level of mitigation.  However, MOEs were greater than 1000 and not of
concern to HED with a quarter-face dust/mist respirator:

mixing/loading liquid concentrates for aerial applications to carrots,
apples, onions, and lettuce;

mixing/loading liquid concentrates for chemigation applications to
carrots, apples, onions, and lettuce; and

flagging for aerial spray applications to lettuce.

Only engineering control (enclosed cockpit) data are available to assess
short- and intermediate-term inhalation risks to handlers operating
aircraft.  The short- and intermediate-term inhalation risks do not
exceed HED’s level of concern for pilots using enclosed cockpits and
wearing no respirator.

Table 9.1.  Short- and Intermediate-Term Occupational Handler Dermal
and Inhalation Exposure and Risk for Fluazinam

Exposure Scenario	Crop or Target	App Ratea

(lb ai/A)	Acres Treated Dailyb	Unit Exposurec,d	MOEs

Dermal LOC = 100

Inhalation LOC = 1,000

Baseline Dermal

mg/lbai	PPE-G

Dermal

mg/lb ai	PPE-G, DL

Dermal

mg/lb ai	Baseline Inhalationµg/lb ai	80%

PPE-R Inhalation	Baseline Dermale	PPE-G

Dermale	PPE-G, DL

Dermale	Baseline Inhalationf	80%

PPE-R Inhalation f

Mixer/Loader

Mixing/Loading Liquid Concentrates for Aerial Applications	Carrot, Onion
0.52	350	2.9	0.023	0.017	1.2	0.24	1.3	170	230	440	2,200

	Apple	0.45	350	2.9	0.023	0.017	1.2	0.24	1.5	190	260	510	2,500

	Lettuce	0.99	350	2.9	0.023	0.017	1.2	0.24	0.7	90	120	230	1,200

Mixing/Loading Liquid Concentrates for Chemigation Applications	Carrot,
Onion	0.52	350	2.9	0.023	0.017	1.2	0.24	1.3	170	230	440	2,200

	Apple	0.45	350	2.9	0.023	0.017	1.2	0.24	1.5	190	260	510	2,500

	Lettuce	0.99	350	2.9	0.023	0.017	1.2	0.24	0.7	90	120	230	1,200

Mixing/Loading Liquids Concentrates for Groundboom Applications

	Carrot, Onion	0.52	80	2.9	0.023	0.017	1.2	0.24	5.8	730	990	1,900	9,700

	Lettuce	0.99	80	2.9	0.023	0.017	1.2	0.24	3	380	520	1,000	5,100

Mixing/Loading Liquid Concentrates for Airblast Applications	Apple	0.45
40	2.9	0.023	0.017	1.2	0.24	13	1,700	2,300	4,500	22,000

Applicator

Applying Sprays via Aerial Equipment	Carrot, Onion	0.52	350	0.005 (eng.
control)	No Data	No Data	0.068 (eng. control)	No Data	770

(eng. control)	No Data	No Data	7,800

(eng. control)	No Data

	Apple	0.45	350	0.005 (eng. control)	No Data	No Data	0.068 (eng.
control)	No Data	890

(eng. control)	No Data	No Data	9,000

(eng. control)	No Data

	Lettuce	0.99	350	0.005 (eng. control)	No Data	No Data	0.068 (eng.
control)	No Data	400

(eng. control)	No Data	No Data	4,100

(eng. control)	No Data

Applying Sprays via Groundboom Equipment

	Carrot, Onion	0.52	80	0.014	0.014	0.011	0.74	0.148	1,200	1,200	1,500
3,100	16,000

	Lettuce	0.99	80	0.014	0.014	0.011	0.74	0.148	630	630	800	1,600	8,200

Applying Sprays via Airblast Equipment	Apple	0.45	40	0.360	0.240	0.220
4.50	0.900	110	160	180	1,200	6,000

Flagger g

Flagging for Aerial Sprays Applications	Carrot, Onion	0.52	350	0.011
0.012	0.010	0.35	0.070	350	320	350	1,500	7,600

	Apple	0.45	350	0.011	0.012	0.010	0.35	0.070	400	370	400	1,800	8,800

	Lettuce	0.99	350	0.011	0.012	0.010	0.35	0.070	180	170	180	800	4,000

a.  Application Rates based on proposed uses on labels for fluazinam.

b.  Science Advisory Council Policy No.  9.1

c.  Unit Exposures based on PHED Version 1.1.  Engineering control unit
exposure for applying sprays via aerial equipment = enclosed cockpit.

d.  Baseline Dermal:  Long-sleeve shirt, long pants, and no gloves.

Baseline plus Gloves Dermal (PPE-G): Baseline plus chemical-resistant
gloves.  DL is the addition of double layer body attire.

Baseline Inhalation: No respirator.  PPE – R 80% = A quarter-face
dust/mist respirator (that provides a 5-fold (80%) protection factor).

Those risks specified as engineering control (eng. control) represent
enclosed cockpit application.

e.   Dermal MOE = NOAEL (10 mg/kg/day) / dermal daily dose (mg/kg/day).
Level of concern = 100.

Dermal Dose (mg/kg/day) = daily unit exposure (mg/lb ai) x application
rate (lb ai/acre) x acres treated / body weight (70 kg).

f.   Inhalation MOE = NOAEL (1.38 mg/kg/day) / inhalation daily dose
(mg/kg/day). Level of concern = 1000.

Inhalation Dose (mg/kg/day) daily unit exposure (μg/lb ai) x
application rate (lb ai/acre) x acres treated / body weight (70 kg).

g.  The PPE-G unit exposure for flaggers is considered to be of low
confidence because of the small number of replicates used in determining
the unit exposure value.  HED recommends that all handlers follow label
PPE.

9.2   Postapplication Exposure and Risk

9.2.1   Data and Assumptions for Postapplication Exposure Scenarios

Inhalation

Based on the Agency’s current practices, a quantitative
postapplication inhalation exposure assessment is not being performed
for fluazinam at this time.  However, volatilization of pesticides might
be a potential source of postapplication inhalation exposure to
individuals in close proximity to locations where pesticide applications
are made.  The Agency sought expert advice and input on issues related
to volatilization of pesticides from its FIFRA Scientific Advisory Panel
(SAP) in December 2009.  The Agency received the SAP’s final report on
March 2, 2010
(http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html).  The
Agency is in the process of evaluating the SAP report and might, as
appropriate, develop policies and procedures to identify the need for
and the way to incorporate postapplication inhalation exposure into the
Agency’s risk assessments.  If new policies or procedures are put into
place, the Agency might revisit the need for a quantitative
postapplication inhalation exposure assessment for fluazinam.

Dermal

Chemical-specific dislodgeable foliar residue (DFR) studies on apples
(MRID 45584203) and peanuts (MRID 46991302) were submitted and reviewed
by HED.  The peanut dislodgeable foliar residue (DFR) data were
previously used as surrogate data to assess post application exposure
for all crops when no crop-specific DFR data were available (Memo,
D346976, M. Collantes, 2/27/2008).  As indicated below, a linear
regression analysis was conducted of the individual foliar residue
values collected immediately after the last application through the last
day of sampling for peanuts (42 DAT), which resulted in a regression
(R2) of 0.962.  Regressions close in value to 1.0 are a good indication
of direct correlation between actual and predicted residues.

