[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Rules and Regulations]
[Pages 32133-32138]
[FR Doc No: 2023-10709]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0173; FRL-10940-01-OCSPP]

Benzyl Alcohol; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of benzyl alcohol (CAS Reg. No. 100-51-6)
when used as an inert ingredient (adjuvant) in pesticide formulations
applied to crops and raw agricultural commodities pre- and post-
harvest, limited to no more than 60% by weight in the pesticide
formulation. Landis International, Inc., on behalf of CJB Applied
Technologies, LLC, submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of benzyl alcohol when used in accordance with the terms of
the exemption.

DATES: This regulation is effective May 19, 2023. Objections and
requests for hearings must be received on or before July 18, 2023, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0173, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and OPP Docket is<PHONE_NUMBER>. For the latest status
information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0173 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
July 18, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although the Office
of the Administrative Law Judges, which houses the Hearing Clerk,
encourages parties to file objections and hearing requests
electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0173, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of March 24, 2023 (88 FR 17778) (FRL-10579-
02), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11504) by
Landis International, Inc., 3185 Madison Highway, Valdosta, GA 31603,
on behalf of CJB Applied Technologies, LLC, 1105 Innovation Way, P.O.
Box 5724, Valdosta, GA 31603. The petition requested that 40 CFR
180.910 be amended by establishing an exemption from the requirement of
a tolerance for residues of benzyl alcohol (CAS Reg. No. 100-51-6) when
used as an inert ingredient (adjuvant) in pesticide formulations
applied to crops and raw agricultural commodities pre- and post-
harvest, limited to no more than 60% by weight in the pesticide
formulation. That document referenced a summary of the petition
prepared by Landis International, Inc., on behalf of CJB Applied
Technologies, LLC, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own):

solvents such as alcohols and hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty acids; carriers such as clay and
diatomaceous earth; thickeners such as carrageenan and modified
cellulose; wetting, spreading, and dispersing agents; propellants in
aerosol dispensers; microencapsulating agents; and emulsifiers. The
term ``inert'' is not intended to imply nontoxicity; the ingredient may
or may not be chemically active. Generally, EPA has exempted inert
ingredients from the requirement of a tolerance based on the low
toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance or exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue . . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a tolerance is not necessary to ensure that there is a
reasonable certainty that no harm will result from aggregate exposure
to the inert ingredient, an exemption from the requirement of a
tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure to benzyl alcohol, including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with benzyl alcohol
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by benzyl alcohol as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    Benzyl alcohol exhibits low acute oral and inhalation toxicity,
while acute dermal toxicity is moderate. Benzyl alcohol shows none to
weakly irritating properties to the skin, but it is not a skin
sensitizer.
    Based on the available repeated-dose toxicity data on benzyl
alcohol, the central nervous system is a major target organ in rats and
mice. In rats, mortality, staggering, labored breathing, lethargy, and
necrosis of the denta gyrus of the hippocampus are seen at 800 mg/kg/
day following dosing in a 13-week oral toxicity study via gavage. In
mice, lethargy is seen at 500 mg/kg/day and staggering at 800 mg/kg/day
following dosing in a 16-day and 13-week oral toxicity study via
gavage, respectively. Maternal (mortality, reduced body weights,
clinical signs of neurotoxicity) and offspring (reduced bodyweight)
toxicity are seen in mice at 750 mg/kg/day in a developmental toxicity
study. No adverse effects are seen in rats at 750 mg/kg/day in a
developmental toxicity study. Due to the neurotoxic effects seen
following dosing in the 13-week oral toxicity studies in rats and mice
at 800 mg/kg/day, the highest doses tested in the chronic/
carcinogenicity studies were 400 and 200 mg/kg/day for rats and mice,
respectively. No systemic toxicity or treatment related tumors were
seen in rats or mice at these doses.
    Neurotoxicity studies are not available for review. However, signs
of neurotoxicity are seen in mice (lethargy) at 500 mg/kg/day following
dosing in a 16-day oral toxicity study and in rats (staggering, labored
breathing, lethargy, necrosis of the denta gyrus of the hippocampus)
and mice (staggering) at 800 mg/kg/day in a 13-week oral toxicity study
via gavage. However, clear NOAELs were established for these effects
and the acute population adjusted dose (aPAD) of 4 mg/kg/day and the
chronic population adjusted dose (cPAD) of 2 mg/kg/day are protective
of the neurotoxic effects observed at 500 mg/kg/day and 800 mg/kg/day
in the rat and mouse, respectively. Therefore, there is no concern for
neurotoxicity.
    Immunotoxicity studies are not available for review. Thymic
congestion, hemorrhage, and atrophy were observed at 800 mg/kg/day in
rats in a 13-week oral toxicity study via gavage. However, a clear
NOAEL was established for these effects and the cPAD (2 mg/kg/day) is
protective of the immunotoxic effects observed at 800 mg/kg/day.
Therefore, there is no concern for immunotoxicity.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    A summary of the toxicological endpoints for benzyl alcohol used
for

human health risk assessment is shown in Table 1 of this unit.

