[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Proposed Rules]
[Pages 16279-16281]
[FR Doc No: 2020-05774]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0271; Product Identifier 2017-SW-017-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus Helicopters Model AS350B2 helicopters. This proposed
AD would require performing a test of the main rotor RPM (NR)
indicator, and depending on the results, altering the wiring. This
proposed AD is prompted by reports of some NR indicators displaying
incorrect information. The actions of this proposed AD are intended to
address an unsafe condition on these products.

DATES: The FAA must receive comments on this AD by May 22, 2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0271; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Union Aviation Safety Agency (previously
European Aviation Safety Agency) (EASA) AD, any comments received, and
other information. The street address for Docket Operations is listed
above. Comments will be available in the AD docket shortly after
receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
view the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: George Schwab, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views. The FAA also invites comments
relating to the economic, environmental, energy, or federalism impacts
that might result from adopting the proposals in this document. The
most helpful comments reference a specific portion of the proposal,
explain the reason for any recommended change, and include supporting
data. To ensure the docket does not contain duplicate comments,
commenters should send only one copy of written comments, or if
comments are filed electronically, commenters should submit only one
time.
    The FAA will file in the docket all comments received, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal,
the FAA will consider all comments received on or before the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this proposal in light of the
comments received.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2016-0260, dated December 21,
2016, to correct an unsafe condition for Airbus Helicopters Model
AS350B2 helicopters with a certain part-numbered NR sensor installed.
EASA advises of several occurrences where the NR indicator has
displayed incorrect data. According to EASA, an investigation
determined that whenever the emergency cut-out control was activated,
such as during a practice autorotation, electrical power to the NR
indicator was lost. The EASA AD states that this condition, if not
detected and corrected, could result in a significant increase in pilot
workload, disruption of the autorotation training, and subsequent
reduced control of the helicopter. To address this unsafe condition,
the EASA AD requires a functional check of the NR indicator display,
and, if required, altering the wiring to ensure a dual power supply to
the NR indicator.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that an
unsafe condition is likely to exist or develop on other helicopters of
the same type designs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Airbus Helicopters Alert Service Bulletin No.
AS350-63.00.27, Revision 0, dated May 17, 2016. This service
information contains procedures for performing a functional check of
the NR indicator, and, if necessary, altering the wiring to add a
direct battery supply to the NR indicator. Airbus Helicopters
identifies this alteration as Modification 350A084886.00.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements

    This proposed AD would require compliance with certain procedures
described in the manufacturer's service bulletins. For Model AS350B2
helicopters with an NR sensor part number 704A37614007 installed, this
proposed AD would require, before further flight, performing a test to
determine if the NR indicator display changes or drops to zero when the
emergency cut-out control is activated. If the NR display changes or
drops to zero during the ground run, this proposed AD would require,
before further flight, altering the NR sensor wiring.

Differences Between This Proposed AD and the EASA AD

    The EASA AD requires compliance within 75 flight hours, within 90
days, or before the next autorotation training flight, whichever occurs
first. This proposed AD would require compliance before further flight
due to the critical nature of NR information for the pilot during an
autorotation.

Costs of Compliance

    The FAA estimates that this proposed AD affects 352 helicopters of
U.S. Registry. The FAA estimates that operators may incur the following
costs in order to comply with this AD. Labor costs are estimated at $85
per work-hour.
    Performing a functional test of the NR indicator would require
about 0.5 work-hours for an estimated cost of $43 per helicopter and
$15,136 for the U.S. fleet. If required, altering the NR sensor wiring
would take about 2 work-hours, and parts would cost about $154, for an
estimated cost of $324 per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Will not affect intrastate aviation in Alaska; and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus Helicopters: Docket No. FAA-2020-0271; Product Identifier
2017-SW-017-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model AS350B2 helicopters,
certificated in any category, with a main rotor RPM (NR) sensor part
number 704A37614007 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as loss of electrical power
to the NR indicator when the emergency cutout control is activated.
This condition could result in increased pilot workload and reduced
helicopter control.

(c) Comments Due Date

    The FAA must receive comments by May 22, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Before further flight, perform a ground run-up with the fuel
flow control lever in the flight gate with the collective control in
the down/locked position. While at flight NR speed, activate the
emergency cut-out control and observe the NR indicator display
value. If the NR indicator display changes or drops to zero, before
further flight, do the following:
    (1) Alter the NR indicator wiring as depicted in Figures 1 and 2
of Airbus Helicopters Alert Service Bulletin No. AS350-63.00.27,
Revision 0, dated May 17, 2016; and, Note 1 to paragraph (e)(1) of
this AD: Airbus Helicopters identifies the alteration of the wiring
as Modification 350A084886.00.
    (2) Conduct a continuity test to confirm correct alteration of
the wiring.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch FAA, may approve AMOCs for this AD. Send your proposal to:
George Schwab, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office, before operating any
aircraft complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Union Aviation
Safety Agency (previously European Aviation Safety Agency) (EASA) AD
No. 2016-0260, dated December 21, 2016. You may view the EASA AD on
the internet at https://www.regulations.gov in the AD Docket.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6340 Main Rotor
Drive Indicating System.