For this assessment, peanut DFR data were used as surrogate data to
assess postapplication exposure for lettuce, onions, and carrots.  The
apple DFR data were used to assess postapplication exposure for apples.
A summary of each study is provided below.  In addition to the DFR data,
maximum dermal transfer coefficients from the Science Advisory Council
for Exposure Policy Number 3.1: Agricultural Transfer Coefficients,
August 2000, (summarized in Table 9.2.a, below) and the following
assumptions were used in the postapplication assessment:

Max Application Rate	= 	0.52 lb ai/A for carrots and onions; 0.45 lb
ai/A for apples; 0.99 lb ai/A for lettuce

Exposure Duration	=	8 hours per day

Body Weight		=	70 kg, and

Dermal Absorption	= 	Not applicable

Table 9.2.a.   Anticipated Postapplication Activities and Dermal
Transfer Coefficients

Proposed Crops	Policy Crop Group Category	Exposure Potential	Transfer
Coefficients (cm2/hr)	Activities

Carrots	Vegetable, “root”  SEQ CHAPTER \h \r 1 	Low	300	hand
weeding, irrigation, and scouting

High	2,500	hand harvest

Onion	Vegetable, “root”	Low	300	hand weeding, irrigation, and
scouting

Lettuce	Vegetable, leafy	Low	500	hand weeding, thinning

Medium	1,500	irrigation, scouting

High	2,500	hand harvest

Apple	Tree, “fruit” deciduous	Low	1,000	hand weeding, irrigation,
and scouting

High	1,500	hand harvesting, propping, training, hand pruning

Very High	3,000	thinning

Summary of Dislodgeable Foliar Residue Study on Peanut (MRID 45584201)

This study was designed to determine the dissipation of dislodgeable
foliar residues (DFR) of fluazinam applied to peanut fields located in
Sampson County near Garner, North Carolina (EPA Region 2).  Two
applications of Fluazinam 500F, a flowable liquid formulation containing
41.5% fluazinam as the ai, were made to peanut crops.  The target
application rate was 0.79 lbs ai/A for each application which was the
maximum label use rate.  The total application rate for both
applications was 1.58 lb ai/A.  Applications were made as a foliar
broadcast spray at a spray volume of about 20 gallons per acre (GPA).
Samples were collected before the first application and at the following
time periods thereafter:  immediately, 7 days, 14 days, and 21 days.
Samples were also collected at the following time periods after the
second (final) application:  immediately, 8 hours, and 1, 2, 4, 7, 10,
14, 21, 28, 35, and 42 days.  At each sampling interval, triplicate
samples were collected from the control plot and from the treated plot.
Field-fortified samples using leaf samples from the control plot were
prepared on days 7, 14, and 35 after the second application to evaluate
the stability of the field samples during shipping and storage.

Fluazinam residue values were not corrected for field fortification or
concurrent percent recoveries by the Registrant.  The DFR residues were
corrected by HED using the average field fortification recovery from the
fortification level closest to the DFR value (63.2% for low level
fortification and 62.2% for high level fortification).

The highest average DFR value occurred immediately after the first
application (1.56 μg/cm2).  The residues then declined to 0.0085
μg/cm2 by 21 days after the first application (21DAT1).  The average
residues after the final application were highest immediately after that
application (1.29 μg/cm2).  Following the second application, residues
declined to 0.013 μg/cm2 by 42 days after treatment (42 DAT2).  All
residue values remained above the LOQ out to the last day of sampling.
Rainfall occurred throughout the entire sampling period, with the first
rainfalls after application occurring 3 days after the first application
and 3 days after the last application.

A linear regression analysis was conducted using the natural logarithm
of the individual foliar residue values collected immediately after the
last application through the last day of sampling (42 DAT). The
estimated half-life life value for fluazinam was 6.30 days (R2 = 0.962).

Upon review of the data, HED determined that for days 0-2, the actual
measured (raw) DFR data were more protective than the predicted DFR
values, which would potentially underestimate residue values and risk of
exposure.  Therefore, measured DFR values were used to assess post
application exposure for days 0 through 2.

Summary of Dislodgeable Foliar Residue Study on Apple (MRID 45584203)

This study was designed to determine the dissipation of dislodgeable
foliar residues (DFR) of fluazinam applied to apple trees at a test site
in Concord, Ohio.  Fluazinam 500F, a flowable liquid formulation
containing 41.1% fluazinam as the ai, was applied as a foliar directed
spray using an airblast sprayer to two plots consisting of five apple
trees each.  One plot received a single application at the reported
recommended rate (0.4 lb ai/A) and the other plot received a single
application at three times the reported recommended rate (1.2 lb ai/A).
A third plot was used to collect untreated (control) samples. Samples
were collected prior to the application and at intervals from 1 hr to 35
days after the application.  At each sampling interval, triplicate
samples were collected from the control plot and from the treated plots.
 Field-fortified samples and storage stability samples were not prepared
for this study.

HED and the registrant calculated DFR values in µg/cm2 by dividing the
corrected residue found in each sample by the total surface area of each
sample (400 cm2).  Residue values that dropped below the limit of
quantitation (LOQ) were assigned a value of ½LOQ.

For both treatment plots, the highest average residue was observed 1
hour after application (0.071 μg/cm2 for the 1x plot and 0.086 for the
3x plot).  The average residue dropped to below the LOQ (0.00005
μg/cm2) by day 28 for the 1x plot and day 35 for the 3x plot.  A
significant drop in residues between the Day 2 and Day 4 sampling
intervals was seen in both plots.  From day 2 to day 4, the average
residue dropped from 0.053 μg/cm2 to 0.0086 μg/cm2 in the 1x plot and
from 0.056 μg/cm2 to 0.0059 μg/cm2 in the 3x plot.

A linear regression analysis was conducted using the natural logarithm
of the individual foliar residue values.  The estimated half-life values
for fluazinam from the 1x and 3x plots were 3.06 days (R2 = 0.937) and
2.93 days (R2 = 0.931), respectively.

The significant drop in day 4 residues was the result of a heavy
thunderstorm with at least 0.33 inches of rain that occurred on the
night before the day 4 sampling interval.  The rainfall did not
significantly affect the overall dissipation curve, but it did result in
predicted residues on day 0 (0.045 µg/cm2 for 1x rate and 0.046 µg/cm2
for 3x rate) that were lower than the actual residue on day 0 (0.071
µg/cm2 for 1x rate and 0.086 for 3x rate).

For purposes of this assessment, HED chose to use the actual residues on
day 0, rather than the predicted residues on day 0.  HED believes that
this analysis provides a more realistic assessment of actual residue
decline.

Equations/Calculations:

The following equations were used to calculate risks for workers
performing postapplication activities:

Adjusted DFR (µg/cm2) = Study DFR (µg/cm2) x crop application rate (lb
ai/A)

			             Study application rate (lb ai/A)

Daily Dermal Dose t (mg/kg-day) = DFRt (µg/cm2) x 1E-3 mg/µg x Tc
(cm2/hr) x DA x ET (hrs)									BW (kg)

	Where,

	t	= 	number of days after application day (days)

	DFRt 	=	dislodgeable foliage residue on day t (µg/cm2)

	Tc	=	transfer coefficient (cm2/hr)

     	DA	=     	dermal absorption factor (unitless)

	ET	=	exposure time (hr/day)

	BW	=	body weight (kg)

9.2.2   Postapplication Exposure and Risk

The postapplication exposure associated with the use of fluazinam is
summarized in Table 9.2.b.

Table 9.2.b.  Occupational Postapplication Exposure and Risk for
Fluazinam

Crop	Activity	Application Rate

(lb ai/A)	Transfer

Coefficienta

(cm2/hr)	Normalized DFR b

(μg/cm2)	Short- and Intermediate-Term

	Daily Dermal Dosec (mg/kg/day)	MOE on Day 0d	Days after Application
until MOE ≥100

Carrots	Hand weeding, irrigation, and scouting	0.52	300	0.860	0.0295	340
0

	Hand harvest

2,500	0.340	0.0971	41	6

Onions	hand weeding, irrigation, and scouting	0.52	300	0.860	0.0295	340
0

Lettuce	Hand weeding, thinning	0.99	500	1.637	0.0939	110	0

	Irrigation, scouting

1,500	0.520	0.0892	35	8

	Hand harvest

2,500	0.330	0.0943	21	12

Apples	Hand weeding, irrigation, and scouting	0.45	1,000	0.080	0.0091
1100	0

	Hand harvesting, propping, training, hand pruning

1,500	0.080	0.0137	730	0

	Thinning

3,000	0.080	0.0274	360	0

a.	Transfer coefficients and associated activities from ExpoSAC Policy
Memo #003.1 “Agricultural Transfer Coefficients,” 8/17/2000.

b.	DFR = Dislodgeable Foliar Residue from the submitted studies,
adjusted to compensate for difference in application rates (AR) between
study and actual label application rates.

c.	Daily Dermal Dose = [(DFR x Tc x Dermal Absorption x 8-hr Exposure
Time)] / [(CF: 1000 µg/mg) x (70-kg Body Weight)].

d.	MOE = NOAEL/Daily Dose   (Short- and intermediate-term Dermal NOAEL =
10 mg/kg/day).

9.2.3  Postapplication Risk Characterization

The restricted entry interval (REI) for fluazinam is based on the acute
toxicity of technical material.  Fluazinam is classified as Toxicity
Category I for eye irritation.  Under the Worker Protection Standard for
Agricultural Pesticides, active ingredients classified as acute toxicity
category I for any of these routes are assigned a 48-hour REI.

