[Federal Register Volume 79, Number 12 (Friday, January 17, 2014)]
[Notices]
[Page 3210]
[FR Doc No: 2014-00870]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0485]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Premarket Approval of Medical
Devices--21 CFR Part 814

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Premarket Approval of Medical
Devices--21 CFR Part 814'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 22, 2013, the Agency submitted a
proposed collection of information entitled ``Premarket Approval of
Medical Devices--21 CFR Part 814'' to OMB for review and clearance
under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. OMB has now
approved the information collection and has assigned OMB control number
0910-0231. The approval expires on January 31, 2017. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00870 Filed 1-16-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 30, 2005 (Volume 70, Number 229)]
[Notices]
[Page 71819-71820]
[DOCID:fr30no05-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-22-000]

Texas Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

November 22, 2005.
    Take notice that on November 9, 2005, Texas Gas Transmission, LLC
(Texas Gas), 3800 Frederica Street, Owensboro, Kentucky 42301, filed in
Docket No. CP06-22-000, an application pursuant to Sections 157.205,
157.208, and 157.216 of the Commission's Regulations under the Natural
Gas Act (NGA) as amended, for authorization to construct the West
Greenville--Elkton Lateral in Muhlenberg and Todd Counties, Kentucky,
to decrease the risk of service interruption during periods of peak
customer demand, under Texas Gas' blanket certificate issued in Docket
No. CP82-407-000, all as more fully set forth in the application which
is on file with the Commission and open to public inspection.
    Texas Gas states that it proposes to construct and operate the West
Greenville--Elkton Lateral, which would consist of approximately 27.5
miles of natural gas pipeline (12.8 miles of 12-inch diameter and 14.7
miles of 10-inch diameter pipe) and appurtenant facilities, to provide
an additional means of transporting natural gas to the Bowling Green,
Kentucky, market area. Texas Gas also states that the proposed lateral
would decrease the risk of service interruptions during customer demand
periods. Texas Gas estimates that it would spend $14,165,000 to
construct the proposed lateral.
    Any questions concerning this application may be directed to
counsel for Texas Gas, Kathy D. Fort, Manager of Certificates and
Tariffs, Texas Gas Transmission, LLC, P.O. Box 20008,

Owensboro, Kentucky 42304; telephone<PHONE_NUMBER> or facsimile 270-688-
5871.
    This filing is available for review at the Commission or may be
viewed on the Commission's Web site at http://www.ferc.gov, using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number filed to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or call toll-free at<PHONE_NUMBER>, or, for

TTY, contact<PHONE_NUMBER>. Comments, protests and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
intervenors to file electronically.
    Any person or the Commission's staff may, within 45 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the Regulations under the Natural Gas Act (18 CFR 157.205) a protest to
the request. If no protest is filed within the time allowed therefor,
the proposed activity shall be deemed to be authorized effective the
day after the time allowed for filing a protest. If a protest is filed
and not withdrawn within 30 days after the time allowed for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to Section 7 of the Natural Gas Act.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6684 Filed 11-29-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: June 16, 2006 (Volume 71, Number 116)]
[Notices]
[Page 34904]
[DOCID:fr16jn06-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-385-000]

Distrigas of Massachusetts LLC; Notice of Proposed Changes in
FERC Gas Tariff

June 8, 2006.
    Take notice that on June 5, 2006, Distrigas of Massachusetts LLC
(DOMAC) tendered for filing as part of its FERC Gas Tariff, First
Revised Volume No. 1, the following revised Tariff sheets proposed to
be effective July 6, 2006:

Sixth Revised Sheet No. 29
Fifth Revised Sheet No. 38
Fifth Revised Sheet No. 39
Fifth Revised Sheet No. 40
Fifth Revised Sheet No. 41
First Revised Sheet No. 48A
First Revised Sheet No. 48B
First Revised Sheet No. 48C
First Revised Sheet No. 48D
First Revised Sheet No. 48E
First Revised Sheet No. 48F
First Revised Sheet No. 48G
First Revised Sheet No. 48H
First Revised Sheet No. 48I

    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 on-line 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. E6-9372 Filed 6-15-06; 8:45 am]

BILLING CODE 6717-01-P


UNITED STAES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

 PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	11/6/06

SUBJECT:	Famoxadone Chronic Dietary Exposure Assessment for the Use on Grapes, Hops, and Caneberries.