    Issued on March 13, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-05774 Filed 3-20-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]
[Page 37612-37618]
[DOCID:fr29jy09-19]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0556; FRL-8420-6]

Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues
of fenpyroximate in or on raw agricultural commodities (RAC):
Vegetables, fruiting, group 8 at 0.20 ppm; okra at 0.20 ppm; melon
subgroup 9A at 0.10 ppm; and cucumber at 0.10 ppm. The Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 29, 2009. Objections and
requests for hearings must be received on or before September 28, 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-2008-0556. 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: Sidney Jackson, 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-2008-0556 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 28, 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-2008-0556, 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 August 13, 2008 (73 FR 47186) (FRL-8375-
8), 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
8E7365) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.566 be amended by
establishing tolerances for residues of the insecticide fenpyroximate,
(E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)
methylene] amino]oxy]methyl] benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene]
amino]oxy] methyl] benzoate in or on food commodities vegetables,
fruiting, group 08 at 0.20 ppm; okra at 0.20 ppm; melon subgroup 09A at
0.03 ppm; and cucumber at 0.05 ppm. That notice referenced a summary of
the petition prepared by Nichino America, Inc., of Wilmington, DE
19808, 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 available field trial residue data supporting
the petition, EPA determined that the proposed tolerance levels for
certain crops should be revised as follows: Melon subgroup 9A increased
from 0.03 ppm to 0.10 ppm and cucumber increased from 0.05 ppm to 0.10
ppm. The reasons for these changes are explained in Unit IV.D.

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 combined residues of fenpyroximate and its Z-isomer in
or on food commodities vegetables, fruiting, group 8 at 0.20 ppm; okra
at 0.20 ppm; melon subgroup 9A at 0.10 ppm; and cucumber at 0.10 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 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.
    Fenpyroximate has moderate oral and inhalation toxicity. It has low
dermal toxicity and is not an eye or skin irritant. Fenpyroximate is a
slight to moderate skin sensitizer by the maximization test method.
    Subchronic oral toxicity studies in the rat show the primary
effects included decreased body-weight and weight gain at the lowest
observed adverse effect level (LOAEL) while there were hematological
effects at higher doses. In the 21-day dermal toxicity study in rats,
there were clinical signs in the females (including red nose/mouth/
nasal discharge); decreased body-weights, body-weight gains, and food
consumption in males and females; and increased liver weights and
hepatocellular necrosis in the females. In the subchronic oral dog
study, there was bradycardia observed at the LOAEL. This effect was
present at 6 weeks (first time point measured) and did not appear to
increase in severity with time. Also observed at this dose level were
diarrhea, decreased body-weight, body-weight gain, and food
consumption. At higher doses, there was also emesis. The highest dose
resulted in first- and second-degree heart block, increased urea
concentration, decreased glucose and altered plasma electrolyte levels
among other signs of toxicity.
    In the chronic oral rat and mouse studies, signs of toxicity were
similar to those in the oral subchronic rat study. The chronic dog
study also revealed signs of toxicity including bradycardia, diarrhea,
decreased body-weight gain, and food consumption.
    The 2-generation reproductive toxicity study indicated that
maternal (decreased body-weight) and offspring toxicity (decreased
lactational weight gain) occurred at the same dose, suggesting no
evidence of sensitivity or susceptibility. Reproductive parameters were
not affected in this 2-generation reproduction study. The rat and
rabbit developmental toxicity studies were tested at doses that
produced minimal maternal toxicity.
    There are no neurotoxicity studies other than a negative delayed
acute neurotoxicity study in the hen. There was no indication of
neurotoxicity present in any of the existing subchronic or chronic
toxicity studies.
    There was no concern for mutagenic activity in several studies
including: Salmonella, E. Coli, in vitro mammalian cell gene mutation
assay at the HGPRT locus, mammalian cell chromosome aberration assay,
in vivo mouse bone marrow micronucleus assay, DNA repair disk diffusion
assay, and an unscheduled DNA synthesis assay.
    There was no evidence of carcinogenic potential in either the rat
or mouse study.
    Specific information on the studies received and the nature of the
adverse effects caused by fenpyroximate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document Fenpyroximate. Petition for the
Establishment of Permanent Tolerances for Residues on Fruiting
Vegetable (crop Group 8), Okra. Human Health Risk Assessment, dated 12/
23/2008, page 14 in docket ID number EPA-HQ-OPP-2008-0556-0004.