Postapplication MOEs were estimated for “Day 0” exposure (i.e., the
day of application).  In cases where the MOE was less than the LOC of
100 on Day 0, residue dissipation data/assumptions were used to
determine the day for which the risk would be not of concern (i.e., MOE
of 100 or greater).  Based on HED’s postapplication exposure
calculations, the dermal risks for all proposed crops were greater than
100 within 48 hours, which is in accordance with the current label REI.

•	Apple and onion postapplication dermal risks were 100 or greater
within 12 hours of application;

•	Carrot postapplication dermal risks were 100 or greater within 48
hours of application for low to medium contact activities (i.e. hand
weeding, irrigation, and scouting).

However, carrots did not reach a MOE of 100 or greater for high contact
activities (i.e., hand harvesting) until day 6.  Furthermore, lettuce
did not reach a MOE of 100 or greater for medium contact activities
(i.e., irrigation, scouting) until day 8 and for high contact activities
(i.e., hand harvesting) until day 12.  Risks from these activities are
of concern until the specified intervals have elapsed.  HED recommends
that the Registration Division ensure that the appropriate REI is
provided on all registered labels.

10.0   Data Needs and Label Recommendations  TC \l1 "10.0	Data Needs and
Label Requirements

10.1   Toxicology

As a result of new data requirements in the 40 CFR Part 158 for
conventional pesticide registration, an immunotoxicity study is required
for fluazinam.  Additionally, a subchronic (28-day) inhalation toxicity
study is required.  HED recommends that these studies be made a
condition of registration for the proposed uses.

	10.2   Residue Chemistry  TC \l2 "10.2	Residue Chemistry

No major deficiencies were noted in the current petitions that would
preclude establishing permanent tolerances for fluazinam residues of
concern on head lettuce; leaf lettuce; Onion, bulb, subgroup 3-07A; and
Bushberry, subgroup 13-07B.  In addition, the deficiency listed below
for lettuce field trials needs to be resolved as a condition of
registration.  A revised Section F is needed as detailed below
(860.1550).

Because of major data deficiencies, HED does not recommend in favor of
the establishment of tolerances for apples or carrots.  HED also does
not recommend in favor of tolerances for animal commodities.  The data
deficiencies associated with the apple and carrot petitions are
discussed below.

List of Deficiencies

860.1200 Directions for Use

 	•	The use directions for all the subject crops (lettuce, onions,
bushberries, apples, and carrots) should include a prohibition against
addition of adjuvants to the spray mixture.

The following deficiency applies to both existing and proposed uses of
fluazinam

860.1650 Submittal of Analytical Reference Standards

	•	An analytical reference standard for the AMGT metabolite is not
available.  RD should request that the registrant submit this standard
to the EPA’s National Pesticide Repository as soon as possible.

List of Deficiencies by Petition

PP# 8E7506 (Lettuce, Onion, Bushberry Subgroup)

860.1500 Crop Field Trials

 	•	Samples from the lettuce field trial need to be analyzed for
residues of AMGT.  The residue data should also be supported by data
depicting the frozen storage stability of AMGT in the lettuce samples.
HED recommends that these data be made a condition of registration for
the use on lettuce.

860.1550 Proposed Tolerances

	•	The registrant should submit a revised section F in which a
tolerance of 0.2 ppm is proposed for Onion, bulb, subgroup 3-07A, and a
tolerance of 7.0 ppm is proposed for Bushberry, subgroup 13-07B.

PP#s 9E7570 (Carrots) and 9F7571 (Apples)

860.1340 Residue Analytical Methods

•	At the present time, an analytical method is not available for
enforcement of fluazinam tolerances in animal commodities.  The
registrant should submit an ILV of the revised method.  This method
needs to be adequate for analysis of parent fluazinam as well as the
metabolites AMPA and DAPA in animal commodities for which tolerances
will be established.

•	If the registrant resolves the data deficiencies associated with the
apple and carrot petitions and re-submits the tolerance petitions,
multiresidue method testing data will be required for the regulated
animal metabolites, AMPA and DAPA.

860.1480 Meat, Milk, Poultry, and Eggs

	•	The residue data from the cattle feeding study are not adequate to
satisfy data requirements.  To support tolerances for apples and
carrots, the registrant needs to submit a new cattle feeding study.
When this study is repeated, the samples need to be analyzed as soon as
possible after sacrifice in order to minimize degradation of residues.

860.1520 Processed Food and Feed (Applies Only to Apple Petition)

	•	The apple processing study is not adequate to satisfy data
requirements.  The processing study needs to be repeated at a
sufficiently high rate that residues of both parent and AMGT are
quantifiable in the RAC.  In the event that the potential for
phytotoxicity exists, the application rate does not need to be greater
than the rate at which phytotoxicity occurs.

  TC \l2 "10.1	Toxicology 10.3   Occupational and Residential Exposure

HED recommends that the Registration Division ensure that the
appropriate REI is provided on all registered labels.  HED also
recommends that the PPE required on the label be expanded to all
handlers.  Workers conducting flagger-related activities should wear the
same PPE as applicators in order to reduce exposures.

REFERENCES:

Fluazinam: Human Health Risk Assessment for Proposed Use on
Edible-Podded Beans, Shelled Succulent and Dried Beans, Brassica Leafy
Vegetables, Bushberries, and Ginseng.  PC Code: 129098, Petition No:
6E7139, DP Barcode: D334949, K. Bailey, et al., 8/22/2007

Fluazinam.  Petitions for the Establishment of Tolerances and
Registration of New Uses on Apples, Carrots, Lettuce, and Bulb Onion
Subgroup (3-07A), and a Request for a Reduced Tolerance on Bushberry
Subgroup (13-07B).  Summary of Analytical Chemistry and Residue Data,
D360840, D. Dotson, 3/31/2010

Fluazinam: Acute and Chronic Aggregate Dietary (Food and Drinking Water)
Exposure and Risk Assessments for the Section 3 Registration Action on
Apples, Carrots, Head Lettuce, Leaf Lettuce, and the Bulb Onion Subgroup
(3-07A), D374522, D. Dotson, 3/31/2010

Tier I Estimated Drinking Waters Concentrations (EDWCs) of Fluazinam and
its Transformation Products for the Use in the Human Health Risk
Assessment for the Registration of the Following New Food Uses: Lettuce,
Apples, Carrots and Bulb Vegetables (Crop Subgroup 3-07A), D360713, J.
Melendez, 2/24/2010

Fluazinam: Occupational and Residential Risk Assessment for Proposed Use
of Fluazinam on Apples, Carrots, Lettuce (Head and Leaf), and Onions
(Bulb), D371446, Z. Figueroa, 3/30/2010

Appendix A:  Toxicology Assessment  TC \l1 "Appendix A:  Toxicology
Assessment

A.1   Toxicology Data Requirements TC \l2 "A.1  Toxicology Data
Requirements

 TC \l2 "A.1  Toxicology Data Requirements The requirements (40 CFR
158.340) for a food use for fluazinam are in Table A.1.  Use of the new
guideline numbers does not imply that the new (1998) guideline protocols
were used.

