<COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (19 March 2007)>

<EPA Registration Division contact: [  SEQ CHAPTER \h \r 1 Joanne I.
Miller:<PHONE_NUMBER>]>

<INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
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the information specific to your action.]>

<TEMPLATE:>

<[Bayer Crop Science]>

<[Revised - PP 6F7161]>

<	EPA has received a revised pesticide petition ([PP 6F7161])   SEQ
CHAPTER \h \r 1 Bayer CropScience, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709  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 180.473(a) General, and eliminate the reference to
180.473(2) transgenic crops tolerant to glufosinate ammonium such that
the crop tolerances listed under subsection (a) General., support uses
in all of the crops listed to include both conventional and transgenic
crops. The same inclusive tolerances for glufosinate-ammonium and its
metabolites expressed as butanoic acid,
2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt,
2-acetamido-4-methylphosphinico-butanoic acid and
3-methylphosphinico-propionic acid expressed as glufosinate free acid
equivalents are already listed for the commodities printed under both
subsections (1) and (2) under (a) General.

 <(Options (pick one)>

<	1. by listing the established tolerances for residues of>

<<glufosinate-ammonium and its metabolites expressed as butanoic acid,
2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt,
2-acetamido-4-methylphosphinico-butanoic acid and
3-methylphosphinico-propionic acid expressed as glufosinate free acid
equivalents in or on the raw agricultural commodity aspirated grain
fractions at [25.0] parts per million (ppm), beet, sugar, molasses at
[5.0] parts per million (ppm), beet, sugar, roots at [0.9] parts per
million (ppm) beet, sugar, tops (leaves) at [1.5] parts per million
(ppm) canola, meal at [1.1] parts per million (ppm), canola, seed at
[0.4 ] at parts per million (ppm), field corn, forage at [4.0] parts per
million (ppm), field corn, grain at [0.2] parts per million (ppm), field
corn, stover at [6.0] parts per million (ppm), rice, grain at [1.0]
parts per million (ppm), rice, hull at [2.0] parts per million (ppm)
rice, straw at [2.0] parts per million (ppm), soybean, at [2.0] parts
per million (ppm) and soybean, hulls at [5.0] parts per million (ppm)
under Section (a) General (1) of 40 CFR part 180.473 in addition to the
commodities already listed under this section . EPA has determined that
the petition contains data or information regarding the elements set
forth in section 408 (d)(2) of the 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>

<	1. Plant metabolism.   SEQ CHAPTER \h \r 1 A confined rotational crop
study has been submitted and reviewed by the Agency. Based on the
previously submitted and reviewed confined and field rotational crop
studies, the EPA has determined that the residues of concern in
rotational crops, for the purpose of risk assessments and tolerance
expression are glufosinate ammonium (HOE 061517) and 2
methylphosphinicoacetic acid (HOE 064619).  The results of these studies
are consistent with other metabolism studies conducted with
glufosinate-ammonium on other crops and support the contention that the
nature of residues found in plants as a result of a treatment of
glufosinate-ammonium is well understood.>

<	2. Analytical method.   SEQ CHAPTER \h \r 1 The enforcement analytical
method utilizes gas chromatography for detecting and measuring levels of
glufosinate-ammonium and metabolites with a general limit of
quantification of 0.05 ppm.  This method allows detection of residues at
or above the existing tolerances.

<	3. Magnitude of residues. Tolerances are currently listed in 40 CFR
§180.473(2) for transgenic canola, transgenic field corn and transgenic
soybean.

<B. Toxicological Profile>

<	1. Acute toxicity.    SEQ CHAPTER \h \r 1 Glufosinate-ammonium has
been classified as toxicity category III for acute oral, dermal, and
inhalation toxicity; and for eye irritation.  Glufosinate-ammonium is
not a dermal irritant (toxicity category IV) nor is it a dermal
sensitizer.  The oral LD50 is 4010 mg/kg in male rats and 3030 mg/kg in
female rats. >

<	2. Genotoxicty.   SEQ CHAPTER \h \r 1 Based on results of a complete
genotoxicity database, there is no evidence of mutagenic activity in a
battery of studies, including:  Salmonella spp., E. coli, in vitro
mammalian cell gene mutation assays, mammalian cell chromosome
aberration assays, in vivo mouse bone marrow micronucleus assays, and
unscheduled DNA synthesis assays .