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 fenpyroximate used for
human risk assessment can be found at http://www.regulations.gov in
document Fenpyroximate. Petition for the Establishment of Permanent
Tolerances for Residues on Fruiting Vegetable (Crop Group 8), Okra.
Human Health Risk Assessment, dated 12/23/2008, page 12 in docket ID
number EPA-HQ-OPP-2008-0556-0004.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenpyroximate, EPA considered exposure under the
petitioned-for tolerances as well as all existing fenpyroximate
tolerances in (40 CFR 180.566). EPA assessed dietary exposures from
fenpyroximate 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. An acute dietary-exposure
assessment was conducted for females 13-49 years old. Since an effect
of concern attributable to a single dose in toxicity studies was not
identified for the general U.S. population, an acute dietary-exposure
assessment was not

performed for subgroups other than females 13-49 years old.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA conducted acute
dietary analysis for fenpyroximate assuming 100 percent crop treated
(PCT) and existing and proposed tolerance-level residues for all
commodities. DEEM (ver. 7.81) default processing factors were assumed
for all commodities excluding apple, pear, and grape juice (0.11x);
grape, raisin (2.7x); orange, grapefruit, tangerine, lemon and lime
juice (0.06x); tomato paste (1.0x) and puree (1.0x); and peppermint and
spearmint oil (0.08x). The petitioner submitted adequate tomato
processing data indicating that residues of fenpyroximate per se did
not concentrate in tomato paste or puree as all processing factors were
<1.0x. Residues of the Z-isomer did not concentrate in tomato puree;
however, residues of Z-isomer concentrated slightly in tomato paste.
When residues are combined, the average processing factors were <0.89x
for tomato paste and <0.57x for tomato puree. Default processing factor
of 1.0x was assumed for both tomato paste and tomato puree. Available
data support processing factors presented in Unit C.1. for stated
commodities.
    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 assumed 100 PCT and
existing and proposed tolerance-level residues for all commodities.
DEEM (ver. 7.81) default processing factors were assumed with the
exceptions listed in Unit C.1.
    iii. Cancer. Fenpyroximate is classified as ``not likely to be a
human carcinogen.'' There was no evidence of carcinogencity in mice
studies or in combined chronic/carcinogenicity studies in the rat. In
addition, bacterial reverse mutation and in vitro mammalian cell gene
mutation studies showed no mutagenic effects. Therefore, a cancer
dietary exposure assessment was not performed.
    The assumption of 100 PCT and tolerance level residues was made for
all registered and proposed commodity uses of fenpyroximate.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fenpyroximate in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenpyroximate. 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 nature of fenpyroximate residues in plants and animals is
understood. The residues of concern for plants are fenpyroximate and
its Z-isomer (also referred to as M-1). The residues of concern for
livestock milk, fat, meat and meat by-products are parent and multiple
metabolites. Livestock residues, however, are not relevant to this
petition. EPA determined that the residues in plants and livestock raw
agricultural commodities for the purposes of tolerance enforcement and
risk assessment are the parent compound, fenpyroximate, plus its Z-
isomer and metabolites and that parent, Z-isomer and metabolite M-3
should be considered as residues of concern in drinking water. Based on
the proposed application rates and the environmental fate properties of
fenpyroximate, some surface and ground water contamination may occur.
However, the risk of water contamination from parent compound is
relatively low, based on its high sorption potential. Unlike parent
compound, the sorption of the M-3 metabolite is much less, and it may
move into water resources more readily. Environmental fate data
indicate that parent and its Z-isomer are stable to photolysis in soil
and immobile in soil. Major degradates formed in the aqueous layer were
M-3 (50%), M-8 (36%), M-16 (4-hydroxymethylbenzoic acid, 58%) and M-11
(25 to 30%), and M-3 (>10%), M-11 (25 to 30%) and M8 (16 to 19%) in the
soil. However, data from a field dissipation study showed M3 (32%)
being the only significant degradate found in the field. Based on the
structural similarity between parent and M-3, the Agency concluded that
parent and M-3 should be included in the risk assessment.
    The EDWCs were Tier 1 estimates for ground water using the
Screening Concentration in Ground Water (SCI-GROW) model and surface
water using the First Index Reservoir Screening Tool (FIRST) model for
fenpyroximate and its metabolites. The models utilized an application
rate of 0.2 lb ai/A with 2 applications per season.
    Based on the FIRST, and SCI-GROW models, the EDWCs of fenpyroximate
for acute exposures are estimated to be 8.74 parts per billion (ppb)
for surface water and 0.001 ppb for ground water. For chronic exposures
for non-cancer assessments are estimated to be 0.51 ppb for surface
water and 0.001 ppb for ground water. Parent, Z-isomer and metabolite
M-3 are of concern in water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 8.74 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.51 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).
    Fenpyroximate 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 fenpyroximate to share a common mechanism of
toxicity with any other substances, and fenpyroximate does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fenpyroximate 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 are available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no concern for pre-
and/or post-natal toxicity resulting from exposure to fenpyroximate.
There is no evidence (qualitative or quantitative) of increased
susceptibility following pre- and post-natal exposure in adequate
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat.
    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 fenpyroximate is adequate to
characterize potential pre-natal and post-natal risk for infants and
children. Acceptable/guideline studies for developmental toxicity in
rats and rabbits and reproduction toxicity in rats are available for
FQPA assessment.
    EPA began requiring functional immunotoxicity testing of all food
and non-food use pesticides on December 26, 2007. Since this
requirement went into effect relatively recently, these studies are not
yet available for fenpyroximate. In the absence of specific
immunotoxicity studies, EPA has evaluated the available fenpyroximate
toxicity database to determine whether an additional database
uncertainty factor is needed to account for potential immunotoxicity.
No evidence of immunotoxicity was found. Due to the lack of evidence of
immunotoxicity for fenpyroximate, EPA does not believe that conducting
immunotoxicity testing will result in a NOAEL less than the cRfD NOAEL
of 0.97 mg/kg bw/day already established for fenpyroximate, and an
additional factor (UFDB) for database uncertainties is not
needed to account for potential immunotoxicity.
    Acute and subchronic neurotoxocity testing in rats is also required
as a result of changes made to the pesticide data requirements in
December of 2007. Although neurotoxicity studies in rats have not yet
been submitted, there is no evidence of neurotoxicity in any study in
the toxicity database for fenpyroximate. Therefore, EPA has concluded
that an additional uncertainty factor is not needed to account for the
lack of these data.
    The residue chemistry and environmental fate databases are
complete.
    ii. There is no indication that fenpyroximate 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 fenpyroximate 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 for existing and proposed uses.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to fenpyroximate in
drinking water. These assessments will not underestimate the exposure
and risks posed by fenpyroximate.

