                                  Aprehend(TM)

Active Ingredient: Beauveria bassiana Strain GHA*	2.0%
Other Ingredients**:	98.0%
Total: 	100.0%
*Contains a minimum of 2.2 X 10[9] viable spores per milliliter of product.
**Contains petroleum distillates.

                         KEEP OUT OF REACH OF CHILDREN
                                    CAUTION

FIRST AID
If in eyes

 Hold eye open and rinse slowly and gently with water for 15  -  20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.
 Call a poison control center or doctor for treatment advice.
If swallowed
 Immediately call a poison control center or doctor.
 Do not induce vomiting unless told to do so by the poison control center or doctor.
 Do not give any liquid to the person.  Do not give anything by mouth to an unconscious person.
HOT LINE NUMBER
Note to Physician:  Contains petroleum distillate.  Vomiting may cause aspiration pneumonia.  Have the product container or label with you when calling a poison control center or doctor, or going for treatment.  You may also contact 1-800-222-1222 for emergency medical treatment information.

EPA Reg. No.: (pending as File Symbol 89186-R)	EPA Est. No.:  89186-PA-001
Net Contents: XX
(Batch)(Lot) No: XXXX

Manufactured (by)(Sold by):
ConidioTec
2610 Sleepy Hollow Drive
State College, PA 16803

                           PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS - CAUTION: Avoid contact with eyes or clothing. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.  Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse.

When handling this product, wear a long-sleeved shirt; long pants; socks; shoes; barrier laminate, nitrile rubber, neoprene rubber, or Viton gloves; and a NIOSH approved particulate respirator with any R or P filter with NIOSH approval number prefix TC-84A or a NIOSH approved powered air purifying respirator with an HE filter with NIOSH approval number prefix TC-21C. Repeated exposure to high concentrations of microbial proteins can cause allergic sensitization.

Follow the manufacturer's instructions for cleaning/maintaining protective equipment.  If no such instructions for washables, use detergent and hot water.  Keep and wash protective equipment separately from other laundry.

                              DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

For indoor use only.

Apply in an inconspicuous area to test for possible staining or discoloration. Evaluate test area after drying.

SHAKE WELL

                                 PRODUCT FACTS
Aprehend[TM]

 Aprehend[TM] is a ready-to-use oil formulation containing viable spores (conidia) of the fungus Beauveria bassiana Strain GHA, a biological insecticide that is specific to insects. The fungal spores act like a contact insecticide by sticking to the outer cuticle of the insect.  Bed bugs are affected by walking on a previously treated surface.  Following exposure, the fungal spores will germinate and penetrate the cuticle, colonizing the body of the bed bug and resulting in death within 4 to 10 days.
 Treated painted and unpainted surfaces will remain effective for up to 3 months, providing long-term control and protection from re-infestation.
Aprehend[TM]
Specifications
 Use for control and prevention of bed bug infestations.
 Up to three months residual effect on bed bug nymphs and adults.
 Effective against pyrethroid-resistant bugs.
 No odor.
 Ready-to-use.
 Can be used after heat treatments.
Controls
 Kills bed bug nymph stages by exposure to previously treated surfaces.
 Kills bed bug adults by exposure to previously treated surfaces.
How to use
 Invert bottle and shake well before using.
 Do not dilute this product.
 Do not mix Aprehend[TM] with water or other products.
Where to apply
 For indoor use only.
 See instructions below.
 In buildings and structures including houses, apartments, hotel and motel rooms, offices, and seating areas in theatres and modes of transport.
Treatment specifications
 Aprehend(TM) must be applied at low volume application rates using a Low Volume Low Pressure spray applicator. Contact ConidioTec LLC or your distributor for specific information about applicator system.
 DO NOT USE STANDARD (HIGH VOLUME) SPRAY APPLICATION EQUIPMENT TO APPLY THIS PRODUCT.
How to apply
 Invert bottle of Aprehend(TM) and shake bottle thoroughly before use to suspend contents.
 Remove cartridge from applicator and fill with shaken Aprehend(TM).
 Connect the filled cartridge to the applicator.
 Hold the applicator close to the surface to be treated and apply at a speed of approximately >=1 foot per second making a continuous 2" wide swath (barrier) of Aprehend(TM).
 Resulting volume application will be approximately 0.5 fl. oz. of Aprehend(TM)/50 linear ft. of surface.
 Do not allow excessive dripping or run-off to occur on surfaces.
Re-entry
 Keep unprotected persons and pets out of treated areas while treating and after treating for 4 hours.
Precautions/
restrictions
 Do not apply to bare floors  -  slipping hazard.
 Do not apply on wet surfaces.
 Do not apply on fresh painted surfaces.
 Do not apply to wallpaper.
 Do not apply to silk.
 Do not apply on hot surfaces.
 Do not apply where electrical short circuits can occur.
 Do not apply to furniture, upholstery or mattresses where prolonged contact with humans will occur.
 Do not apply to flat surfaces where prolonged human contact will occur.
 To ensure long-term residual activity, do not clean or wipe spray residue from treated surfaces.

Bed Bug Treatments

Use this product for control and prevention of bed bug infestations.  Aprehend(TM) is intended as a barrier treatment, bed bugs are affected by crossing a surface (barrier) that has been treated with Aprehend(TM).  Create a continuous 2" swath (barrier) of Aprehend(TM), in locations where bed bugs are likely to walk when emerging from their harborages in search of a blood meal..

Directions for use to control existing bed bug infestations:

Beds and Bedrooms  -  Remove all bedding including sheets, pillows, blankets, comforters and other linen, such as a box spring skirt.  These Items should be bagged and then laundered in hot water at 120 °F minimum and/or placed in a clothes drier at highest temperature for one hour.

For best results, hold the applicator close to the surface to be treated and apply at a speed of approximately >=1 foot per second making a continuous 2" wide barrier of Aprehend(TM), which on drying will be invisible but will remain effective for up to 3 months on painted and unpainted surfaces.  All bed bugs crossing the barrier will become infected and go on to die.

The key to effective application of Aprehend(TM) is to ensure that the barrier is continuous around the perimeter of each item being treated.   Apply a continuous 2" barrier of Aprehend(TM) around all potential harborage sites including tables, wall crevices, mirrors, picture frames and backs, door jambs, moldings and hinges, window ledges, sills, drapery rods, curtains, blinds and mounting hardware, closet shelving and hardware, chairs, sofas, bedroom furniture including, headboard, nightstands, dressers and wardrobes, TV stands, and around the perimeter of the room and baseboards.  DO NOT TREAT INSIDE ELECTRICAL OUTLETS OR FIXTURES.

Treat items as follows:

    Bed Frame  -  Once the mattress and/or box spring have been removed from the frame, treat the frame with Aprehend(TM).  It is NOT necessary to treat the entire surface of the bed frame.  Simply ensure that a complete 2" barrier of Aprehend(TM) has been applied around the outside of the frame, and the inside of the frame close to the base where the slats or mattress support board meet the frame.  Make sure that all cracks, crevices, joints, screw-holes and channels are also treated.  Allow the treatment to dry prior to replacing the mattress.
    Headboard  -  Treat the rear surface of the headboard that faces away from the mattress with Aprehend(TM). Create a continuous 2" barrier of Aprehend(TM) around the entire perimeter of the back of the headboard.  Make sure that all cracks, crevices, joints, screw holes and channels are also treated. Allow the treatment to dry.
    Box Spring  -  Apply Aprehend(TM) as a 2" barrier around the bottom perimeter of the box spring where the fabric dust cover is fixed and around the perimeter of the top surface of the box spring. If no dustcover is present, apply inside of the box spring, paying particular attention to the side-walls. Allow the treatment to dry.
    Picture Frames  -  Remove pictures from wall, particularly those close to the bed and apply Aprehend(TM) around the perimeter of the back of the frame.
    Bedroom - Apply Aprehend(TM) around the perimeter of the room where the baseboard meets the wall.  Ensure all furniture is moved away from the walls to permit treatment of all areas.
    Do not treat mattresses, sheets, pillows, blankets, comforters and other linen directly with Aprehend(TM).