<	3. Reproductive and developmental toxicity.   SEQ CHAPTER \h \r 1 In a
developmental toxicity study, groups of 20 pregnant female Wistar rats
were administered glufosinate-ammonium by gavage at doses of 0, 0.5,
2.24 10, 50 and 250 mg/kg/day from days 7 to 16 of pregnancy.  The NOAEL
for maternal toxicity is 10 mg/kg/day; the LOAEL is 50 mg/kg/day based
on vaginal bleeding and hyperactivity in dams.  In the fetus, the NOAEL
is 50 mg/kg/day, based on dilated renal pelvis observations at the LOAEL
of 250 mg/kg/day.  In a developmental toxicity study, groups of 15
pregnant female Himalayan rabbits were administered glufosinate-ammonium
by gavage at doses of 0, 2.0, 6.3, or 20.0 mg/kg/day from days 7 to 19
of pregnancy.  In maternal animals, decreases in food consumption and
body weight gain were observed at the 20 mg/kg/day dose level.  The
NOAEL for maternal toxicity was 6.3 mg/kg/day and that for developmental
toxicity was 20 mg/kg/day.

In a multi-generation reproduction study, glufosinate-ammonium was
administered to groups of 30 male and 30 female Wistar/Han rats in the
diet at concentrations of 0, 40, 120, or 360 ppm.  The LOAEL for
systemic toxicity is 120 ppm based on increased kidney weights in both
sexes and generations. The systemic toxicity NOAEL is 40 ppm. The LOAEL
for reproductive/developmental toxicity is 360 ppm based on decreased
numbers of viable pups in all generations.  The NOAEL is 120 ppm.

  SEQ CHAPTER \h \r 1 In a developmental neurotoxicity study, groups of
25 bred female rats were fed glufosinate ammonium at doses of 0, 200,
1000 or 4500 ppm in the diet. Body weights and food consumption were
decreased at 1000 and 4500 ppm. No effects were seen in treated animals
for the functional observation battery, developmental landmarks, grip
strength, startle response or learning and memory. Motor activity was
increased at the mid and high dose. The NOAEL for developmental
neurotoxicity was determined to be 200 ppm.

<	4. Subchronic toxicity   SEQ CHAPTER \h \r 1 In a sub-chronic oral
toxicity study, glufosinate-ammonium was administered to 10 NMRI
mice/sex/ dose in the diet at levels of 0, 80, 320 or 1,280 ppm
(equivalent to 0, 12, 48 or 192 millgrams/kilogram/day (mg/kg/day)) for
13 weeks.  Significant (p< 0.05) increases were observed in serum
aspartate aminotransferase and in alkaline phosphatase in high-dose (192
mg/kg/ day) males.  Also observed were increases in absolute and
relative liver weights in mid-(48 mg/kg/day) and high-dose males.  The
no observed adverse effect level (NOAEL) is 12 mg/kg/day, the lowest
observed adverse effect level (LOAEL) is 48 mg/kg/day based on the
changes in clinical biochemistry and liver weights.

<	5. Chronic toxicity.   SEQ CHAPTER \h \r 1 In a combined chronic
toxicity/oncogenicity study, glufosinate-ammonium was administered to 50
Wistar rats/sex/dose in the diet for 130 weeks at dose levels of 0, 40,
140, or 500 ppm (mean compound intake in males was 0, 1.9, 6.8, and 24.4
mg/kg/day and for females was 0, 2.4, 8.2 and 28.7 mg/kg/day,
respectively).  A dose-related increase in mortality was noted in
females at 140 and 500 ppm, whereas in males increased absolute and
relative kidney weights were noted at 140 ppm and 500 ppm.  The NOAEL
was considered to be 40 ppm.  No treatment-related oncogenic response
was noted.

In an oncogenicity study, glufosinate-ammonium was administered to 50
NMRI mice/sex/dose in the diet at dose levels of 0, 80, 160 (males only)
or 320 (females only) ppm for 104 weeks.  The NOAEL for systemic
toxicity is 80 ppm (10.82/16.19 mg/kg/day in males/females (M/F)), and
the LOAEL is 160/320 ppm (22.60/ 63.96 mg/kg/day in M/F), based on
increased mortality in males, increased glucose levels in males and
females, and changes in glutathione levels in males.  No increase in
tumor incidence was found in any treatment group.