Table 1--Summary of Toxicological Doses and Endpoints for Benzyl Alcohol for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary (General population      NOAEL = 400 mg/kg/day    Acute RfD = 4.00 mg/kg/  13-week oral toxicity--
 including infants and children).      UFA = 10x..............   day.                     Rat LOAEL = 800 mg/kg/
                                       UFH = 10x..............  aPAD = 4.0 mg/kg/day...   day based on clinical
                                       FQPA SF = 1x...........                            signs of neurotoxicity
                                                                                after a single dose.
Chronic dietary (All populations)....  NOAEL= 250 mg/kg/day     Chronic RfD = 2.0 mg/kg/ 16-day oral toxicity--
                                       UFA = 10x..............   day.                     Mouse LOAEL = 500 mg/
                                       UFH = 10x..............  cPAD = 2.0 mg/kg/day...   kg/day based on
                                       FQPA SF = 1x...........                            lethargy.
Incidental oral short- and             NOAEL= 250 mg/kg/day     LOC for MOE = 100......  16-day oral toxicity--
 intermediate-term (1 to 30 days and   UFA = 10x..............                            Mouse LOAEL = 500 mg/
 1 to 6 months).                       UFH = 10x..............                            kg/day based on
                                       FQPA SF = 1x...........                            lethargy.
Dermal short- and intermediate-term    NOAEL = 250 mg/kg/day    LOC for MOE = 100......  16-day oral toxicity--
 (1 to 30 days and 1 to 6 months).      (dermal absorption                                Mouse LOAEL = 500 mg/
                                        rate = 100%)                                      kg/day based on
                                       UFA = 10x..............                            lethargy.
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
Inhalation short- and intermediate-    Inhalation study NOAEL=  LOC for MOE = 100......  4-week inhalation
 term (1 to 30 days and 1 to 6          1,072 mg/m\3\ (~328 mg/                           toxicity study--Rat
 months).                               kg/day) (inhalation                              LOAEL was not
                                        absorption rate =                                 established.
                                        100%)
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
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Cancer (Oral, dermal, inhalation)....  Benzyl alcohol is not expected to be carcinogenic, based on available
                                        data for benzyl alcohol in rats and mice, and a cancer dietary exposure
                                        assessment was not performed.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benzyl alcohol, EPA considered exposure that may occur from
the existing and proposed uses of benzyl alcohol. EPA assessed dietary
exposures from benzyl alcohol in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
after a single exposure. Such effects were identified for benzyl
alcohol. Acute dietary (food only) exposure and risk assessments were
conducted using the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID) Version 4.02. This software
uses 2005-2010 food consumption data from the U.S. Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). The current assessment
includes every commodity available in DEEM.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment using DEEM-FCID, Version 4.02, EPA used food consumption
information from USDA's 2005-2010 NHANES/WWEIA. As to residue levels in
food, no residue data were submitted for benzyl alcohol. In the absence
of specific residue data, EPA has developed an approach which uses
surrogate information to derive upper bound exposure estimates for the
subject inert ingredient. Upper bound exposure estimates are based on
the highest tolerance for a given commodity from a list of high use
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled ``Update to
D361707: Dietary Exposure and Risk Assessments for the Inerts.'' (12/
21/2021) and can be found at https://www.regulations.gov in docket ID
number EPA-HQ-OPP-2018-0090.
    In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest levels of
tolerances would be no higher than the concentration of the active
ingredient. However, to account for the proposed uses of benzyl alcohol
up to 60% by weight in pesticide formulations, EPA assumed a 60%
concentration of benzyl alcohol in the dietary exposure assessment.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products are
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single

inert ingredient in the pesticide product in relation to that of the
active ingredient. Second, the conservatism of this methodology is
compounded by EPA's decision to assume that, for each commodity, the
active ingredient which will serve as a guide to the potential level of
inert ingredient residues is the active ingredient with the highest
tolerance level. This assumption overstates residue values because it
would be highly unlikely, given the high number of inert ingredients,
that a single inert ingredient or class of ingredients would be present
at the level of the active ingredient in the highest tolerance for
every commodity. Finally, a third compounding conservatism is EPA's
assumption that all foods contain the inert ingredient at the highest
tolerance level. In other words, EPA assumed 100 percent of all foods
are treated with the inert ingredient at the rate and manner necessary
to produce the highest residue legally possible for an active
ingredient. In summary, EPA chose a very conservative method for
estimating what level of inert residue could be on food, then used this
methodology to choose the highest possible residue that could be found
on food and assumed that all food contained this residue. No
consideration was given to potential degradation between harvest and
consumption even though monitoring data shows that tolerance level
residues are typically one to two orders of magnitude higher than
actual residues in food when distributed in commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for benzyl alcohol, a
conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, for lawn and garden pest control, indoor pest control,
termiticides, flea and tick control on pets and hard surface
disinfection on walls, floors, tables).
    Benzyl alcohol is currently approved for use as an inert ingredient
in antimicrobial pesticides and nonfood use pesticides (e.g., pet spot-
on treatments; products used on lawn, turf, or gardens) that could
result in short-term residential exposure. Although benzyl alcohol is
approved as an active ingredient, currently there are no active
registrations for its use as an active ingredient. Short-term
residential exposure for adults combines high-end dermal and inhalation
handler exposure from indoor hard surface, aerosol sprays with high-end
post-application dermal exposure from contact with treated lawns and
results in an MOE of 161. Short-term residential exposure for children
includes total exposures associated with contact with treated lawns
(dermal and hand-to-mouth exposures) and results in an MOE of 540.
Because EPA's level of concern (LOC) for benzyl alcohol is an MOE below
100, these MOEs are not of concern.
    Intermediate-term residential exposure for adults includes high-end
post-application dermal exposure from contact with treated lawns and
results in an MOE of 3800. Intermediate-term residential exposure for
children includes total exposures associated with contact with treated
lawns (dermal and hand-to-mouth exposures) and results in an MOE of
2,000. Because EPA's LOC for benzyl alcohol is an MOE below 100, these
MOEs are not of concern.
    Benzyl alcohol is also used in products such as cosmetics and
personal care products that could result in short-, intermediate- and
long-term exposures. The International Fragrance Association calculated
a dermal exposure of 0.042 mg/kg/day using the reported 97.5th
percentile concentration based on the levels of the same fragrance
ingredient in ten of the most frequently used personal care and
cosmetic products (i.e., anti-perspirant, bath products, body lotion,
eau de toilette, face cream, fragrance cream, hair spray, shampoo,
shower gel, and toilet soap). An inhalation exposure level of 0.0026
mg/kg/day was calculated based on the combined (fine fragrances, hair
sprays, antiperspirants/deodorants, candles, aerosol air fresheners,
and reed diffusers/heated oil plug-ins) result calculated using the
Research Institute for Fragrance Material, Inc. (RIFM) 2-Box/MPPD in
silico models, based on the International Fragrance Association (IFRA)
survey results for the 97.5th percentile use in hydro alcoholics for a
60 kg individual. Total systemic exposure due to use in cosmetics and
personal care products is 0.0446 mg/kg/day. The MOE is 5605. Because
EPA's LOC for benzyl alcohol is an MOE below 100, this MOE is not of
concern.
    4. Cumulative effects from substances with a common mechanism of
toxicity. 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.''
    EPA has not found benzyl alcohol to share a common mechanism of
toxicity with any other substances, and benzyl alcohol does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
benzyl alcohol does not have 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 EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall
apply an additional tenfold (10X) margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the Food Quality Protection
Act safety factor. In applying this provision, EPA either retains the
default value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    The Agency has concluded that there is reliable data to determine
that infants and children will be safe if the FQPA SF of 10x is reduced
to 1X for the following reasons. The toxicity database for benzyl
alcohol is adequate, it contains developmental toxicity studies in the
mouse and a four-generation reproduction toxicity study in the rat. No
fetal susceptibility or reproduction toxicity is observed in these
studies. Lethargy is observed in mice at 500 mg/