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. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
fenpyroximate will occupy 6.6% of the aPAD for (females 13-49 years)
the only population group of interest.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fenpyroximate from food and water will utilize 38% of the cPAD for
(children 1-2 years old) the population group receiving the greatest
exposure. There are no residential uses for fenpyroximate.
    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).
    Fenpyroximate is not registered for any use patterns that would
result in residential exposure. Therefore, the short-term aggregate
risk is the sum of the risk from exposure to fenpyroximate through food
and water and will not be greater than the chronic aggregate risk.
    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).
    Fenpyroximate is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to fenpyroximate through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Fenpyroximate is
classified as not likely to be carcinogenic to humans. Therefore,
fenproximate is not expected to 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 fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method is available for determination of
fenpyroximate residues of concern in plants. A gas chromatography
method with nitrogen/phosphorus detection (GC/NPD), Method S19, has
passed an Agency validation. Method S19 has a limit of quantitation of
0.10 ppm for the combined residues of fenpyroximate and its Z-isomer.
    Adequate enforcement methodology (gas chromatography (GC/NPD) is
available to enforce the tolerance expression. 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

    Codex and Mexican maximum residue limits (MRLs) are established for
residues of fenpyroximate per se in/on several crop commodities but not
for the crops requested. Harmonization with the other Codex and Mexican
MRLs is not possible because the U.S. tolerance expressions include
additional metabolites/isomers. There are currently no established
Canadian MRLs.

C. Revisions to Petitioned-For Tolerances

    Based upon available data supporting petitioned-for tolerances, the
Agency revised and/or modified the petitions as proposed in the notice
of filing, as follows:
    1. Proposed tolerance level for melon subgroup 9A at 0.03 ppm was
increased to 0.10 ppm. Available residue data for cantaloupe, the
representative crop, are adequate to fulfill data requirements. The
number and locations of field trials conducted are in accordance with
EPA Guideline 860.1500, and the trials reflect the proposed use
pattern. The residue data were not entered into the Agency's tolerance
spreadsheet because all treated samples bore combined residues below
the limit of quantitation (LOQ) of <0.10 ppm. The available data for
cantaloupe will support a tolerance of 0.10 ppm (the combined LOQs of
the enforcement method for the parent compound and the Z-isomer) for
fenpyroximate residues in/on melon subgroup 9A.
    2. The Agency modified the proposed tolerance for residues in/on
cucumber from 0.05 ppm to 0.10 ppm based on available residue data.
Residue data include field trials where a single foliar application of
fenpyroximate at maximum proposed seasonal rate was made. Results show
that the maximum combined residues of fenpyroximate and its Z-isomer
in/on cucumbers was <0.03 ppm at 7-day PHI.
    These data were entered into the Agency's tolerance spreadsheet as
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP to determine an appropriate tolerance level. The
Agency determined that the appropriate RAC tolerance for cucumber is
0.10 ppm (the combined LOQs of the enforcement method for the parent
compound and the Z-isomer).