Table A.1                              Test

Technical

Required

Satisfied

870.1100	Acute Oral Toxicity

870.1200	Acute Dermal Toxicity

870.1300	Acute Inhalation Toxicity

870.2400	Primary Eye Irritation

870.2500	Primary Dermal Irritation

870.2600	Dermal Sensitization

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.3100	Oral Subchronic (rodent)

870.3150	Oral Subchronic (nonrodent)

870.3200	21/28-Day Dermal

870.3250	90-Day Dermal

870.3465	28-Day Inhalation

yes

yes

yes

no

yes

yes

yes

yes

---

no

870.3700a	Developmental Toxicity (rodent)

870.3700b	Developmental Toxicity (nonrodent)

870.3800	Reproduction

yes

yes

yes

yes

yes

yes

870.4100a	Chronic Toxicity (rodent)

870.4100b	Chronic Toxicity (nonrodent)

870.4200a	Oncogenicity (rat)

870.4200b	Oncogenicity (mouse)

870.4300	Chronic/Oncogenicity

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.5100	Mutagenicity—Gene Mutation - bacterial

870.5300	Mutagenicity—Gene Mutation - mammalian

870.5375	Mutagenicity—Structural Chromosomal Aberrations

870.5395	Mutagenicity—Mammalian Erythrocyte Micronucleus

yes

yes

yes

yes

yes

yes

yes

yes

870.6100a	Acute Delayed Neurotoxicity. (hen)

870.6100b	90-Day Neurotoxicity (hen)

870.6200a	Acute Neurotoxicity Screening Battery (rat)

870.6200b	90 Day Neurotoxicity Screening Battery (rat)

870.6300	Develop. Neurotoxicity

no

no

yes

yes

yes

---

---

yes

yes

yes

870.7485	General Metabolism

870.7600	Dermal Penetration

yes

no

yes

---

870.7800
Immunotoxicity…………………………………………

yes

no

A.2   Toxicity Profiles

Table A.2.a.  Acute Toxicity Data on Fluazinam Technical

Guideline No./ Study Type	Test Substance	MRID No.	Results	Toxicity
Category

870.1100

Acute oral toxicity

rats	Technical grade fluazinam (lot #109; 95.3%)	42248603

M: LD50 = 4500 mg/kg

F: LD50 = 4100 mg/kg	III

	Technical grade fluazinam (lot #8412-20; 95.3%)	42248602	M: LD50 >5000
mg/kg

F: LD50 >5000 mg/kg

IV

	Technical grade fluazinam (lot #1/87; 97.9%)	42248604	M: LD50 >5000
mg/kg

F: LD50 >5000 mg/kg

IV

870.1200

Acute dermal toxicity

rats

Technical grade fluazinam (lot #8303-2; 98.5%)

42248605

M: LD50 >2000 mg/kg

F: LD50 >2000 mg/kg

III

870.1300

Acute inhalation toxicity

rats

Technical grade fluazinam (lot #109; 95.3%)

42270601

M: LC50 = 0.463 mg/L

F: LD50 = 0.476 mg/L

II

870.2400

Acute eye irritation

rabbits

Technical grade fluazinam (lot # SNPE B-1216, No. 1006; 97.9%)

42248606

Extremely irritating.  Corneal opacity did NOT reverse in 21 days.

I

870.2500 Acute dermal irritation

rabbits

Technical grade fluazinam (lot # SNPE B-1216, No. 1006; 97.9%)

42248607

Slightly irritating

IV

870.2600 Dermal sensitization

guinea pigs

Technical grade fluazinam (lot # 1030/91; 96.7%)

42274401

Positive

NA

Ultra-purified fluazinam (lot #Y910401; 100%)

42248608

Negative

NA

Table A.2.b.  Acute Toxicity Data on Fluazinam (Formulation)

Guideline No./ Study Type	Test Substance	MRID No.	Results	Toxicity
Category

870.1100

Acute oral toxicity

rats

Omega 500F

(40% fluazinam)

42974907

M: LD50 >5000 mg/kg

F: LD50 >5000 mg/kg

IV

870.1200

Acute dermal toxicity

rabbits

Omega 500F

(40% fluazinam)

42974908

M: LD50 >2000 mg/kg

F: LD50 >2000 mg/kg

III

870.1300

Acute inhalation toxicity

rats

Fluazinam 50% WP (1)

(51.3% fluazinam)

42311001

M: LC50 = 3.0 mg/L

F: LD50 = 3.4 mg/L

IV

870.2400

Acute eye irritation

rabbits

Omega 500F

(40% fluazinam)

42974910

Slightly irritating

III

870.2500 Acute dermal irritation

rabbits

Omega 500F

(40% fluazinam)

42974911

Moderately irritating

II

870.2600 Dermal sensitization

guinea pigs

Omega 500F

(40% fluazinam)

42974912

Positive

NA

(1)   Study satisfies requirement for testing on Omega 500F

Table A.2.c.   Subchronic, Chronic, and Other Toxicity Studies

Guideline No.

 Study Type

MRID No./ (year) Classification /Doses

Results

870.3100

90-Day oral toxicity rats

42248610 (1984); 44807214 (1998)

Acceptable/guideline

M : 0, 0.15, 0.77, 3.8, 38 mg/kg/day;

F: 0, 0.17, 0.86, 4.3, 44 mg/kg/day

NOAEL: Males: 3.8 mg/kg/day; Females: 4.3 mg/kg/day

LOAEL Males = 38 mg/kg/day; Females = 44 mg/kg/day based on increased
liver weights and liver histopathology in males, and increased lung and
uterus weights in females.

870.3150

90-Day oral toxicity

dogs

42248611 (1991); 44807215 (1998)

Acceptable/guideline

M & F: 0, 1, 10, 100 mg/kg/day

NOAEL = 10 mg/kg/day

LOAEL = 100 mg/kg/day based on retinal effects, increased relative liver
weight, liver histopathology and possible increased serum alkaline
phosphatase in females and possible marginal vacuolation of the cerebral
white matter (equivocal)

870.3200

21-Day dermal toxicity

rats

42270602 (1985)

Acceptable/guideline

M & F: 0, 10, 100, 1000 mg/kg/day

Systemic NOAEL = 10 mg/kg/day

 LOAEL = 100 mg/kg/day based on increased AST and cholesterol levels in
clinical chemistry determinations (males)

Dermal NOAEL = not identified

LOAEL = 10 mg/kg/day based on erythema, acanthosis, and dermatitis

870.3250

90-Day dermal toxicity

NA

NA

870.3465

90-Day inhalation toxicity

NA

NA

870.3700a

Prenatal developmental toxicity

rats

42248613 (1985)

Acceptable/guideline

F: 0,10, 50, 250 mg/kg/day

Maternal NOAEL = 50 mg/kg/day

LOAEL = 250 mg/kg/day based on decreased body weight gain and food
consumption and increased water consumption and urogenital staining

Developmental NOAEL = 50 mg/kg/day

LOAEL = 250 mg/kg/day based on decreased fetal body weights and
placental weights, increased facial/cleft palates, diaphragmatic hernia,
and delayed ossification in several bone types, greenish amniotic fluid
and possible increased late resorptions and postimplantation loss

870.3700b

Prenatal developmental toxicity

rabbits

42248616 (1988)

Acceptable/guideline

F: 0, 2, 4, 7, 12 mg/kg/day

Maternal NOAEL = 4 mg/kg/day

LOAEL = 7 mg/kg/day based on decreased food consumption and increased
liver histopathology.

Developmental NOAEL = 7 mg/kg/day

LOAEL = 12 mg/kg/day based on an increase in total litter resorptions
and possible fetal skeletal abnormalities

870.3700b

Prenatal developmental toxicity

rabbits

42248615 (1985); 42248614 (1984); 42248617 (1984)

Unacceptable/guideline

F: 0, 0.3, 1, 3 mg/kg/day

Maternal NOAEL = 3 mg/kg/day

LOAEL = not identified (>3 mg/kg/day)

Developmental NOAEL = 3 mg/kg/day

LOAEL = not identified (>3 mg/kg/day)

870.3800

Reproduction and fertility effects

rats

42248619 (1987); 42208406 (1985); 42248618 (1986)

Acceptable/guideline

F0 males: 0, 1.5, 7.3, 36.6 mg/kg/day

F0 females: 0, 1.7, 8.4, 42.1 mg/kg/day

F1 males: 0, 1.9, 9.7, 47.3 mg/kg/day

F1 females: 0, 2.2, 10.6, 53.6 mg/kg/day

Parental/Systemic NOAEL = 1.9 mg/kg/day

LOAEL = 9.7 mg/kg/day based on liver pathology in F1 males

Reproductive NOAEL = 10.6 mg/kg/day

LOAEL = 53.6 mg/kg/day based on decreased number of implantation sites
and decreased litter sizes to day 4 post-partum for F1 females (F2
litters).

Offspring NOAEL = 8.4 mg/kg/day

LOAEL = 42.1 mg/kg/day based on reduced F1 and F2 pup body weight gains
during lactation.

