<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  >

<EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>>

<  SEQ CHAPTER \h \r 1 Interregional Research Project Number 4 (IR-4)>

<Petition Number 9E7615>

<	EPA has received a pesticide petition (PP 9E7615) from   SEQ CHAPTER
\h \r 1 IR-4,

500 College Road East, Suite 201 W., Princeton, New Jersey 08540,
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing a tolerance for residues of the fungicide   SEQ CHAPTER \h
\r 1 cyazofamid,   SEQ CHAPTER \h \r 1
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonam
ide and its metabolite CCIM,
4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, expressed as
cyazofamid, in or on the following raw agricultural commodities:
brassica, head and stem, subgroup 5A at 1.2 parts per million (ppm);
brassica, leafy greens, subgroup 5B at 12.0 ppm; turnip, greens at 12.0
ppm; spinach at 9.0 ppm; and hops at 10.0 ppm.  EPA has determined that
the petition contains data or information regarding the elements set
forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data supports granting of the petition. Additional data may be
needed before EPA rules on the petition.>

<A. Residue Chemistry>

<Plant metabolism.   SEQ CHAPTER \h \r 1 The plant metabolism of
cyazofamid is understood for the purposes of this petition.  The
proposed metabolic pathways in plants (tomato, potato and grape) are
identical.  Nature of the residue studies showed that other than parent
cyazofamid, no single identifiable residue represents more than about 7%
of the total radioactive residue.  The nature of the residue studies
showed that cyazofamid was the major identifiable residue with low
levels of CCIM.  The tolerance expression for Brassica (cole) crops,
turnip greens, spinach, and hops, will include parent, cyazofamid, and
the metabolite CCIM.   SEQ CHAPTER \h \r 1 >

<	2. Analytical method.   SEQ CHAPTER \h \r 1 Residues of cyazofamid and
CCIM were extracted from samples (5 g for broccoli, cabbage, mustard
greens & spinach; 1 g for hops) with acetonitrile.  The combined
extracts were partitioned with hexane and then reduced to 1-2 mL.  The
residues were dissolved in 20% acetonitrile/water and passed through a
Nexus or Strat-X Polymeric solid phase extraction column (SPE).  The
residues were eluted with 60/40 acetonitrile/water and then diluted in
50/50 acetonitrile/water.  The samples were quantitated by LC/MS/MS.>

<	3. Magnitude of residues. The results from 6 field trials conducted in
2006 show that the maximum total residue (cyazofamid + CCIM) in broccoli
flower heads was 0.915 ppm after one application applied as a drench to
the base of the plants at the time of transplanting and five
applications of cyazofamid at 7 (±1) day intervals with a 0 day PHI.
The results from 9 field trials show that the maximum total residue
(cyazofamid + CCIM) in cabbage (head) was 0.895 ppm after one
application applied as a drench to the base of the plants at the time of
transplanting and five applications of cyazofamid at 7 (±1) day
intervals with a 0 day PHI.  The results from 9 field trials show that
the maximum total residue (cyazofamid + CCIM) in mustard greens was
6.856 ppm after one application applied as a drench to the base of the
plants at the time of transplanting and five applications of cyazofamid
at 7 (±1) day intervals with a 0 day PHI.  The results from 10 field
trials show that the maximum total residue (cyazofamid + CCIM) in
spinach (leaves) was 6.620 ppm after five applications of cyazofamid at
7 (±1) day intervals with a 0 day PHI.  The results from 3 field trials
show that the maximum total residue (cyazofamid + CCIM) in hops was 7.03
ppm after six applications of cyazofamid at 7 (±1) day intervals with a
3 day PHI.>

<B. Toxicological Profile>

<	1. Acute toxicity.    SEQ CHAPTER \h \r 1 Results from a battery of
acute toxicity studies place technical cyazofamid in Toxicity Category
IV for oral LD50, inhalation LC50 and eye irritation, and Category III
for dermal irritation and dermal LD50.  Technical cyazofamid was
determined to be a weak dermal sensitizer. In an acute neurotoxicity
study, no treatment related effects were observed at any dose.  The NOEL
was 2,000 mg/kg bw.>

<	2. Genotoxicty.   SEQ CHAPTER \h \r 1 A battery of five tests has been
conducted to assess the genotoxic potential of technical cyazofamid.
Assays conducted included in vitro reverse gene mutation tests in
bacteria and in vitro forward gene mutation test in a mammalian cell
system, a chromosomal damage test in mammalian cells, a DNA repair test
in bacteria, and an in vivo micronucleus test in mice. Cyazofamid did
not elicit a genotoxic response in any of the studies conducted. >

<	3. Reproductive and developmental toxicity.   SEQ CHAPTER \h \r 1 In a
two-generation reproductive toxicity study, the only effects observed
were body weight effects which were observed at 20,000 ppm in dams
during gestation and lactation and in weanling pups.  No reproductive
effects were observed.  The NOEL for reproductive effects was 20,000 ppm
(1,338 mg/kg bw/day).  The NOEL for parental toxicity was 2,000 ppm (134
mg/kg bw/day).