Chairs, Couches and Seating Areas  -  Treat under cushions and underneath chair, couch or seating area. Ensure that the barrier of Aprehend(TM) is continuous around the entire perimeter of the chair, couch or seating area.  Make sure that all cracks, crevices, joints, screw holes and channels are also treated. Apply a 2" barrier of Aprehend(TM) around the bottom perimeter of the dust cover where it is attached to the frame. Do not treat where people may come into direct contact with the treated area.  Do not treat silk fabrics.

Offices  - Treat the underside of chairs where bed bugs have been observed or expected to occur by applying a 2" barrier of Aprehend(TM) around the perimeter of the underside of the chair.  Treat cracks and crevices underneath desk where bed bugs have been observed or expected to occur. If treating shelves, treat underneath the bottom shelf.  Apply around the perimeter of the room where the baseboard meets the wall.  Ensure all furniture is moved away from the walls to permit treatment of all areas.  Allow treatment to dry.  Do not treat where people may come into direct contact with the treated area.

For perimeter treatment and/or treatment of furniture inside other building interiors (theatres) or inside motor vehicles, buses, trains, airplane cabins, or boat cabins, follow the instructions listed above for offices, bedrooms and seating areas.

Directions for use to prevent the establishment of introduced bed bugs:

This treatment is intended for sites that are at risk of developing infestations from introduced bed bugs (e.g. hotels and motels).  Reapply every 3 months to ensure continuous protection against bed bug establishment.

Beds and Bedrooms  -  Remove all bedding including sheets, pillows, blankets, comforters and other linen. These items should be removed from the area and replaced after treatment.

    Bed Frame and Boxspring  -  Remove the mattress and place it away from the area to be treated.  Apply Aprehend(TM) as a 2" barrier of Aprehend(TM) around the perimeter of the bed frame and box spring. It is not necessary to remove the dust cover, but ensure that the barrier is applied around edge of the frame where the dust cover is fixed.  If no dustcover is present, apply inside of the box spring, paying particular attention to the side-walls.  Make sure that all areas where the frame surfaces meet are treated.  Treat the perimeter of the top surface of the box spring with Aprehend(TM).  Allow the treatment to dry.
    Headboard  -  Treat the rear surface of the headboard that faces away from the mattress with Aprehend(TM). Create a continuous 2" barrier of Aprehend(TM) around the entire perimeter of the back of the headboard.  Make sure that all cracks, crevices, joints, screw holes and channels are also treated. Allow the treatment to dry.  Re-attach the headboard to the frame/wall. If the headboard is permanently fixed to the wall, apply around the perimeter of the headboard at the wall interface, paying particular attention to the gap between the headboard and the wall.
    Picture Frames  -  Remove pictures from wall, particularly those close to the bed and apply around the perimeter of the back of the frame.
    Room - Apply around the perimeter of the room where the wall meets the baseboard.  Ensure all furniture is moved away from the walls to permit treatment of all areas.
    Apply a continuous 2" barrier of Aprehend(TM) around other potential harborage sites including, luggage racks, mirrors, picture frames, window ledges, closet shelving, and other cracks and crevices.
    Do not treat sheets, pillows, blankets, comforters and other linen directly with Aprehend(TM).

Chairs, Couches and Seating Areas  -  Remove cushions if applicable, and apply as a 2" barrier of Aprehend(TM) around the inside perimeter of the chair/couch. Treat under cushions and underneath chair,  couch or seating area. Do not treat where people may come into direct contact with the treated area.  Do not treat silk fabrics.

Offices  -  Ensure all employees have left the office area before commencing treatment. Before treating, remove all clutter.

Office desks and Chairs -Treat the underside of desks and chairs.  Treat cracks and crevices underneath desk. If treating shelves, treat the bottom perimeter of each shelf.  Apply around the perimeter of the room where the wall meets the baseboard.  Ensure all furniture is moved away from the walls to permit treatment of all areas.  Allow treatment to dry.  Do not treat where people may come into direct contact with the treated area.

For perimeter treatment and/or treatment of furniture inside other building interiors (theatres) or inside motor vehicles, buses, trains, airplane cabins, or boat cabins, follow the instructions listed above for offices, bedrooms and seating areas.

--------------------------------------------------------------------------------
STORAGE AND DISPOSAL
--------------------------------------------------------------------------------
Do not contaminate water, food or feed by storage or disposal.
--------------------------------------------------------------------------------
Storage: Store between 40° F and 77° F in a cool, dry place away from heat or open flame. Do not store product in vehicles.  Use a cooler box with an ice pack to transport product in vehicles prior to use.  Do not expose product to temperatures above 77°F for long periods of time.  Pesticide Disposal: To avoid waste, use all material in this container by application according to label directions.  If waste cannot be avoided, offer remaining product to a waste disposal facility or pesticide disposal program (often such programs are run by state or local governments or industry).
--------------------------------------------------------------------------------
Container Handling: Nonrefillable container. Do not reuse or refill this container of Aprehend(TM). Offer for recycling if available or dispose of in trash or in a sanitary landfill or by incineration.

Optional Label Claims:

-	Insecticide
-	Biological Insecticide
-	Kills bedbugs (within 7 days)
-	Provides control for up to 3 months
-	Ready-to-Use (RTU)
-	No mixing or dilution required.
-	Low odor
-	Non-repellent
-	Unique ready-to-use oil formulation
-	For use after heat treatments
-	Ready-to-Use biological mycoinsecticide for the control and prevention of bed bugs.
-	Prevents the establishment of bed bug populations when applied (quarterly) (every 3 months).


COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

NOTICE OF FILING

EPA Registration Division Contact: Mary Waller (PM#21),<PHONE_NUMBER>

ISAGRO S.p.A.

[5F6971]

EPA has received a pesticide petition ([5F6971]) from Isagro S.p.A.,
Centro Uffici San-Edifico D-ala 3, Via Caldera, 21-20153 Milan, Italy
proposing, pursuant to section 408(d)of the Federal Code, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.:

1. by establishing a tolerance for residues of

tetraconazole in or on the raw agricultural commodities: soybean, seed
at 0.1, aspirated grain fractions (AGF) and refined oil at 0.5; and
poultry, meat, liver, byproducts, egg at 0.01, and fat at 0.05 parts per
million (ppm).  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of the
FFDCA; 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.

Residue Chemistry

1. Plant and animal metabolism.  In plants and animals, the metabolism
of tetraconazole is adequately understood for the purposes of
establishing the proposed tolerances.  Tetraconazole metabolites include
1,2,4-triazole, and two conjugates, triazolylalanine and triazolyl
acetic acid, which are common to most of the triazole fungicides.  Based
on the available metabolism and toxicology data, parent tetraconazole is
proposed to be considered as the residue of concern in plant and animal
matrices.

