[Federal Register: July 10, 2009 (Volume 74, Number 131)]
[Rules and Regulations]
[Page 33165-33170]
[DOCID:fr10jy09-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0461; FRL-8422-5]

Mandipropamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
mandipropamid in or on hops, dried cones. Syngenta Crop Protection,
Inc. requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective July 10, 2009. Objections and
requests for hearings must be received on or before September 8, 2009,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0461. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Rose Mary Kearns, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2007-0461 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before September 8, 2009.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0461, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of June 13, 2008, (73 FR 33814) (FRL-8367-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7342) by Syngenta Crop Protection, Inc., 410 Swing Road, P.O. Box
18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.637
be amended by establishing tolerances for residues of the fungicide
mandipropamid [4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
a-(2-propynyloxy)-benzeneacetamide], regulated chemical, in or on hops,
at 50 parts per million (ppm). That notice referenced a summary of the
petition prepared by Syngenta Crop Protection, Inc, the registrant,
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
changed the requested commodity ``hops'' to ``hop, dried cones.'' The
reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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 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....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 for the petitioned-for
tolerances for residues of mandipropamid on hop, dried cones at 50 ppm.
EPA's assessment of exposures and risks associated with establishing
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Mandipropamid has low or minimal acute toxicity via the oral,
dermal, and inhalation routes of exposure. It is minimally irritating
to the eye and non-irritating to the skin. It is also negative for skin
sensitization.
    Liver toxicity was the primary effect and was observed in rats,
mice, and dogs. In the 24-month rat study, nephrotoxicity was observed
in males only. The lack of liver toxicity in this long-term study was
probably due to the lower doses when compared with the 90-day study. In
a 90-day rat study, there was slight hepatotoxicity in both

sexes; there was the suggestion of effects on the liver in the 90-day
mouse study in which increased liver weights in both sexes and
microscopic pathology were observed. In the 90-day dog study liver
effects included increased cholesterol, increased liver weights and
liver enzymes (alkaline phosphatase activity, alanine aminotransferase)
and increased pigment in hepatocytes and Kupffer cells in both sexes.
Additionally, centrilobular hepatocyte vacuolation in females was
observed. In the combined chronic/carcinogenicity rat study, no effects
on the liver were noted at doses up to and including the highest dose
tested (HDT) of 61/70 mg/kg/day (M/F); however, increased
nephrotoxicity occurred in males. No liver effects were observed in the
mouse carcinogenicity study at doses up to 223/285 mg/kg/day (M/F). The
following effects on the liver were present in the 1-year dog study:
Increased incidence and severity of microscopic pigment in the liver
and increased alkaline phosphatase activity in both sexes, as well as
increased alanine aminotransferase activity in males. Therefore,
effects on the liver of rats, mice and dogs appear within 90-days (also
in the 1-year dog study); whereas, in the 24-month rat study, only
nephrotoxicity was observed and, in the 18-month mouse study, only
decreased body weight and food utilization was noted.
    There was no evidence of teratogenicity or indications of increased
neonatal sensitivity in the developmental and reproduction toxicity
studies. In the rat and rabbit developmental toxicity studies, there
were no treatment-related maternal or developmental effects observed up
to the limit dose of 1,000 mg/kg/day. In the 2-generation rat
reproduction study, the only parental/systemic effects were decreased
body weights, body weight gains, food consumption and food utilization
in males. No effects on reproduction were observed at any dose.
Offspring effects were decreased pup body weights in both sexes, but
this effect occurred at doses which also caused effects in parental
animals.
    Dermal exposure to mandipropamid for 28-days in the rat did not
result in systemic or dermal toxicity up to the limit dose of 1000 mg/
kg/day. There was no evidence of developmental effects, neurotoxicity,
mutagenicity or carcinogenicity after exposure to mandipropamid.
     Specific information on the studies received and the nature of the
adverse effects caused by mandipropamid 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 the final rule
published in the Federal Register of January 16, 2008, (73 FR 2812)
(FRL-8346-6).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    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
greater than that 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 http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for mandipropamid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of January 16, 2008.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mandipropamid, EPA considered exposure under the
petitioned-for tolerance as well as all existing mandipropamid
tolerances in (40 CFR 180.637). EPA assessed dietary exposures from
mandipropamid 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
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
mandipropamid; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues and assumed 100 percent of all crops are treated 100 percent
crop treated (PCT).
    iii. Cancer. EPA has determined that mandipropamid classified as
``not likely to be carcinogenic to humans'' based on the absence of
treatment-related increases in tumors in rat and mouse carcinogenicity
studies. Therefore, there is no cancer risk associated with the
proposed use of mandipropamid.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for mandipropamid. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    EPA did not use PCT information in assessing dietary exposure to
mandipropamid.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for mandipropamid in drinking water. These simulation models
take into