In a rat developmental study, pregnant rats were dosed by gavage with
cyazofamid from Days 0 to 19 of gestation.  There were no
treatment-related effects observed in the study.  The NOEL for maternal
effects was 1,000 mg/kg bw/day.  Due to the increased incidence of bent
ribs, a reversible developmental anomaly, in fetuses treated at the
highest dose, the developmental NOEL was set conservatively at 100 mg/kg
bw/day.

In a rabbit developmental study, pregnant rabbits were dosed by gavage
with cyazofamid on Days 4 to 28 of gestation.  There were no
treatment-related effects observed in the study.  The NOEL for maternal
and developmental effects was 1000 mg/kg bw/day.

The developmental studies (prenatal developmental studies in rat and
rabbit and the two generation reproduction study in rat) provided no
indication of increased sensitivity of rats or rabbits from in utero or
post-natal exposure to cyazofamid.  Cyazofamid is not a developmental or
reproductive toxicant.

>

<	4. Subchronic toxicity.   SEQ CHAPTER \h \r 1 The oral toxicity of
cyazofamid was investigated in rats and dogs in 13-week studies.  The
exposure was by dietary administration for the rats and by capsule for
the dogs.  There were no treatment-related effects observed in dogs up
to 1,000 mg/kg bw/day which was the highest dose tested.  In rats,
treated at 5,000 ppm there was a treatment related increase in kidney
and liver weights and increased observation of basophilic tubules.  The
latter was observed only in males.   The NOEL was 500 ppm which was
equivalent to a dosage of 29.9 mg/kg bw/day to males and 33.3 mg/kg
bw/day to females.>

<	5. Chronic toxicity.   SEQ CHAPTER \h \r 1 A combined chronic and
oncogenicity study was conducted in rats.  Cyazofamid was administered
continuously for a period of 104 weeks to male and female Fischer rats.
Cyazofamid was not carcinogenic in this study.  The NOEL for chronic
effects was 5000 ppm (171 mg/kg bw/day).

In a long-term feeding study, mice were dosed with cyazofamid in the
diet for 78 weeks.  There was no evidence of carcinogenicity.  The NOEL
was 700 ppm (94.8  mg/kg bw/day for males) based on increased incidence
of skin lesions in the high dose animals.

In a chronic dog study, four groups of six dogs/sex/group received
cyazofamid via capsule for 52 weeks. The NOEL was determined as 200
mg/kg bw/day based on increased cysts in parathyroids in both sexes and
increased pituitary cysts in females at the LOAEL of 1,000 mg/kg
bw/day.>

<	6. Animal metabolism.   SEQ CHAPTER \h \r 1 Studies on the metabolism
of cyazofamid in animals using radioactive test material have been
conducted with cyazofamid, labeled with 14C in two positions, the
benzene [14C-Bz]- or imidazole [14C-Im] position.  Absorption is rapid,
but the percentage of Cyazofamid   SEQ CHAPTER \h \r 1 absorbed after an
oral dosage decreases as the dosage is increased. All absorbed
radiocarbon is rapidly eliminated with urinary and biliary elimination
of radiocarbon nearly complete within 24 hours. The metabolic pathway of
cyazofamid includes the rapid hydrolysis of the dimethylsulfonamide
group and the oxidation of the benzyl methyl group.>

<	7. Metabolite toxicology.   SEQ CHAPTER \h \r 1 Comparison of the
metabolism of cyazofamid by plants and in animals indicates that a
number of the identified metabolites are common to both plants and
animals but metabolism in plants is more extensive than in animals.  The
data indicate that the final products of the metabolism of cyazofamid in
animals and plants represent differences in the extent of metabolism.
Several of the metabolites resulting from cyazofamid are similar in
plants and animals and, therefore, have already been evaluated
toxicologically.>

<	8. Endocrine disruption.   SEQ CHAPTER \h \r 1 An evaluation of the
potential effects on the endocrine systems of mammals has not been
determined; however, no evidence of such effects was reported in
subchronic, chronic or reproductive toxicology. There was no observed
pathological finding of the endocrine organs in these studies, and there
were no reproductive effects at the maximum dose tested of 20,000 ppm.
There is no evidence at this time that cyazofamid causes endocrine
effects.>

<C. Aggregate Exposure>

<	1. Dietary exposure.   SEQ CHAPTER \h \r 1  Potential dietary
exposures from food were estimated for all proposed and established
tolerances for the crops listed below, using the Dietary Exposure
Evaluation Model-Food Consumption Intake Database (DEEM-FCIDTM) version
2.16, and percent crop treated of 100%.  The following raw agricultural
commodities were included: brassica (cole) leafy vegetables (crop group
5) including turnip greens; carrot; cucurbits (crop group 9); fruiting
vegetables (crop groups 8); okra; potatoes; grapes (east of the Rocky
Mountains); spinach; and hops.