2. Analytical method. In plants and animals, the residue of concern,
parent tetraconazole, can be determined using High Pressure Liquid
Chromatography (HPLC) with a Mass Spectrometer (MS) detector.  The
proposed limit of quantitation (LOQ) for the methods are 0.01 ppm for
soybean seed and processed commodities, and 0.02 ppm for poultry meat,
fat, byproducts, liver, and 0.01 ppm for egg.

3. Magnitude of the residues. For soybean, a total of twenty residue
trials were conducted to evaluate the magnitude of the residues of
tetraconazole following two applications of Domark 230 ME at 0.09 lbs of
active ingredient (ai) per acre with treatments at growth stages R3 and
R5.  Soybean mean and relative standard deviation residue for all sites
was 0.022 ppm ± 0.0125 ppm with a maximum residue of 0.068 ppm.
Soybean seed residues concentrated in AGF and refined oil by factors of
5.8 and 4.6, respectively.

For poultry, a total of 10 birds each were dosed at 0.077, 0.231, and
0.77 mg ai/kg (equivalent to 2, 6, and 20x the anticipated soybean
residue dietary burden).  Residues at the lowest dose were 0.038 ppm for
fat, <0.01 ppm for meat, liver, and kidney, and <0.005 for egg.

Toxicological Profile

1. Acute toxicity. Acute oral lethal dose (LD)50 = 1,031
milligrams/kilogram (mg/kg) (toxicity category III); acute dermal LD50 <
2,000 mg/kg (toxicity category III); acute inhalation lethal
concentration (LC)50 = 3.66 mg/liter (toxicity category IV); primary eye
irritation - clear by 72 hours (toxicity category III); primary skin
irritation - slight irritation (toxicity category IV); and dermal
sensitization - negative.

2. Genotoxicity. Numerous mutagenicity studies were conducted with
tetraconazole and no genotoxic effects were reported,

3. Reproductive and developmental toxicity. A two-generation
reproduction study was conducted in rats at dietary concentrations of 0,
10, 70 or 490 ppm.  The LOAEL for parental toxicity = 70 ppm, equivalent
to 4.9/5.9 (male/female) mg/kg/day based on increased mortality in P
generation females. The NOAEL = 10 ppm, equivalent to 0.7/0.8 (M/F)
mg/kg/day. The LOAEL for off spring toxicity = 490 ppm (40.6 mg/kg/day
from the P generation female intake) based on decreased litter weight
and mean pup weight in litters of all generations before weaning and
increased relative liver weights at weaning in both sexes of all
litters. The NOAEL = 70 ppm (5.9 mg/kg/day). The LOAEL for reproductive
toxicity = 70 ppm, equivalent to 4.9/5.9 (M/F) mg/kg/day based on
increased mean gestation duration in P generation parental females and
related evidence of compound toxicity in the parturition process.  The
NOAEL was 10 ppm (0.7 mg/kg/day for males and 0.8 for females).

A developmental toxicity study was conducted using rats gavaged with
doses of 0, 5, 22.5, and 100 mg/kg/day from days 2 through 15 of
gestation. The maternal toxicity LOAEL is 100 mg/kg/day based on
decreased body weight gain, and food consumption and increased liver and
kidney weights. The maternal toxicity NOAEL is 22.5 mg/kg/day.
Developmental toxicity was noted at 100 mg/kg/day and consisted of an
increased incidence of small fetuses, and supernumerary ribs. The LOAEL
and NOAEL for developmental toxicity were 100 and 22.5 mg/kg/day,
respectively.

A developmental toxicity study was conducted using rabbits gavaged with
doses of 0, 7.5, 15, or 30 mg/kg/day.  The maternal toxicity NOAEL = 13
mg/kg/day and LOAEL = 30 mg/kg/day, based upon decreased body weight
gain.  The developmental toxicity NOAEL = 30 mg/kg/day and the LOAEL was
not established.

4. Subchronic toxicity. Ninety-day feeding studies were conducted in
rats and mice.  The rat study was conduced at dietary concentrations of
0, 10, 60, or 360 ppm.  The NOAEL = 4.1/5.5 (M/F) mg/kg/day.  The LOAEL
= 23.9/28.7 (M/F) mg/kg/day, based on single liver cell degeneration in
males, and increased SGPT and SGOT, decreased BUN levels, increased
absolute and relative liver weights and presence of hepatocellular
single cell necrosis in females.  The mouse study was conducted at
dietary concentrations of 0, 5, 25, 125, or 625 ppm.  The NOAEL = 4
(M/F) mg/kg/day.  The LOAEL = 16/20 (M/F) mg/kg/day, based on single
liver cell degeneration in males, and increased SGPT and SGOT, decreased
BUN levels, increased absolute and relative liver weights and presence
of hepatocellular single cell necrosis in females.

5. Chronic toxicity. A two year combined chronic
toxicity/carcinogenicity study was conducted in rats at dietary
concentrations of 0, 10, 80, 640 or 1280 ppm.  The NOAEL = 3.4/4.4 (M/F)
mg/kg/day.  The LOAEL = 27.7/39.4 (M/F) mg/kg/day, based upon
histopathology of the bone (osseous hypertrophy of the cranium/parietal
bone), pale and thickened incisors, and decreased absolute and relative
adrenal and pituitary weights in males; decreased body weight (at
terminal sacrifice) in females.  No treatment-related increases in tumor
incidence were observed.

A 52-week chronic toxicity study was conducted in dogs at dietary
concentrations of 0, 22.5, 90 or 360 ppm.  The NOAEL = 0.73/0.82 (M/F)
mg/kg/day.  The LOAEL = 27.7/39.4 (M/F) mg/kg/day, based upon increased
absolute and relative kidney weights and histopathological changes in
the male kidney.

6. Carcinogenicity.  An 80 week mouse oncogenicity study was conducted
at dietary concentrations of 0, 10, 90, 800, or 1250 ppm.  The NOAEL =
1.4/1.5 (M/F) mg/kg/day.  The LOAEL = 12/14.5 (M/F) mg/kg/day, based
upon increased liver weights and hepatocellular vacuolation in both
sexes and increased kidney weights in males.  Treatment-related
increased incidences of combined benign and malignant liver tumors in
both sexes were observed.

7. Animal metabolism. The nature of tetraconazole residues is adequately
understood.  Tetraconazole is extensively metabolized very quickly and
eliminated from the body by fecal and urinary routes.

8. Metabolite toxicology.  1,2-4-Triazole is the major metabolite
identified in urine and feces with minor amounts of triazole acid and
alcohol.  The most conservative toxicology endpoint for 1,2,4-triazole
is 15 mg/kg/day, based on body weight decreases in male rats in the
reproductive study.

9. Endocrine disruption. Tetraconazole did not have effects on endocrine
organs or tissues, nor were there any indications of effects on fetal
development in either rats or rabbits, or on reproductive performance in
rats.  Therefore, at doses likely to be encountered, tetraconazole in
not likely to be an endocrine disruptor.