870.4100a

Chronic toxicity

rats

44839901 (1993)

Acceptable/guideline

M: 0, 1.0, 1.9, 3.9 mg/kg/day

F: 0, 1.2, 2.4, 4.9 mg/kg/day

NOAEL = Males: 1.9 mg/kg/day; Females: 4.9 mg/kg/day

LOAEL = Males: 3.9 mg/kg/day; Females: not identified (>4.9 mg/kg/day)
based on increased testicular atrophy in males and no effects in females

870.4100b

Chronic toxicity

dogs	42270603 (1987); 44807219 (1998)

Acceptable/guideline

M & F: 0, 1, 10, 50 mg/kg/day

NOAEL = 1 mg/kg/day

LOAEL = 10 mg/kg/day based on gastric lymphoid hyperplasia in both sexes
and nasal dryness in females

870.4300

Combined chronic toxicity/carcino-genicity

rats

42248620 (1988); 44807223 (1999); 45150201 (2000)

Acceptable/guideline

M: 0, 0.04, 0.38, 3.8, 40 mg/kg/day

F: 0, 0.05, 0.47, 4.9, 53 mg/kg/day

NOAEL = Males: 0.38 mg/kg/day; Females: 0.47 mg/kg/day

LOAEL = Males: 3.8 mg/kg/day; Females: 4.9 mg/kg/day based on liver
toxicity in both sexes, pancreatic exocrine atrophy in females and
testicular atrophy in males.

Some evidence of carcinogenicity (thyroid gland follicular cell tumors)
in male rats, but not in females.

870.4200b

Carcinogenicity

mice

42208405 (1988); 4807220 (1996)

Acceptable/guideline

M: 0, 0.12, 1.1, 10.7, 107 mg/kg/day

F: 0, 0.11, 1.2, 11.7, 117 mg/kg/day

NOAEL =  Males:1.1 mg/kg/day; Females: 1.2 mg/kg/day

LOAEL = Males: 10.7 mg/kg/day; Females: 11.7 mg/kg/day based on
increased incidences of brown macrophages in the liver of both sexes,
eosinophilic vacuolated hepatocytes in males, and increased liver weight
in females

Clear evidence of carcinogenicity (hepatocellular tumors) in male mice,
but not in females

870.4200b

Carcinogenicity

mice

44807222 (1996); 44807221 (1998); 45201301 (2000)

Acceptable/guideline

M: 0, 126, 377, 964 mg/kg/day

F: 0, 162, 453, 1185 mg/kg/day

NOAEL =  Males:<126 mg/kg/day, Females: <162 mg/kg/day

LOAEL = Males: 126 mg/kg/day; Females: 162 mg/kg/day based on increased
liver weights and liver and brain histopathology in both sexes

Equivocal/some evidence of carcinogenicity (hepatocellular tumors) in
male mice, but not in females

870.5100

Bacterial reverse mutation assay (Ames test)

42270605 (1988)

Acceptable/Guideline

Up to 2 μg/plate for S. typhimurium strains and up to 250 μg/plate for
E. coli (-S9).  Up to 100 μg/plate for S. typhimurium strains and up to
500 μg/plate for E. coli (+ S9)

Negative with and without S9 up to cytotoxic concentrations.

870.5100

Bacterial reverse mutation assay (Ames test)

42270604 (1989)

Acceptable/Guideline

Up to 1μg/plate for S. typhimurium strains and up to 250 μg/plate for
E. coli (-S9) and  up to 100 μg/plate for S. typhimurium strains and up
to 500 μg/plate for E. coli (+S9)

Negative with and without S9 up to cytotoxic concentrations.

870.5300

In vitro mammalian gene mutation assay

45261801 (2000)

Acceptable/guideline

Up to 9 μg/ml (+S9), up to 0.3  μg/ml (-S9)

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Negative with S9 activation up to 9 μg/ml.  Negative without S9
activation up to 0.3 μg/ml.

Compound tested to cytotoxic concentrations.

870.5300

In vitro mammalian gene mutation assay

45156902 (1986)

Acceptable/guideline

Up to 5 μg/ml (+/-S9)

Negative with and without S9 activation up to 5 μg/ml.

Compound tested to cytotoxic concentrations.

870.5375

In vitro mammalian chromosome aberration (CHL cells)

42270606 (1988)

Acceptable/guideline

Up to 9.5 μg/ml (+S9) up to 4 μg/ml (-S9)

Negative with and without S9 up to cytotoxic concentrations.  Cells
harvested at 24 and 48 hours in nonactivated studies and at 24 hours in
activated studies.

870.5395

Mammalian erythrocyte micronucleus test

44807224 (1999)

Acceptable/guideline

500, 1000, 2000 mg/kg (oral gavage)

Negative at 24 hour sacrifice (500, 1000, 2000 mg/kg).

Negative at 24, 48, and 72 hour sacrifices (2000 mg/kg).

870.5550

UDS in primary rat hepatocytes

45156901 (1984)

Unacceptable/guideline

0.05 to 6.25 μg/ml

Negative; however there were several serious study deficiencies:
treatment time shorter than recommended, no data supporting the claim of
cytotoxicity, data variability for major endpoints.

870.5550

Differential killing/growth inhibition in B. subtilis

42270607 (1988)

Unacceptable/guideline

0.003 to 0.3 μg/disk (-S9)

0.3 to 30 μg/disk (+S9)

Negative, however only one replicate plate/dose was used.

870.6200a

Acute neurotoxicity screening battery

rats

44807210 (1995)

Acceptable/guideline

M & F: 0, 50, 1000, 2000 mg/kg

Systemic NOAEL = 50 mg/kg

LOAEL = 1000 mg/kg based on soft stools and decreased motor activity on
day of dosing.

Neurotoxicity NOAEL = 2000 mg/kg

LOAEL = not identified (>2000 mg/kg)

870.6200b

Subchronic neurotoxicity screening battery

rats

44807217 (1998); 44807218 (1998)

Acceptable/guideline

M :0, 21, 69, 74, 149, 233 mg/kg/day;

F: 0, 23, 81, 89, 175, 280 mg/kg/day

Neurotoxicity NOAEL = Males: 233 mg/kg/day; Females: 280 mg/kg/day

LOAEL = not identified (Males: >233 mg/kg/day; Females: > 280 mg/kg/day)

870.6300

Developmental neurotoxicity

46534401, 47018301 and 47037001.

Acceptable/Non-Guideline

0, 2, 10 or 50 mg/kg/day

Maternal:

NOAEL not established.  No toxicity at highest dose tested.

Developmental:

NOAEL = 2 mg/kg/day.

LOAEL = 10 mg/kg/day based on decreased pup weight and gain and delayed
balano-preputial separation.

870.7485

Metabolism and pharmacokinetics

rats

44807233 (1995); 43521004 thru 43521008, 43553001 (1993-1995)

Acceptable/guideline

0.5, 50 mg/kg

Only 33-40% of the administered dose was absorbed.  Most of the
administered dose was recovered in the feces (>89%).   Excretion via the
urine was minor (<4%).  Total biliary radioactivity, however,
represented 25-34% of the administered dose, indicating considerable
enterohepatic circulation.

A.3 Executive Summaries TC \l2 "A.3  Executive Summaries

For the executive summaries of the toxicology studies submitted for
fluazinam, refer to the previous risk assessment that HED prepared for
fluazinam (Memo, D334949, K. Bailey, 8/22/2007).

Appendix B:  Tolerance Summary Table

Table B.1.   Tolerance Summary for Fluazinam

Commodity	Proposed  Tolerance (ppm)	Recommended Tolerance (ppm)
Comments; Correct Commodity Definition

PP#8E7506

Bushberry, subgroup 13-07B	4.5	7.0

	Adequate blueberry residue data are available.  The recommended
tolerance for Subgroup 13-07B is the same as that for Subgroup 13B
(i.e., 7.0 ppm)

The established individual tolerances for aronia berry, buffalo currant,
Chilean guava, European barberry, highbush cranberry, edible
honeysuckle, edible jostaberry, Juneberry, lingonberry, native currant,
salal, and sea buckthorn should be deleted because they are included
under the revised Bushberry subgroup, 13-07B.

Onion, bulb, subgroup 3-07A	0.15	0.20	Adequate bulb onion residue data
are available.

Lettuce, head	0.02	0.02	Adequate head lettuce residue data are
available.

Lettuce, leaf	2.0	2.0	Adequate leaf lettuce residue data are available.

PP#9E7570

Carrot, roots	0.8	None*	Adequate carrot residue data are available.
HED’s tolerance generator directs that the tolerance for this data set
should be 0.70 ppm.

PP#9F7571

Apples	1.7	None*	Adequate apple residue data are available.  HED’s
tolerance generator directs that the tolerance for this data set should
be 1.50 ppm.  The USEPA and Canada’s PMRA agreed to establish the
tolerance at 2.0 ppm at such time as the data deficiencies are resolved.