In a chronic feeding study, technical glufosinate-ammonium was fed to
male and female beagle dogs for 12 months in the diet at levels of 2.0,
5.0, or 8.5 mg/kg/day.  The NOAEL is 5.0 mg/kg/day based on clinical
signs of toxicity, reduced weight gain and mortality 8.5 mg/kg/day.

In a rat oncogenicity study, glufosinate-ammonium was administered to
Wistar rats (60/sex/group) for up to 24 months at 0, 1,000, 5,000, or
10,000 ppm (equivalent to 0, 45.4, 228.9, or 466.3 mg/kg/day in males
and 0, 57.1, 281.5, or 579.3 mg/kg/day in females).  The LOAEL for
chronic toxicity is 5,000 ppm (equivalent to 228.9 mg/kg/day for male
rats and 281.5 mg/kg/day for females), based on increased incidences of
retinal atrophy.  The chronic NOAEL is 1,000 ppm.  Under the conditions
of this study, there was no evidence of carcinogenic potential.  Dosing
was considered adequate based on the increased incidence of   SEQ
CHAPTER \h \r 1 retinal atrophy.

<	6. Animal metabolism.   SEQ CHAPTER \h \r 1 Studies conducted in rats
using 14C- glufosinate-ammonium have shown that the compound is poorly
absorbed (5-10%) after oral administration and is rapidly eliminated
primarily as the parent compound.  The highest residue levels were found
in liver and kidney tissues.

The metabolic profile and the quantitative distribution of metabolites
were very similar in both goat and hen.  The vast majority of the dose
was excreted, primarily as parent compound.  The very limited residues
found in edible tissues, milk and eggs were comprised principally of
glufosinate and 3-methylphosphinico-propionic acid (Hoe 061517), with
lesser amounts of N-acetyl-L-glufosinate (Hoe 099730) and
2-methylohosphinico-acetic acid (Hoe 064619).

<	7. Metabolite toxicology.   SEQ CHAPTER \h \r 1 Additional testing has
been conducted with the major metabolites, 3-methylphosphinico-propionic
acid, and N-acetyl-L-glufosinate.  Based on sub-chronic and
developmental toxicity study results, a profile of similar or less
toxicity was observed for the metabolites as compared to the parent
compound, glufosinate-ammonium.

<	8. Endocrine disruption.   SEQ CHAPTER \h \r 1 No special studies have
been conducted to investigate the potential of glufosinate-ammonium to
induce estrogenic or other endocrine effects.  However, no evidence of
estrogenic or other endocrine effects have been noted in any of the
toxicology studies that have been conducted with this product and there
is no reason to suspect that any such effects would be likely.

<C. Aggregate Exposure>

<	1. Dietary exposure.   SEQ CHAPTER \h \r 1 Tolerances have been
established (40CFR part 180.473) for the combined residues of
glufosinate-ammonium and metabolites in or on a variety of raw
agricultural commodities. No appropriate toxicological endpoint
attributable to a single exposure was identified in the available
toxicity studies. EPA did not, therefore, establish an acute reference
dose (RfD) for the general population. An acute RfD of 0.0063 mg/kg/day
was established, however, for the females 13+ subgroup, based on a
developmental NOAEL of 6.3 mg/kg/day in the rabbit and a 100x
uncertainty factor (10x inter- 10x intra-species extrapolation) and a
10x FQPA data uncertainty factor. EPA determined that the Special FQPA
uncertainty factor would be 1X for the acute dietary risk assessment
based on conclusions of the HIARC and the complete residue and
environmental fate data bases. The developmental LOAEL (20 mg/kg/day)
was based on increased fetal death in the presence of maternal toxicity.
There was no qualitative or quantitative indication of increased
susceptibility in the prenatal developmental toxicities in rats and
rabbits or in the 2-generation reproductive study in rats with parent
compound or metabolites of concern. Toxicological studies showed
clinical signs in short term studies described as aggressive behavior,
piloerection and a high startle response at dosages of 300 mg/kg/day.
Based on these effects, EPA determined that a 10x FQPA data uncertainty
factor was appropriate for the risk assessment for the food and feed use
of glufosinate-ammonium. Using the 10x FQPA data uncertainty factor, the
acute population adjusted dose (aPAD) for glufosinate-ammonium is 0.0063
mg/kg/day.