PC Code:		113202

Decision Number: 	369719

DP Number:		332298

REVIEWER:	W. Cutchin, Acting Branch Senior Scientist

Alternative Risk Integration and Assessment (ARIA) Team

Technical Review Branch (TRB)

Registration Division (RD) (7505P)

	and

	B. Hanson, Biologist

ARIA

Risk Integration Minor Use and Emergency Response Branch(RIMUERB) RD (7505P)

THROUGH:	D. Dotson, Chemist

D. Soderberg, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (HED) (7509P)

TO:	S. Brothers, RM 05

	RIMUERB/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a chronic dietary exposure analysis for Interregional Research Project No. 4 (IR-4) petitions for the fungicide famoxadone for a domestic registration for the use on grapes east of the Rocky Mountains, hops, and caneberries, subgroup 13A (PP#5E7001 & 6E7099).  The chronic dietary risk assessment was conducted using the Dietary Exposure Evaluation Model (DEEM-FCID™, Version 2.03) which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.

Acute Dietary Exposure Results and Characterization

In meetings on December 5, 2002 and April 4, 2003 HED’s Hazard Identification Assessment Review Committee (HIARC) agreed upon the doses and endpoints for use in human health risk assessments for famoxadone.  There was no appropriate endpoint for assessing acute dietary exposure; therefore, no acute dietary risk assessment was performed.

Chronic Dietary Exposure Results and Characterization

The Tier 1 chronic dietary risk assessment for famoxadone showed that dietary risk estimates exceeded HED's level of concern (i.e. >100% chronic population adjusted doses (cPAD)); therefore, a partially refined chronic dietary assessment was performed using anticipated residues (ARs) and with use of percent crop treated (%CT) information from the Biological and Economic Analysis Division (BEAD).  The refined assessment shows that for all included commodities, the chronic dietary risk estimates are below HED's level of concern (i.e. <100% cPAD).  The highest chronic drinking water concentration of 0.47 μg/L (ppb) was used in this analysis.  The results of the analysis indicate that chronic risk from the dietary (food + drinking water) exposure to famoxadone will not exceed HED’s level of concern for the general U.S. population, and all population subgroups.  The chronic dietary risk estimate for the highest reported exposed population subgroup, children 1-2 years old, is 65% of the cPAD.  The general US population utilizes 51% of the cPAD.

Cancer

The HIARC classified famoxadone as a “not likely carcinogen;” therefore, quantification of human cancer risk is not required.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose.  This is the population adjusted dose (PAD), which HED has concluded will result in no unreasonable adverse health effects.  The PAD is the Reference Dose (RfD) divided by the FQPA Safety Factor.  Dietary risk is expressed as a percentage of the PAD.  For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (8/20/99).

The most recent dietary risk assessment for famoxadone was conducted by D. McNeilly (DP Number: 321684, 04/17/2006) for its use on soybean to control soybean rust.  The first dietary risk assessment for famoxadone was conducted in connection with Section 3 registration of fruiting vegetables, cucurbit vegetables, head lettuce, and potatoes and an import tolerance for grapes (DP Number: 288138, M. Doherty, 04/18/2003).

II.	Residue Information

Famoxadone Use

In this analysis the chronic dietary exposure and risk estimates resulting from food intake were determined for the general U.S. population and various population subgroups resulting from the addition of a domestic registration for the use on grapes east of the Rocky Mountains, hops, and caneberries, subgroup 13A to the existing food uses for famoxadone.

Permanent tolerances for famoxadone have been established in 40 CFR §180.587.  Temporary tolerances have been established for soybean/soybean commodities.  Current tolerances range from 0.02 ppm in cattle, goat, horse and sheep fat to 10 ppm in lettuce.

HED believes that a metabolism study with an oilseed or grain crop is needed to complete a general understanding of the nature of the residue in all crops.  However, for the purposes of this IR-4 request for use of famoxadone on caneberry, the residue of concern for tolerance expression and risk assessment purposes is considered to be the parent compound.

Residue Data Used for Chronic Assessments

The previous dietary exposure analyses used average field trial values for crops and anticipated residues for ruminant fat, liver, and milk fat.  Empirical processing factors were used to refine the residue estimates of processed tomato, pepper, potato, and grape commodities.  Average field trial values and processing factors are taken from the famoxadone residue chemistry summary document (DP Number: 287253, M. Doherty, 4/16/2003).  The assessments assumed 100% crop treated for all commodities.  Those residue levels and processing factors used in the previous dietary exposure analyses are shown in Table 1.

Table 1.  Residue Levels Used in Previous Chronic Dietary Assessment for Famoxadone.