account data on the physical, chemical, and fate/transport
characteristics of mandipropamid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The Agency used the FIRST (Version 1.1.0) model for estimation of
surface water and the Screening Concentration in Ground Water (SCI-
GROW, Version 2.3) model, for estimation of ground water to determine
estimated drinking water concentrations (EDWC) of mandipropamid.
    For chronic exposures for non-cancer assessment the EDWCs are
estimated to be 36.5 ppb for surface water and 2.4 ppb for ground
water.
    Modeled estimates of surface water drinking water concentrations
were directly entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of
value 36.5 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Mandipropamid is not registered for any specific use patterns that
would result in residential exposure.
    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 mandipropamid to share a common mechanism of
toxicity with any other substances, and mandipropamid does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
mandipropamid 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 http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. 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 FQPA safety
factor (SF). 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.
    2. Prenatal and postnatal sensitivity. There is no evidence
(quantitative or qualitative) of increased susceptibility and no
residual uncertainties with regard to prenatal toxicity following in
utero exposure to rats or rabbits (developmental studies) and pre and/
or post-natal exposures to rats (reproduction study).
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
     i. The toxicity database for mandipropamid is not complete because
an immunotoxicity study is required. Despite this data gap, EPA has
concluded that the database is adequate to assess the pre- and
postnatal toxicity of mandipropamid and that there is no need for an
additional database uncertainty factor to account for the missing
study.
    EPA began requiring functional immunotoxicity testing of all food
and nonfood use pesticides on December 26, 2007. This study is not yet
available for mandipropamid. EPA has evaluated the available
mandipropamid toxicity studies for evidence of potential
immunotoxicity, including hematology, gross organ weights for spleen
and thymus, clinical chemistry and histopathology, to determine if an
additional database uncertainty factor is needed to account for
potential immunotoxicity. The overall weight of evidence suggests that
mandipropamid does not directly target the immune system. Therefore,
the Agency does not believe that conducting a functional immunotoxicity
study will result in a lower POD than the currently selected for
overall risk assessment, and therefore, a database uncertainty (UFDB)
is not needed to account for the lack of this study.
    ii. There is no indication that mandipropamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that mandipropamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to mandipropamid in drinking water. These
assessments will not underestimate the exposure and risks posed by
mandipropamid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
mandipropamid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
mandipropamid from food and water will utilize 30% of the cPAD for
(children 1-2 years of age) the population group receiving the greatest
exposure. There are no residential uses for mandipropamid.
    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).
    Mandipropamid is not registered for any use patterns that would
result in

residential exposure. Therefore, a short-term aggregate risk assessment
was not needed.
    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).
    Mandipropamid is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, an
intermediate-term aggregate risk was not needed.
    5. Aggregate cancer risk for U.S. population. Based on the absence
of treatment-related increases in tumors in rat and mouse
carcinogenicity studies with mandipropamid, EPA concludes that
mandipropamid does not pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, 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 mandipropamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem
mass spectrometry (LC/MS/MS)) is available to enforce tolerances for
mandipropamid. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no specific Codex, Canadian, or Mexican maximum residue
limits (MRLs) for mandipropamid.