using Exponent, Inc.’s DEEM™ software. Consumption data used in this
program were taken from USDA’s CSFII, 1994-1996.1998. A retreat
interval of 28 days was used for apples as opposed to a 14 day retreat
interval. Under this scenario, the acute EEC estimates from use in
apples for sucker control drops to 67 ppb, and the next highest exposure
level becomes that associated with weed control in tree nut crops at 74
ppb.>

Acute dietary risk was expressed as a percentage of the acute Population
Adjusted Dose (aPAD) of 0.0063 mg/kg bw/day based on a NOEL of 6.3 mg/kg
bw/day with an uncertainty factor of 1000. The EPA identified an acute
endpoint of concern for females of childbearing age. No endpoint
attributed to a single exposure was identified for the general
population, including infants and children. The estimated risk from
acute dietary exposure (95th percentile) for women 13-50 years of age
was 85.6% of the aPAD. Beef liver (31%), water (40%) and potato (22%)
were the major contributors to the acute exposure for this subgroup.

Chronic dietary risk was expressed as a percentage of the chronic
Population Adjusted Dose (cPAD) of 0.006 mg/kg bw/day based on a NOEL of
6.0 mg/kg bw/day with an uncertainty factor of 1000. The most highly
exposed subpopulation was infants (<1 year) at 57.0% of the cPAD. The
chronic value for the the U.S Population was 20.9% of the cPAD. A major
contributor to the overall dietary exposure for the <1 year old subgroup
was water at 86% and water at 72% for the U.S. Population.

<

<	2. Non-dietary exposure. Glufosinate-ammonium is currently registered
for use on the following non-food sites: areas around ornamentals, shade
trees, Christmas trees, shrubs, walks, driveways, flower beds, farmstead
buildings, in shelter belts, and along fences.  It is also registered
for use as a post-emergent herbicide on farmsteads, areas associated
with airports, commercial plants, storage and lumber yards, highways,
educational facilities, fence lines, ditch banks, dry ditches, schools,
parking lots, tank farms, pumping stations, parks, utility rights-of
-way, roadsides, railroads, and other public areas and similar
industrial and non-food crop areas.

The EPA has determined that there are no acute or chronic non-dietary
exposure scenarios.  Further, the Agency has determined that it is not
appropriate to aggregate short- and intermediate-term non-dietary
exposure with dietary exposures in risk assessments because the
end-points are different.

>

<D. Cumulative Effects>

<	EPA has indicated that, at this time, the Agency does not have
available data to determine whether glufosinate-ammonium has a common
mechanism of toxicity with other substances or how to include this
pesticide in a cumulative risk assessment.  Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, glufosinate-ammonium does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance petition, therefore, it has not been assumed that
glufosinate-ammonium has a common mechanism of toxicity with other
substances.

<E. Safety Determination>

<	1. U.S. population. Using the conservative assumptions described
above, based on the completeness and reliability of the toxicity data,
it is concluded that chronic dietary exposure to the registered and
proposed uses of glufosinate-ammonium will utilize at most 20.9% of the
chronic reference dose for the US Population. The actual exposure is
likely to be much less as more realistic data and models are developed.
Exposures below 100% of the reference dose are generally assumed to be
of no concern because the reference dose represents the level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risk to human health.

The acute population of concern, female 13-50 yrs. utilizes ~85.6% of
the aPAD and the actual exposure is likely to be far less.

It is not appropriate to aggregate non-dietary exposures with dietary
exposures uses because the toxicity end-points are different. Therefore,
there is a reasonable certainty that no harm will occur to the US
Population from aggregate exposure (food, drinking water and
nonresidential) to residues of glufosinate-ammonium and metabolites.

<	2. Infants and children. The toxicological data base is sufficient for
evaluating prenatal and postnatal toxicity for glufosinate-ammonium.
There are no prenatal or postnatal susceptibility concerns for infants
and children, based on the results of the rat and rabbit developmental
toxicity studies and the 2-generation reproduction study. Based on
clinical signs of neurological toxicity in short and intermediate dermal
toxicity studies with rats, and due to the lack of a DNT (study
submitted January 2005 – MRID 48455701) EPA determined that an added
FQPA data uncertainty factor of 10x is appropriate for assessing the
risk of glufosinate-ammonium derived residues in crop commodities.