RAC

Food Form

Residue Level, ppm

Processing Factor

Comments

Grape

RAC

0.67

Not Applicable

Grape AR

Grape

Juice

0.67

0.01

Grape AR

Grape

Raisin

0.67

1.9

Grape AR

Grape

Wine and Sherry

0.67

0.01

Grape AR

Potato

Chips

0.01

1

Potato AR

Potato

Dry (granules/flakes)

0.01

1

Potato AR

Potato

Flour

0.01

1

Potato AR

Potato

Tuber, w/ peel

0.01

Not Applicable

Potato AR

Potato

Tuber, w/o peel

0.01

1

Potato AR

Lettuce, Head

RAC

0.55

Not Applicable

Lettuce AR (w/o wrapper)

Eggplant

RAC

0.35

Not Applicable

Bell Pepper AR

Okra

RAC

1.31

Not Applicable

Non-bell Pepper AR

Pepper

Bell

0.35

Not Applicable

Bell Pepper AR

Pepper

Bell, Dried

0.35

1.65 (tomato)

Bell Pepper AR

Pepper

Nonbell

1.31

Not Applicable

Non-bell Pepper AR

Pepper

Nonbell, Dried

1.31

1.65 (tomato)

Non-bell Pepper AR

Tomatillo

RAC

0.28

Not Applicable

Tomato AR

Tomato

RAC

0.28

Not Applicable

Tomato AR

Tomato

Paste

0.28

1.3

Tomato AR

Tomato

Puree

0.28

0.4

Tomato AR

Tomato

Dried

0.28

1.65

Tomato AR

Tomato

Juice

0.28

0.3

Tomato AR

Balsam pear

RAC

0.05

Not Applicable

Cucumber AR

Cantaloupe

RAC

0.13

Not Applicable

Cantaloupe AR

Casaba

RAC

0.13

Not Applicable

Cantaloupe AR

Chayote

RAC

0.11

Not Applicable

Summer Squash AR

Chinese waxgourd

RAC

0.05

Not Applicable

Cucumber AR

Cucumber

RAC

0.05

Not Applicable

Cucumber AR

Honeydew melon

RAC

0.13

Not Applicable

Cantaloupe AR

Pumpkin

RAC

0.11

Not Applicable

Summer Squash AR

Pumpkin

Seed

0.11

Not Applicable

Summer Squash AR

Squash, summer

RAC

0.11

Not Applicable

Summer Squash AR

Squash, winter

RAC

0.11

Not Applicable

Summer Squash AR

Watermelon

RAC

0.13

Not Applicable

Cantaloupe AR

Watermelon

Juice

0.13

1

Cantaloupe AR

Soybean

seeds

0.02

1

Recommended tolerance level  - 05MN13

Soybean

flour

0.02

1	Recommended tolerance level  - 05MN13

Soybean

flour-babyfood

0.02

1	Recommended tolerance level  - 05MN13

Soybean

soy milk

0.02

1	Recommended tolerance level  - 05MN13

Soybean

soy milk-babyfood

0.02

1	Recommended tolerance level  - 05MN13

Soybean

oil

0.02

1	Recommended tolerance level  - 05MN13

Soybean

oil-babyfood

0.02

1	Recommended tolerance level  - 05MN13

Fat of cattle, goats, and sheep

RAC

0.0075

Not Applicable

AR from a dietary burden of 0.0405 ppm

Liver of cattle, goats, and sheep

RAC

0.00285

Not Applicable

AR from a dietary burden of 0.0405 ppm

Milk, fat

RAC

0.00506

Not Applicable

AR from a dietary burden of 0.0305 ppm

The partially refined dietary exposure analysis used a Screening-Level Usage Analysis (SLUA), provided by the Biological and Economic Analysis Division (BEAD), for %CT information of current uses of famoxadone (J. Alsadek, 08/31/2006).  This information is listed in Table 2, below.

Table 2.  Percent Crop Treated Information Used in Chronic Dietary Exposure Analysis

Commodity	Percent of Crop Treated

Cucumbers	5

Peppers	5

Potatoes	5

Pumpkins	5

Squash

	<1

Tomatoes	10

Watermelons	<1

As part of the current petition, ARIA recommends establishing the permanent tolerances listed in Table 3 for residues of famoxadone.  The dietary assessment used the highest average field trial (HAFT) level for hops and caneberries.  The existing ARs for grape commodities were also used since the data used for the existing tolerance without a domestic registration was used in support of the proposed use on grapes east of the Rocky Mountains.