kg/day following dosing in a 16-day oral toxicity study. In a 13-week
oral toxicity study, staggering, labored breathing, lethargy, and
necrosis of the denta gyrus of the hippocampus were observed in rats,
and staggering was observed in mice at 800 mg/kg/day. Thymic
congestion, hemorrhage, and atrophy were observed in rats at 800 mg/kg/
day in a 13-week oral toxicity study. However, clear NOAELs were
established for these effects and the selected points of departure
(PODs) are based on the neurological effects observed at 500 mg/kg/day
and are protective of the immunological effects observed at 800 mg/kg/
day. Therefore, there is no concern for potential neurotoxicity or
immunotoxicity. Based on the adequacy of the toxicity database, the
conservative nature of the exposure assessment and the lack of concern
for prenatal and postnatal sensitivity, the Agency has concluded that
there is reliable data to determine that infants and children will be
safe if the FQPA SF of 10x is reduced to 1x.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to benzyl alcohol will occupy 74% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account chronic exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions described in this unit
for chronic exposure, EPA has concluded that chronic exposure to benzyl
alcohol from food and water will utilize 61% of the cPAD for children 1
to 2 years old, the population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Benzyl alcohol may be used as an inert ingredient in pesticide
products that are registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to benzyl alcohol.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term
aggregated food, water, and residential pesticide and non-pesticide
exposures result in an aggregate MOE of 112 for adults. Adult
residential pesticide exposure combines high-end dermal and inhalation
handler exposure from indoor hard surface aerosol spray with high-end
post-application dermal exposure from contact with treated lawns. EPA
has concluded the combined short-term aggregated food, water, and
residential pesticide and non-pesticide exposures result in an
aggregate MOE of 123 for children. Children's residential pesticide
exposure includes total exposures associated with contact with treated
lawns (dermal and hand-to-mouth exposures). Because EPA's LOC for
benzyl alcohol is an MOE below 100, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Benzyl alcohol may be used as an inert ingredient in pesticide
products that are registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to benzyl alcohol.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the intermediate-
term aggregated food, water, and residential exposures result in an
aggregate MOE of 337 for adults. Adult residential pesticide exposure
combines high-end dermal and inhalation handler exposure from indoor
hard surface aerosol spray with a high-end post-application dermal
exposure from contact with treated lawns. EPA has concluded the
combined intermediate-term aggregated food, water, and residential
pesticide and non-pesticide exposures result in an aggregate MOE of 147
for children. Children's residential exposure includes total exposures
associated with contact with treated lawns (dermal and hand-to-mouth
exposures). Because EPA's LOC for benzyl alcohol is an MOE below 100,
these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in adequate rodent carcinogenicity studies,
benzyl alcohol is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on the risk assessments and
information described above, EPA concludes that there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to benzyl alcohol
residues. More detailed information on this action can be found in the
document titled ``Benzyl Alcohol Human Health Risk Assessment and
Ecological Effects Assessment to Support an Exemption from the
Requirement of a Tolerance When Used as an Inert Ingredient in
Pesticide Formulations'' in docket ID EPA-HQ-OPP-2021-0173.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
benzyl alcohol in or on any food commodities. EPA is establishing a
limitation on the amount of benzyl alcohol that may be used in
pesticide formulations. This limitation will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA
will not register any pesticide formulation for food use that exceeds
60% benzyl alcohol in the final pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established for residues of benzyl alcohol (CAS Reg. No. 100-51-6) when
used as an inert ingredient (adjuvant) in pesticide formulations
applied to crops and raw agricultural commodities pre- and post-harvest
under 40 CFR 180.910, limited to no more than 60% by weight in the
pesticide formulation.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled

``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), or
Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: May 15, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

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

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

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

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

0
2. In Sec.  180.910, amend table 1 to the section by adding, in
alphabetical order, the inert ingredient ``Benzyl alcohol (CAS Reg. No.
100-51-6)'' to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
       Inert ingredients               Limits               Uses
------------------------------------------------------------------------

                              * * * * * * *
Benzyl alcohol (CAS Reg. No.     60% by weight in   Adjuvant.
 100-51-6).                       pesticide
                                  formulation.

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2023-10709 Filed 5-18-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 7, 2009 (Volume 74, Number 193)]
[Notices]
[Page 51572]
[DOCID:fr07oc09-44]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13392-000]

Lock+\TM\ Hydro Friends Fund II, LLC; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comment, Motions
To Intervene, and Competing Applications

September 30, 2009.
    On March 6, 2009, Lock+\TM\ Hydro Friends Fund II, LLC filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Mississippi River Lock and
Dam No. 9 Water Power Project (Gumby Project), to be located on the
Mississippi River in Allamakee County, Iowa, and Crawford, Wisconsin,
and near the town of Lynxville, WI.
    The proposed Lock & Dam 9 Project would be integral with: (1) The
existing U.S. Army Corps of Engineers Lock & Dam No. 9 comprised of an
811-foot-long gated dam section with 5 roller gates and 8 tainter
gates, and a 600 foot-long lock, and; (2) an existing 17-mile-long
reservoir extending from River Mile 648 to River Mile 679 at a normal
pool elevation of 620.0 feet mean sea level.
    The proposed project would consist of: (1) Seven generating units
and installed in a new door installed in the auxiliary lock with a
total capacity of 4,963; and (2) a new 1,000-foot-long, 36.7-kilovolt
transmission line connected to an existing above ground local
distribution system. The project would have an estimated average annual
generation of 41.3 gigawatt-hours.
    Applicant Contact: Mr. Wayne F. Krouse, Hydro Friends Fund II LLC,
5090 Richmond Avenue 390, Houston, TX 77056, phone (877) 556-
6566 x709.
    FERC Contact: Michael Spencer,<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.
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
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project 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-
13392) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-24126 Filed 10-6-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Pages 50916-50921]
[FR Doc No: 2017-23825]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81967; File No. SR-MIAX-2017-44]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend MIAX Options Rule 518 Relating to Derived
Orders