For chronic dietary exposure, the chronic reference dose (RfD) of 0.95
mg/kg bw/day was proposed by EPA for humans, based on the NOAEL from the
mouse carcinogenicity study (94.5 mg/kg bw/day) and dividing by an
uncertainty factor of 100.  The chronic population adjusted dose (cPAD)
is also 0.95 mg/kg bw/day since the FQPA safety factor is 1 for
cyazofamid.

For acute dietary exposure, the acute RfD of 1.0 mg/kg bw/day was based
on the NOAEL of 100 mg/kg bw/day from the rat developmental toxicity
study adjusted by the uncertainty factor of 100.  The acute population
adjusted dose (aPAD) is also 1 mg/kg bw/day since the cyazofamid FQPA
safety factor is 1.>

<	i. Food.   SEQ CHAPTER \h \r 1 Tier 1 chronic and acute dietary
exposure analyses were conducted for cyazofamid in/on the crops noted
above to determine the exposure contribution of these commodities to the
diet and to ascertain the chronic and acute risk potential.  The
estimates were based on current and proposed tolerance level residues
for all crops, potato and tomato processing studies, conservative market
share assumptions of 100% crop treated, and consumption data from the
USDA’s CSFII (1994 through 1996 and 1998) continuing survey of food
intake.  Since specific processing studies demonstrated that residues
were unlikely to concentrate in processed commodities, no adjustment for
processing factors was necessary.

Even using all of the worst case exposure scenarios listed above, the
Tier 1 chronic dietary (food +   SEQ CHAPTER \h \r 1 drinking water)
exposure estimates resulted in an estimated exposure for the general
U.S. population of 0.004969 mg/kg bw/day.  This exposure corresponds to
less than 1% of the cPAD of 0.95 mg/kg bw/day.  The highest exposure
estimate calculated was for the subgroup all infants (< 1 year).  This
exposure was determined to be 0.012254 mg/kg bw/day (1.3% of the cPAD).

A Tier 1 acute dietary exposure assessment was performed for the
subpopulation of females aged 13-49 years old only, since the only
endpoint of concern was from the rat prenatal developmental study.  The
acute dietary exposure estimate for females aged 13-49 is 0.012142 mg/kg
bw/day, well below HED’s level of concern at the 95th percentile.
This is equivalent to 1.21% of the aPAD.

It can be concluded that acute or long-term dietary exposure to
cyazofamid through residues on treated brassica (cole) leafy vegetables
(Crop Group 5), including turnip greens, carrots, cucurbit vegetables
(Crop Group 9), fruiting vegetables (Crop Group 8), grapes, hops, okra,
potatoes, and spinach, should not be of cause for concern.>

<	ii. Drinking water.   SEQ CHAPTER \h \r 1 Since cyazofamid is intended
for application outdoors to turf, ornamentals, and field grown crops,
the potential exists for parent and or metabolites to reach ground or
surface water that may be used for drinking water.  EPA assumed drinking
water concentrations of 133 ppb and 136 ppb for the chronic and acute
assessments, respectively, based on modeling of potential surface water
residues of CTCA (the terminal degradate of cyazofamid) for the
turf/ornamental use.  Because the application rates for the proposed
uses are lower than the rate for turf/ornamentals, the turf use
represents the worst-case for potential drinking water residues.
Therefore, these estimates of drinking water were directly entered into
the dietary exposure model.>

<	2. Non-dietary exposure.

  SEQ CHAPTER \h \r 1 Cyazofamid can be applied to commercially treated
residential turf and ornamentals only.  Therefore, non-occupational
exposure of cyazofamid to the general population is not expected,
however, postapplication exposure is possible.  For Dermal Short-Term
exposure, no toxicity was found at 1000 mg/kg in a 28-day dermal
toxicity study, therefore, in the absence of any hazard identified for
children, a risk assessment was not necessary.  The residential dermal
MOE for adults of 1,100, based on 2 hours of extensive contact with the
turf, was used to calculate the adult short-term aggregate risk
assessment in the EPA assessment. EPA calculated
non-occupational/residential MOEs for the day of application.

The post application children’s MOE (including incidental oral
exposures) from residential lawns is 1,600.  All MOEs, including
children’s aggregate, are greater than 100, and therefore, are not of
concern.  >

<D. Cumulative Effects>

<  SEQ CHAPTER \h \r 1 Cyazofamid is a cyanoimidazole fungicide.  Since
there are no other members of this class of fungicides, it is considered
unlikely that cyazofamid would have a common mechanism of toxicity with
any other pesticide in use at this time.

>

<E. Safety Determination>

<	1. U.S. population.   SEQ CHAPTER \h \r 1 Dietary and occupational
exposure will be the major routes of exposure to the U.S. population.
Ample margins of safety have been demonstrated for both situations. For
the general U.S. population, the chronic dietary exposure to cyazofamid
is 0.0004339 mg/kg bw/day, which utilizes less than 1% of the RfD for
the overall U.S. population, assuming 100% of the crops are treated. A
cancer dietary assessment was not conducted because this product has
been classified as “not likely to be carcinogenic to humans.”