Table 3.   Proposed Tolerance Summary and AR for Famoxadone

Commodity	Proposed Tolerance	AR

Grapes	2.50	Existing AR

Hops	80	45.66

Caneberries, subgroup 13A

	   10 ppm	6.05

III.  	Drinking Water Data

For this chronic dietary exposure analysis, residues in water were included directly in the DEEM analysis.  The Environmental Fate and Effects Division (EFED) sent a memorandum (P. Jennings, 8/31/2005) stating that the estimated drinking water concentrations (EDWCs) appropriate for chronic exposure comparisons are 0.47 μg/L (ppb) in surface water and 0.23 μg/L (ppb) in ground water.  These values generally represent upper-bound estimates of the concentrations that might be found in surface water and groundwater resulting from the use of famoxadone.  The assessment was based on the registered potato use because it has the highest application rate, 0.1875 lbs ai/acre, with 6 applications at 5 day intervals.  The PRZM/EXAMS Model was used to estimate surface water concentrations and the SCIGROW Model was used to estimate groundwater concentrations.

.	DEEM-FCID™ Program and Consumption Information

The famoxadone chronic dietary assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID(, Version 2.03), which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  Consumption data are averaged for the entire U.S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

Based on analysis of the 1994-96, 98 CSFII consumption data which took into account dietary patterns and survey respondents, HED concluded that it is appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic exposure and risk assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form.  The resulting residue consumption estimate for each food/food form is summed with the residue consumption estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

In meetings on December 5, 2002 and April 4, 2003 HED’s Hazard Identification Assessment Review Committee agreed upon the doses and endpoints for use in human health risk assessments for famoxadone.  As there were no toxic effects attributable to a single dose, an endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-49 years old.  There was no appropriate endpoint for assessing acute dietary exposure.  For chronic dietary exposure, the toxicology endpoint was selected from a subchronic feeding study in dogs in which the LOAEL was 1.4 mg/kg/day based on microscopic lens lesions (cataracts) in the eyes of female dogs.  An additional Uncertainty Factor (UF) of 10 was added to the conventional UF of 100 for the use of a LOAEL and the use of a subchronic study.  The cRfD is 0.0014 mg/kg/day.  The doses relevant to dietary exposure are summarized in Table 4, below.

The Cancer Assessment Review Committee (CARC) classified famoxadone as “not likely to be carcinogenic to humans.” As such, a cancer dietary risk assessment is not warranted.

Table 4.  Summary of Toxicological Doses and Endpoints for Famoxadone Relevant to Human Health Dietary Risk Assessment.

Exposure

Scenario

Dose Used in Risk Assessment, UF

Special FQPA SF and LOC for Risk Assessment

Study and Toxicological Effects

Acute Dietary

(All populations)

NOAEL = none

UF = none

Acute RfD = none

NA

No appropriate endpoint attributable to a single oral dose was identified in the available toxicology studies on Famoxadone.

Chronic Dietary

(All populations)

LOAEL= 1.4 mg/kg/day

UF = 1000

Chronic RfD = 0.0014 mg/kg/day

FQPA SF = 1

Chronic PAD =

Chronic RfD

 FQPA SF

Chronic PAD = 0.0014

 mg/kg/day

13-Week Feeding Study in Dogs

LOAEL = 1.4 mg/kg/day based on microscopic lens lesions (cataracts) in eyes of female dogs.

Cancer (oral, dermal, inhalation)

Classification: Not Likely to be carcinogenic to humans

UF = uncertainty factor; FQPA SF =  FQPA SF; NOAEL = no observed adverse effect level; LOAEL = lowest observed adverse effect level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference dose.

VI.	Results/Discussion

For acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in the Summary Table (Table 5) are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

For the general population, there were no appropriate toxicological effects attributable to a single exposure (dose); therefore, an acute dose and endpoint were not identified for this risk assessment.  The HIARC classified famoxadone as a “not likely carcinogen”; therefore, quantification of human cancer risk is not required and a cancer dietary assessment was not performed.

Results of the Chronic Dietary Exposure Analysis

The chronic dietary exposure for food and surface water utilized 51% of the cPAD for the U.S. population.  The chronic dietary exposure for the highest reported exposed population subgroup, children 1-2 years old, was 65% of the cPAD.

Table 5.  Summary of Dietary Exposure and Risk for Famoxadone

Population Subgroup	Acute Dietary

(95.0 Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD*	Dietary Exposure

(mg/kg/day)	% cPAD*	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	N/A	0.000712	51	N/A

All Infants (< 1 year old)

0.000232	17

	Children 1-2 years old

0.000915	65

	Children 3-5 years old

0.000842	60

	Children 6-12 years old

0.000517	37

	Youth 13-19 years old

0.000424	30

	Adults 20-49 years old

0.000883	63

	Adults 50+ years old

0.000583	42

	Females 13-49 years old

0.000524	37

	* % PADs are reported to 2 significant figures.