October 27, 2017.
    Pursuant to the provisions of section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on October 19, 2017, Miami International
Securities Exchange, LLC (``MIAX Options'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') a proposed rule
change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange is filing a proposal to amend Exchange Rule 518(a)(9)
to: (i) Update the definition of a derived order on the Exchange, (ii)
clarify the circumstances under which a derived order is generated by
the Exchange's System, and the price at which a derived order may be
generated, and (iii) expand the situations under which a derived order
is removed from the Exchange's Simple Order Book.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/rule-filings/ at MIAX Options'
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 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 Exchange Rule 518(a)(9) to: (i)
Update the definition of a derived order on the Exchange, (ii) clarify
the circumstances under which a derived order is generated by the
Exchange's System,\3\ and the price at which a derived order may be
generated, and (iii) expand the situations under which a derived order
is removed from the Exchange's Simple Order Book.\4\
---------------------------------------------------------------------------

    \3\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \4\ The ``Simple Order Book'' is the Exchange's regular
electronic book of orders and quotes. See Exchange Rule 518(a)(15).
---------------------------------------------------------------------------

    A ``derived order'' is an Exchange-generated limit order on the
Simple Order Book that represents either the bid or offer of one
component of a complex order resting on the Strategy

Book \5\ that is comprised of orders to buy or sell an equal quantity
(currently with a one-to-one ratio) of two option components.\6\
Derived orders will not be routed outside of the Exchange regardless of
the price(s) disseminated by away markets. The Exchange will determine
on a class-by-class basis to make available derived orders and
communicate such determination to Members \7\ via a Regulatory
Circular. Derived orders are firm orders (i.e., if executed, firm for
the disseminated price and size) that are included in the MBBO.\8\
---------------------------------------------------------------------------

    \5\ The ``Strategy Book'' is the Exchange's electronic book of
complex orders and complex quotes. See Exchange Rule 518(a)(17).
    \6\ See Exchange Rule 518(a)(9).
    \7\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
    \8\ The term ``MBBO'' means the best bid or offer on the Simple
Order Book (as defined below) on the Exchange. See Exchange Rule
518(a)(13).
---------------------------------------------------------------------------

    The Exchange is proposing to amend the definition of a ``derived
order'' in two ways. First, the Exchange is proposing to revise the
current requirement in Rule 518(a)(9) that a derived order can only be
generated from one component of a complex order resting on the Strategy
Book that is comprised of orders to buy or sell an equal quantity
(currently with a one-to-one ratio) of two option components. Under the
proposal, a derived order may now be comprised of orders to buy or sell
two option components, where the size of one component has a base ratio
of ``one'' relative to the other component (1:1, 1:2, or 1:3). Thus,
the basis for the generation of derived orders on the Exchange will not
be restricted to complex orders of equal size with a one-to-one ratio;
instead, a derived order may be generated by using a complex order
resting on the Strategy Book with two components, provided that one
component of the complex order has a base ratio of one relative to the
other component. For example, a complex order whose components have a
size ratio of 1:3 could be used to generate a derived order, whereas a
complex order whose components have a size ratio of 2:3 could not.\9\
The Exchange notes that another options exchange permits a derived, or
``leg'' order, to be generated using a complex order with a ratio
greater than 1:1.\10\ The Exchange believes that the revision of the
one-to-one ratio limitation should increase the potential number of
derived orders that may be generated by the System, which should result
in greater liquidity and more opportunities for participants to trade
complex orders on the Exchange.\11\
---------------------------------------------------------------------------

    \9\ A leg order may only be generated for the legs of complex
orders with a ratio of 1:1, 1:2, or 1:3. (A leg order will not be
generated for the legs of a complex order with a 1:4 ratio). For
example, if a complex order to buy 10 of series A and sell 20 of
series B is resting on the Strategy Book, a leg order will be
generated for the leg to buy 10 of series A (ratio of 1:2), but not
for the leg to sell 20 of series B (ratio of 2:1). If a complex
order to buy 20 of series A and sell 30 of series B is resting on
the Strategy Book, no leg orders will be generated for either leg
(ratio is 2:3 for leg 1 and 3:2 for leg 2).
    \10\ See Chicago Board Options Exchange, Inc. (``CBOE'') Rule
6.53(x).
    \11\ The Exchange notes that other exchanges require a complex
order used to generate a derived or ``legging'' order to be for an
equal quantity of two options. See, e.g., NASDAQ PHLX LLC (``Phlx'')
Rule 1098(f)(iii)(C)(1). See also, Nasdaq ISE, LLC (``ISE'') Rule
715(k). The Exchange's proposal is distinguished in that it seeks to
expand its current one-to-one ratio requirement to include any
complex order with a component that has a base of one with respect
to the other component.
---------------------------------------------------------------------------

    The Exchange is also proposing to amend Rule 518(a)(9) by adding a
final sentence stating that derived orders are subject to the managed
interest process described in Rule 515(c)(1)(ii).\12\ The purpose of
this provision is to ensure that a derived order (which is firm for its
price and size) is handled in accordance with that Rule so that it does
not lock or cross an away market price at the NBBO.\13\ An example of a
derived order subject to the managed interest process is provided
below.
---------------------------------------------------------------------------

    \12\ Under the managed interest process, non-routable orders
whose limit price locks or crosses the current opposite side
National Best Bid or Offer (``NBBO'') are displayed one Minimum
Price Variation (``MPV'') away from the current opposite side NBBO,
and placed on the Simple Order Book at a price that will lock the
current opposite side NBBO. Should the NBBO price change to an
inferior price level, the order's price on the Simple Order Book
will continuously re-price to lock the new NBBO and the managed
order's displayed price will continuously re-price one MPV away from
the new NBBO. See Exchange Rule 515(c)(1)(ii).
    \13\ The term ``NBBO'' means the national best bid or offer as
calculated by the Exchange based on market information received from
OPRA. See Exchange Rule 100.
---------------------------------------------------------------------------