C. Aggregate Exposure

1. Dietary exposure.  Using 100% crop treated scenarios and existing
sugar beet, cattle, horse, goat, and sheep RAC tolerances and proposed
soybean and poultry RAC tolerance for residue exposure assumptions,
acute dietary exposure from food to tetraconazole occupies 0.5% of the
aPAD (0.225 mg/kg at UF = 100) for females 13 to 49 years old, the only
population subgroup for which an acute toxicity endpoint was determined.
 Using the same exposure assumptions, chronic dietary exposure from food
to tetraconazole occupies 3.9% and 11.1% of the cPAD (0.0073 mg/kg/day
at UF = 100) for the U.S. population and the most sensitive
subpopulation, non-nursing infants, respectively.  The most potent unit
risk used for the purpose of lifetime cancer risk assessment by the
Agency is Q1* = 2.30 x 10-2 in human equivalents.  Using the same
assumptions except for 50% and 10% crop treated scenarios for sugar beet
and soybean, respectively, and mean residue exposure for soybean oil and
seed, the estimated aggregate cancer risk from dietary exposure for the
proposed use on soybeans is 0.21 x 10-6, a value that falls within the
Agency's acceptable risk standard for cancer in the range of <1 x 10-6.

i. Food. The cRfD and aRfD values of 0.0073 mg/kg bw and 0.225 mg/kg bw,
respectively, were used to assess risk from dietary exposure.  Tier 1
dietary risk assessments indicate that the highest chronic and acute
exposures never exceed 11.1% and 0.5% (at the 99.9th percentile of
exposure) for the cRfD and aRfD, respectively.

ii. Drinking water. The standard EPA Mississippi soybean PRZM/EXAMS
modeling scenario with index reservoir (IR) was used to conservatively
estimate concentrations of tetraconazole in drinking water resulting
from the proposed use on soybeans.  Extensive surface water monitoring
results generated by the Minnesota Department of Agriculture were used
to estimate concentrations of tetraconazole in drinking water resulting
from use on sugar beets.  The drinking water estimated concentrations
(DWECs) from the Mississippi soybean scenario model were 2.19 ppb
(acute), 0.578 ppb (chronic) and 0.441ppb (30 year lifetime average).
These are 6 to 28 times greater than the highest level of tetraconazole
detected in Minnesota surface water, which was 0.075 ppb (1/2 Level of
Quantitation).  Thus, the Mississippi DWECs were used to assess dietary
risks from exposure to drinking water for uses on sugar beets and
soybeans.  The DWECs are lower than the lowest drinking water level of
comparison (DWLOC) values of 6,720 ppb (acute), 69 to 249 ppb (chronic),
and 1.516 ppb (cancer).  When DWLOC values are not exceed by DWEC values
it can be concluded that dietary risks from exposure to drinking water
are acceptable.

2. Non-dietary exposure. Tetraconazole is currently not registered for
use on any residential non-food site.  Therefore, residential exposure
to tetraconazole residues will be through dietary exposure only.

D. Cumulative Effects

EPA has not made a common mechanism of toxicity finding as to
tetraconazole and any other substance.  However, the Agency does have
concern about potential toxicity to 1,2,4-triazole and two conjugates,
triazolylalanine and triazolyl acetic acid.  To support the extension of
existing parent triazole-derivative fungicide tolerances, EPA conduced
an interim human health assessment for aggregate exposure to
1,2,4-triazole.

Based on this assessment EPA concluded that for all exposure durations
and population subgroups, aggregate exposures to 1,2,4-triazole are not
expected to exceed its level of concern.

E. Safety Determination

1. U.S. population. Based on the exposure assumptions described above
and on the completeness of the toxicology database, it can be concluded
that total aggregate exposure from food and water to the U.S. population
and all evaluated population subgroups from tetraconazole exposure from
all proposed uses will be below 100% of the RfDs.  EPA generally has no
concerns for estimated exposures below 100% of the RfD, since the RfD
represents the level at or below which daily aggregate exposure will not
pose an appreciable risk to human health.  Thus, ISAGRO believes it can
be concluded that there is reasonable certainty that no harm will result
from aggregate exposure to tetraconazole residues for registered and
proposed uses on sugar beets and soybeans.

2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of tetraconazole, the
data from developmental toxicity studies in both the rat and rabbit and
a two generation reproduction study in rats have been considered.  These
toxicity studies indicate the offspring are not more sensitive and all
developmental and reproductive effects were secondary to severe maternal
toxicity. Thus, ISAGRO believes that infants and children are protected
and that an additional uncertainty factor for infants and children is
not warranted.

F. International Tolerances

Maximum residue levels (MRL) have been established for tetraconazole in
the following countries (in ppm).

Belgium: sugar beet root, 0.05; wheat grain, 0.05; wheat straw, 2.0.

France: apple, 0.2; barley grain, 0.02; grape, 0.2; wine, 0.01; sugar
beet root, 0.05; wheat grain, 0.02.

Italy: apple, 0.5; artichoke, 0.2; barley grain, 0.1; courgette, 0.2;
cucumber, 0.2; grape, 0.5; melon, 0.05; peach, 0.2; pear, 0.2; pepper,
0.2; tomato, 0.2, watermelon, 0.05; wheat grain, 0.05

Portugal: apple, 0.3; grape, 0.2; melon, 0.1; peach, 0.2; pear, 0.3;
strawberry, 0.2; sugar beet root, 0.05.

Spain: apple, 0.2; artichoke, 0.05; cucurbit fruit & edible peel, 0.2;
nectarine, 0.2; peach, 0.2; pear, 0.2; sugar beet leaves, 0.3; sugar
beet root; 0.05; tomato, 0.1.

United Kingdom: barley grain, 0.2; barley straw, 10; oat grain, 0.1; oat
straw, 2; wheat grain, 0.05; wheat straw, 5.

Czech Republic: apple, 0.5; grape, 0.05

Hungary: apple, 0.2; grape, 0.5; sugar beet root & leaves, 0.5; sugar
beet root, 0.1; wheat grain, 0.05; wheat straw, 3.

Poland: apple, 0.5; cereal grain, 0.05; cereal straw, 3; cucumber edible
peel, 0.2.

Japan: wheat, 0.05; barley; 0.2 other cereal grain, 0.1; sugar beet,
0.5; artichoke, 0.2; tomato, 1; cucumber, 0.5; pumpkin (including
squash), 1; oriental cucurbitaceous vegetables, 0.2; apple, 0.5,
Japanese pear, 0.5, pear, 0.5 quince, 0.5 peach, 0.3, nectarine, 0.2;
apricot, 0.2; Japanese plum (including prune); 0.2; cherry, 0.2;
strawberry, 2; watermelon, 0.2, melon, 0.2; makuwauri, 0.2; grape, 0.5;
tea, 20.

Page  PAGE  1  of 6


[Federal Register: June 5, 2006 (Volume 71, Number 107)]
[Notices]
[Page 32337-32338]
[DOCID:fr05jn06-46]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Non-Project Use of Project Lands and
Waters and Soliciting Comments, Motions To Intervene, and Protests

May 30, 2006.
    a. Type of Application: Application for Non-Project Use of Project
Lands and Waters.
    b. Project Number: P-2686-044.
    c. Date Filed: May 16, 2006.
    d. Applicant: Duke Power.
    e. Name of Project: Westfork Hydroelectric Project No. 2686.
    f. Location: The project is located on the West Fork of the
Tuckasegee River in Jackson County, North Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a) 825(r)
and 799 and 801.
    h. Applicant Contact: Ms. Beth Mosteller, Mountain Lake Permit
Service, 878 Mountain Cove Road, Waynesville, North Carolina 28786,
phone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    i. FERC Contact: Any questions on this notice should be addressed
to Chris Yeakel at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>
    j. Deadline for filing comments and or motions: June 19, 2006.
    k. Description of Request: Duke Power proposes to grant a lease of
0.47 acre of project lands for non-project use as a private marina to
provide access to Lake Glenville for residents of the Glenville Lake
Club Subdivision. The marina will consist of a cluster dock with nine
boat-docking locations, a 75 feet by 6 feet access ramp, leading to a
72 feet by 6 feet ramp, with three 20 feet by 4 feet fingers to provide
the nine docking locations.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field (p-2686) to access the document. You
may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or e-mail<EMAIL_ADDRESS>for TTY,

call<PHONE_NUMBER>. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers (p-2686-044). All documents (original and eight
copies) should be filed with: Magalie R. Salas, Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington DC
20426. A copy of any motion to intervene must also be served upon each
representative of the Applicant specified in the particular
application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Magalie R. Salas,
Secretary.
[FR Doc. E6-8666 Filed 6-2-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: June 2, 2010 (Volume 75, Number 105)]
[Notices]
[Page 30811-30812]
[DOCID:fr02jn10-69]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of FERC Attendance at the Entergy Regional State Committee
Meeting

May 26, 2010.
    The Federal Energy Regulatory Commission hereby gives notice that
Commissioners and members of its staff may attend the meeting noted
below. Their attendance is part of the Commission's ongoing outreach
efforts.