* *The values for the highest exposed population for each type of risk assessment are bolded.

These analyses are partially refined dietary exposure assessments.  Further refinement to the analyses could be made through the use of anticipated residues, incorporation of percentages of other crops treated with famoxadone and/or monitoring data that better reflect residues at the time of consumption.  Since risk estimates are below HED’s level of concern, a more highly refined analysis is not needed at this time.

VII.	Conclusions

A chronic dietary exposure assessment was conducted for the proposed and existing food uses and drinking water from surface water sources.

The chronic dietary (food + drinking water) exposure to famoxadone is below HED’s level of concern for the general U.S. population and all population subgroups.  The chronic dietary exposure utilized 51% cPAD for the general U.S. population and 65% cPAD for children 1-2 years old, the most highly exposed population subgroup.

VIII.	List of Attachments

Attachment 1:  Chronic Food plus Water Residue Input File

Attachment 2:  Chronic Results File

Attachment 3:  Famoxadone SLUA

cc:  B. Hanson

Attachment 1:  Chronic Food plus Water Residue Input File

Filename: I:\working\Famox\113202_3.R98                    Chemical: Famoxadone

RfD(Chronic): .0014 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 10-25-2006/15:25:20/8          Program ver. 2.03

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

09020210 9B   Balsam pear                        0.050000   1.000  1.000  Cucumb

          Full comment: Cucumber AR

21000470 M    Beef, fat                          0.007500   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

21000471 M    Beef,fat-babyfood                  0.007500   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

21000490 M    Beef, liver                        0.002850   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

21000491 M    Beef, liver-babyfood               0.002850   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

13010550 13A  Blackberry                         6.050000   1.000  1.000  6E7099

13010560 13A  Blackberry, juice                  6.050000   1.000  1.000  6E7099

13010561 13A  Blackberry, juice-babyfood         6.050000   1.000  1.000  6E7099

13010580 13A  Boysenberry                        6.050000   1.000  1.000  6E7099

09010750 9A   Cantaloupe                         0.130000   1.000  1.000  Cantal

          Full comment: Cantaloupe AR

09010800 9A   Casaba                             0.130000   1.000  1.000  Cantal

          Full comment: Cantaloupe AR

09020880 9B   Chayote, fruit                     0.110000   1.000  1.000  Summer

          Full comment: Summer Squash AR

09021020 9B   Chinese waxgourd                   0.050000   1.000  1.000  Cucumb

          Full comment: Cucumber AR

09021350 9B   Cucumber                           0.050000   1.000  0.050  Cucumb

          Full comment: Cucumber AR

13011420 13A  Dewberry                           6.050000   1.000  1.000  6E7099

08001480 8    Eggplant                           0.350000   1.000  1.000  Bell P

          Full comment: Bell Pepper AR

23001710 M    Goat, fat                          0.007500   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

23001730 M    Goat, liver                        0.002850   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

95001750 O    Grape                              0.670000   1.000  1.000  Grape

          Full comment: Grape AR

95001760 O    Grape, juice                       0.670000   0.010  1.000  Grape

          Full comment: Grape AR

95001761 O    Grape, juice-babyfood              0.670000   0.010  1.000  Grape

          Full comment: Grape AR

95001780 O    Grape, raisin                      0.670000   1.900  1.000  Grape

          Full comment: Grape AR

95001790 O    Grape, wine and sherry             0.670000   0.010  1.000  Grape

          Full comment: Grape AR

09011870 9A   Honeydew melon                     0.130000   1.000  1.000  Cantal

          Full comment: Cantaloupe AR

95001880 O    Hop                               45.660000   1.000  1.000

04012040 4A   Lettuce, head                      0.550000   1.000  1.000  Lettuc

          Full comment: Lettuce AR (w/o wrapper)

13012080 13A  Loganberry                         6.050000   1.000  1.000  6E7099

27002220 D    Milk, fat                          0.005060   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.005060   1.000  1.000