Example 1
Option A ($.05 MPV) \14\
---------------------------------------------------------------------------

    \14\ The default Minimum Price Variation (``MPV'') of an option
contract trading at less than $3.00 per option is $.05. See Exchange
Rule 510.
---------------------------------------------------------------------------

    MBBO: $2.00 x $2.20
    ABBO: $2.00 x $2.10
    NBBO: $2.00 x $2.10
Option B ($.05 MPV)
    MBBO: $1.00 x $1.05
    ABBO: $1.00 x $1.05
    NBBO: $1.00 x $1.05
Strategy: Buy 1 Option A, Sell 1 Option B
    icMBBO: \15\ $.95 x $1.20
---------------------------------------------------------------------------

    \15\ The ``icMBBO'' is the Implied Complex MIAX Best Bid or
Offer. The icMBBO is a calculation that uses the best price from the
Simple Order Book for each component of a complex strategy including
displayed and non-displayed trading interest. See Exchange Rule
518(a)(11).
---------------------------------------------------------------------------

    cNBBO: \16\ $.95 x $1.10
---------------------------------------------------------------------------

    \16\ The ``cNBBO'' is the Complex National Best Bid or Offer.
The cNBBO is calculated using the NBBO for each component of a
complex strategy to establish the best net bid and offer for a
complex strategy. See Exchange Rule 518(a)(2).
---------------------------------------------------------------------------

Strategy Order
    Buy 1 (+1A -1B) $1.10 net debit

    The System will create a derived order to buy Option A at a price
of $2.10. The new MBBO would be $2.10 x $2.20. However, the $2.10 bid
price would lock the ABBO \17\ offer for Option A, which is being
quoted on an away exchange at $2.00 x $2.10. Therefore, the derived
order will be managed in accordance with the Exchange's managed
interest process. Under the Exchange's managed interest process for
non-routable orders defined in Rule 515(c)(1)(ii)(A), if the limit
price of an order ($2.10 bid) locks or crosses the current opposite
side NBBO ($2.10 offer), the System will display the order one MPV
($.05) away from the current opposite side NBBO ($2.05 bid), and book
the order at a price that will lock the current side NBBO. Therefore,
the derived order in Option A will have a Book \18\ price of $2.10 and
will be displayed at $2.05, the MBBO will therefore be $2.05 x $2.20.
---------------------------------------------------------------------------

    \17\ The term ``ABBO'' means the best bid(s) or offer(s)
disseminated by other Eligible Exchanges (defined in Exchange Rule
1400(f)) and calculated by the Exchange based on market information
received by the Exchange from OPRA. See Exchange Rule 100.
    \18\ The term ``Book'' means the electronic book of buy and sell
orders and quotes maintained by the System. See Exchange Rule 100.
---------------------------------------------------------------------------

Option A
    MBBO: $2.05 x $2.20
    ABBO: $2.00 x $2.10
    NBBO: $2.05 x $2.10

    Should interest arrive on MIAX Options to sell at $2.10 or lower,
it will trade at $2.10 against the derived order, as Rule
515(c)(1)(ii)(A) provides that if the Exchange receives a new order or
quote on the opposite side of the market from the managed order that
can be executed, the System will immediately execute the remaining
contracts from the initiating order to the extent possible at the
order's current Book price ($2.10), provided that the execution price
does not violate the current NBBO. The other side of the complex order
will execute against the $1.00 bid price for Option B, effectively
legging the complex order for a net price of $1.10.
    The Exchange believes that generating and managing a derived order
(rather

than simply preventing its generation) \19\ creates and preserves
additional opportunities for complex orders to be executed as
individual components against orders resting on the Simple Order Book
as market conditions change.
---------------------------------------------------------------------------

    \19\ Other exchanges have determined not to generate derived or
``leg'' orders that would lock or cross the NBBO. See, e.g., CBOE
Rule 6.53C(c)(iv)(1)(A). See also, ISE Rule 715(k)(1). Despite this
distinction, the Exchange's inclusion of derived orders in the
managed interest process is intended to achieve the same result,
i.e., to prevent a derived order from locking or crossing an away
market.
---------------------------------------------------------------------------

    The Exchange is also proposing to amend Rule 518(a)(9)(i) to
provide more detail regarding the circumstances under which a derived
order is generated by the Exchange's System, and the price at which a
derived order must be generated. Currently, a derived order may be
automatically generated for one or more legs of a complex order at a
price: (A) That matches or improves upon the best displayed bid or
offer in the affected series on the Simple Order Book; and (B) at which
the net price of the complex order on the Strategy Book can be achieved
when the other component of the complex order is executed against the
best displayed bid or offer on the Simple Order Book. Additionally, a
derived order will not be displayed at a price that locks or crosses
the best bid or offer of another exchange. In such a circumstance, the
System will display the derived order on the Simple Order Book at a
price that is one MPV away from the current opposite side best bid or
offer of such other exchange, and rank the derived order on the Simple
Order Book according to its actual price.\20\
---------------------------------------------------------------------------

    \20\ See Exchange Rule 518(a)(9)(ii).
---------------------------------------------------------------------------

    The Exchange is proposing to amend Rule 518(a)(9)(i) to add more
detail to the rule stating that a derived order may be automatically
generated if the complex order is eligible for ``Legging'' pursuant to
Rule 518(c)(2)(iii), and meets the requirements set forth therein.\21\
The purpose of this proposed amendment is to establish clearly in the
Exchange's Rules that the System will only generate derived orders for
complex orders that are eligible for legging--that is, complex orders
whose components can be executed as individual legs against orders
resting on the Simple Order Book. Conversely, if a complex order is not
eligible for legging, then the System will not generate derived orders
with respect to that complex order.\22\
---------------------------------------------------------------------------

    \21\ Complex orders up to a maximum number of legs (determined
by the Exchange on a class-by-class basis as either two or three
legs and communicated to Members via Regulatory Circular) may be
automatically executed against bids and offers on the Simple Order
Book for the individual legs of the complex order (``Legging''),
provided the complex order can be executed in full or in a
permissible ratio by such bids and offers, and provided that the
execution price of each component is not executed at a price that is
outside of the NBBO. See Exchange Rule 518(c)(2)(iii).
    \22\ The Exchange notes that while derived order functionality
was approved with the Exchange's filing to adopt new rules to govern
the trading of Complex orders, the functionality has not yet been
implemented in the System. See Exchange Act Release No. 79072
(October 7, 2016), 81 FR 71131 (October 14, 2016) (SR-MIAX-2016-26).
---------------------------------------------------------------------------