Using the conservative assumptions described in the exposure section
above, the percent of the cPAD that will be used for exposure to
residues of glufosinate-ammonium in food and water is 57.0 percent for
infants less than on year of age. Of this, water composes 86% of the
total. As in the adult situation, drinking water levels of comparison
are higher than the worst case drinking water estimated concentrations,
if they occur at all.

Therefore, there is a reasonable certainty that no harm will occur to
infants and children from aggregate exposure to residues of
glufosinate-ammonium.

<F. International Tolerances>

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at 10.0 ppm, soya bean (dry), at 2.0 ppm, rape seed, at 5.0 ppm, rape
seed oil (crude) at 0.05 ppm, sugar beet at 0.05 ppm and sugar beet
leaves or tops at 0.1 ppm.


[Federal Register: July 10, 2009 (Volume 74, Number 131)]
[Notices]
[Page 33290-33293]
[DOCID:fr10jy09-85]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60220; File No. SR-NASDAQ-2009-064]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to NASDAQ Options Market Options Participant Membership
Requirements, Order Entry Times and Confirmation Statements

July 1, 2009.
    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 June 26, 2009, The NASDAQ Stock Market LLC (``NASDAQ'') 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 NASDAQ. NASDAQ has designated the proposed rule
change as constituting a non-controversial rule change under Rule 19b-
4(f)(6) under the Act,\3\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    NASDAQ proposes to make three noncontroversial amendments to the
NASDAQ Options Market (``NOM'' or ``Exchange'') rule. First, Chapter
II, Section 2 would be amended to modify a requirement that NOM Options
Participants at all times maintain membership in another options
exchange. Second, Chapter VI, Sections 1, 2, 7 and 9 would be amended
to change the time of day at which NOM begins accepting orders. Third,
Chapter XI, Section 11, would be amended to make clear that the rule
does not require confirmation statements to contain the name of the
option exchange or exchanges on which an option contract is executed.
    The text of the proposed rule change is below. Proposed new
language is underlined and proposed deletions are in brackets.
* * * * *
Chapter II, Participation
* * * * *
Section 2, Requirements for Options Participation
    (a)-(e) No Change.
    (f) Every Options Participant shall at all times maintain
membership in another registered options exchange that is not
registered solely under Section 6(g) of the Securities Exchange Act of
1934, or in FINRA. Options Participants that transact business with
customers shall at all times be members of the FINRA.
    (g)-(h) No Change.
    Commentary .01 No Change.
Chapter VI, Trading Systems
Section 1, Definitions
    The following definitions apply to Chapter VI for the trading of
options listed on NOM.
    (a)-(f) No Change.
    (g) The term ``Time in Force'' shall mean the period of time that
the System will hold an order for potential execution, and shall
include:
    (1) ``Expire Time'' or ``EXPR'' shall mean, for orders so
designated, that if after entry into the System, the order is not fully
executed, the order (or the unexecuted portion thereof) shall remain
available for potential display and/or execution for the amount of time
specified by the entering Participant unless canceled by the entering
party. EXPR Orders shall be available for entry from [9 a.m.] the time
prior to market open specified by the Exchange on its website until
market close Eastern Time and for execution from 9:30 a.m. until market
close.
    (2) ``Immediate or Cancel'' or ``IOC'' shall mean for orders so
designated, that if after entry into the System a marketable limit
order (or unexecuted portion thereof) becomes non-marketable, the order
(or unexecuted portion thereof) shall be canceled and returned to the
entering participant. IOC Orders shall be available for entry from [9
a.m.] the time prior to market open specified by the Exchange on its
Web site until market close and for potential execution from 9:30 a.m.
until market close. IOC Orders entered between [9 a.m.] the time
specified by the Exchange on its Web site and 9:30 a.m. Eastern Time
will be held within the System until 9:30 a.m. at which time the System
shall determine whether such orders are marketable.
    (3) ``DAY'' shall mean for orders so designated, that if after
entry into the System, the order is not fully executed, the order (or
unexecuted portion thereof) shall remain available for potential
display and/or execution until market close, unless canceled by the
entering party, after which it shall be returned to the entering party.
DAY Orders shall be available for entry from [9 a.m.] the time prior to
market open specified by the Exchange on its Web site until market
close and for potential execution from 9:30 a.m. until market close.
    (4) ``Good Til Cancelled'' or ``GTC'' shall mean for orders so
designated, that if after entry into System, the order is not fully
executed, the order (or unexecuted portion thereof) shall remain
available for potential display and/or execution unless cancelled by
the entering party, or until the option expires, whichever comes first.
GTC Orders shall be available for entry from [9 a.m.] the time prior to
market open specified by the Exchange on its Web site until market
close and for potential execution from 9:30 a.m. until market close.
    (5) No Change.
    (h) No Change.
Chapter VI, Trading Systems
* * * * *
Section 2, Days and Hours of Business
    (a) The System operates and shall be available to accept bids and
offers and orders from [9 a.m.] the time prior to market open specified
by the Exchange on its Web site to market close on each business day,
unless modified by NOM. Orders and bids and offers shall be open and
available for execution as of 9:30 a.m. Eastern Time and shall close as
of 4 p.m. Eastern Time except for option contracts on fund shares or
broad-based indexes which will close as of 4:15 p.m. Eastern Time.
    (b)-(c) No Change.
Chapter VI, Trading Systems
* * * * *
Section 7, Entry and Display Orders
    (a) Entry of Orders--Participants can enter orders into the System,
subject to the following requirements and conditions:
    (1)-(2) No Change.
    (3) Orders can be entered into the System (or previously entered
orders cancelled) from [9 a.m.] the time prior to market open specified
by the