Apple, pomace, wet	5.0	None*	Adequate apple processing data are not
available.

Cattle, fat	0.03	None	An adequate cattle feeding study is not available.
 Based on the results of the inadequate study, the maximum expected
residues in meat byproducts and fat is 0.05 ppm.  This value can be used
as a very conservative residue value for the dietary exposure
assessment.

Based on the results of the inadequate feeding study, tolerances will
probably not be needed for milk and meat of cattle, goat, horse, and
sheep.

Cattle, kidney	0.03	Not required

	Cattle, liver	0.03	Not required

	Cattle, meat	0.03	Not required

	Cattle, meat byproducts	0.03	None

	Goat, fat	0.03	None

	Goat, kidney	0.03	Not required

	Goat, liver	0.03	Not required

	Goat, meat	0.03	Not required

	Goat, meat byproducts	0.03	None

	Horse, fat	0.03	None

	Horse, kidney	0.03	Not required

	Horse, liver	0.03	Not required

	Horse, meat	0.03	Not required

	Horse, meat byproducts	0.03	None

	Milk	0.03	Not required

	Sheep, fat	0.03	None

	Sheep, kidney	0.03	Not required

	Sheep, liver	0.03	Not required

	Sheep, meat	0.03	Not required

	Sheep, meat byproducts	0.03	None

*  HED is recommending against the establishment of tolerances on apples
and carrots because of deficiencies in the livestock residue analytical
method, the cattle feeding study, and the apple processing study.

HED recommends that 40CFR §180.574(a)(1) be amended by replacing the
tolerance expression with the following:  “Tolerances are established
for residues of fluazinam
(3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluor
omethyl)-2-pyridinamine), including its metabolites and degradates, in
or on the commodities in the table below.  Compliance with the tolerance
levels specified below is to be determined by measuring only
fluazinam.”  HED further recommends that 40CFR §180.610(a)(2) be
amended by replacing the tolerance expression with the following:
“Tolerances are established for residues of fluazinam, including its
metabolites and degradates, in or on the commodities in the table below.
 Compliance with the tolerance levels specified below is to be
determined by measuring only fluazinam and its metabolite AMGT
(3-[[4-amino-3-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]amino]-2-nitro
-6-(trifluoromethyl) phenyl]thio]-2-(beta-D-glucopyranosyloxy) propionic
acid).”

 of    NUMPAGES \* arabic \* MERGEFORMAT  67

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[Federal Register: November 9, 2006 (Volume 71, Number 217)]
[Notices]
[Page 65794]
[DOCID:fr09no06-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-48-000]

National Fuel Gas Supply Corporation; Notice of Tariff Filing

November 2, 2006.
    Take notice that on October 31, 2006, National Fuel Gas Supply
Corporation (National) tendered for filing as part of its FERC Gas
Tariff, Fourth Revised Volume No. 1, Ninety Fifth Revised Sheet No. 9,
to become effective November 1, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-18939 Filed 11-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 15 (Monday, January 24, 2022)]
[Notices]
[Pages 3632-3635]
[FR Doc No: 2022-01218]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93986; File No. SR-Phlx-2022-01]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Phlx's
Pricing Schedule at Options 7, Section 3

January 18, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on January 3, 2022, Nasdaq PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Phlx's Pricing Schedule at Options
7, Section 3, ``Rebates and Fees for Adding and Removing Liquidity in
SPY.'' The Exchange also proposes to remove obsolete rule text within
Options 7, Section 9, ``Other Member Fees.''

    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, 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, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    Phlx proposes to amend its pricing at Options 7, Section 3,
``Rebates and Fees for Adding and Removing Liquidity in SPY.''
Specifically, Phlx proposes to amend its Simple Order Customer \4\ Fee
for Removing Liquidity in options overlying the SPDR[supreg] S&P 500
ETF Trust (``SPY''). The Exchange also proposes to remove obsolete rule
text within Options 7, Section 9, ``Other Member Fees.'' Each change
will be described below.
---------------------------------------------------------------------------

    \4\ The term ``Customer'' applies to any transaction that is
identified by a member or member organization for clearing in the
Customer range at The Options Clearing Corporation (``OCC'') which
is not for the account of a broker or dealer or for the account of a
``Professional'' (as that term is defined in Options 1, Section
1(b)(45)). See Options 7, Section 1(c).
---------------------------------------------------------------------------

Options 7, Section 3
    Today, the Exchange assesses a $0.38 per contract Customer Simple
Order Fee for Removing Liquidity in SPY. The Exchange assesses a Lead
Market Maker,\5\ Market Maker,\6\ Firm,\7\ Broker-Dealer \8\ and
Professional \9\ Simple Order Fee for Removing Liquidity in SPY of
$0.48 per contract. The Exchange proposes to increase the Customer
Simple Order Fee for Removing Liquidity in SPY from $0.38 to $0.41 per
contract. Notwithstanding the increase, the Customer Simple Order Fee
for Removing Liquidity in SPY remains the lowest fee for removing
liquidity in SPY. The Exchange believes that the Customer Simple Order
Fee for Removing Liquidity in SPY will continue to attract order flow
to the Exchange despite the increase.
---------------------------------------------------------------------------

    \5\ The term ``Lead Market Maker'' applies to transactions for
the account of a Lead Market Maker (as defined in Options 2, Section
12(a)). A Lead Market Maker is an Exchange member who is registered
as an options Lead Market Maker pursuant to Rule Options 2, Section
12(a)[sic]. An options Lead Market Maker includes a Remote Lead
Market Maker which is defined as an options Lead Market Maker in one
or more classes that does not have a physical presence on an
Exchange floor and is approved by the Exchange pursuant to Options
2, Section 11.
    \6\ The term ``Market Maker'' is defined in Options 1, Section
1(b)(28) as a member of the Exchange who is registered as an options
Market Maker pursuant to Options 2, Section 12(a). A Market Maker
includes SQTs and RSQTs as well as on and Floor Market Makers.
    \7\ The term ``Firm'' applies to any transaction that is
identified by a member or member organization for clearing in the
Firm range at OCC.
    \8\ The term ``Broker-Dealer'' applies to any transaction which
is not subject to any of the other transaction fees applicable
within a particular category.
    \9\ The term ``Professional'' applies to transactions for the
accounts of Professionals, as defined in Exchange Rule 1000(b)(43)
means any person or entity that (i) is not a broker or dealer in
securities, and (ii) places more than 390 orders in listed options
per day on average during a calendar month for its own beneficial
account(s).
---------------------------------------------------------------------------

Options 7, Section 9
    The Exchange proposes to remove obsolete rule text within Options
7, Section 9.B, Port Fees. Options 7, Section 9.B refers to a
technology infrastructure migration that occurred in 2019. The rule
text related to the migration is now obsolete. At this time, the
Exchange proposes to remove the rule text which describes the migration
within Options 7, Section 9.B because it is outdated.
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
Sections 6(b)(4) and 6(b)(5) of the Act,\11\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees, and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange's proposed changes to its Pricing Schedule are
reasonable in several respects. As a threshold matter, the Exchange is
subject to significant competitive forces in the market for options
securities transaction services that constrain its pricing
determinations in that market. The fact that this market is competitive
has long been recognized by the courts. In NetCoalition v. Securities
and Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .'' \12\
---------------------------------------------------------------------------

    \12\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \13\
---------------------------------------------------------------------------

    \13\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
options security transaction services. The Exchange is only one of
sixteen options exchanges to which market participants may direct their
order flow. Within this environment, market participants can freely and
often do shift their order flow among the Exchange and competing venues
in response to changes in their respective pricing schedules. As such,
the proposal represents a reasonable attempt by the Exchange to
increase its liquidity and market share relative to its competitors.