V. Conclusion

    Therefore, tolerances are established for combined residues of
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl) methylene] amino]oxy]methyl] benzoate and its Z-isomer,
(Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene] amino]oxy] methyl] benzoate in or on food commodities:
vegetables, fruiting, group 8 at 0.20 ppm; okra at 0.20 ppm; melon
subgroup 9A at 0.10 ppm; and cucumber at 0.10 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: July 20, 2009.
G. Jeffrey Herndon,
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 180.566 is amended by revising the term ``residues'' to read
``combined residues'' in introductory paragraphs (a)(1), (a)(2) and
(a)(3); and by alphabetically adding the following commodities to the
table in paragraph (a)(1) to read as follows:

Sec. 180.566  Fenpyroximate; tolerances for residues.

    (a) General. (1) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Cucumber..............................................                                                      0.10
                                                    * * * * *
Melon subgroup 9A.....................................                                                      0.10
                                                    * * * * *
Okra..................................................                                                      0.20
                                                    * * * * *
Vegetable, fruiting, group 8..........................                                                      0.20
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. E9-17942 Filed 7-28-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Notices]
[Page 15788-15789]
[DOCID:fr29mr06-145]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53535; File No. SR-NASD-2006-027]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Order Granting Accelerated Approval
of Proposed Rule Change and Amendment Nos. 1 and 2 Thereto Establishing
CTCI Station-Based Pricing for Non-Members

March 21, 2006.
    Pursuant to 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 February 22, 2006, the National Association of Securities Dealers,
Inc. (``NASD''), through its subsidiary, The Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by Nasdaq. Nasdaq filed
Amendment No. 1 on March 10, 2006, and Amendment No. 2 on March 14,
2006. The Commission is publishing this notice to solicit comments on
the proposed rule change, as modified by Amendment Nos. 1 and 2, from
interested persons, and simultaneously granting accelerated approval of
the proposed rule change, as amended.
---------------------------------------------------------------------------

    \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

    Nasdaq proposes to modify fees for Nasdaq access through the
Computer to Computer Interface (``CTCI'') protocol for non-members. The
text of the proposed rule change is below. Proposed new language is in
italics; proposed deletions are in brackets.\3\
---------------------------------------------------------------------------

    \3\ Changes are marked to the rule text that appears in the
electronic NASD Manual found at http://www.nasd.com, as amended on

an immediately effective basis by SR-NASD-2006-026. See footnote 3
supra. Prior to the date when The NASDAQ Stock Market LLC (``NASDAQ
LLC'') commences operations, NASDAQ LLC will file a conforming
change to the rules of NASDAQ LLC approved in Securities Exchange
Act Release No. 53128 (January 13, 2006), 71 FR 3550 (January 23,
2006) (File No. 10-131).
---------------------------------------------------------------------------

Rule 7010. System Services
    (a)-(e) No Change
    (f)(1)-(3) No Change
(4) Computer to Computer Interface (CTCI)
    The fees in the table below are applicable to CTCI subscribers
[NASD members] that have transitioned off of Nasdaq-supported circuits,
and as of the July 1, 2006, also apply to CTCI subscribers [NASD
members] that have not transitioned.

                                Stations
------------------------------------------------------------------------
                                                          Fee  Station/
                     Fee component                            month
------------------------------------------------------------------------
1st Station............................................             $200
Each Additional Station................................              600
------------------------------------------------------------------------

    The bandwidth fees in the table below apply to [NASD members] CTCI
subscribers that have not transitioned off of Nasdaq-supported
circuits[, and, pending approval of SR-NASD-2006-027, to non-members as
indicated].

                                Bandwidth
------------------------------------------------------------------------
             Fee component                             Fee
------------------------------------------------------------------------
Single 56kb line with single hub and     $900/month [for members $975/
 router (for remote disaster recovery     month for non-members].
 sites only).
Option 1 Dual 56kb lines (one for        $1,000/month [for members
 redundancy) and single hub and router.   $1,275/month for non-members].
Option 2 Dual 56kb lines (one for        $1,200/month [for members
 redundancy), dual hubs (one for          $1,600/month for non-members].
 redundancy), and dual router (one for
 redundancy).
Option 3 Dual T1 lines (one for          $2,500/month [for members
 redundancy), dual hubs (one for          $8,000/month for non-members].
 redundancy), and dual routers (one for
 redundancy). Includes base bandwidth
 of 128kb.
Bandwidth Enhancement Fee (for T1        $200/month [for members $600/
 subscribers only) Per 64kb increase      month for non-members]
 above 128kb T1 base.
Option 1, 2, or 3 with Message Queue     Fee for Option 1, 2, or 3
 software enhancement.                    (including any Bandwidth
                                          Enhancement Fee) plus 20%
Installation Fee.......................  $2,000 per site for dual hubs
                                          and routers.
                                         $1,000 per site for single hub
                                          and router.
Relocation Fee (for the movement of TCP/ $1,700 per relocation.
 IP--capable lines within a single
 location).
------------------------------------------------------------------------