08002340 8    Okra                               1.310000   1.000  1.000  Non-be

          Full comment: Non-bell Pepper AR

08002700 8    Pepper, bell                       0.350000   1.000  0.050  Bell P

          Full comment: Bell Pepper AR

08002701 8    Pepper, bell-babyfood              0.350000   1.000  0.050  Bell P

          Full comment: Bell Pepper AR

08002710 8    Pepper, bell, dried                0.350000   1.650  0.050  Bell P

          Full comment: Bell Pepper AR

08002711 8    Pepper, bell, dried-babyfood       0.350000   1.650  0.050  Bell P

          Full comment: Bell Pepper AR

08002720 8    Pepper, nonbell                    1.310000   1.000  0.050  Non-be

          Full comment: Non-bell Pepper AR

08002721 8    Pepper, nonbell-babyfood           1.310000   1.000  0.050  Non-be

          Full comment: Non-bell Pepper AR

08002730 8    Pepper, nonbell, dried             1.310000   1.650  0.050  Non-be

          Full comment: Non-bell Pepper AR

01032960 1C   Potato, chips                      0.010000   1.000  0.050  Potato

          Full comment: Potato AR

01032970 1C   Potato, dry (granules/ flakes)     0.010000   1.000  0.050  Potato

          Full comment: Potato AR

01032971 1C   Potato, dry (granules/ flakes)-b   0.010000   1.000  0.050  Potato

          Full comment: Potato AR

01032980 1C   Potato, flour                      0.010000   1.000  0.050  Potato

          Full comment: Potato AR

01032981 1C   Potato, flour-babyfood             0.010000   1.000  0.050  Potato

          Full comment: Potato AR

01032990 1C   Potato, tuber, w/peel              0.010000   1.000  0.050  Potato

          Full comment: Potato AR

01032991 1C   Potato, tuber, w/peel-babyfood     0.010000   1.000  0.050  Potato

          Full comment: Potato AR

01033000 1C   Potato, tuber, w/o peel            0.010000   1.000  0.050  Potato

          Full comment: Potato AR

01033001 1C   Potato, tuber, w/o peel-babyfood   0.010000   1.000  0.050  Potato

          Full comment: Potato AR

09023080 9B   Pumpkin                            0.110000   1.000  0.050  Summer

          Full comment: Summer Squash AR

09023090 9B   Pumpkin, seed                      0.110000   1.000  0.050  Summer

          Full comment: Summer Squash AR

13013200 13A  Raspberry                          6.050000   1.000  1.000  6E7099

13013201 13A  Raspberry-babyfood                 6.050000   1.000  1.000  6E7099

13013210 13A  Raspberry, juice                   6.050000   1.000  1.000  6E7099

13013211 13A  Raspberry, juice-babyfood          6.050000   1.000  1.000  6E7099

26003410 M    Sheep, fat                         0.007500   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

26003411 M    Sheep, fat-babyfood                0.007500   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

26003430 M    Sheep, liver                       0.002850   1.000  1.000  AR Die

          Full comment: AR Diet = 0.05 ppm

06003470 6    Soybean, seed                      0.020000   1.000  1.000  Tolera

          Full comment: Tolerance level est for 18

06003480 6    Soybean, flour                     0.020000   1.000  1.000  Tolera

          Full comment: Tolerance level est for 18

06003481 6    Soybean, flour-babyfood            0.020000   1.000  1.000  Tolera

          Full comment: Tolerance level est for 18

06003490 6    Soybean, soy milk                  0.020000   1.000  1.000  Tolera

          Full comment: Tolerance level est for 18

06003491 6    Soybean, soy milk-babyfood or in   0.020000   1.000  1.000  Tolera

          Full comment: Tolerance level est for 18

06003500 6    Soybean, oil                       0.020000   1.000  1.000  Tolera

          Full comment: Tolerance level est for 18

06003501 6    Soybean, oil-babyfood              0.020000   1.000  1.000  Tolera

          Full comment: Tolerance level est for 18

09023560 9B   Squash, summer                     0.110000   1.000  0.010  Summer

          Full comment: Summer Squash AR

09023561 9B   Squash, summer-babyfood            0.110000   1.000  0.010  Summer

          Full comment: Summer Squash AR

09023570 9B   Squash, winter                     0.110000   1.000  0.010  Summer

          Full comment: Summer Squash AR

09023571 9B   Squash, winter-babyfood            0.110000   1.000  0.010  Summer

          Full comment: Summer Squash AR

08003740 8    Tomatillo                          0.280000   1.000  1.000  Tomato

          Full comment: Tomato AR

08003750 8    Tomato                             0.280000   1.000  0.100  Tomato

          Full comment: Tomato AR

08003751 8    Tomato-babyfood                    0.280000   1.000  0.100  Tomato

          Full comment: Tomato AR

08003760 8    Tomato, paste                      0.280000   1.300  0.100  Tomato

          Full comment: Tomato AR

08003761 8    Tomato, paste-babyfood             0.280000   1.300  0.100  Tomato

          Full comment: Tomato AR

08003770 8    Tomato, puree                      0.280000   0.400  0.100  Tomato

          Full comment: Tomato AR

08003771 8    Tomato, puree-babyfood             0.280000   0.400  0.100  Tomato

          Full comment: Tomato AR

08003780 8    Tomato, dried                      0.280000   1.650  0.100  Tomato