Entergy Regional State Committee Meeting

June 15, 2010 (1 p.m.-5 p.m.)
June 16, 2010 (1 p.m.-5 p.m.) Grand Hotel Marriott Resort, One Grand
Blvd., Point Clear, AL 36564,<PHONE_NUMBER>.
    The discussions may address matters at issue in the following
proceedings:

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

----------------------------------------------------------------------------------------------------------------
Docket No. OA07-32.....................  Entergy Services, Inc.
Docket No. OA08-59.....................  Entergy Services, Inc.
Docket No. EL00-66.....................  Louisiana Public Service Commission v. Entergy Services, Inc.
Docket No. EL01-88.....................  Louisiana Public Service Commission v. Entergy Services, Inc.
Docket No. EL05-15.....................  Arkansas Electric Cooperative Corp. v. Entergy Arkansas, Inc.
Docket No. EL07-52.....................  Louisiana Public Service Commission v. Entergy Services, Inc.
Docket No. EL08-51.....................  Louisiana Public Service Commission v. Entergy Services, Inc.
Docket No. EL08-60.....................  Ameren Services Co. v. Entergy Services, Inc.
Docket No. EL09-43.....................  Arkansas Public Service Commission v. Entergy Services, Inc.
Docket No. EL09-61.....................  Louisiana Public Service Commission v. Entergy Services, Inc.
Docket No. EL09-78.....................  South Mississippi Electric Power Association v. Entergy Services, Inc.
Docket No. EL10-55.....................  Louisiana Public Service Commission v. Entergy Services, Inc.
Docket No. EL10-65.....................  Louisiana Public Service Commission v. Entergy Services, Inc.
Docket No. ER05-1065...................  Entergy Services, Inc.
Docket No. ER07-682....................  Entergy Services, Inc.
Docket No. ER07-956....................  Entergy Services, Inc.
Docket No. ER08-767....................  Entergy Services, Inc.
Docket No. ER08-1056...................  Entergy Services, Inc.
Docket No. ER08-1057...................  Entergy Services, Inc.
Docket No. ER09-636....................  Entergy Services, Inc.
Docket No. ER09-833....................  Entergy Services, Inc.
Docket No. ER09-877....................  Entergy Services, Inc.
Docket No. ER09-882....................  Entergy Services, Inc.
Docket No. ER09-1214...................  Entergy Services, Inc.
Docket No. ER09-1224...................  Entergy Services, Inc.
Docket No. ER10-794....................  Entergy Services, Inc.
Docket No. ER10-879....................  Entergy Services, Inc.
Docket No. ER10-984....................  Entergy Services, Inc.
----------------------------------------------------------------------------------------------------------------

    These meetings are open to the public.
    For more information, contact Patrick Clarey, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (317) 249-
5937 or<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-13272 Filed 6-1-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Page 11198]
[FR Doc No: 2018-05095]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-178-000]

Alaska Gasline Development Corporation; Notice of Technical
Conference

    Take notice that a technical conference will be held on Thursday,
March 22, 2018 at 9:00 a.m., in Room 3M-4 A and B at the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The technical conference will provide an opportunity for Commission
staff and representatives from Alaska Gasline Development Corporation
to discuss clarifications on the Commission staff's February 15, 2018
environmental data request for the Alaska LNG Project. While all
interested persons and Commission staff are permitted to attend, no
comments or statements during the conference will be permitted.
Further, there will be no discussion of Critical Energy Infrastructure
Information or privileged materials. For further information please
contact Jennifer Zielinski at<PHONE_NUMBER> or email
[email protected].
    Federal Energy Regulatory Commission conferences are accessible
under section 508 of the Rehabilitation Act of 1973. For accessibility
accommodations please send an email to [email protected] or call
toll free<PHONE_NUMBER> (voice) or<PHONE_NUMBER> (TTY), or send a fax
to<PHONE_NUMBER> with the required accommodations.

    Dated: March 8, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-05095 Filed 3-13-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74195-74196]
[FR Doc No: 2012-30033]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1161]

Draft Guidance for Industry and Food and Drug Administration
Staff; Design Considerations for Devices Intended for Home Use;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Design Considerations for
Devices Intended for Home Use.'' This document is intended to assist
manufacturers in designing and developing home use medical devices that
comply with applicable standards of safety and effectiveness and other
regulatory requirements. Home use devices are associated with unique
risks created by the interactions among the user (often a layperson),
the use environment, and the device. This document identifies several
factors that manufacturers should consider, especially during device
design and development, and provides recommendations for reducing or
minimizing these unique risks. This draft guidance is not final nor is
it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 13, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Design Considerations for Devices Intended
for Home Use'' to the Division of Small Manufacturers, International,
and Consumer Assistance, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 4613, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development (HFM-40), Center for

Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist that office in processing your request, or fax
your request to<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance.
    Submit electronic comments on the draft guidance to  http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For information concerning the guidance as it relates to devices
regulated by CDRH: Mary Brady, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5426, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    For information concerning the guidance as it relates to devices
regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

I. Background

    For a variety of reasons, use of devices outside professional
healthcare facilities or clinical laboratories is on the rise. First,
the U.S. population is aging, and the elderly are more likely to live
with chronic diseases that require daily medical care at home. Second,
due to medical advancements, many individuals with chronic diseases are
living longer, but are dependent on home medical care. Finally, an
increasing focus on reducing healthcare costs for patients of all ages
has spurred the growth of the home health care market. Integral to the
home health care market are home use devices. Although home use devices
provide significant benefits to patients and families, including
quality of life improvements and cost savings, home use devices are
also associated with unique risks. Reducing or minimizing the risks
posed by home use devices can greatly improve the public health.
    This draft guidance provides recommendations for designing and
developing medical devices intended for home use through considerations
involving the physical environment, the user, the device or system, the
labeling, and the utilization of human factors. This should result in a
safe and easier-to-use device, minimize use error, and reduce the
likelihood that adverse events will occur. The recommendations in the
guidance apply to both prescription and over-the-counter medical
devices that are intended for home use.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the total
product life cycle for devices intended for home use. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Design Considerations for Devices Intended for Home Use'' from CDRH,
you may either send an email request to<EMAIL_ADDRESS>to receive
an electronic copy of the document or send a fax request to 301-847-
8149 to receive a hard copy. Please use the document number 1750 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801 and 21 CFR 809.10 have
been approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 803 have been approved under OMB control
number 0910-0437; the collections of information in 21 CFR part 807,
subpart E have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231; the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073; and the
collections of information in Form FDA 3500A have been approved under
OMB control number 0910-0291.