An acute aggregate risk assessment was conducted for the population
subgroup of concern, females 13-49 years old.  Since an appropriate
endpoint for the general population was not identified, a corresponding
assessment is not required for any other population subgroup.  For this
subgroup, the acute dietary (food and drinking water) risk assessment
reported above as 0.009951 mg/kg bw/day (95th percentile), 1.21% of the
aPAD, represents the acute aggregate risk since the dietary route alone
is relevant for acute exposure and risk assessment.

The short-term aggregate risk is made up of average dietary exposures
from food and drinking water sources as well as from dermal and oral
residential exposure.   Potential inhalation exposure was not considered
since it is negligible when assessing re-entry risks.  The aggregate
short-term MOE for the US general population is 1040.

Using only pesticide handlers exposure data base (PHED) data levels A
and B (those with a high level of confidence), the margins of exposure
(MOE) for occupational exposure are 341 to 98,000 for use on turf and
ornamentals and of 23,000 to 220,000 for use on crops.  Based on the
completeness and reliability of the toxicity data and the conservative
exposure assessments, there is a reasonable certainty that no harm will
result from the aggregate exposure of residues of cyazofamid including
all anticipated dietary exposure and all other non-occupational
exposures.>

<	2. Infants and children.   SEQ CHAPTER \h \r 1 As noted above, chronic
dietary exposure of the most highly exposed subgroup in the population,
all infants (< 1 yr old), is 0.010897 mg/kg bw/day or 1.1% of the RfD.
The short-term aggregate risk MOE for children (food and residential) is
1400. Thus, it can be concluded that there is reasonable certainty that
no harm will result to infants and children from acute or chronic
exposure to Cyazofamid.

Based on the completeness and reliability of the toxicity data, the lack
of toxicological endpoints of special concern, the lack of any
indication of greater sensitivity of children, and the conservative
exposure assessment, there is a reasonable certainty that no harm will
result to infants and children from the aggregate exposure to residues
of cyazofamid from all anticipated sources of dietary and
non-occupational exposure.

>

<F. International Tolerances>

<Presently, there are no Codex maximum residue levels (MRLs) established
for residues of cyazofamid on any crop.    SEQ CHAPTER \h \r 1 The
following Canadian tolerances have been established: Carrots, 0.09 ppm;
Potatoes, 0.02 ppm; and Tomatoes (Import), 0.2 ppm.

 >

 PAGE

 PAGE   7


[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Proposed Rules]
[Pages 10707-10710]
[FR Doc No: 2014-04140]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0058; Directorate Identifier 2013-NM-116-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede airworthiness directive (AD) 94-12-03
that applies to certain Airbus Model A320 series airplanes. AD 94-12-03
requires modification of the belly fairing structure. Since we issued
AD 94-12-03, fatigue testing of Model A320 series airplanes showed
cracks at the lower riveting of the four titanium angles that connect
the belly fairing to the keel beam side panels on both sides of the
fuselage. This proposed AD also would require repetitive inspections
for cracking of the four titanium angles between the belly fairing and
the keel beam side panel, an inspection for cracking of the open holes
if any cracking is found, and repair or replacement if necessary. This
proposed AD would also expand the applicability of AD 94-12-03. We are
proposing this AD to detect and correct cracking of the titanium angles
that connect the belly fairing to the keel beam side panels on both
sides of the fuselage, which could affect the structural integrity of
the airplane.

DATES: We must receive comments on this proposed AD by April 14, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0058; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0058;
Directorate Identifier 2013-NM-116-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On May 26, 1994, we issued AD 94-12-03, Amendment 39-8930 (59 FR
28763, June 3, 1994). AD 94-12-03 superseded AD 93-24-11, Amendment 39-
8760 (58 FR 64875, December 10, 1993). AD 94-12-03 requires actions
intended to address an unsafe condition on Airbus Model A320 series
airplanes having serial numbers 0003 through 0092 inclusive. These
serial numbers apply to Model A320-111, -211, and -231 series
airplanes.
    Since we issued AD 94-12-03, Amendment 39-8930 (59 FR 28763, June
3, 1994), The European Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA Airworthiness Directive 2013-0122, dated June 5, 2013
(referred to after this as the Mandatory Continuing Airworthiness
Information, or ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    During the fatigue test campaign of the A320 family type design,
cracks have been found at the lower riveting of the four titanium
angles which connect the belly fairing to the keel beam side panels
between frames FR40 and FR42, on both sides of the fuselage.
    This condition, if not detected and corrected, could affect the
structural integrity of the aeroplane.
    In 1992, DGAC France issued AD 92-201-030 (http://ad.easa.europa.eu/blob/19922010tb_superseded.pdf/AD_F-1992-201-030_1) (which corresponds to FAA AD 94-12-03, Amendment 39-8930 (59
FR 28763, June 3, 1994)) to require reinforcement of the belly
fairing structure, which addressed part of the unsafe condition.
    For the reason described above, this [EASA] AD retains the
requirements of DGAC France AD 92-201-030, which is superseded, and
requires repetitive detailed inspections [for cracking] of the
affected titanium angles and, depending on findings, repair or
replacement of parts.