    The Exchange is proposing to amend Rule 518(a)(9)(i)(B) to make a
technical modification to the current rule text. Currently, the rule
provides that a derived order may automatically be generated for one or
more legs of a complex order at a price, ``at which the net price of
the complex order on the Strategy Book can be achieved when the other
component(s) of the complex order is (are) executed against the best
displayed bid or offer on the Simple Order Book.'' The Exchange
proposes to make the word ``components'' singular by removing the
``(s)'' and removing the word ``(are)'' following the phrase ``complex
order'' so that the new sentence has the proper subject-verb agreement.
The Exchange believes this change describes System functionality with
more accuracy and precision.
    The Exchange is proposing to amend Rule 518(a)(9)(i)(B) to state
that a derived order may be automatically generated for one or more
legs of a complex order at a price at which the net price of the
complex order ``at the best price'' on the Strategy Book can be
achieved when the other component of the complex order is executed
against the best displayed bid or offer on the Simple Order Book. This
requirement is intended to ensure that a complex order executed by way
of generating and Legging a derived order for execution against an
order on the Simple Order Book is not executed at a net price that is
inferior to the best net price displayed on the Strategy Book. A
derived order could not, therefore, result in a trade-through of a
complex order resting on the Strategy Book at the Exchange's best
displayed net price.
    The Exchange is also proposing to amend Rule 518(a)(9)(vi), which
describes the various circumstances under which a derived order that
has been generated is removed from the Simple Order Book. Specifically,
the Exchange is proposing to amend Rule 518(a)(9)(vi)(B), which
currently provides that a derived order is automatically removed from
the Simple Order Book if the execution of the derived order would no
longer achieve the net price of the complex order on the Strategy Book
when the other component of the complex order is executed against the
best bid or offer on the Simple Order Book. The Exchange is proposing
to replace the word ``would'' with the word ``may'' in this sub-
paragraph in order to broaden the rule to reflect that the System will
remove a derived order from the Simple Order Book any time the price of
the best bid or offer on the Simple Order Book changes such that the
net price of the complex order to be executed may not be achieved. A
price change of the best bid or offer could be either: (i) Improving
(raising the bid or lowering the offer) or, (ii) worsening (lowering
the bid or raising the offer). In scenario (i), the derived order could
remain on the Simple Order Book as it could still achieve the net price
of the complex order. However, in scenario (ii), the derived order may
not achieve the net price of the complex order depending upon how much
the price had moved. For the sake of processing efficiency and speed,
rather than perform the calculation to determine if the derived order
could still achieve the net price for the complex order in scenario
(ii), the System simply cancels any derived order in scenario (i) or
(ii). The Exchange believes that removal of the derived order from the
Simple Order Book when there is a possibility that the complex order
may not be executed at its net price is prudent and is an appropriate
safeguard against such an execution.\23\ The Exchange's System re-
evaluates each strategy on the Strategy Book on a periodic basis to
ascertain if the creation of a derived order is warranted. If, upon re-
evaluation, the new price allows a new derived order for the strategy,
such new derived order will then be created.\24\ As re-evaluation is a
continual process, the Exchange believes it is more expedient to cancel
a derived order where a change in price may no longer allow the derived
order to achieve the net price for the complex order and rely upon the
re-evaluation process to create a new derived order when warranted. The
Exchange believes that changing the language in the rule from ``would''
to ``may'' more accurately describes the operation of Exchange
functionality.
---------------------------------------------------------------------------

    \23\ The System continually evaluates complex orders and quotes
on the Strategy Book to determine, among other things, whether a
derived order should be generated or cancelled. See Exchange Rule
518(c)(5)(ii). Thus, when the System cancels and removes a derived
order from the Simple Order Book, the System could thereafter
generate another derived order using the same complex order based
upon the evaluation process if the appropriate conditions are
present.
    \24\ Id.

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

    The Exchange is also proposing to amend Rules 518(a)(9)(vi)(C) and
(D), which currently describe the automatic removal of a derived order
from the Simple Order Book when the complex order is executed in full,
or is cancelled. The Exchange is proposing to consolidate sub-
paragraphs (C) and (D) into one sub-paragraph (C), to delete the phrase
``in full,'' and to broaden the rule by stating that a derived order is
automatically removed from the Simple Order Book if the complex order
is executed, cancelled, or modified in any way.\25\ The Exchange
believes that any change to a complex order used to generate a derived
order obviates the need for the derived order at its limit price and
size on the Simple Order Book. The phrase ``modified in any way'' is
intended to capture, without limitation, any modification to the price
or size of the complex order. Such a modification could require a
different limit price for the derived order to achieve the best
execution price of the complex order, or result in a size ratio that
does not comply with the ``base of one'' ratio in proposed Rule
518(a)(9) discussed above, in which case the complex order could not be
executed. The Exchange is proposing to remove the derived order from
the Simple Order Book when the complex order is modified in any way in
order to prevent these circumstances.
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    \25\ This is substantially similar to rules that are currently
operative on other exchanges. See ISE Rule 715(k)(3)(iii) and (iv).
See also, CBOE Rule 6.53C(c)(iv)(3)(B)(II) and (III), and Phlx Rule
1098(f)(iii)(C)(4)(iii) and (iv).
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    The Exchange is also proposing to amend Rule 518(a)(9)(vi)(D) by
deleting the current text (see above) and adopting new Rule
518(a)(9)(vi)(D) to state that a derived order is automatically removed
from the Simple Order Book if the strategy \26\ enters a cPRIME Auction
(as described in Rule 515A, Interpretations and Policies .12) \27\ or a
Complex Auction (pursuant to Rule 518(d)).\28\ This would include any
strategy that has, as a component, an option that is of the same type
as a derived order.\29\ To illustrate, using the example set forth
above,\30\ the System would automatically remove from the Simple Order
Book the derived order in Option A if strategy AB (or any other
strategy having Option A as a component) enters a cPRIME Auction or a
Complex Auction. The System would wait until a cPRIME Auction or
Complex Auction is concluded before creating a derived order for an
option that is subject to such an auction.\31\ A complex order that
enters and is processed in a cPRIME Auction or a Complex Auction is
subject to execution at improved prices against complex orders
submitted in response to the Exchange's notification, and thus could
cause the derived order to be priced such that it may no longer achieve
the best net price of the complex order. In this situation, therefore,
the System will automatically remove the derived order from the Simple
Order Book. Finally, the Exchange proposes to amend Rule
518(a)(9)(vi)(E) by adding a sentence stating that, if a derived order
is removed from the Simple Order Book, the System will continually
evaluate any remaining complex order(s) on the Strategy Book to
determine whether a new derived order should be generated, as described
in Rule 518(c)(5).\32\ The purpose of this provision is to ensure that
a new derived order can and will be generated by the System under the
proper conditions even after a previously generated derived order has
been removed from the Simple Order Book. The Exchange believes that
this provides additional opportunities to execute complex orders
through Legging using derived orders as market conditions change.
---------------------------------------------------------------------------