Exchange on its Web site until market close.
    (b) No Change.
Chapter VI, Trading Systems
* * * * *
Section 9, Nasdaq Closing Cross
    (a) Definitions. For the purposes of this rule the term:
    (1)-(2) No Change.
    (3) ``Imbalance Only Order'' or ``IO'' shall mean an order to buy
or sell at a specified price or better that may be executed only during
the Nasdaq Closing Cross and only against MOC or LOC orders. IO orders
can be entered between [9 a.m.] the time prior to market open specified
by the Exchange on its Web site and the beginning of the Closing Cross
but they cannot be modified after 10 minutes prior to the Closing Cross
except to increase the number of contracts. IO orders can be cancelled
between 10 and 5 minutes prior to the Closing Cross only by requesting
Nasdaq to correct a legitimate error (e.g., side, size, symbol, price
or duplication of an order). IO orders cannot be cancelled after 5
minutes prior to the Closing Cross for any reason. IO sell (buy) orders
will only execute at or above (below) the System offer (bid) at the
time of the Closing Cross.
    (4) ``Limit On Close Order'' or ``LOC'' shall mean an order to buy
or sell at a specified price or better that is to be executed only
during the Nasdaq Closing Cross. LOC orders can be entered, cancelled,
and corrected without restriction between [9 a.m.] the time prior to
market open specified by the Exchange on its Web site and 10 minutes
prior to the Closing Cross LOC orders can be cancelled between 10 and 5
minutes prior to the Closing Cross only by requesting Nasdaq to correct
a legitimate error (e.g., side, size, symbol, price or duplication of
an order). LOC orders cannot be cancelled after 5 minutes prior to the
Closing Cross for any reason. LOC Orders will execute only at the price
determined by the Nasdaq Closing Cross.
    (5) ``Market on Close Order or MOC'' shall mean an order to buy or
sell at the market that is to be executed only during the Nasdaq
Closing Cross. MOC orders can be entered, cancelled, and corrected
between [9 a.m.] the time prior to market open specified by the
Exchange on its Web site and 10 minutes prior to the Closing Cross MOC
orders can be cancelled between 10 and 5 minutes prior to the Closing
Cross only by requesting Nasdaq to correct a legitimate error (e.g.,
side, size, symbol, price or duplication of an order). MOC orders
cannot be cancelled after 5 minutes prior to the Closing Cross for any
reason. MOC orders will execute only at the price determined by the
Nasdaq Closing Cross.
    (6)-(7) No Change.
    (b) No Change.
Chapter XI, Doing Business with the Public
* * * * *
Section 11, Confirmation to Public Customers
    (a) No Change.
    (b) The confirmation shall, by appropriate symbols, distinguish
between [NOM Transactions and other transactions in options contracts]
Exchange options transactions and other transactions in option
contracts though such confirmation does not need to specify the
exchange or exchanges on which such option contracts were executed.
* * * * *

