Jun/Oct 25 Jelly Roll:

--Buy XYZ Jun 25 put and sell XYZ Jun 25 call
--Sell XYZ Oct 25 Put and buy XYZ Oct 25 call

Market BBO:
    Jun 25 call .51 at .53
    Jun 25 put .72 at .74
    Oct 25 call 1.52 at 1.55
    Oct 25 put 2.35 at 2.39

    .74(long Jun put) + 1.52(long Oct call)-.51(short Jun call)-
2.35(short Oct put) = .60 credit received for the Jelly roll.
    Because the referenced Jelly Rolls are commonly executed in large
volumes with profit margins that are generally narrow, the Exchange
proposes to cap the transaction fees associated with such executions at
$750 per strategy execution that is executed on the same trading day in
the same option class. In addition, Jelly Rolls will be included in the
monthly cap of $25,000 per initiating firm for all strategy executions.
NYSE Arca believes that by keeping fees low, the Exchange is able to
attract liquidity by accommodating these transactions.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act, in general, and Section 6(b)(4), in particular, in
that it provides for the equitable allocation of dues, fees and other
charges among its members and other market participants that use the
trading facilities of NYSE Arca. Under this proposal, all similarly
situated Exchange participants will be charged the same reasonable
dues, fees and other charges.

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

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

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

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

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \5\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \6\ thereunder, because it establishes a due, fee, or other charge
imposed by NYSE Arca.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2009-49 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2009-49. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of the filing will also be available for
inspection and copying at the principal office of the self-regulatory
organization. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEArca-2009-49 and should be submitted on or before July 10, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-14351 Filed 6-18-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 17 (Thursday, January 28, 2021)]
[Notices]
[Pages 7426-7429]
[FR Doc No: 2021-01830]

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

[Release No. 34-90966; File No. SR-C2-2021-001]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
To Amend Its Opening Process for Simple Orders

January 22, 2021.
    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 January 11, 2021, Cboe C2 Exchange, Inc. (the ``Exchange'' or
``C2'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by the Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2'') proposes to
amend its opening process for simple orders. The text of the proposed
rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 6.11 regarding its opening
process for simple orders. Currently, following the occurrence of an
opening rotation trigger pursuant to Rule 6.11(d), the System conducts
an opening rotation for an option series. Following the opening
rotation trigger, the System conducts the Maximum Composite Width Check
pursuant to Rule 6.11(e)(1) to determine if a series is eligible to
open. If the Composite Market \5\ of a series is not crossed, and the
Composite Width \6\ of the series is less than or equal to the Maximum
Composite Width (as defined in Rule 6.11(a)), the series is eligible to
open. Additionally, if the Composite Market of a series is not crossed,
and the Composite Width of the series is greater than the Maximum
Composite Width, but there are (i) no non-M Capacity (a) market orders
or (b) buy (sell) limit orders with prices higher (lower) than the
Composite Market midpoint and (ii) no orders or quotes marketable
against each other, the series is eligible to open. Once a series
become eligible to open, the System conducts the opening auction for
the series (i.e., determines the opening trade price pursuant to Rule
6.11(e)(2) and opens the series pursuant to Rule 6.11(e)(3)). The
Exchange may also determine to compel a series to open in the interest
of fair and orderly markets, including if the opening width is wider
than the Maximum Composite Width, pursuant to Rule 6.11(h).
---------------------------------------------------------------------------

    \5\ The term ``Composite Market'' means the market for a series
comprised of (1) the higher of the then-current best appointed
Market-Maker bulk message bid on the Exchange and the away best bid
(``ABB'') (if there is an ABB) and (2) the lower of the then-current
best appointed Market-Maker bulk message offer on the Exchange and
the away best offer (``ABO'') (if there is an ABO). The term
``Composite Bid (Offer)'' means the bid (offer) used to determine
the Composite Market. See Rule 6.11(a).
    \6\ The term ``Composite Width'' means the width of the
Composite Market (i.e., the width between the Composite Bid and the
Composite Offer) of a series. See Rule 6.11(a).
---------------------------------------------------------------------------

    Currently, if a series cannot satisfy these conditions described
above (and thus is not eligible to open), the series is ineligible to
open.\7\ When that occurs,

the Queuing Period \8\ for the series continues (including the
dissemination of opening auction updates) until the Maximum Composite
Width Check is satisfied or the Exchange determines to open the series
pursuant to Rule 6.11(h). The proposed rule change adds that such a
series may open pursuant to a forced opening as set forth in proposed
Rule 6.11(f).\9\ Specifically, as proposed, if a series in an equity or
exchange-traded product (``ETP'') option class \10\ is unable to open
because it does not satisfy the Maximum Composite Width Check described
above within a time period (which the Exchange determines for all
equity and ETP option classes) \11\ after the occurrence of the opening
rotation trigger for the class pursuant to Rule 6.11(d), and the
Composite Market is not crossed, the System forces the series to open
after that time period upon the System's observation of an away best
bid and offer (``ABBO'') (with a non-zero offer) \12\ for the
series.\13\ For a series subject to a forced opening, the opening trade
price determination and series open set forth in Rule 6.11(e)(2) and
(3) (i.e., the opening auction) do not occur; instead, the System opens
the series without a trade. This will permit a series to open for
trading on the Exchange if the series is open for trading on at least
one other options exchange, even though the market for the series on
the Exchange may be wide.
---------------------------------------------------------------------------