    As an option to extend the repetitive inspection interval, after
the first detailed inspection is accomplished and on condition of no
crack findings, this proposed AD would allow operators to remove the
four titanium angles, perform a rototest for cracking on the open holes
and, provided no cracks are found, install new titanium angles,
followed by post-modification detailed inspections of the new titanium
angles.
    For any titanium angle crack findings, this proposed AD would
require removing any cracked angle, performing a rototest for cracking
on the open holes and, provided no cracks are found, installing a new
titanium angle, followed detailed inspections of the new titanium
angles.
    For any hole cracking found during any rototest, this proposed AD
would require repair.
    This proposed AD expands the applicability of AD 94-12-03,
Amendment 39-8930 (59 FR 28763, June 3, 1994) to include all Airbus
Model A318, Model A319, Model A320, and Model A321 series airplanes.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2014-0058.

Relevant Service Information

    Airbus has issued Service Bulletin A320-53-1014, Revision 02, dated
September 1, 1994; and Service Bulletin A320-53-1259, dated November 6,
2012. The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Repair Approvals

    In many FAA transport ADs, when the service information specifies
to contact the manufacturer for further instructions if certain
discrepancies are found, we typically include in the AD a requirement
to accomplish the action using a method approved by either the FAA or
the State of Design Authority (or its delegated agent).
    We have recently been notified that certain laws in other countries
do not allow such delegation of authority, but some countries do
recognize design approval organizations. In addition, we have become
aware that some U.S. operators have used repair instructions that were
previously approved by a State of Design Authority or a Design Approval
Holder (DAH) as a method of compliance with this provision in FAA ADs.
Frequently, in these cases, the previously approved repair instructions
come from the airplane structural repair manual or the DAH repair
approval statements that were not specifically developed to address the
unsafe condition corrected by the AD. Using repair instructions that
were not specifically approved for a particular AD creates the
potential for doing repairs that were not developed to address the
unsafe condition identified by the MCAI AD, the FAA AD, or the
applicable service information, which could result in the unsafe
condition not being fully corrected.
    To prevent the use of repairs that were not specifically developed
to correct the unsafe condition, this proposed AD would require that
the repair approval specifically refer to the FAA AD. This change is
intended to clarify the method of compliance and to provide operators
with better visibility of repairs that are specifically developed and
approved to correct the unsafe condition. In addition, we use the
phrase ``its delegated agent, or by the DAH with State of Design
Authority design organization approval, as applicable'' in this
proposed AD to refer to an DAH authorized to approve required repairs
for this proposed AD.

Costs of Compliance

    We estimate that this proposed AD affects 851 airplanes of U.S.
registry.
    The actions that are required by AD 94-12-03, Amendment 39-8930 (59
FR 28763, June 3, 1994), and retained in this proposed AD take about
288 work-hours per product, at an average labor rate of $85 per work-
hour. Required parts cost about $1,045 per product. Based on these
figures, the estimated cost of the actions that were required by AD 94-
12-03 is $25,525 per product.
    We also estimate that it would take about 7 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $506,345, or $595
per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions and optional action costs
specified in this proposed AD.

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.
    We are 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

    We 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 above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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 removing airworthiness directive (AD)
94-12-03, Amendment 39-8930 (59 FR 28763, June 3, 1994), and adding the
following new AD:

Airbus: Docket No. FAA-2014-0058; Directorate Identifier 2013-NM-
116-AD.

(a) Comments Due Date

    We must receive comments by April 14, 2014.

(b) Affected ADs

    This AD supersedes AD 94-12-03, Amendment 39-8930 (59 FR 28763,
June 3, 1994).

(c) Applicability

    This AD applies to the Airbus airplanes specified in paragraphs
(c)(1) through (c)(4) of this AD, certificated in any category, all
manufacturer serial numbers.
    (1) Airbus Model A318-111, -112, -121, and -122 airplanes.

    (2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes.
    (3) Airbus Model A320-111, -211, -212, -214, -231, -232, and -
233 airplanes.
    (4) Airbus Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by reports of cracks at the lower riveting
of the four titanium angles that connect the belly fairing to the
keel beam side panels on both sides of the fuselage. We are issuing
this AD to detect and correct cracking of the titanium angles that
connect the belly fairing to the keel beam side panels on both sides
of the fuselage, which could affect the structural integrity of the
airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Retained Modification