Options 7, Section 3
    The Exchange's proposal to increase the Customer Simple Order Fee
for Removing Liquidity in SPY from $0.38 to $0.41 per contract is
reasonable. Notwithstanding the increase, the Customer Simple Order Fee
for Removing Liquidity in SPY remains the lowest fee for removing
liquidity in SPY. The Exchange believes that the Customer Simple Order
Fee for Removing Liquidity in SPY will continue to attract order flow
to the Exchange despite the increase.
    The Exchange's proposal to increase the Customer Simple Order Fee
for Removing Liquidity in SPY from $0.38 to $0.41 per contract is
equitable and not unfairly discriminatory. Priority Customers continue
to be assessed the lowest Simple Order Fee for Removing Liquidity in
SPY. Priority Customer liquidity benefits all market participants by
providing more trading opportunities, which attracts Market Makers. An
increase in the activity of these market participants in turn
facilitates tighter spreads, which may cause an additional
corresponding increase in order flow from other market participants.
Options 7, Section 9
    The Exchange's proposal to remove obsolete rule text within Options
7, Section 9.B, Port Fees is reasonable, equitable and not unfairly
discriminatory. Options 7, Section 9.B refers to a technology
infrastructure migration that occurred in 2019. The rule text related
to the migration is outdated and would not apply to any Phlx market
participant.

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.
Inter-Market Competition
    The proposal does not impose an undue burden on inter-market
competition. The Exchange believes its proposal remains competitive
with other options markets and will offer market participants with
another choice of where to transact options. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges that have been exempted from compliance with the statutory
standards applicable to exchanges. Because competitors are free to
modify their own fees in response, and because market participants may
readily adjust their order routing practices, the Exchange believes
that the degree to which fee changes in this market may impose any
burden on competition is extremely limited.
Intra-Market Competition
    The proposed amendments do not impose an undue burden on intra-
market competition.
Options 7, Section 3
    The Exchange's proposal to increase the Customer Simple Order Fee
for Removing Liquidity in SPY from $0.38 to $0.41 per contract does not
impose an undue burden on competition. Priority Customers continue to
be assessed the lowest Simple Order Fee for Removing Liquidity in SPY.
Priority Customer liquidity benefits all market participants by
providing more trading opportunities, which attracts Market Makers. An
increase in the activity of these market participants in turn
facilitates tighter spreads, which may cause an additional
corresponding increase in order flow from other market participants.
Options 7, Section 9
    The Exchange's proposal to remove obsolete rule text within Options
7, Section 9.B, Port Fees does not impose an undue burden on
competition. The rule text related to the migration is outdated and
would not apply to any Phlx market participant.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\14\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-Phlx-2022-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2022-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2022-01, and should be submitted on
or before February 14, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-01218 Filed 1-21-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70876-70878]
[FR Doc No: 2014-28087]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1152]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Petition To Request
an Exemption From 100 Percent Identity Testing of Dietary Ingredients:
Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
December 29, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0608.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
    Petition to Request an Exemption from 100 Percent Identity Testing
of Dietary Ingredients:

Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements--21 CFR
111.75(a)(1)(ii) (OMB Control Number 0910-0608)--Reinstatement

    The Dietary Supplement Health and Education Act (DSHEA) (Pub. L.
103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the
Secretary of Health and Human Services (the Secretary) may, by
regulation, prescribe good manufacturing practices for dietary
supplements. Section 402(g)(1) of the FD&C Act states that a dietary
supplement is adulterated if ``it has been prepared, packed, or held
under conditions that do not meet current good manufacturing practice
regulations.'' Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives
us the authority to issue regulations for the efficient enforcement of
the FD&C Act.
    Part 111 of our regulations (21 CFR part 111) establishes the
minimum current good manufacturing practice (CGMP) necessary for
activities related to manufacturing, packaging, labeling, or holding
dietary supplements to ensure the quality of the dietary supplement.
Section 111.75(a)(1) of our regulations establishes a procedure for a
petition to request an exemption from 100 percent identity testing of
dietary ingredients. In accordance with Sec.  111.75(a)(1)(ii),
manufacturers may request an exemption from the requirements set forth
in Sec.  111.75(a)(1)(i) when the dietary ingredient is obtained from
one or more suppliers identified in the petition. The regulation
clarifies that we are willing to consider, on a case-by-case basis, a
manufacturer's conclusion, supported by appropriate data and
information in the petition submission, that it has developed a system
that it would implement as a sound, consistent means of establishing,
with no material diminution of assurance compared to the assurance
provided by 100 percent identity testing, the identity of the dietary
ingredient before use.
    Section 111.75(a)(1) reflects our determination that manufacturers
that test or examine 100 percent of the incoming dietary ingredients
for identity can be assured of the identity of the ingredient. However,
we recognize that it may be possible for a manufacturer to demonstrate,
through various methods and processes in use over time for its
particular operation, that a system of less than 100 percent identity
testing would result in no material diminution of assurance of the
identity of the dietary ingredient as compared to the assurance
provided by 100 percent identity testing. To provide an opportunity for
a manufacturer to make such a showing and reduce the frequency of
identity testing of components that are dietary ingredients from 100
percent to some lower frequency, we added to Sec.  111.75(a)(1), an
exemption from the requirement of 100 percent identity testing when a
manufacturer petitions the Agency for such an exemption to 100 percent
identity testing under Sec.  10.30 and the Agency grants such
exemption. Such a procedure would be consistent with our stated goal,
as described in the CGMP final rule, of providing flexibility in the
CGMP requirements. Section 111.75(a)(1)(ii) sets forth the information
a manufacturer is required to submit in such a petition. The regulation
also contains a requirement to ensure that the manufacturer keeps our
response to a petition submitted under Sec.  111.75(a)(1)(ii) as a
record under Sec.  111.95. The collection of information in Sec.
111.95 has been approved under OMB control number 0910-0606.
    Description of Respondents: The respondents to this collection of
information are firms in the dietary supplement industry, including
dietary supplement manufacturers, packagers and re-packagers, holders,
labelers and re-labelers, distributors, warehouses, exporters,
importers, large businesses, and small businesses.
    In the Federal Register of November 14, 2013 (78 FR 68453), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. While three comments were received, none
were responsive to the four collection of information topics solicited
in the notice and therefore are not discussed in this document.
Additionally, although FDA was unable to publish a 30 day notice before
the information collection expiration and is therefore requesting its
reinstatement, the Agency has not conducted or sponsored any collection
of information under OMB control number 0910-0608 in the interim
period.
    We estimate the annual burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
     21 CFR Section; CGMP requirements for dietary supplements          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75(a)(1)(ii)...................................................               1                1                1                8                8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the last 3 years, we have not received any new petitions to
request an exemption from 100 percent identity testing of dietary
ingredients; therefore, the Agency estimates that one or fewer
petitions will be submitted annually. Based on our experience with
petition processes, we estimate it will take a requestor about 8 hours
to prepare the factual and legal information necessary to support a
petition for exemption and to prepare the petition. Although we have
not received any new petitions to request an exemption from 100 percent
identity testing of dietary ingredients in

the last 3 years, we believe that OMB approval of these information
collection provisions should be extended to provide for the potential
future need of a firm in the dietary supplement industry to petition
for an exemption from 100 percent identity testing of dietary
ingredients.

    Dated: November 21, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28087 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P


21.111 Criteria for IRB approval of research.
21.112 Review by institution.
21.113 Suspension or termination of IRB approval of research.
21.114 Cooperative research.
21.115 IRB records.
21.116 General requirements for informed consent.
21.117 Documentation of informed consent.
21.118 Applications and proposals lacking definite plans for
involvement of human subjects.
21.119 Research undertaken without the intention of involving human
subjects.
21.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
21.121 [Reserved]
21.122 Use of Federal funds.
21.123 Early termination of research support: Evaluation of
applications and proposals.
21.124 Conditions.

    Authority: 5 U.S.C. 301; 29 U.S.C. 551.

Christopher P. Lu,
Deputy Secretary of Labor.

DEPARTMENT OF DEFENSE

32 CFR Part 219

List of Subjects in 32 CFR Part 219

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Defense
proposes to revise 32 CFR part 219, as set forth at the end of the
common preamble of this document.

PART 219--PROTECTION OF HUMAN SUBJECTS

Sec.
219.101 To what does this policy apply?
219.102 Definitions for purposes of this policy.
219.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
219.104 Exempt research.
219.105 Protection of biospecimens and identifiable private
information.
219.106 [Reserved]
219.107 IRB membership.
219.108 IRB functions and operations.
219.109 IRB review of research.
219.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
219.111 Criteria for IRB approval of research.
219.112 Review by institution.
219.113 Suspension or termination of IRB approval of research.
219.114 Cooperative research.
219.115 IRB records.
219.116 General requirements for informed consent.
219.117 Documentation of informed consent.
219.118 Applications and proposals lacking definite plans for
involvement of human subjects.
219.119 Research undertaken without the intention of involving human
subjects.
219.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
219.121 [Reserved]
219.122 Use of Federal funds.
219.123 Early termination of research support: Evaluation of
applications and proposals.
219.124 Conditions.