    \7\ See Rule 6.11(e)(1)(C). The proposed rule change codifies in
this provision that a series is not eligible to open if there is no
Composite Market or if the Composite Market is crossed. This is true
today and implied by the current rule text. Rule 6.11(e)(1)(A) and
(B) both state that the Maximum Composite Width Check is only
satisfied if the Composite Market of a series is not crossed, and
the proposed rule change merely adds the same language to
subparagraph (C) (i.e., if the Composite Market of a series is
crossed, then neither of the conditions in subparagraph (A) or (B)
could be satisfied, and the series would be ineligible to open).
Additionally, if there were no Composite Market or if it were
crossed, the System would be unable to perform the Maximum Composite
Width Check, thus meaning the series could not satisfy that check
and thus would not be eligible to open. This proposed change merely
adds detail to the Rules for additional transparency.
    \8\ The term ``Queuing Period'' means the time period prior to
the initiation of an opening rotation during which the System
accepts orders and quotes in the Queuing Book (the book into which
Users may submit orders for participation in the opening rotation)
for participation in the opening rotation for the applicable trading
session. See Rule 6.11(a).
    \9\ The proposed forced opening process has no impact on the
modified opening auction process set forth in Rule 6.11(j).
    \10\ The proposed rule change is limited to series in equity and
ETP option classes because these classes are eligible for listing on
all U.S. options exchanges.
    \11\ See Rule 1.2 (which permits the Exchange to announce
determinations by, among other things, notice, regulatory circular,
and specification).
    \12\ Such an ABBO would indicate that an away exchange is open,
as it would have disseminated an opening quote.
    \13\ The Exchange currently has a similar forced opening after a
specified amount of time for complex order strategies. See Rule
6.13(c)(2)(C).
---------------------------------------------------------------------------

    The proposed change to Rule 6.11(f) provides that in the event of a
forced opening of a series pursuant to proposed Rule 6.11(e)(4) or a
compelled opening of a series pursuant to paragraph (h), the System
enters all of a User's orders in that series in the Queuing Book into
the Book in the manner set forth in current Rule 6.11(f), unless a User
instructs the System to cancel its market orders or all of its orders,
in which case the System enters only the non-cancelled orders into the
Book in this manner. Specifically, they will be processed in accordance
with Rule 6.12 (as unexecuted orders and quotes are handled following
the conclusion of the opening rotation), which describes how the System
processes, handles, and executes orders. If any order or quote in the
Queuing Book is marketable upon the forced opening (and the User does
not instruct the System to cancel it as proposed), the System would
execute marketable orders subject to the priority rules set forth in
Rule 6.12. If an order is marketable against away interest and is
eligible for routing, the System may route the order for execution to
an away exchange. Any non-marketable order would enter the Book or
cancel, subject to the User instructions. This proposed change provides
Users with flexibility for automated handling of their orders in the
event a series opens with a wide market or is otherwise manually opened
when the opening conditions may not otherwise be standard.
    If a series satisfies the Maximum Composite Width Check prior to
the System's observation of an ABBO for the series, the series opens
pursuant to Rule 6.11(d)(2) and (3) (i.e., the standard opening auction
process occurs for the series). For example, suppose the Exchange
determined the ``forced opening'' timer to be three minutes. If the
opening trigger for a series occurs at 9:30:05 Eastern time but the
series does not satisfy the Maximum Composite Width Check after the
trigger, the System will force the series open after 9:33:05 Eastern
time if it has received an ABBO by that time. However, if the series
satisfies the Maximum Composite Width Check at 9:32:30, the series will
open in accordance with the normal opening auction process.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\14\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \15\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \16\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(5).
    \16\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes the proposed forced opening
process for simple orders will remove impediments to and perfect the
mechanism of a free and open market and a national market system and
protect investors. The proposed rule change will provide for series to
open for trading on the Exchange sooner than they may open currently,
as long as they are open for trading on other options exchanges. The
Exchange believes the proposed rule change will benefit investors,
because it may permit these options to open sooner and increase the
times during which investors may conduct trading in these options.
Additionally, this may increase liquidity in the market for a series
that is otherwise open on another options exchange. While the market on
the Exchange for a series may be wider than the Maximum Composite
Width,\17\ the Exchange believes it is reasonable to open the series if
it opened for trading on another options exchange pursuant to that
exchange's Commission-approved rules. Options exchanges have varying
opening processes and have made separate determinations on what
constitutes separate, reasonable opening market widths. The Exchange
believes if other options exchanges opened a series with a market
width, it is reasonable to open the series for trading on the Exchange
as well (as orders submitted to other exchanges may be trading at those
widths). Since orders may not trade outside of the disseminated NBBO
(which defines the then-current market for the series), any orders
resting in the Queuing Book that may execute following the forced
opening will receive protection against executions at potentially
erroneous prices. Additionally, the proposed ability of