    This paragraph restates the requirements of paragraph (a) of AD
94-12-03, Amendment 39-8930 (59 FR 28763, June 3, 1994), with new
service information. For Model A320-111, -211, and -231 series
airplanes, manufacturer serial numbers 0003 through 0092 inclusive:
Prior to the accumulation of 12,000 total landings on the airplane,
or within 300 days after January 10, 1994 (the effective date of AD
93-24-11, Amendment 39-8760 (58 FR 64875, December 10, 1993)),
whichever occurs later, modify the belly fairing structure, in
accordance with the Accomplishment Instructions of an Airbus service
bulletin specified in paragraph (g)(1), (g)(2), or (g)(3) of this
AD. As of the effective date of this AD, use only the Airbus service
bulletin specified in paragraph (g)(3) of this AD.
    (1) Airbus Service Bulletin A320-53-1014, dated June 25, 1992.
    (2) Airbus Service Bulletin A320-53-1014, Revision 1, dated May
26, 1993.
    (3) Airbus Service Bulletin A320-53-1014, Revision 2, dated
September 1, 1994.

(h) New Requirement of This AD: Repetitive Inspection

    At the latest of the compliance times specified in paragraphs
(h)(1), (h)(2), and (h)(3) of this AD: Do a detailed inspection for
cracking of the four titanium angles between the belly fairing and
the keel beam side panel, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-53-1259, dated November
6, 2012.
    (1) Before the accumulation of 30,000 total flight cycles or
60,000 total flight hours, whichever occurs first after first flight
of the airplane.
    (2) Within 30,000 flight cycles or 60,000 flight hours,
whichever occurs first after modification of the airplane as
required by paragraph (g) of this AD, or after installation of new
titanium angles, provided that, prior to installation, a rototest
for cracking on the open holes has been accomplished with no crack
findings, in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A320-53-1259, dated November 6, 2012.
    (3) Within 3,000 flight cycles or 6,000 flight hours, whichever
occurs first after the effective date of this AD.

(i) New Requirement of This AD: Post-Inspection Actions for No Crack
Findings

    If, during any inspection required by paragraph (h) of this AD,
there is no crack finding: Accomplish the actions specified in
either paragraph (i)(1) or (i)(2) of this AD.
    (1) Repeat the inspection required by paragraph (h) of this AD
at intervals not to exceed 5,000 flight cycles or 10,000 flight
hours, whichever occurs first.
    (2) Before further flight after the inspection required by
paragraph (h) of this AD, remove all inspected titanium angles,
accomplish a rototest for cracking on the open holes and, provided
no cracks are found, install new titanium angles, in accordance with
the Accomplishment Instructions of Airbus Service Bulletin A320-53-
1259, dated November 6, 2012.

(j) New Requirement of This AD: Post-Inspection Actions for Any Crack
Findings

    If, during any inspection required by paragraph (h) of this AD,
there is any crack finding: Before further flight, remove the
affected titanium angle(s), accomplish a rototest for cracking on
the open holes, and, provided no cracks are found, install new
titanium angles, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A320-53-1259, dated November 6, 2012.

(k) New Requirement of This AD: Post-Installation Repetitive
Inspections

    For airplanes on which new titanium angles were installed as
specified in paragraph (i)(2) or (j) of this AD: Within 30,000
flight cycles or 60,000 flight hours, whichever occurs first after
the installation: Accomplish a detailed inspection for cracking of
the four titanium angles between the belly fairing and the keel beam
side panel, in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A320-53-1259, dated November 6, 2012. Repeat
the inspection thereafter at intervals not to exceed 5,000 flight
cycles or 10,000 flight hours, whichever occurs first.

(l) New Requirement of This AD: Post Inspection Actions for Any Crack
Findings During Post-Installation Inspections

    If, during any inspection as required by paragraph (k) of this
AD, there is any crack finding: Before further flight, remove the
affected titanium angles, accomplish a rototest for cracking on the
open holes, and, provided no cracks are found, install new titanium
angles, in accordance with the Accomplishment Instructions of Airbus
Service Bulletin A320-53-1259, dated November 6, 2012.

(m) New Requirement of This AD: Corrective Action for Rototest Crack
Finding

    If, during any rototest as required by paragraph (i), (j), or
(l) of this AD, any crack is found: Before further flight, repair
using a method approved by the Manager, International Branch, ANM-
116, Transport Airplane Directorate, FAA; or the European Aviation
Safety Agency (EASA) (or its delegated agent, or by the Design
Approval Holder (DAH) with EASA design organization approval, as
applicable). For a repair method to be approved, the repair approval
must specifically refer to this AD.

(n) New Provision of This AD: No Termination Action for Repetitive
Inspections

    Repair or replacement of parts as specified in this AD does not
terminate the repetitive inspections required by this AD.

(o) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer, use these actions if they
are FAA approved. Corrective actions are considered FAA-approved if
they were approved by the State of Design Authority (or its
delegated agent, or the Design Approval Holder with a State of
Design Authority's design organization approval, as applicable). You
are required to ensure the product is airworthy before it is
returned to service.