V. Comments

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

    Dated: December 5, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30033 Filed 12-12-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 8, 2006 (Volume 71, Number 216)]
[Notices]
[Page 65555-65559]
[DOCID:fr08no06-126]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54681; File No. SR-NASD-2006-103]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing of a Proposed Rule Change Relating to
TRACE Requirements in Connection With the Exercise or Settlement of
Options, Swaps, or Similar Instruments

 November 1, 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 August 28, 2006, the National Association of Securities Dealers,
Inc. (``NASD'') filed with the Securities and Exchange Commission
(``Commission'') the

proposed rule change as described in Items I, II, and III below, which
items have been prepared by NASD. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    NASD is proposing: (1) To adopt NASD IM-6230, which would provide
exemptive relief from various reporting requirements for transactions
in TRACE-eligible securities executed in connection with the
termination or settlement of a credit default swap or a similar
instrument; and (2) to amend NASD Rule 6250 to not disseminate
information on certain transactions in TRACE-eligible securities
executed in connection with the exercise or settlement of an option or
similar instrument or the settlement or termination of a credit default
swap, any other type of swap, or similar instrument.
    The text of the proposed rule change is available on NASD's Web
site at http://www.nasd.com, at NASD's principal office, and at the

Commission's Public Reference Room.

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

    In its filing with the Commission, NASD included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposal. The text of these
statements may be examined at the places specified in Item IV below.
NASD 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
    NASD is proposing NASD IM-6230, ``Reporting Transactions Executed
in Connection with the Termination or Settlement of a Credit Default
Swap,'' to provide exemptive relief from certain reporting requirements
in NASD Rule 6230 for transactions in TRACE-eligible securities that
occur in connection with the termination or settlement of CDSs or
similar instruments. For certain transactions executed in connection
with a broader class of instruments (options or similar instruments and
CDSs, any other type of swaps, or similar instruments), NASD is
proposing to amend its Rule 6250 to not disseminate information on
transactions in TRACE-eligible securities executed in connection with
the exercise, settlement, or termination of such instruments.

Background

    When a CDS is subject to physical settlement, the buyer effects
contract settlement by communicating to the seller, in a single or the
first of two or more Notice(s) of Physical Settlement (or a similar
document(s)) (``First NOPS'') within a fixed period, the TRACE-eligible
security or securities, by CUSIP, that the buyer will deliver to the
seller. However, following delivery of the First NOPS, the buyer may
have additional business days (for example, three additional business
days) to change the specific TRACE-eligible securities the buyer will
deliver. Once the TRACE-eligible securities to be delivered are
determined, the buyer delivers the TRACE-eligible securities to the
seller and the seller delivers cash (e.g., the par value of the
securities or some other pre-determined amount per debt security).

Proposed NASD IM-6230

    In Notice to Members 05-77 (November 2005), NASD clarified that a
member that is a party to a transaction in TRACE-eligible securities
that occurs in connection with the termination or settlement of a CDS
\3\ or a similar instrument must report the transaction to TRACE under
NASD Rule 6230.\4\ Since publishing this Notice to Members, NASD has
received inquiries regarding the application of certain reporting
requirements, including requirements relating to the time of execution,
the application of the 15-minute reporting period, and how to report
transactions when, under certain often-used CDS documentation providing
for termination or settlement, parties may be permitted to substitute
one TRACE-eligible security for another.
---------------------------------------------------------------------------

    \3\ In a CDS, one party purchases protection from third-party
credit risk from a counterparty seller. The purchaser of the
protection is referred to as the ``buyer'' and the provider of the
credit protection is referred to as the ``seller'' in proposed NASD
IM-6230. Under a standard CDS agreement, an event such as a default
is deemed a ``credit event.'' When a credit event occurs, a ``credit
event notice'' is delivered by either the buyer or seller. Within a
fixed period from the date a credit event notice is received (e.g.,
30 days), the parties must communicate specific information needed
to settle the CDS.
    \4\ NASD Notice to Members 05-77 (November 2005), among other
things, clarified that the reporting requirement applies only to
those CDSs that are terminated or settled in whole or in part by the
physical settlement involving TRACE-eligible securities, and has no
application to CDSs that are cash-settled. NASD also addressed the
TRACE reporting requirements for TRACE-eligible securities
transactions executed in connection with a broader class of
instruments--options and similar instruments, and CDSs, any other
type of swaps and similar instruments--and not just those TRACE-
eligible securities transactions executed in connection with CDSs.
---------------------------------------------------------------------------

Timely Reporting

    Under NASD Rule 6230, a member is required to provide timely
reports for transactions in TRACE-eligible securities. In addition, in
most instances, such transactions must be reported within 15 minutes of
the time of execution to be considered timely.
    NASD is proposing to provide exemptive relief from certain
provisions of NASD Rule 6230 under proposed NASD IM-6230 for
transactions that are executed in connection with the termination or
settlement of a CDS, subject to certain conditions. Under proposed NASD
IM-6230(a), such transactions would be deemed to be timely reported if
they are reported before 8:15:00 a.m. E.T. on the next business day
following receipt of the First NOPS, if the First NOPS was received on
a business day, or before 6:30:00 p.m. on the next business day, if the
First NOPS was received on a non-business day. In addition, a member
would have to report such transactions using the TRACE memo field and
include a ``CDS'' memo.\5\ The CDS memo would allow NASD to properly
categorize such transactions for purposes of examining the member for
compliance with its reporting obligations and, as discussed below, for
decisions to not disseminate the transaction information.
---------------------------------------------------------------------------

    \5\ NASD also requires that such transactions be reported using
the ``special price'' modifier or flag, which is appropriately used
when a transaction is executed at a price based on arm's length
negotiation and done for investment, commercial, or trading
considerations, but does not appear to reflect current market
pricing. See Notice to Members 05-77 (November 2005).
---------------------------------------------------------------------------

    NASD also proposes that the ``time of execution'' be construed as
the time the transaction report is submitted. Under proposed NASD IM-
6230(b), a member would enter as the ``time of execution'' the time
that the member submits the transaction report.\6\
---------------------------------------------------------------------------

    \6\ If a transaction is reported before 8:15:00 a.m. E.T., NASD
would assume that the First NOPS was delivered the prior business
day. If a transaction is reported on or after 8:15:00 a.m. E.T.,
NASD would assume that the transaction was not reported timely.
Firms would be expected to retain documentation, including the First
NOPS, for transactions reported in connection with the termination
or settlement of CDSs.
---------------------------------------------------------------------------

    NASD believes that the reporting scheme in proposed NASD IM-6230(a)
and (b) is appropriate for several reasons. NASD believes that the
``time

of execution'' for CDS-related transactions is of less regulatory
importance than for other reported transactions in TRACE-eligible
securities because the price of a transaction in a TRACE-eligible
security executed pursuant to a CDS is arrived at under the terms of
the CDS agreement that are established at the time the CDS is agreed
upon by the parties. Consequently, NASD believes that a precise time of
execution is not required for regulatory purposes because such
transactions are terminations or settlements of executory contractual
obligations that do not provide useful data in connection with price
discovery, determining best execution, or assessing reasonable mark-ups
(or mark-downs). Rather, NASD requires the reports of CDS-related
transactions in order to facilitate NASD's surveillance of the
corporate bond market for the detection of various fraudulent or
manipulative acts and unfair practices. Therefore, NASD is proposing
that the time of execution of such transactions mirror the time of
reporting. Moreover, for the same reasons, NASD believes that applying
the 15-minute reporting requirement to such transactions imposes an
unnecessary regulatory burden at this time. In addition, NASD believes
that waiving the 15-minute reporting requirement will allow CDS buyers
and sellers to process the First NOPS in all cases efficiently at some
time during the business day that the First NOPS is received or the
following morning through the first 15 minutes that the TRACE system is
open, or, if the First NOPS is received on a non-business day,
throughout the next business day until 6:29:59 p.m. E.T. Finally, NASD
represents that the substantial costs to NASD of receiving and
reviewing for market surveillance purposes a large number of ``late''
transactions (and the related ``cancel/correct'' late reports, as
discussed below) and the substantial costs to members in respect of
transactions where the time of execution is not critical for the
purposes of NASD's regulatory review are secondary, but significant,
reasons for proposing the exemptive relief in proposed IM-6230(a) and
(b).