          Full comment: Tomato AR

08003781 8    Tomato, dried-babyfood             0.280000   1.650  0.100  Tomato

          Full comment: Tomato AR

08003790 8    Tomato, juice                      0.280000   0.300  0.100  Tomato

          Full comment: Tomato AR

86010000 O    Water, direct, all sources         0.000470   1.000  1.000

86020000 O    Water, indirect, all sources       0.000470   1.000  1.000

09013990 9A   Watermelon                         0.130000   1.000  0.010  Cantal

          Full comment: Cantaloupe AR

09014000 9A   Watermelon, juice                  0.130000   1.000  0.010  Cantal

          Full comment: Cantaloupe AR

Attachment 2:  Chronic Results File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FAMOXADONE                       (1994-98 data)

Residue file name: I:\working\Famox\113202_3.R98     Adjustment factor #2 used.

Analysis Date 10-26-2006/12:41:59     Residue file dated: 10-25-2006/15:25:20/8

Reference dose (RfD, Chronic) = .0014 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000712                50.9%

U.S. Population (spring season)             0.000768                54.9%

U.S. Population (summer season)             0.000835                59.6%

U.S. Population (autumn season)             0.000622                44.5%

U.S. Population (winter season)             0.000624                44.6%

Northeast region                            0.000644                46.0%

Midwest region                              0.000764                54.5%

Southern region                             0.000615                43.9%

Western region                              0.000874                62.4%

Hispanics                                   0.000620                44.3%

Non-hispanic whites                         0.000776                55.4%

Non-hispanic blacks                         0.000464                33.1%

Non-hisp/non-white/non-black                0.000601                43.0%

All infants (< 1 year)                      0.000232                16.6%

Nursing infants                             0.000144                10.3%

Non-nursing infants                         0.000266                19.0%

Children 1-6  yrs                           0.000837                59.8%

Children 7-12 yrs                           0.000490                35.0%

Females 13-19 (not preg or nursing)         0.000331                23.7%

Females 20+ (not preg or nursing)           0.000532                38.0%

Females 13-50 yrs                           0.000556                39.7%

Females 13+ (preg/not nursing)              0.000295                21.1%

Females 13+ (nursing)                       0.000490                35.0%

Males 13-19 yrs                             0.000513                36.7%

Males 20+ yrs                               0.001042                74.4%

Seniors 55+                                 0.000526                37.6%

Children 1-2 yrs                            0.000915                65.4%

Children 3-5 yrs                            0.000842                60.2%

Children 6-12 yrs                           0.000517                36.9%

Youth 13-19 yrs                             0.000424                30.3%

Adults 20-49 yrs                            0.000883                63.1%

Adults 50+ yrs                              0.000583                41.6%

Females 13-49 yrs                           0.000524                37.4%

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

Attachment 3:  Famoxadone SLUA

Famoxadone (PC 113202)

Screening-level Usage Analysis (SLUA)

Date:  August 31, 06

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used on.

Available pesticide usage information (i.e., does not include all of the United States).

Annual percent of crop treated (average & maximum) for each agricultural crop.

Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by merging pesticide usage data sources together; averaging by year, averaging across all years, & then rounding.  Note:  If the estimated value is less than 500, then that value is labeled <500.  Estimated values between 500 & <1,000,000 are rounded to 1 significant digit.  Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)

Average percent of crop treated - Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5.  Note:  If the estimated value is less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5.  Note:  If the estimated value is less than 2.5, then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National Agricultural Statistics Service) – pesticide usage data from 1999 to 2004.

Private Pesticide Market Research – pesticide usage data from 1999 to 2004.

NCFAP 97 (National Center for Food and Agricultural Policy), and NPUD 2002 (National Pesticide Use Database) – insecticide usage data from NCFAP 97, and fungicide and herbicide usage data from NPUD 02, of the CropLife Foundation,  are used only if data are not available from the other sources.

California DPR data can be requested separately.

What are the data limitations?

Additional registered uses may exist but are not included because the available surveys do not report usage (e.g., small acreage crops).