(p) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency Airworthiness Directive 2013-
0122, dated June 5, 2013, for related information. This MCAI may be
found in the AD docket on the Internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2014-0058.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61

93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on: February 18, 2014.
Ross Landes,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-04140 Filed 2-25-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34161-34163]
[FR Doc No: 2023-11260]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0737]

Non-Clinical Performance Assessment of Tissue Containment Systems
Used During Power Morcellation Procedures; Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Non-Clinical
Performance Assessment of Tissue Containment Systems Used During Power
Morcellation Procedures.'' This guidance document provides
recommendations that may help manufacturers comply with the special
controls related to non-clinical performance data for gynecologic and
general laparoscopic power morcellation containment systems (``tissue
containment systems''). Tissue containment systems are used to enable
isolation and containment of tissue during a power morcellation
procedure performed following a laparoscopic procedure for the excision
of benign tissue that is not suspected to contain malignancy.

DATES: The announcement of the guidance is published in the Federal
Register on May 26, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0737 for ``Non-Clinical Performance Assessment of Tissue
Containment Systems Used During Power Morcellation Procedures.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Non-Clinical Performance Assessment of Tissue Containment Systems
Used During Power Morcellation Procedures'' to the Office of Policy,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Prasanna Hariharan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 2222, Silver Spring, MD 20993-0002, 301-
796-2689 or by email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document provides recommendations that may help
manufacturers comply with the special controls related to non-clinical
performance data for gynecologic and general laparoscopic power
morcellation containment systems (``tissue containment systems'').
Tissue containment systems are used to enable isolation and containment
of tissue during a power morcellation procedure performed following a
laparoscopic procedure for the excision of benign tissue that is not
suspected to contain malignancy. This guidance recommends non-clinical
test methods that may help manufacturers meet the non-clinical
performance data requirements identified in the special controls
codified in Sec.  884.4050(b)(4) (21 CFR 884.4050(b)(4)) (for
gynecologic use) and Sec.  878.4825(b)(4) (21 CFR 878.4825(b)(4)) (for
general use), and also includes other non-clinical testing
recommendations to support a 510(k) submission/substantial equivalence
determination. The recommendations in this guidance are based on FDA's
experience evaluating the safety and effectiveness of tissue
containment systems. However, manufacturers may use alternative
approaches and provide different documentation so long as their
approach and documentation satisfy premarket submission requirements in
applicable statutory provisions and regulations.
    A notice of availability of the draft guidance appeared in the
Federal Register of June 21, 2022 (87 FR 36859). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including a clarification that material permeability
testing is recommended to aid in demonstrating substantial equivalence
but is not required in the special controls in Sec.  884.4050(b)(4) and
Sec.  878.4825(b)(4); specifying that aged samples may be subject to
accelerated or real time aging; and indicating that a manufacturer
conducting final finished testing of a tissue containment system with
multiple device sizes may use the worst-case size sample(s), but, if
doing so, should provide a justification for the

choice of worst-case size sample(s) in its submission.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Non-Clinical Performance Assessment of
Tissue Containment Systems Used During Power Morcellation Procedures.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Non-Clinical Performance Assessment of
Tissue Containment Systems Used During Power Morcellation Procedures''
may send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number
GUI00019015 and complete title to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
     21 CFR part or guidance             Topic          OMB control No.
------------------------------------------------------------------------
807, subpart E..................  Premarket                    0910-0120
                                   notification.
``Requests for Feedback and       Q-submissions......          0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
------------------------------------------------------------------------

    Dated: May 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11260 Filed 5-25-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Proposed Rules]
[Pages 26376-26377]
[FR Doc No: 2019-11776]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0355; Airspace Docket No. 19-AGL-15]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Marion, OH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend the Class E airspace extending
upward from 700 feet above the surface at Marion Municipal Airport,
Marion, OH. The FAA is proposing this action as the result of an
airspace review caused by the decommissioning of the Marion localizer/
distance measuring equipment (LOC/DME) navigation aid, which provided
navigation information for the instrument procedures at this airport.
Airspace redesign is necessary for the safety and management of
instrument flight rules (IFR) operations at this airport.

DATES: Comments must be received on or before July 22, 2019.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-0355; Airspace Docket No. 19-AGL-15, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11C, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend the Class E airspace extending upward from 700 feet
above the surface at Marion Municipal Airport, Marion, OH, to support
IFR operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2019-0355;
Airspace Docket No. 19-AGL-15.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action

on the proposed rule. The proposal contained in this notice may be
changed in light of the comments received. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace
Designations and Reporting Points, dated August 13, 2018, and effective
September 15, 2018. FAA Order 7400.11C is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11C lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending the Class E airspace extending
upward from 700 feet above the surface to within a 6.5-mile radius
(reduced from a 7-mile radius) of Marion Municipal Airport, Marion, OH;
adding an extension 9.6 miles north and 6 miles south of the 081[deg]
radial from the Buckeye VOR extending from the 6.5-mile radius to 7
miles from the Buckeye VOR; and removing the exclusion verbiage as it
is no longer required.
    This action is necessary due to an airspace review caused by the
decommissioning of the Marion LOC/DME VOR, which provided navigation
information for the instrument procedures at this airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11C, dated August 13, 2018, and effective September 15,
2018, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C,
Airspace Designations and Reporting Points, dated August 13, 2018, and
effective September 15, 2018, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL OH E5 Marion, OH [Amended]

Marion Municipal Airport, OH
    (Lat. 40[deg]36'59'' N, long. 83[deg]03'49'' W)
Buckeye VOR
    (Lat. 40[deg]37'00'' N, long. 83[deg]03'50'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Marion Municipal Airport, and within 9.6
miles north and 6 miles south of the 081[deg] radial from the
Buckeye VOR extending from the 6.5-mile radius to 7 miles east of
the Buckeye VOR.