C. Revisions to Petitioned-For Tolerances

    EPA changed the requested commodity ``hops'' to ``hop, dried
cones'' to harmonize with accepted tolerance terminology.

V. Conclusion

    Therefore, tolerances are established for residues of
mandipropamid, [4-chloro-N-[2-[3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-a-(2-propynyloxy)-benzeneacetamide in or on
hop, dried cones at 50 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA 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 final rule has been
exempted from review under Executive Order 12866, this final rule 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 final rule 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 section 408(d) of FFDCA, such as the tolerance 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: June 23, 2009.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. Section 180.637 is amended by alphabetically adding the following
commodity to the table in paragraph (a) to read as follows:

Sec. 180.637  Mandipropamid; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Hop, dried cones...............................                       50
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-16369 Filed 7-9-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8803-8805]
[FR Doc No: 2016-03527]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77144; File No. SR-BOX-2016-07]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend the Fee Schedule on the BOX Market LLC (``BOX'') Options Facility

February 16, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 5, 2016, BOX Options Exchange LLC (the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Exchange filed the
proposed rule change pursuant to Section 19(b)(3)(A)(ii) of the Act,\3\
and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule to
make two changes to the Volume Based Rebates for Market Makers in Non-
Auction

Transactions. First, the Exchange proposes to specify that transactions
which are not the result of a Market Maker quotation will be considered
exempt from the Tiered Volume Rebate for Market Makers in Non-Auction
Transactions. Additionally, the Exchange proposes to amend the
structure and distinguish between whether the Market Maker is a
liquidity provider or a liquidity taker within the transactions. Market
Makers will no longer be eligible for a rebate on their Non-Auction
Transactions which take liquidity. Market Maker transactions which take
liquidity or are not the result of a Market Maker quote will continue
to count toward the Market Maker's overall executed volume on BOX each
month. The text of the proposed rule change is available from the
principal office of the Exchange, at the Commission's Public Reference
Room and also on the Exchange's Internet Web site at http://boxexchange.com.

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 Section I.A.1 of the BOX Fee
Schedule (Tiered Volume Rebate for Non-Auction Transactions).
    The Exchange currently provides tiered rebates to Public Customers
and Market Makers in Non-Auction Transaction who achieve certain volume
based thresholds. The Exchange calculates percentage thresholds on a
monthly basis by totaling the Market Maker or Public Customer's
executed volume on BOX, relative to the total national Market Maker or
Customer volume in multiply-listed options classes.
    The Exchange proposes to make two changes to the Volume Based
Rebates for Market Makers in Non-Auction Transactions. First, the
Exchange proposes to specify that transactions which are not the result
of a Market Maker quotation will be considered exempt from the Tiered
Volume Rebate for Market Makers in Non-Auction Transactions.
Additionally, the Exchange proposes to amend the structure and
distinguish between whether the Market Maker is a liquidity provider or
a liquidity taker within the transactions. Market Makers will no longer
be eligible for a rebate on their Non-Auction Transactions which take
liquidity. Market Maker transactions which take liquidity or are not
the result of a Market Maker quote will continue to count toward the
Market Maker's overall executed volume on BOX each month.
    The new per contract rebate for Market Makers in Non-Auction
Transactions as set forth in Section I.A.1. of the BOX Fee Schedule
will be as follows:

----------------------------------------------------------------------------------------------------------------
                                                    Percentage thresholds of            Per contract rebate
                                                 national market maker volume in -------------------------------
                     Tier                        multiply-listed options classes
                                                            (monthly)                  Maker           Taker
----------------------------------------------------------------------------------------------------------------
1.............................................  0.000%-0.069%...................           $0.00           $0.00
2.............................................  0.070%-0.249%...................         ($0.03)           $0.00
3.............................................  0.250%-0.299%...................         ($0.05)           $0.00
4.............................................  0.300% and Above................         ($0.10)           $0.00
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                   Percentage                           Per contract rebate
                                  thresholds of  ---------------------------------------------------------------
                                    national            Penny pilot classes           Non-Penny pilot classes
                                 customer volume ---------------------------------------------------------------
             Tier                 in multiply-
                                 listed options
                                     classes           Maker           Taker           Maker           Taker
                                    (monthly)
----------------------------------------------------------------------------------------------------------------
1.............................  0.000%-0.129%...           $0.00           $0.00           $0.00           $0.00
2.............................  0.130%-0.339%...         ($0.15)         ($0.15)         ($0.40)         ($0.40)
3.............................  0.340%-0.549%...         ($0.25)         ($0.25)         ($0.50)         ($0.50)
4.............................  0.550% and Above         ($0.40)         ($0.40)         ($0.90)         ($0.70)
----------------------------------------------------------------------------------------------------------------

    The Exchange also proposes to make non-substantive technical
changes to the date and volume based fees and rebates within the BOX
Fee Schedule. Specifically, the Exchange proposes to relabel the
highest tier within each structure to clarify what percentage of volume
is needed to qualify for the tier. The Exchange also proposes to remove
the reference date at the beginning of the BOX Fee Schedule.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5) of the Act,\5\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed changes to the Tiered
Volume Rebates for Market Makers in Non-Auction Transactions are
reasonable, equitable and not unfairly discriminatory.
    Specifically, the Exchange believes that exempting transactions
which are not the result of Market Maker quote from the Market Maker
Tiered Volume Rebate is reasonable, equitable and not unfairly
discriminatory. BOX provides these volume based rebates to incentivize
Market Makers to direct order flow to the Exchange to obtain the
benefit of the rebate, which will in turn benefit all market
participants by increasing liquidity on the Exchange. The Exchange
believes by providing a rebate to only those transactions that are the
result of a quote, Market Makers will

be further encouraged to direct liquidity to BOX.
    The Exchange believes it is reasonable to amend the structure of
the Tiered Volume Rebates for Market Makers in Non-Auction Transactions
to distinguish whether the Market Maker is a liquidity provider or
liquidity taker, and remove the rebate for Market Makers that take
liquidity. As stated above, the volume thresholds and applicable
rebates are meant to incentivize Market Makers to direct order flow to
the Exchange to obtain the benefit of the rebate, which will in turn
benefit all market participants by increasing liquidity on the
Exchange. The Exchange notes that, while certain Market Maker
transactions will no longer receive a rebate, Market Maker Non-Auction
transaction fees remain lower than other account types and are in line
with the Market Maker fees at other exchanges.\6\
---------------------------------------------------------------------------

    \6\ Market Makers are charged anywhere from to $0.05 to $0.29 on
the Miami International Securities Exchange, LLC (``MIAX''), See the
MIAX Fee Schedule Section I(a)(i) ``Market Maker Transaction Fees''
and ``Market Maker Sliding Scale''; and charged $0.39 to $0.95 on
the NASDAQ OMX BX, Inc. (``BX Options'') Chapter XV, Section 2 BX
Options Market--Fees and Rebates; and charged $0.35 to $1.10 on
NASDAQ Stock Market LLC (``NOM'') Chapter XV, Section 2 NASDAQ
Options Market--Fees and Rebates.
---------------------------------------------------------------------------

    In summary, the proposed changes to the Market Maker Tiered Volume
Rebate are intended to attract order flow to the Exchange by
incentivizing Market Makers to post liquidity on BOX. The practice of
providing incentives to increase order flow is, and has been, a common
practice in the options markets. Further, the Exchange believes it is
appropriate to provide incentives for Market Makers which will result
in greater liquidity and ultimately benefit all Participants trading on
the Exchange.
    The Exchange believes that the non-substantive technical changes to
the BOX Fee Schedule are reasonable, equitable and not unfairly
discriminatory. Specifically, the Exchange believes it is reasonable
and appropriate to clarify the parameters of those tiers in order for
Participants to better understand what percentage of volume qualifies
for a rebate. The Exchange also believes it is reasonable to remove the
reference date, as doing so will reduce investor confusion.