    \26\ The term ``complex strategy'' means a particular
combination of components and their ratios to one another. New
complex strategies can be created as the result of the receipt of a
complex order or by the Exchange for a complex strategy that is not
currently in the System. The Exchange may limit the number of new
complex strategies that may be in the System at a particular time
and will communicate this limitation to Members via Regulatory
Circular. See Exchange Rule 518(a)(6).
    \27\ The Exchange recently adopted rules that permit the
submission of complex orders for price improvement and execution in
the MIAX Price Improvement Mechanism (``PRIME''). Complex orders
submitted into PRIME are known as ``cPRIME Orders'' and are
processed in a ``cPRIME Auction.'' See Securities Exchange Act
Release No. 81131 (July 12, 2017), 82 FR 32900 (July 18, 2017) (SR-
MIAX-2017-19).
    \28\ Currently, the Exchange may determine to automatically
submit a Complex Auction-eligible order into a Complex Auction and
begin the Complex Auction process by sending a message to
participants requesting responses to the Complex Auction. See
Exchange Rule 518(d). For a complete description of the Complex
Auction, see Securities Exchange Act Release No. 79072 (October 7,
2016), 81 FR 71131 (October 14, 2016) (SR-MIAX-2016-26).
    \29\ An option of the same type would be either the put or call
option in the same series as a component in the strategy. (E.g., if
the complex strategy was a long straddle to Buy 1 JNJ Oct 141 Call
and to Buy 1 JNJ Oct 141 Put, a derived order in either of those
options would be considered an option of the same type, and would be
removed if the strategy entered a cPRIME Auction or a Complex
Auction).
    \30\ See Example 1 on page 6 [sic].
    \31\ See supra note 23.
    \32\ Id.
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    The Exchange believes that the proposed rule change relating to
derived orders will facilitate more interaction between the Strategy
Book and the Simple Order Book, resulting in increased execution
opportunities and better execution prices for complex orders and for
orders resting on the Simple Order Book.
    The Exchange will announce the implementation date of the proposed
rule change by Regulatory Circular to be published no later than 60
days following the operative date of the proposed rule. The
implementation date will be no later than 60 days following the
issuance of the Regulatory Circular.
2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with section 6(b) of the Act \33\ in general, and furthers the
objectives of section 6(b)(5) of the Act \34\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in, securities, to remove impediments to and
perfect the mechanisms of a free and open market and a national market
system and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78f(b).
    \34\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange's proposal to amend Rule 518(a)(9) to remove the
limitation on the generation of derived orders to use only complex
orders of equal size with a one-to-one ratio, and instead to permit a
derived order to be generated by using a complex order resting on the
Strategy Book with a ratio of greater than one-to-one, provided that
one component of the complex order that is used to generate the derived
order has a base ratio of one relative to the other component, is
designed to remove impediments to and perfect the mechanisms of a free
and open market and a national market system. Specifically, the
Exchange believes that this proposal will increase the number of
derived orders that may be generated on the Exchange, thus enhancing
liquidity and increasing the number of opportunities for the execution
of complex orders on the Exchange.
    The Exchange's proposal to state in Rule 518(a)(9) that derived
orders are subject to the managed interest process described in Rule
515(c)(1)(ii) is designed protect investors and the public interest by
ensuring that a derived order (which is firm for its price and size)
does not lock or cross an away market price at the NBBO. If a derived
order were to lock or cross an away market price at the NBBO, the
Exchange would not be able to route the derived

order to such a market because derived orders are not routable. The
inclusion of derived orders in the managed interest process thus
protects investors and the public interest by removing the possibility
that this situation could occur, while maintaining the derived order on
the Simple Order Book.
    The proposed amendment to Exchange Rule 518(a)(9)(i), adding the
requirement that a derived order may be automatically generated if the
complex order is eligible for Legging pursuant to Rule 518(c)(2)(iii),
is designed to remove impediments to and perfect the mechanisms of a
free and open market by establishing clearly in the Exchange's Rules
that the System will generate derived orders only for complex orders
whose components (including the component represented by a derived
order) can be executed as individual legs against orders on the Simple
Order Book. In order for a component to be executed against an order on
the Simple Order Book, the complex order must be executed by way of its
individual legs; there is thus no need for, or purpose in, generating a
derived order for a complex order that is not eligible for Legging.
    The Exchange's proposal to amend Rule 518(a)(9)(i)(B) to clarify
the conditions required for the creation of derived orders would
promote just and equitable principles of trade and remove impediments
to a free and open market by providing greater transparency concerning
the operation of Exchange functionality.
    The Exchange's proposal to amend Rule 518(a)(9)(i)(B), to require
that a derived order be generated at a price at which the net price of
the complex order at the best price on the Strategy Book can be
achieved, is designed to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest by ensuring
that a complex order executed by way of Legging against orders on the
Simple Order Book could not result in a trade-through of a complex
order at the Exchange's best displayed net price.
    The proposed amendment to Exchange Rule 518(a)(9)(vi)(B) is
designed to remove impediments to and perfect the mechanisms of a free
and open market and a national market system and, in general, to
protect investors and the public interest by ensuring that a derived
order is removed from the Simple Order Book any time the price of the
best bid or offer on the Simple Order Book changes such that the net
price of a complex order at the top of the Strategy Book may not be
achieved by executing the derived order and another order at the
changed price, thus protecting investors by ensuring a safeguard
against such an execution.
    The proposed amendments to Rules 518(a)(9)(vi)(C) and (D),
describing the automatic removal of derived orders from the Simple
Order Book, are designed to protect investors and the public interest
by ensuring that derived orders do not result in executions that trade
through the top of the Exchange's Simple Order Book and Strategy Book,
and that executions on the Simple Order Book and on the Strategy Book
do not result in prices that trade through away markets.
    Amended Rule 518(a)(9)(vi)(E), stating that the System will
continually evaluate any remaining complex order(s) on the Strategy
Book to determine whether a new derived order should be generated,
ensures that a new derived order can and will be generated by the
System under the proper conditions even after a previously generated
derived order has been removed from the Simple Order Book. This
provision is designed to promote just and equitable principles of trade
and also to remove impediments to and perfect the mechanisms of a free
and open market and a national market system by providing more
opportunities to execute complex orders through Legging using derived
orders as market conditions change.
    The Exchange also believes that the proposed rule change removes
impediments to and perfects the mechanisms of a free and open market
and a national market system by attracting more order flow and by
increasing the frequency with which MIAX Options participants are able
to trade complex orders.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes that the
proposed rule change enhances intermarket competition by providing
market participants with additional opportunities to execute complex
orders through the generation of a greater number of derived orders
using an expanded permissible size ratio. The Exchange believes that
the additional opportunities to trade complex orders will result in the
submission of more complex orders for execution on the Exchange, thus
enhancing the Exchange's competitive position by increasing liquidity
and order flow on the Exchange. Moreover, the proposed rule change is
consistent with the rules of other exchanges, as cited above.\35\
---------------------------------------------------------------------------