Substitution of Securities; Exemption From Reporting; Exemption From
Correction

    NASD is also proposing that a limited group of transactions in
TRACE-eligible securities that are executed in connection with the
termination or settlement of a CDS be exempt from reporting and that a
related group be exempt from the requirement to correct a previously
transmitted erroneous trade report. Under proposed IM-6230(c), if a
buyer submits the First NOPS and triggers the obligation of one or both
parties to the CDS to report the TRACE-eligible securities
transactions, and then substitutes another TRACE-eligible security for
delivery, NASD would not require a member to submit a ``reversal''
trade report (to cancel the previously submitted report for a
transaction in a TRACE-eligible security that did not occur as a result
of the substitution and delivery of another TRACE-eligible security).
In addition, NASD would not require the member to submit a transaction
report (i.e., a ``cancel/correct'' trade report using an as/of date) to
report the transaction in the substituted TRACE-eligible debt security.
    NASD believes that the proposed exemptive relief under NASD IM-
6230(c) recognizes the nature of CDS-related transactions and provides
for reporting, but does not affect adversely the settlement process or
the market in CDSs. Several factors informed NASD's proposed exemptive
provision in NASD IM-6230(c). First, NASD notes that certain CDSs--
sometimes referred to as ``single name default swaps''--are not viewed
as CDSs on a single debt security, but rather are considered a CDS on
all of the issuer's debt securities of similar credit and seniority--
i.e., securities that are pari passu.\7\ For purposes of a CDS, such
debt securities of similar credit and seniority are viewed as virtually
fungible within the issuer's capital structure. As a result, a
purchaser of a CDS often may be permitted to choose from among several
debt securities that are pari passu to make good delivery. NASD
believes that the reporting of transactions in TRACE-eligible
securities in connection with the termination or settlement of a CDS
provides important market surveillance information that is not changed
materially even if, subsequently, one or more of the specific TRACE-
eligible securities reported initially to the TRACE system is
substituted and a different TRACE-eligible security of the same issuer
is delivered to effectuate settlement.
---------------------------------------------------------------------------

    \7\ Securities that are pari passu are those that are entitled
to be paid on an equal basis from the same pool of assets.
---------------------------------------------------------------------------

    Also, NASD has determined that any additional regulatory
information and regulatory benefit obtainable from the ``cancel/
correct'' trade reports and ``late'' reports (for any TRACE-eligible
security delivered in substitution, as described above) are outweighed
by the substantial costs that would be incurred by both NASD and
members by requiring such follow-up reporting.

Proposed Amendments to NASD Rule 6250

    NASD Rule 6250 currently requires that information on all
transactions in TRACE-eligible securities be disseminated immediately
upon receipt of the transaction report, except transactions in TRACE-
eligible securities that are purchased or sold pursuant to Rule 144A of
the Securities Act of 1933 (``Rule 144A transactions''). NASD proposes
to amend its Rule 6250 to not disseminate information on certain
transactions in TRACE-eligible securities executed in connection with
the exercise or settlement of an option or similar instrument or the
settlement or termination of a CDS, any other type of swap, or similar
instrument (hereinafter, the exercise, settlement or termination of
such instruments is referred to collectively as ``option exercises and/
or swap settlements''). NASD proposes that such information not be
publicly disseminated because it does not contribute to price discovery
and may cause investor confusion. NASD also proposes to re-number
current NASD Rule 6250(b), the exception from dissemination that
applies to Rule 144A transactions, as new NASD Rule 6250(b)(1).
    As noted previously, NASD clarified that transactions in TRACE-
eligible securities occurring as a result of such option exercises and/
or swap settlements are required to be reported to TRACE.\8\ However,
although reported, NASD believes that the dissemination of pricing and
other information on such transactions does not appear to provide
market participants with information useful for price discovery
purposes. NASD believes that this is due primarily to the fact that
such options, CDSs, other types of swaps, and similar instruments are
generally entered into significantly earlier than the occurrence of the
option exercise and/or swap settlement. NASD notes that the agreements
setting out the terms for these transactions generally determine the
price of the TRACE-eligible securities at arm's length for investment,
commercial, or trading purposes in a manner that tends not to be
reflective of the current market price of the TRACE-eligible security
as of the day and time that the transaction or transactions in TRACE-
eligible securities occur (e.g., at the option exercises and/or swap
settlement),

which may be several weeks, months, or years later.
---------------------------------------------------------------------------

    \8\ See supra note 4.
---------------------------------------------------------------------------

    In addition, NASD is concerned that for some investors, especially
retail investors, the dissemination of such pricing information may
cause significant investor confusion. If a significant number of
transactions occur in a specific TRACE-eligible security as a result of
option exercises and/or swap settlements and, at the same time, other
market participants are executing transactions in the same TRACE-
eligible security, the pricing information that would be disseminated
would reflect divergent prices for the same security during the same
period. For example, if a credit event occurs with respect to the
issuer of the TRACE-eligible security or securities that are the
subject of a CDS, a number of transactions in such TRACE-eligible
securities would be reported at par (i.e., a price of 100) to TRACE and
disseminated to the public when one or more CDSs are settled. At the
same time, other transactions in the same TRACE-eligible security might
be reported as executed at a price substantially discounted from par
(e.g., a price of 60) and immediately disseminated (unless they are
Rule 144A transactions). NASD has seen several such scenarios unfold
and believes that such price dissemination may confuse investors,
particularly less sophisticated investors.
    For these reasons, NASD proposes an exception to the general
principle stated in NASD Rule 6250(a) requiring dissemination of
transaction information of all TRACE-eligible securities except Rule
144A transactions. Proposed NASD Rule 6250(b)(2) provides that certain
transactions that occur as a result of options exercises and/or swap
settlements would not be disseminated. However, this proposed exception
to dissemination is subject to certain important conditions. NASD
represents that these conditions are intended to insure that the
options, CDSs, other types of swaps, and similar instruments resulting
in such transactions are bona fide and to limit the exception to TRACE
transactions occurring as a result of instruments that, by the nature
of their terms are not designed, at the time the agreement is entered
into, to replicate, as option exercises and/or swap settlements, the
then-current market price of the TRACE-eligible security.
    First, the proposed exception to dissemination would apply only to
options, CDSs, other types of swaps, or similar instruments that are in
writing and express legal and enforceable contractual obligations.
Second, such instruments must have a term of at least 20 business days
and could not be exercised, terminated, or settled earlier than the end
of the 20th business day from the date of issuance. NASD represents
that this condition is intended to limit the dissemination exception by
excluding short-term options or similar instruments because they are
more likely to be utilized as proxies for current market transactions
in the underlying TRACE-eligible securities.
    The third condition is that the instrument must have an exercise or
strike price that is fixed and out-of-the-money by at least 10 percent
at the date of issuance, or a price formula that is fixed and results
in an exercise or strike price that is out-of-the-money by at least 10
percent at the date of issuance, or a price formula that is fixed and
results in a final price--combining any premium, installment or similar
payment, and any strike or exercise price or similar term--that is out-
of-the money by at least 10 percent at the date of issuance. Like the
second condition above, NASD represents that this condition is intended
to limit the dissemination exception to transactions that are not based
on a current market price or negotiation or are not intended as a proxy
for a current market transaction. For example, an option written deep
in-the-money would be considered a proxy for a current market
transaction and the exercise-related transaction would not be eligible
for the TRACE dissemination exception. Similarly, the exercise-related
transaction of an option with a pricing formula that at exercise
utilizes the current market price or calls for a negotiation at the
current market would not be eligible for the TRACE dissemination
exception.\9\ NASD believes that such formulas may result in
transactions that provide important price discovery information to the
market when disseminated and also are not likely to cause investor
confusion if an investor seeks to determine the current market price of
a particular TRACE-eligible security. Thus, as part of the third
condition, NASD is proposing that the instrument be out-of-the money by
at least 10 percent at issuance to ensure that instruments not be
written ``near the money'' to serve as proxies for current market
transactions. This may occur when two parties enter into an instrument
expecting that, after the option or similar instrument is in place, one
of them (or another party, as directed) will be able to move the
current market price of an illiquid TRACE-eligible security by
executing one or a few transactions in the security, resulting in the
option or similar instrument becoming ``in-the-money'' and being
exercised.
---------------------------------------------------------------------------