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 amending the proposed rebate structure
for Marker [sic] Maker Non-Auction Transactions will not impose a
burden on competition among various Exchange Participants. The Exchange
believes that the proposed changes will result in Market Makers being
rebated appropriately for these transactions. Further, the Exchange
believes that this proposal will enhance competition between exchanges
because it is designed to allow the Exchange to better compete with
other exchanges for order flow.
    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing exchanges. In such an environment, the Exchange must
continually review, and consider adjusting, its fees and credits to
remain competitive with other exchanges. For the reasons described
above, the Exchange believes that the proposed rule change reflects
this competitive environment.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act\7\ and Rule 19b-4(f)(2)
thereunder,\8\ because it establishes or changes a due, or fee.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BOX-2016-07 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2016-07. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BOX-2016-07, and should be
submitted on or before March 14, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Brent J. Fields,
Secretary.
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2016-03527 Filed 2-19-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Page 7894]
[FR Doc No: 2011-3229]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

Time and Date: March 3, 2011, 12 noon to 3 p.m., Eastern Daylight Time.

Place: This meeting will take place telephonically. Any interested
person may call<PHONE_NUMBER>, passcode, 4856462 to participate in this
meeting.

Status: Open to the public.

Matters To Be Considered: The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Issued on: February 8, 2011.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. 2011-3229 Filed 2-9-11; 4:15 pm]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 74 (Wednesday, April 17, 2019)]
[Notices]
[Pages 16007-16008]
[FR Doc No: 2019-07717]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG19-90-000.
    Applicants: Mesteno Windpower, LLC.
    Description: Self-Certification of Exempt Wholesale Generator
Status of Mesteno Windpower, LLC.
    Filed Date: 4/11/19.

    Accession Number: 20190411-5049.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: EG19-91-000.
    Applicants: Kawailoa Solar, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5108.
    Comments Due: 5 p.m. ET 5/2/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2437-012.
    Applicants: Arizona Public Service Company.
    Description: Additional Supplement to December 28, 2018 Triennial
Market Power Update of Arizona Public Service Company.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5113.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-610-000.
    Applicants: Marengo Battery Storage, LLC.
    Description: Second Supplement to December 20, 2018 Marengo Battery
Storage, LLC tariff filing.
    Filed Date: 4/10/19.
    Accession Number: 20190410-5246.
    Comments Due: 5 p.m. ET 4/17/19.

    Docket Numbers: ER19-871-000.
    Applicants: Southwestern Electric Power Company.
    Description: Report Filing: SWEPCO-ETEC Contracting Services Agrs.
Refund Report to be effective N/A.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5123.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-1548-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: E&P Agreement for EDPR CA
Solar Park to be effective 4/11/2019.
    Filed Date: 4/10/19.
    Accession Number: 20190410-5161.
    Comments Due: 5 p.m. ET 5/1/19.

    Docket Numbers: ER19-1549-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Sec.  205(d) Rate Filing: 2019-04-10_SA 2880 Att A-
Project Specifications No. 3 WVPA-EnerStar-Ferrell to be effective 3/
18/2019.
    Filed Date: 4/10/19.
    Accession Number: 20190410-5177.
    Comments Due: 5 p.m. ET 5/1/19.

    Docket Numbers: ER19-1550-000.
    Applicants: New England Power Pool Participants Committee, ISO New
England Inc.
    Description: Sec.  205(d) Rate Filing: Lotus Danbury One
Termination to be effective 6/10/2019.
    Filed Date: 4/10/19.
    Accession Number: 20190410-5200.
    Comments Due: 5 p.m. ET 5/1/19.