Users to cancel orders in the event of a forced opening will provide
Users with additional protection. Additionally, the Exchange believes
opening series for trading on the Exchange that are open for trading on
other options exchanges will put Exchange Users on equal footing with
other market participants, as it will provide Users' orders that are
otherwise resting in the Queuing Book and awaiting execution with the
ability to get into the market for potential execution.
---------------------------------------------------------------------------

    \17\ The Exchange notes pursuant to Rule 6.11(e)(1)(B), there
are currently instances in which the Exchange will open for trading
despite the Composite Market Width being larger than the Maximum
Composite Width.
---------------------------------------------------------------------------

    The Exchange currently has the authority to deviate from the
standard opening process, including to temporarily increase the Maximum
Composite Width amounts (i.e., widen the permissible opening market)
and to compel a series open, even if the Maximum Composite Width check
is not satisfied, but that may only happen manually if the Exchange
determines it is necessary in the interests of a fair and orderly
market.\18\ Currently, if a series is open on another exchange but not
on the Exchange, the Exchange generally manually increases the Maximum
Composite Width for the series until the series opens. Manually
increasing the Maximum Composite Width for a series until the series
open is a different manual process than compelling the series to open,
but ultimately achieves the same result of causing a series that does
not satisfy the Maximum Composite Width check to otherwise open. The
Exchange believes it is in the interests of a fair and orderly market
to deviate from the opening process to systematically force a series to
open, despite a wide Exchange market, if the series is open for trading
on another exchange to provide investors with orders in that series
resting on the Exchange's Queuing Book to have the same execution
opportunities as other investors who submitted orders to other options
exchanges with different opening conditions. The proposed rule change
is consistent with this authority and creates an automated compelled
opening in certain circumstances to replace the manual process
currently used. This will benefit investors by providing additional
transparency to the Rules regarding when a series may open despite not
satisfying the Maximum Composite Width check as well as remove
impediments to and perfect the mechanism of a free and open market and
a national market system by automating an otherwise manual process.
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    \18\ See Rule 6.11(h); see also definition of Maximum Composite
Width and Opening Collar in Rule 6.11(a).
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    The Exchange believes the proposed rule change to permit Users to
give the System a standing instruction regarding how to handle their
orders when a forced or manually compelled (for simple orders) opening
of series occurs will benefit investors, as it will give them an
additional tool to manage their orders in connection with the opening
of series. Users may currently cancel any of their orders resting in
the Queuing Book prior to the opening of a series, and they may cancel
any orders that do not execute at the open once those orders are in the
Book or COB, as applicable. Because the Exchange market may be wider in
these situations, the Exchange believes it is appropriate to provide
Users with the ability to cancel market orders so they don't execute at
the wider market prices once in the Book or cancel all of their orders
if they prefer.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe that the proposed rule change will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because all Users may trade in
any series that opens subject to the proposed forced opening process.
The Exchange believes it is appropriate to limit the forced opening to
equity and ETP options, as those may be multiply listed on exchanges.
Additionally, all Users will have the opportunity to instruct the
System to cancel its market orders or all open orders in the event of a
forced or otherwise manual opening. Cancellation of some or all of a
User's orders in the event of such an opening would be voluntary and
completely within the User's discretion.
    The Exchange does not believe that the proposed rule change will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
proposed forced opening process will permit series to open on the
Exchange that are otherwise open for trading on other options Exchange,
which may increase liquidity and competition in those series sooner.
Additionally, the Exchange believes opening series for trading on the
Exchange that are open for trading on other options exchanges will put
Exchange Users on equal footing with other market participants, as it
will provide Users' orders that are otherwise resting in the Queuing
Book and awaiting execution with the ability to get into the market for
potential execution. The proposed flexibility for Users to instruct the
System how to handle their orders in the event of a forced or manual
opening applies only to how a Users' orders on the Exchange will be
handled in such a circumstance.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The Exchange has designated this rule filing as non-controversial
under Section 19(b)(3)(A) \19\ of the Act and Rule 19b-4(f)(6) \20\
thereunder. Because the proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6) thereunder.\21\
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the
filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exhange has satisfied this
requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \22\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\23\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative upon filing. Waiver of the operative delay will
immediately permit series to open for trading on the Exchange when
those series are already open for trading on other options exchanges
pursuant their respective rules, and provide Users' orders that are
otherwise resting in the Queuing Book and awaiting execution with the
ability to get into the market for potential execution, thereby putting
such Users on equal footing

with other market participants as soon as possible. In addition, the
proposal automates an aspect of the opening process that the Exchange
currently has the authority to perform manually. Therefore, the
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The Commission hereby designates the proposed rule change to be
operative upon filing.\24\
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    \22\ Id.
    \23\ 17 CFR 240.19b-4(f)(6)(iii).
    \24\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-C2-2021-001 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 Number SR-C2-2021-001. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549-1090 on official business days between the hours of 10:00 a.m.
and 3:00 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2021-001 and should be
submitted on or before February 18, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
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    \25\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-01830 Filed 1-27-21; 8:45 am]
BILLING CODE 8011-01-P