    \35\ See supra notes 10, 11, 19 and 25.
---------------------------------------------------------------------------

    The Exchange also believes that its proposal enhances intra-market
competition, as all Exchange participants in the same category are able
to participate on an equal basis with respect to the trading of complex
orders.
    For all the reasons stated, the Exchange does not believe that the
proposed rule change will impose any burden on competition not
necessary or appropriate in furtherance of the purposes of the Act, and
believes the proposed change will in fact enhance competition.

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

    Written comments were neither solicited nor received.

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

    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 \36\ and Rule 19b-4(f)(6) thereunder.\37\
---------------------------------------------------------------------------

    \36\ 15 U.S.C. 78s(b)(3)(A).
    \37\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    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 protected]. Please include
File Number SR-MIAX-2017-44 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MIAX-2017-44. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. 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-MIAX-2017-44 and should be
submitted on or before November 24, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\38\
---------------------------------------------------------------------------

    \38\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-23825 Filed 11-1-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8885-8886]
[FR Doc No: 2012-3549]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0611]

Draft Guidance for Industry on Biosimilars: Questions and Answers
Regarding Implementation of the Biologics Price Competition and
Innovation Act of 2009; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Biosimilars:
Questions and Answers Regarding Implementation of the Biologics Price
Competition and Innovation Act of 2009.'' This draft guidance is
intended to provide answers to common questions from sponsors
interested in developing proposed biosimilar products, biologics
license application (BLA) holders, and other interested parties
regarding FDA's interpretation of the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 16, 2012. Submit either electronic or written
comments on the proposed collection of information by April 16, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Biosimilars: Questions and Answers Regarding Implementation
of the Biologics Price Competition and Innovation Act of 2009.'' This
draft guidance provides answers to common questions from sponsors
interested in developing proposed biosimilar products, BLA holders, and
other interested parties regarding FDA's interpretation of the BPCI
Act.
    The BPCI Act, enacted as part of the Patient Protection and
Affordable Care Act (Pub. L. 111-148) on March 23, 2010, created an
abbreviated licensure pathway under section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)) for biological products demonstrated to
be biosimilar to, or interchangeable with, an FDA-licensed biological
reference product. This draft guidance describes FDA's current
interpretation of certain statutory requirements added by the BPCI Act
and includes questions and answers (Q&As) in the following categories:

 Biosimilarity or Interchangeability
 Provisions Related to Requirement to Submit a BLA for a
``Biological Product''
 Exclusivity

The Q&A format is intended to promote transparency and facilitate
development programs for proposed biosimilar products by addressing
questions that may arise in the early stages of development. In
addition, these Q&As respond to questions the Agency has received from
prospective BLA and new drug application (NDA) applicants regarding the
appropriate statutory authority under which certain products will be
regulated.
    FDA intends to update this guidance to include additional Q&As as
appropriate and intends to post information by Q&A number on FDA's Web
site regarding the publication date of draft guidance Q&As for comment,
the comment period, and the publication date of final guidance Q&As.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. The Paperwork Reduction Act

    This draft guidance describes information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520). In
particular, the draft guidance refers to information collections
related to the submission of a 351(k) application. In accordance with
the PRA, FDA is soliciting public comment, in a separate document
published elsewhere in this issue of the Federal Register (see ``Agency
Information Collection Activities; Proposed Collection; Comment
Request; General Licensing Provisions; Section 351(k) Biosimilar
Applications'') on the information collection associated with the
submission of a 351(k) application. FDA will also seek OMB approval for
this information collection.
    In addition, this draft guidance references other information
collections that are already approved by OMB and are not expected to
change as a result of the draft guidance. This includes information
collections related to the submission of (1) an investigational NDA,
which is covered under 21 CFR part 312 and approved under OMB control
number 0910-0014; (2) an NDA, which is covered under 21 CFR 314.50 and
approved under OMB control number 0910-0001; (3) a biologics license
application, which is covered under 21 CFR part 601 and approved under
OMB control number 0910-0338; and (4) labeling, which is covered under
21 CFR 201.57 and approved under OMB control number 0910-0572.
    The draft guidance also discusses the retention of reserve samples
of the biological products used in comparative clinical pharmacokinetic
and/or pharmacodynamic studies intended to support a proposed 351(k)
application. Such reserve samples are samples of products or other
physical objects exempt under 5 CFR 1320.3(h)(2), and thus not
considered ``information'' as that term is defined under the PRA.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3549 Filed 2-14-12; 8:45 am]
BILLING CODE 4160-01-P