    Docket Numbers: ER19-1551-000.
    Applicants: Old Dominion Electric Cooperative.
    Description: Sec.  205(d) Rate Filing: Superseding Cost-of-Service
Rate Schedule to be effective 6/10/2019.
    Filed Date: 4/10/19.
    Accession Number: 20190410-5201.
    Comments Due: 5 p.m. ET 5/1/19.

    Docket Numbers: ER19-1552-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Notice of Termination of Small Generator
Interconnection Agreement (No. 404) of Pacific Gas and Electric
Company.
    Filed Date: 4/10/19.
    Accession Number: 20190410-5204.
    Comments Due: 5 p.m. ET 5/1/19.

    Docket Numbers: ER19-1553-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: SCE Transmission Owner
Tariff Formula Rate Filing (TO2019A) to be effective 6/12/2019.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5001.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-1554-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3548 Rolling Thunder I Power
Partners GIA to be effective 4/4/2019.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5021.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-1555-000.
    Applicants: Mt. Tom Generating Company, LLC.
    Description: Tariff Cancellation: Notice of Cancellation of FERC
Electric Tariff, Volume No. 1 to be effective 4/12/2019.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5037.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-1556-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revision to be effective 6/11/2019.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5060.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-1557-000.
    Applicants: NorthWestern Corporation.
    Description: Tariff Cancellation: Cancellation of LGIA with Rolling
Thunder I Power Partners LLC, SA 30-SD to be effective 4/4/2019.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5061.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-1558-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-04-11_SA 3291 Duke
Energy-Roaming Bison Renewables GIA (J754) to be effective 3/28/2019.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5081.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-1559-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-Sharyland Utilities IA
Second Amend & Restated to be effective 3/27/2019.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5104.
    Comments Due: 5 p.m. ET 5/2/19.

    Docket Numbers: ER19-1560-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: TNC-Sharyland Utilities
Interconnection Agreement to be effective 3/27/2019.
    Filed Date: 4/11/19.
    Accession Number: 20190411-5110.
    Comments Due: 5 p.m. ET 5/2/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 11, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-07717 Filed 4-16-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: October 31, 2008 (Volume 73, Number 212)]
[Rules and Regulations]
[Page 64885]
[DOCID:fr31oc08-10]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]

Oral Dosage Form New Animal Drugs; Firocoxib Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Merial Ltd. The supplemental NADA provides
for veterinary prescription use of firocoxib chewable tablets in dogs
for the control of postoperative pain and inflammation associated with
orthopedic surgery.

DATES: This rule is effective October 31, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, filed a supplement to NADA 141-230 for
PREVICOX (firocoxib) Chewable Tablets. The supplemental application
provides for the veterinary prescription use of firocoxib chewable
tablets in dogs for the control of postoperative pain and inflammation
associated with orthopedic surgery. The NADA is approved as of
September 23, 2008, and the regulations in 21 CFR 520.928 are amended
to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
    The agency has determined under 21 CFR 25.33(d)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  520.928, revise paragraphs (c)(1) and (c)(2) to read as
follows:

Sec.  520.928  Firocoxib tablets.

* * * * *
    (c) * * *
    (1) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily
for osteoarthritis. Administer approximately 2 hours before soft-tissue
or orthopedic surgery.
    (2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis; and for the control of postoperative
pain and inflammation associated with soft-tissue and orthopedic
surgery.
* * * * *

    Dated: October 17, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-26020 Filed 10-30-08; 8:45 am]

BILLING CODE 4160-01-P


BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

Notice of

MESABA AVIATION, INC.

	d/b/a MESABA AIRLINES

of intent to terminate service at Youngstown,

Ohio pursuant to 49 U.S.C. § 41734

and 14 C.F.R. § 323

	)

)

)

)

)

)

)

)

)

)	Docket OST-02-

Dated:  June 10, 2002

NOTICE OF TERMINATION OF SERVICE AT

YOUNGSTOWN, OHIO

Mesaba Aviation, Inc. d/b/a Mesaba Airlines (“Mesaba”) hereby submits notice, pursuant to 49 U.S.C § 41734 and 14 C.F.R. § 323.3, of its intent to terminate service to Youngstown, Ohio, effective September 8, 2002.  Mesaba provides this service as Northwest Airlink.  In support of this Notice, Mesaba states the following:

1.	Mesaba is a certificated air carrier, whose corporate office is located at:

		7501 26th Avenue South

		Minneapolis, MN  55450

<PHONE_NUMBER>.