(5) New Nasdaq Workstation No Change
    (g)-(w) No Change
* * * * *

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

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item III below. Nasdaq 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
    On February 22, 2006, Nasdaq filed SR-NASD-2006-026, to modify fees
for members to establish access to Nasdaq through the CTCI protocol
(effective February 22, 2006). The instant proposed rule change will
apply to non-members a pricing schedule identical to that schedule
Nasdaq instituted for members in SR-NASD-2006-026.\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 53536 (March 21,
2006).
---------------------------------------------------------------------------

    Through the implementation of FIX and QIX and the sunset of the
SDP/API, Nasdaq has continued towards its goal of allowing firms and
service bureaus to choose their own circuit connectivity provider for
access to Nasdaq's products and services. CTCI is the only remaining
Nasdaq protocol that requires the firm to choose a Nasdaq-provided
circuit for connectivity. In order for Nasdaq to complete its strategy,
Nasdaq seeks to modify the CTCI pricing structure in

order to transition from circuit-based fee components based on
bandwidth to ``Station'' fee components that are more synonymous with
logical access ports.
    CTCI Stations are logical channels used to manage the flow of data
to and from the firm user. Stations are synonymous with the logical
access ports used for FIX and QIX as they have the same
characteristics, including a one to one relationship between the firm
and Station and throughput limits. For this reason, Nasdaq chose a
Station-based fee component for its new pricing. In order to facilitate
the transition, Nasdaq seeks to modify the current bandwidth based fees
to Nasdaq's circuit cost imposed by its carrier plus an administration
cost. Firms that decide not to transition off of Nasdaq supported
circuits will pay the new bandwidth-based fees in addition to Station
fees. Nasdaq expects almost all firms to transition to new circuit
connections but that the transition date will be different for each
firm. As a result, Nasdaq intends to implement the new pricing
structure once a firm has transitioned to a different circuit
connection. However, the new pricing will be applied to all firms on
July 1, 2006 regardless of the firm's transition plan. Thus, a firm
that transitions will pay only the station fee. A firm that does not
transition will pay only the bandwidth fee prior to July 1, but will
pay both the station and the bandwidth fee between July 1 and the date
when it does transition.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 15A of the Act,\5\ in general, and with
Section 15A(b)(5) of the Act,\6\ in particular, in that the proposal
provides for the equitable allocation of reasonable dues, fees, and
other charges among members and issuers and other persons using any
facility or system which NASD operates or controls. The proposed rule
change applies to non-members and will modify the current CTCI pricing
structure in order to transition from circuit-based fee components
based on bandwidth to ``Station'' fee components that are more
synonymous with logical access ports.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78o-3.
    \6\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-027 on the subject line.

Paper Comments

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

All submissions should refer to File Number NASD-2006-027. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of the filing
also will be available for inspection and copying at the principal
offices of NASD. 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 NASD-
2006-027 and should be submitted on or before April 19, 2006.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a self-regulatory organization.\7\
Specifically, the Commission believes that the proposed rule change, as
amended, is consistent with Section 15A(b)(5) of the Act,\8\ which
requires that the rules of the self-regulatory organization provide for
the equitable allocation of reasonable dues, fees, and other charges
among members and issuers and other persons using any facilities or
system which it operates or controls.
---------------------------------------------------------------------------

    \7\ In approving the proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition and
capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

    The Commission notes that this proposal would permit the schedule
for non-NASD members to mirror the schedule applicable to NASD members
that became effective on February 22, 2006, pursuant to SR-NASD-2006-
026.
    The Commission finds good cause for approving the proposed rule
change, as amended, prior to the 30th day of the date of publication of
the notice thereof in the Federal Register. The proposed fees for non-
NASD members are identical to those in SR-NASD-2006-026, which
implemented those fees for NASD members and which became effective as
of February 22, 2006. The Commission notes that the instant proposed
rule change will promote consistency in Nasdaq's fee schedule by
applying simultaneously the same pricing schedule for NASD members and
non-NASD members alike. Therefore, the Commission finds that there is
good cause, consistent with Section 19(b)(2) of the Act, to approve the
proposed rule change, as modified by Amendment Nos. 1 and 2, on an
accelerated basis.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change, as amended (SR-NASD-2006-027), is
approved on an accelerated basis.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