    \9\ For example, a transaction in a TRACE-eligible security
occurring as a result of the exercise of a ``zero-strike'' option,
an option which simply tracks the value of the underlying instrument
(in this case, a TRACE-eligible security) and expires (or is
exercised) at the then current market value of the instrument it is
tracking, would not be eligible for the TRACE dissemination
exception.
---------------------------------------------------------------------------

    NASD also proposes to re-number current NASD Rule 6250(b), the
exception to dissemination that applies to Rule 144A transactions, as
new NASD Rule 6250(b)(1).

Effective Date

    NASD would announce the effective date of the proposed rule change
in a Notice to Members to be published no later than 60 days following
Commission approval, if the Commission approves this proposal. NASD
represents that the effective date of the proposed rule change would be
not more than 90 days following publication of the Notice to Members
announcing any Commission approval.
2. Statutory Basis
    NASD believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\10\ which requires, among
other things, that NASD rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. NASD believes that the proposed limited, conditional
exemptive provisions requiring the reporting of transactions executed
in connection with the termination or settlement of a CDS or a similar
instrument would protect investors and are in the public interest in
that they would facilitate and enhance NASD's surveillance of the over-
the-counter corporate debt market, while recognizing the particular
characteristics of such transactions and practices relating to
execution and settlement, and providing sufficient flexibility to avoid
adversely affecting the market in CDSs and similar instruments.
Further, NASD believes that not disseminating information on TRACE-
eligible securities transactions executed in connection with the
exercise or settlement of an option or similar instrument or the
settlement or termination of a CDS, any other type of swap, or similar
instrument is in the public interest and protects investors,
particularly retail investors, because the dissemination of such
information may cause significant investor confusion,

particularly for retail investors, and such information does not appear
to contribute to price discovery by market participants.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which NASD consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-NASD-2006-103 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 SR-NASD-2006-103. 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 such
filing also will be available for inspection and copying at the
principal office 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
SR-NASD-2006-103 and should be submitted on or before November 29,
2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
[FR Doc. E6-18798 Filed 11-7-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: December 18, 2008 (Volume 73, Number 244)]
[Notices]
[Page 77083]
[DOCID:fr18de08-122]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.

Extension: Rule 12a-5, OMB Control No. 3235-79, SEC File No. 270-85.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
existing collection of information provided for in: Rule 12a-5 (17 CFR
240.12a-5) and Form 26 (17 CFR 249.26) under the Securities Exchange
Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act'').
    Section 12(a) of the Exchange Act generally makes it unlawful for
any security to be traded on a national securities exchange unless such
security is registered on the exchange in accordance with the
provisions of the Exchange Act and the rules and regulations
thereunder.
    Rule 12a-5 (the ``Rule'') under the Exchange Act and Form 26 (the
``Form'') were adopted by the Commission in 1936 and 1955,
respectively, pursuant to Sections 3(a)(12), 10(b), and 23(a) of the
Exchange Act. Subject to certain conditions, Rule 12a-5 affords a
temporary exemption (generally for up to 120 days) from the
registration requirements of Section 12(a) of the Exchange Act for a
new security when the holders of a security admitted to trading on a
national securities exchange obtain the right (by operation of law or
otherwise) to acquire all or any part of a class of another or
substitute security of the same or another issuer, or an additional
amount of the original security. The purpose of the exemption is to
avoid an interruption of exchange trading to afford time for the issuer
of the new security to list and register it, or for the exchange to
apply for unlisted trading privileges.
    Under paragraph (d) of Rule 12a-5, after an exchange has taken
action to admit any security to trading pursuant to the provisions of
the Rule, the exchange is required to file with the Commission a
notification on Form 26. Form 26 provides the Commission with certain
information regarding a security admitted to trading on an exchange
pursuant to Rule 12a-5, including: (1) The name of the exchange, (2)
the name of the issuer, (3) a description of the security, (4) the
date(s) on which the security was or will be admitted to when-issued
and/or regular trading, and (5) a brief description of the transaction
pursuant to which the security was or will be issued.
    The Commission generally oversees the national securities
exchanges. This mission requires that, under Section 12(a) of the
Exchange Act specifically, the Commission receive notification of any
securities that are permitted to trade on an exchange pursuant to the
temporary exemption under Rule 12a-5. Without the Rule and the Form,
the Commission would be unable fully to implement these statutory
responsibilities.
    There are currently eleven national securities exchanges subject to
Rule 12a-5. The Commission staff estimates that there could be one Form
26 filed every five years. The reporting burdens are not typically
spread evenly among the exchanges. For purposes of this analysis of
burden, however, the Commission staff has assumed that each exchange
files an equal number of Form 26 notifications. Each notification
requires approximately 20 minutes to complete. Accordingly, the
Commission staff estimates the annual aggregate compliance burden for
all respondents in a given year would be approximately 4 minutes (20
minutes/report x .2 reports/year = 4 minutes), and for each respondent
the annual compliance burden would be approximately .36 minutes (4
minutes/respondent / 11 respondents = .36 minutes), or .006 hours.
    Based on the most recent available information, the Commission
staff estimates that the cost to respondents of completing a
notification on Form 26 is, on average, $43.23 per response. Therefore,
the Commission staff estimates that the total annual related reporting
cost per respondent is $.86 (.02 responses/respondent/year x $43.23
cost/response), for a total annual related cost to all respondents of
$9.46 ($.86 cost/respondent x 11 respondents).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to: (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to:
<EMAIL_ADDRESS>and (ii) Lewis W. Walker, Acting Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted within 30 days
of this notice.

    Dated: December 10, 2008.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-29971 Filed 12-17-08; 8:45 am]

BILLING CODE 8011-01-P