Communications with respect to this Notice should be directed to:

		Robert E. Weil

Vice President and Chief Financial Officer

Mesaba Airlines

7501 26th Avenue South

		Minneapolis, MN  55450

<PHONE_NUMBER>

FAX:<PHONE_NUMBER>

2.	No other carrier is currently serving Youngstown from a large or medium hub.  The Department, moreover, has determined that it cannot require any carrier to continue service beyond the termination period because Youngstown is located only 56 highway miles from a large hub airport:  Pittsburgh.  See DOT Order 99-11-21, at 2-3 (Dec. 3, 1999).

3.	The routing and schedule of the service that Mesaba is terminating on September 8, 2002 is as follows:

From		Departure	To		Arrival	Frequency

DTW		13:50		YNG		15:42		Daily one stop via CAK

DTW		19:50		YNG		20:52		Daily one stop via CAK

YNG		16:05		DTW		17:59		Daily one stop via CAK

YNG		07:30		DTW		09:25		Daily one stop via CAK

4.	Mesaba operates these flights with Saab SF340 aircraft (34 passenger seats).

5.	Mesaba intends to terminate the service on September 8, 2002.

6.	In 1983, the Department determined that the level of essential air service for Youngstown was a minimum of two daily roundtrips to/from Chicago and two daily roundtrips to/from Pittsburgh.  See DOT Order 83-11-19 (Nov. 4, 1983).  This Order required that the Pittsburgh service must be provided on a nonstop basis, while the Chicago service may be provided on a two-stop basis.  Id.  Subsequently, in 1999, the Department amended the 1983 essential air service requirement to recognize service to any large or medium hub.  DOT Order 99-11-21 (Dec. 3, 1999).  The Department also determined that it could not subsidize any carrier serving Youngstown because this community was 56 highway miles from Pittsburgh and, therefore, could not require any carrier to continue serving Youngstown beyond the 90-day termination notice period.  Id.  The Department, however, continued to require notice of the termination, and Mesaba is complying with this notice requirement.

7.	The effective date of this Notice is June 10, 2002.  Objections to this Notice are due within 20 days of this Notice or on July 1, 2002.

8.	As required by 14 C.F.R. § 323.7(a), this Notice is being served upon all persons listed on the attached service list.

Respectfully submitted,

/s/ Robert E. Weil /s/

Robert E. Weil

Vice President and Chief Financial Officer

MESABA AIRLINES

7501 26TH Avenue South

Minneapolis, MS  55450

(612) 726-5151

Dated:  June 10, 2002

SERVICE LIST

On this 10th day of June 2002, a copy of this NOTICE OF TERMINATION was served by first class mail, postage prepaid, upon each of the persons below:

Dennis DeVany, Chief

EAS and Domestic Analysis, X-53

U.S. Department of Transportation

400 Seventh Street, S.W.

Room 6417I

Washington, D.C.  20590

	Thomas P. Nolan, Director

Youngstown-Warren Regional Airport

1453 Youngstown Kingsville Road, N.E.

Vienna, OH  44473

George McKelvey, Mayor

City of Youngstown

120 Market Street

Youngstown, OH  44503

	Patricia E. Davis, Postmaster

Youngstown Post Office

99 South Walnut Street

Youngstown, OH  44501

(…continued)

(continued…)

NOTICE OF TERMINATION OF

MESABA AIRLINES

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