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

    In its filing with the Commission, NASDAQ included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NASDAQ has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to make certain
clarifying and noncontroversial changes to NOM rules, as follows.
Chapter II, Section 2
    Chapter II, Section 2 currently provides that a Participant must be
a member of another registered options exchange that is not registered
solely under Section 6(g) of the Act.\4\ When it adopted Chapter II,
Section 2, Nasdaq made clear its intent not to serve as a Designated
Options Examining Authority (``DOEA''), and stated that it would work
with the Commission and the other registered options exchanges to
ensure that each Options Participant would have as its DOEA a
registered options exchange other than Nasdaq.\5\ The proposed
amendments would provide an alternative to the options exchange
membership requirement, such that a NOM Participant that was a member
of Financial Industry Regulatory Authority, Inc. (``FINRA'')--itself a
DOEA--would not also be required to maintain membership in another
registered options exchange.\6\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(g).
    \5\ See Securities Exchange Act Release No. 55667 (April 25,
2007), 72 FR 23869 (May 1, 2007).
    \6\ See Securities Exchange Act Release No. 55532 (March 26,
2007), 72 FR 15729 (April 2, 2007).
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Chapter VI, Sections 1, 2, 7 and 9
    Chapter VI currently contains a number of provisions which permit
orders to be submitted to the Exchange no earlier than 9 a.m.\7\ The
amendments would eliminate this restriction, and would instead provide
for orders to be submitted no earlier than the time specified by NOM on
its Web site. The proposed amendments are intended to provide
flexibility to permit NOM to change this beginning time for order
submission as circumstances may dictate from time to time, without
filing a proposed rule change with the Commission. The actual hours of
trading on NOM would not be affected by this proposal. The Exchange
will make information regarding new order entry times available to all
market participants at the same time.
---------------------------------------------------------------------------

    \7\ See Chapter VI, Sections 1(g)(1), 1(g)(2), 1(g)(3), and
1(g)(4), Section 2(a), Section 7(a)(3), and Sections 9(a)(3),
9(a)(4) and 9(a)(5).
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Chapter XI, Section 11
    Chapter XI, Section 11, currently provides that a confirmation
shall, by appropriate symbols, distinguish between NOM Transactions and
other transactions in options contracts. The proposed amendments would
clarify that while confirmations are required to distinguish between
Exchange option transactions and other transactions in option
contracts, they do not need to specify the exchange or exchanges on
which such option contracts were executed.\8\ This proposal is similar
to

rule change proposals that have been filed by the American Stock
Exchange LLC, the Financial Industry Regulatory Authority, Inc., the
Chicago Board Options Exchange, Inc. the NASDAQ OMX PHLX, Inc., the
Boston Stock Exchange, Inc., the International Securities Exchange, LLC
and NYSE Arca, Inc.\9\ The Exchange believes that with the expansion of
multi-listing of options and the introduction of new options exchanges,
it has become operationally inefficient to require the disclosure of
the market center on which an order was executed on the confirmation.
As an example, a customer may have a single option order containing
numerous option contracts executed on multiple exchanges. As such, it
would be inefficient for the executing firm to be required to identify
the exchange symbol for each contract executed on that customer's
order. This proposal would clarify that written confirmations furnished
to a customer will not need to specify the exchange or exchanges on
which such option contracts were executed.
---------------------------------------------------------------------------