    Authority: 5 U.S.C. 301.

Patricia L. Toppings,
OSD Federal Register Liaison, Officer, Department of Defense.

DEPARTMENT OF EDUCATION

34 CFR Part 97

List of Subjects in 34 CFR Part 97

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Education
proposes to amend 34 CFR part 97 as follows:

 PART 97--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474.

0
2. Subpart A is revised as set forth at the end of the common preamble
of this document.

Subpart A--Federal Policy for the Protection of Human Subjects
(Basic ED Policy for Protection of Human Research Subjects)

Sec.
97.101 To what does this policy apply?
97.102 Definitions for purposes of this policy.
97.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
97.104 Exempt research.
97.105 Protection of biospecimens and identifiable private
information.
97.106 [Reserved]
97.107 IRB membership.
97.108 IRB functions and operations.
97.109 IRB review of research.
97.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
97.111 Criteria for IRB approval of research.
97.112 Review by institution.
97.113 Suspension or termination of IRB approval of research.
97.114 Cooperative research.
97.115 IRB records.
97.116 General requirements for informed consent.
97.117 Documentation of informed consent.
97.118 Applications and proposals lacking definite plans for
involvement of human subjects.
97.119 Research undertaken without the intention of involving human
subjects.
97.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
97.121 [Reserved]
97.122 Use of Federal funds.
97.123 Early termination of research support: Evaluation of
applications and proposals.
97.124 Conditions.

Arne Duncan,
Secretary of Education.

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 16

List of Subjects in 38 CFR Part 16

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Veterans
Affairs proposes to revise 38 CFR part 16, as set forth at the end of
the common preamble of this document.

PART 16--PROTECTION OF HUMAN SUBJECTS

Sec.
16.101 To what does this policy apply?
16.102 Definitions for purposes of this policy.
16.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
16.104 Exempt research.
16.105 Protection of biospecimens and identifiable private
information.
16.106 [Reserved]
16.107 IRB membership.
16.108 IRB functions and operations.
16.109 IRB review of research.
16.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
16.111 Criteria for IRB approval of research.
16.112 Review by institution.
16.113 Suspension or termination of IRB approval of research.
16.114 Cooperative research.
16.115 IRB records.
16.116 General requirements for informed consent.
16.117 Documentation of informed consent.
16.118 Applications and proposals lacking definite plans for
involvement of human subjects.
16.119 Research undertaken without the intention of involving human
subjects.
16.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
16.121 [Reserved]
16.122 Use of Federal funds.
16.123 Early termination of research support: Evaluation of
applications and proposals.
16.124 Conditions.

    Authority: 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334.

Robert L. Nabors II,
Chief of Staff, U.S. Department of Veterans Affairs,

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

List of Subjects in 40 CFR Part 26

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Environmental
Protection Agency proposes to amend 40 CFR part 26 as follows:

PART 26--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for part 26 continues to read as follows:

    Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21
U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531.

0
2. Subpart A is revised as set forth at the end of the common preamble
of this document.

Subpart A--Basic EPA Policy for Protection of Subjects in Human
Research Conducted or Supported by EPA

Sec.
26.101 To what does this policy apply?
26.102 Definitions for purposes of this policy.
26.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
26.104 Exempt research.
26.105 Protection of biospecimens and identifiable private
information.
26.106 [Reserved]
26.107 IRB membership.
26.108 IRB functions and operations.
26.109 IRB review of research.
26.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
26.111 Criteria for IRB approval of research.
26.112 Review by institution.
26.113 Suspension or termination of IRB approval of research.
26.114 Cooperative research.
26.115 IRB records.
26.116 General requirements for informed consent.
26.117 Documentation of informed consent.
26.118 Applications and proposals lacking definite plans for
involvement of human subjects.
26.119 Research undertaken without the intention of involving human
subjects.
26.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
26.121 [Reserved]
26.122 Use of Federal funds.
26.123 Early termination of research support: Evaluation of
applications and proposals.
26.124 Conditions.

A. Stanley Meiburg,
Acting Deputy Administrator.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46

List of Subjects in 45 CFR Part 46

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Health
and Human Services proposes to amend 45 CFR part 46 as follows:

PART 46--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for part 46 is revised to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 289.

0
2. Subpart A is revised as set forth at the end of the common preamble
of this document.

Subpart A--Basic HHS Policy for Protection of Human Research
Subjects

Sec.
46.101 To what does this policy apply?
46.102 Definitions for purposes of this policy.
46.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
46.104 Exempt research.
46.105 Protection of biospecimens and identifiable private
information.
46.106 [Reserved]
46.107 IRB membership.
46.108 IRB functions and operations.
46.109 IRB review of research.
46.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
46.111 Criteria for IRB approval of research.
46.112 Review by institution.
46.113 Suspension or termination of IRB approval of research.
46.114 Cooperative research.
46.115 IRB records.
46.116 General requirements for informed consent.
46.117 Documentation of informed consent.
46.118 Applications and proposals lacking definite plans for
involvement of human subjects.
46.119 Research undertaken without the intention of involving human
subjects.
46.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
46.121 [Reserved]
46.122 Use of Federal funds.
46.123 Early termination of research support: Evaluation of
applications and proposals.
46.124 Conditions.

Sylvia M. Burwell,
Secretary, HHS.

NATIONAL SCIENCE FOUNDATION

45 CFR Part 690

List of Subjects in 45 CFR Part 690

    Human research subjects, Reporting and record-keeping requirements,
Research.
    For the reasons stated in the preamble, the National Science
Foundation proposes to revise 45 CFR part 690, as set forth at the end
of the common preamble of this document.

PART 690--PROTECTION OF HUMAN SUBJECTS

Sec.
690.101 To what does this policy apply?
690.102 Definitions for purposes of this policy.
690.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
690.104 Exempt research.
690.105 Protection of biospecimens and identifiable private
information.
690.106 [Reserved]
690.107 IRB membership.
690.108 IRB functions and operations.
690.109 IRB review of research.
690.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
690.111 Criteria for IRB approval of research.
690.112 Review by institution.
690.113 Suspension or termination of IRB approval of research.
690.114 Cooperative research.
690.115 IRB records.
690.116 General requirements for informed consent.
690.117 Documentation of informed consent.
690.118 Applications and proposals lacking definite plans for
involvement of human subjects.
690.119 Research undertaken without the intention of involving human
subjects.
690.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
690.121 [Reserved]
690.122 Use of Federal funds.
690.123 Early termination of research support: Evaluation of
applications and proposals.
690.124 Conditions.

    Authority: 5 U.S.C. 301.

Lawrence Rudolph,
General Counsel.

DEPARTMENT OF TRANSPORTATION

49 CFR Part 11

List of Subjects in 49 CFR Part 11

    Human research subjects, Reporting and record-keeping requirements,
Research.
    For the reasons stated in the preamble, the Department of
Transportation proposes to revise 49 CFR part 11, as set forth at the
end of the common preamble of this document.

PART 11--PROTECTION OF HUMAN SUBJECTS

Sec.
11.101 To what does this policy apply?
11.102 Definitions for purposes of this policy.
11.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
11.104 Exempt research.
11.105 Protection of biospecimens and identifiable private
information.
11.106 [Reserved]
11.107 IRB membership.
11.108 IRB functions and operations.
11.109 IRB review of research.
11.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
11.111 Criteria for IRB approval of research.
11.112 Review by institution.
11.113 Suspension or termination of IRB approval of research.
11.114 Cooperative research.
11.115 IRB records.
11.116 General requirements for informed consent.
11.117 Documentation of informed consent.
11.118 Applications and proposals lacking definite plans for
involvement of human subjects.
11.119 Research undertaken without the intention of involving human
subjects.
11.120 Evaluation and disposition of applications and proposals for
research to be conducted or supported by a Federal department or
agency.
11.121 [Reserved]
11.122 Use of Federal funds.
11.123 Early termination of research support: Evaluation of
applications and proposals.
11.124 Conditions.

    Authority: 5 U.S.C. 301.

Anthony R. Foxx,
Secretary of Transportation.
[FR Doc. 2015-21756 Filed 9-2-15; 11:15 am]
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