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

Nancy M. Morris,
Secretary.
 [FR Doc. E6-4538 Filed 3-28-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Page 43327]
[FR Doc No: 2016-15579]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78157; File No. SR-NYSEArca-2016-62]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change Relating to a Change to the Underlying Index for the PowerShares
Build America Bond Portfolio

June 27, 2016.
    On May 3, 2016, NYSE Arca, Inc. filed with the Securities and
Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to: (1) Change the index
underlying the PowerShares Build America Bond Portfolio (``Fund''); (2)
change the name of the Fund as a result of the proposed change to the
underlying index; and (3) permit the continued listing and trading of
shares of the Fund as a result of the change to the underlying index.
The proposed rule change was published for comment in the Federal
Register on May 23, 2016.\3\ The Commission has received no comment
letters on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 77849 (May 17,
2016), 81 FR 32371.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is July 7, 2016. The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider this proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates
August 19, 2016, as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSEArca-2016-62).
---------------------------------------------------------------------------

    \5\ Id.
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-15579 Filed 6-30-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: June 2, 2010 (Volume 75, Number 105)]
[Notices]
[Page 30810-30811]
[DOCID:fr02jn10-68]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 24, 2010.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER09-934-004; ER09-936-001.
    Applicants: Bangor Hydro Electric Company.
    Description: Offer of Settlement of Bangor Hydro Electric Company.
    Filed Date: 05/24/2010.
    Accession Number: 20100524-5035.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Docket Numbers: ER09-1589-003.
    Applicants: FirstEnergy Service Company.
    Description: Request for Waiver for Demand Response Participating
in FRR Integration Auctions of FirstEnergy Service Company.
    Filed Date: 05/20/2010.
    Accession Number: 20100520-5129.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 10, 2010.

    Docket Numbers: ER10-550-002.
    Applicants: Southwest Power Pool Inc.
    Description: Southwest Power Pool, Inc submits Seventh Revised
Sheet 14 et al. to FERC Electric Tariff, Fifth Revised Volume 1.
    Filed Date: 05/21/2010.
    Accession Number: 20100524-0201.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-792-002.
    Applicants: TC Energy Trading, LLC.
    Description: TC Energy Trading, LLC submits errata to revise the
title of the issuer of the tariff sheets.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-0209.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER09-877-001.
    Applicants: Entergy Arkansas, Inc.
    Description: Compliance Refund Report of Entergy Services, Inc.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5103.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1289-000.
    Applicants: California Independent System Operator Corporation.
    Description: The California Independent System Operator Corporation
submits Commission filing and acceptance of amendment to Service
Agreement 798 and Termination of Service Agreement 584.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-0206.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1290-000.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas & Electric Company submits tariff filing
per 35: San Diego Gas & Electric Company Market Based Rates Tariff to
be effective 5/21/2010.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5070.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1291-000.
    Applicants: GenConn Energy LLC.
    Description: GenConn Energy LLC submits tariff filing per 35.12:
Initial Filing of Market-Based Rate Tariff to be effective 5/21/2010.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5113.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1292-000.
    Applicants: CMS Energy Resource Management Company.
    Description: CMS Energy Resource Management Company submits tariff
filing under Schedule No. 1 Electric Tariff, to be effective 5/25/2010.
    Filed Date: 05/24/2010.
    Accession Number: 20100524-5013.
    Comment Date: 5 p.m. Eastern Time on Monday, June 14, 2010.

    Docket Numbers: ER10-1293-000.
    Applicants: American Electric Power Service Corporation.
    Description: AEP Texas Central Company submits Service Agreement
531 et al. to FERC Electric Tariff, Third Revised Volume 6.
    Filed Date: 05/21/2010.
    Accession Number: 20100524-0203.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1294-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits letter
agreement with Solar Millennium, LLC.
    Filed Date: 05/21/2010.
    Accession Number: 20100524-0204.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1295-000.
    Applicants: PJM Interconnection L.L.C.
    Description: PJM Interconnection, LLC submits an executed
Interconnection Construction Service Agreement with Synergics Wind
Energy, LLC et al.
    Filed Date: 05/21/2010.
    Accession Number: 20100524-0205.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1296-000.
    Applicants: Wisconsin Electric Power Company.
    Description: Wisconsin Electric Power Company submits Original
Sheet 2 et al. to FERC Electric Tariff, Original Volume 10 to be
effective 7/21/10.
    Filed Date: 05/21/2010.
    Accession Number: 20100524-0200.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protests do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and

interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-13172 Filed 6-1-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Page 79891]
[FR Doc No: 2015-32194]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0531; FRL-9939-74-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Surface Coating of Large Appliances
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NSPS for Surface Coating of
Large Appliances (40 CFR part 60, subpart SS)'' (EPA ICR No. 0659.13,
OMB Control No. 2060-0108), to the Office of Management and Budget
(OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of
the ICR, which is currently approved through December 31, 2015. Public
comments were previously requested via the Federal Register (80 FR
32116) on June 5, 2015 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An Agency may neither conduct nor sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before January 22,
2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0531, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS (40 CFR part 60, subpart A) and any changes, or
additions, to the Provisions specified at 40 CFR part 60, subpart SS.
Owners or operators of the affected facilities must make an initial
notification reports, performance tests, periodic reports, and maintain
records of the occurrence and duration of any startup, shutdown, or
malfunction in the operation of an affected facility, or any period
during which the monitoring system is inoperative. Reports are also
required semiannually.
    Form Numbers: None.
    Respondents/affected entities: Existing and new large appliance
coating facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart SS).
    Estimated number of respondents: 72 (total).
    Frequency of response: Initially and semiannually.
    Total estimated burden: 7,740 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $787,000 (per year), which includes $8,400 in
annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is a small increase in the total
estimated respondent burden and cost compared with the ICR currently
approved by OMB. This increase is due to assuming that all existing
respondents will need to spend some time reviewing the rule requirement
each year to re-familiarize themselves with it. In previous ICRs, it
was assumed that only new respondents would need to read and review the
rule requirement. In addition, a portion of the increase in burden cost
is due to using updated labor rates from the Bureau of Labor
Statistics.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-32194 Filed 12-22-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Rules and Regulations]
[Page 21041-21042]
[DOCID:fr18ap08-5]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage Form New Animal Drugs;
Florfenicol

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 new animal drug application
(NADA) filed by Schering-Plough Animal Health Corp. The NADA provides
for use of florfenicol injectable solution for the treatment of bovine
respiratory disease.

DATES: This rule is effective April 18, 2008.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901, filed NADA 141-265 for veterinary
prescription use of NUFLOR GOLD (florfenicol) Injectable Solution by
subcutaneous injection in beef and non-lactating dairy cattle for the
treatment of bovine respiratory disease. The NADA is approved as of
March 21, 2008, and the regulations are amended in 21 CFR 522.955 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)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval.
    The agency has determined under 21 CFR 25.33(a)(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 522

    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 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

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

0
2. Revise Sec.  522.955 to read as follows:

Sec.  522.955  Florfenicol.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-
pyrrolidone and triacetin.
    (2) 300 mg florfenicol in the inactive vehicle n-methyl-2-
pyrrolidone.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter for
use of product described in paragraph (a)(1) as in paragraph (d)(1)(i)
and for use of product described in paragraph (a)(2) as in paragraph
(d)(1)(ii).
    (c) Related tolerance. See Sec.  556.283 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) 300 mg/mL florfenicol in 2-
pyrrolidone and triacetin (inactive vehicles).
    (A) Amount. 40 mg/kilogram (kg) body weight as a single
subcutaneous injection.

    (B) Indications for use. For treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni in beef and non-lactating dairy
cattle.
    (C) Limitations. Do not slaughter within 44 days of last treatment.
Do not use in female dairy cattle 20 months of age or older. Use may
cause milk residues. A withdrawal period has not been established in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
    (ii) 300 mg/mL florfenicol in n-methyl-2-pyrrolidone (inactive
vehicle).
    (A)(1) Amount. 20 mg/kg of body weight as an intramuscular
injection. A second dose should be administered 48 hours later.
Alternatively, 40 mg/kg of body weight as a single subcutaneous
injection may be used.
    (2) Indications for use. For treatment of BRD associated with
Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus
somnus. For treatment of bovine interdigital phlegmon (foot rot, acute
interdigital necrobacillosis, infectious pododermatitis) associated
with Fusobacterium necrophorum and Bacteroides melaninogenicus.
    (B)(1) Amount. 40 mg/kg of body weight as a single subcutaneous
injection.
    (2) Indications for use. For control of respiratory disease in
cattle at high risk of developing BRD associated with Mannheimia
(Pasteurella) haemolytica, P. multocida, and Haemophilus somnus.
    (C) Limitations. Do not slaughter within 28 days of last
intramuscular treatment or within 38 days of subcutaneous treatment. Do
not use in female dairy cattle 20 months of age or older. Use may cause
milk residues. A withdrawal period has not been established in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
    (2) [Reserved]

    Dated: April 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-8346 Filed 4-17-08; 8:45 am]

BILLING CODE 4160-01-S