    \8\ The proposed filing is being done pursuant to an industry-
wide initiative under the auspices of the Options Self-Regulatory
Council (``OSRC''), which is a committee comprised of
representatives from each of the options exchanges functioning
pursuant to the OSRC Plan (the ``Plan''). See Securities Exchange
Act Release No. 20158 (September 8, 1983), 48 FR 41256 (September
14, 1983). The Plan is not a National Market System (``NMS'') plan
under Section 1 1A of the Act, but rather is a plan to allocate
regulatory responsibilities under Rule 17d-2 under the Act. 17 CFR
240.17d-2. As a result of the introduction of multiply listed
options and the introduction of the Plan for the Purpose of Creating
and Operating an Intermarket Options Market Linkage (``Options
Linkage Plan''), the contracts in a customer options order could be
executed on more than one options exchange, and the significance of
the options exchange, or exchanges, that execute a particular
options transaction has diminished significantly. See Securities
Exchange Act Release No. 43086 (July 28, 2000), 65 FR 48023 (August
4, 2000). Furthermore, the OSRC believes that in light of best
execution and disclosure requirements, the usefulness of including
on an options confirmation the name of the options exchange, or
exchanges, on which the options transaction was effected does not
outweigh the operational difficulties of capturing the information
given the multiple trading of options and the application of the
Options Linkage Plan industry wide.
    \9\ See Securities Exchange Act Release Nos. 58814 (October 20,
2008), 73 FR 63527 (October 24, 2008); 58932 (November 12, 2008), 73
FR 69696 (November 19, 2008); 58980 (November 19, 2008), 73 FR 72091
(November 26, 2008); 59166 (December 29, 2008), 74 FR 328 (January
5, 2009); 59434 (February 23, 2009), 74 FR 9012 (February 27, 2009);
59806 (April 21, 2009), 74 FR 19254 (April 28, 2009); and 59978 (May
27, 2009), 74 FR 26451 (June 2, 2009).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \10\ in general, and furthers the objectives of Section
6(b)(5) of the Act \11\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest. The Exchange believes that the proposed rules rationalize and
clarify existing rules, in a manner that will benefit all market
participants. In particular, the proposed amendments to Chapter XI,
Section 11 clarify the Exchange's options confirmation rule to better
reflect the realities of the modern options market.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (1)
Significantly affect the protection of investors or the public
interest; (2) impose any significant burden on competition; and (3)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). When filing a proposed rule change
pursuant to Rule 19b-4(f)(6) under the Act, an Exchange is required
to give the Commission written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the date
of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange met this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\14\
However, Rule 19b-4(f)(6) \15\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. Nasdaq has requested that the
Commission waive the 30-day operative delay. The Exchange believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest because it would provide market
participants with clarified and rationalized rules on an expedited
basis. For this reason, the Commission designates the proposal to be
operative upon filing with the Commission.\16\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ Id.
    \16\ For the purposes only of waiving the operative date of this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in the furtherance of the purposes of the Act.

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-NASDAQ-2009-064 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2009-064. 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, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at

the principal office of Nasdaq. 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-NASDAQ-2009-064 and should be submitted on or before
July 31, 2009.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-16315 Filed 7-9-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Notices]
[Page 67524-67525]
[DOCID:fr14no08-95]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0578]

Pediatric Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pediatric Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues. The committee
also advises and makes recommendations to the Secretary of Health and
Human Services under 45 CFR 46.407 on research involving children as
subjects that is conducted or supported by the Department of Health and
Human Services (DHHS), when that research is also regulated by the FDA.
    Date and Time: The meeting will be held on Tuesday, December 9,
2008, from 3:30 p.m. to 6 p.m.
    Location: The Legacy Hotel & Meeting Centre, 1775 Rockville Pike,
Rockville, MD 20852.
    Contact Person: Carlos Pe[ntilde]a, Office of Science and Health
Coordination, Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08),
Rockville, MD 20857,<PHONE_NUMBER>, or by e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
8732310001. Please call the Information Line for up to date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: On December 9, 2008, the Pediatric Advisory Committee will
hear and discuss the recommendation of the Pediatric Ethics
Subcommittee from its meeting on December 9, 2008, regarding a referral
by an Institutional Review Board of a clinical investigation that
involves both an FDA-regulated product and research involving children
as subjects that is conducted or supported by DHHS.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the

year 2008 and scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
December 2, 2008. Oral presentations from the public will be scheduled
between approximately 4 p.m. and 5 p.m. on December 9, 2008. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before November 24, 2008.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by November 25, 2008.
    Electronic comments should be submitted to http://
www.regulations.gov. Select Docket No. FDA-2008-N-0578 entitled ``G-CSF
Stimulated Bone Marrow IRB Referral'' and follow the prompts to submit
your statement. Written comments should be submitted to Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Please submit comments by
4:30 p.m. on December 2, 2008. Received comments may be viewed at
http://www.regulations.gov, or may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Carlos Pe[ntilde]a
at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-27117 Filed 11-13-08; 8:45 am]

BILLING CODE 4160-01-S