    Issued in Fort Worth, Texas, on May 29, 2019.
John Witucki,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2019-11776 Filed 6-5-19; 8:45 am]
 BILLING CODE 4910-13-P


For the Docket

Water Quality Standards for the State of Florida’s Lakes and Flowing
Waters

Docket ID No. OW-2009-0596

Meeting with Representatives from Mosaic and counsel

	September 8, 2010

In Attendance:

U.S. Environmental Protection Agency – Ephraim King, OST

					       Jim Keating, OST

Mosaic – James Voyles

Arnold & Porter, LLP – Jeremy Karpatkin

			   Lester Sotsky

Summary:

Mosaic requested the meeting to discuss the Water Quality Standards for
the State of Florida’s Lakes and Flowing Waters; Supplemental Notice
of Data Availability and Request for Comment (SNODA), published in
August 2010.  Specifically, Mosaic provided comments on:

Proposed criteria for the Bone Valley

Scientific defensibility of the proposed criteria in the SNODA

Timing and schedule of the rulemaking process and subsequent
implementation phase

Procedure for Site-specific Alternative Criteria (SSACs)

The effect of the criteria on permits

Opportunity for public and stakeholder involvement in the implementation
process

EPA did not provide any information about EPA positions regarding
addressing comments received or possible final rule requirements.


[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Pages 20017-20018]
[FR Doc No: 2023-06990]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2010-0164]

Petition for Extension of Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on January 10, 2023, the
International Association of Sheet Metal, Air, Rail and Transportation
Workers (SMART)--Transportation Division and Albany Port Railroad
(Petitioners) petitioned the Federal Railroad Administration (FRA) for
an extension of a waiver of compliance from certain provisions of the
hours of service laws contained at title 49 United States Code (U.S.C.)
section 21103(a). The relevant Docket Number is FRA-2010-0164.
    Specifically, Petitioners requested an extension of the existing
relief from the provisions of 49 U.S.C. 21103(a)(4), which in part,
provides that a train employee may not be required or allowed to remain
or go on duty after that employee has initiated an on-duty period each
day for 6 consecutive days, unless that employee has had at least 48
hours off duty at the employee's home terminal. Petitioners seek to
continue to allow a train employee to initiate an on-duty period for 6
consecutive days followed by 24 hours off duty. Petitioners state that
Albany Port Railroad runs only one shift per day and operates solely
within yard limits. The relief would allow the railroad to serve its
customers on Saturdays.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a

public hearing, they should notify FRA, in writing, before the end of
the comment period and specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at https://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by June 5, 2023 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable. Anyone can search the electronic form of any
written communications and comments received into any of our dockets by
the name of the individual submitting the comment (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). Under 5 U.S.C. 553(c), the U.S. Department of
Transportation (DOT) solicits comments from the public to better inform
its processes. DOT posts these comments, without edit, including any
personal information the commenter provides, to www.regulations.gov, as
described in the system of records notice (DOT/ALL-14 FDMS), which can
be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2023-06990 Filed 4-3-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Page 19750]
[FR Doc No: 2018-09452]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-138-000]

Midcontinent Independent System Operator, Inc., ALLETE, Inc.,
Montana-Dakota Utilities Co., Northern Indiana Public Service Company,
Otter Tail Power Company, Southern Indiana Gas & Electric Company;
Notice of Institution of Section 206 Proceeding and Refund Effective
Date

    On April 27, 2018, the Commission issued an order in Docket No.
EL18-138-000 pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into whether the
transmission formula rate templates of ALLETE, Inc., Montana-Dakota
Utilities Co., Northern Indiana Public Service Company, Otter Tail
Power Company, and Southern Indiana Gas & Electric Company under
Attachment O of the Midcontinent Independent System Operator, Inc. Open
Access Transmission, Energy and Operating Reserve Markets Tariff may be
unjust, unreasonable, or unduly discriminatory or preferential.
Midcontinent Independent System Operator, Inc., et al., 163 FERC 61,
061 (2018).
    The refund effective date in Docket Nos. EL18-138-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket Nos. EL18-138-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street, NE, Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2017),
within 21 days of the date of issuance of the order.

    Dated: April 27, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-09452 Filed 5-3-18; 8:45 am]
 BILLING CODE 6717-01-P