Lack of reported usage data for the pesticide on a crop does not imply zero usage.

Usage data on a particular site may be noted in data sources, but not quantified.  In these instances, the site would not be reported in the SLUA.

Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not reported in the SLUA.  A separate request must be made to receive these estimates.

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☊଀ن㜀Ĥ␸䠁Ĥ᠀Some sites show some use, even though they are not on the label.  This usage could be due to Section 18 requests, existing stocks of the chemical, data collection errors, experimental use permit (EUP), and/or because of an illegal use.

Who do I contact for further information and/or questions on this SLUA?

Jihad Alsadek<PHONE_NUMBER>)

Alan Halvorson<PHONE_NUMBER>)

                                      Thursday, August 31, 2006 12:35

Screening Level Estimates of Agricultural Uses of famoxadone

Sorted Alphabetically

	  	 	Pounds of	Percent      Maximum

	  	 	Active	of Crop     Percent of

		Crop	Ingredient	Treated    Crop Treated

	1 	Cucumbers	1,000	 5             10

	2 	Peppers	2,000	 5              5

	3 	Potatoes	5,000	 5              5

	4 	Pumpkins	2,000	 5              5

	5 	Squash	<500	<1              5

	6 	Tomatoes	6,000	10             20

	7 	Watermelons	1,000	<1           <2.5

______________________________________

All numbers rounded.

'<500' indicates less than 500 pounds of active ingredient.

'<2.5' indicates less than 2.5 percent of crop is treated.

'<1'	indicates less than 1	percent of crop is treated.

Famoxadone		DP Number: 332298

PC Code: 113202

________________________________________________________________________ ______________

 PAGE

Page  PAGE   8  of 16


[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Page 1581]
[FR Doc No: 2021-00162]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2020-104]

National Emergency Medical Services Advisory Council; Notice of
Public Meeting

AGENCY: National Highway Traffic Safety Administration, U.S. Department
of Transportation (DOT).

ACTION: Notice of public meeting.

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

SUMMARY: This notice announces a meeting of the National Emergency
Medical Services Advisory Council (NEMSAC).

DATES: The meeting will be held August 11-12, 2021, from 9:00 a.m. to
5:00 p.m. EDT Requests to attend the meeting must be received by August
6, 2021.
    Requests for accommodations to a disability must be received by
August 6, 2021.
    If you wish to speak during the meeting, you must submit a written
copy of your remarks to DOT by August 6, 2021.
    Requests to submit written materials to be reviewed during the
meeting must be received no later than August 6, 2021.

ADDRESSES: The meeting will be held virtually (depending on the status
of the Coronavirus Disease 2019 (COVID-19) public health emergency) or
at the U.S. Department of Transportation, 1200 New Jersey Avenue SE,
Washington, DC 20590. Copies of the meeting minutes will be available
on the NEMSAC internet website at EMS.gov. The detailed agenda will be
posted on the NEMSAC internet website at EMS.gov at least one week in
advance of the meeting.

FOR FURTHER INFORMATION CONTACT: Clary Mole, EMS Specialist, U.S.
Department of Transportation, at<EMAIL_ADDRESS>or<PHONE_NUMBER>.
Any committee related requests should be sent to the person listed in
this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The NEMSAC was established pursuant to Section 31108 of the Moving
Ahead for Progress in the 21st Century (MAP-21) Act of 2012, under the
Federal Advisory Committee Act. The purpose of NEMSAC is to serve as a
nationally recognized council of emergency medical services (EMS)
representatives to provide advice and consult with:
    a. The Federal Interagency Committee on Emergency Medical Services
(FICEMS) on matters relating to EMS issues; and
    b. The Secretary of Transportation on matters relating to EMS
issues affecting DOT.
    The NEMSAC provides an important national forum for the non-Federal
deliberation of national EMS issues and serves as a platform for advice
on DOT's national EMS activities. NEMSAC also provides advice and
recommendations to the FICEMS. NEMSAC is authorized under Section 31108
of the MAP-21 Act of 2012, codified at 42 U.S.C. 300d-4.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 Updates from Federal Emergency Services Liaisons
 Updates on the FICEMS Initiatives
 Updates on NHTSA Initiatives
 Committee Reports

III. Public Participation

    The meeting will be open to the public. Members of the public who
wish to attend in person must RSVP to the person listed in the FOR
FURTHER INFORMATION CONTACT section with your name and affiliation. The
U.S. Department of Transportation is committed to providing equal
access to this meeting for all participants. If you need alternative
formats or services because of a disability, such as sign language,
interpretation, or other ancillary aids, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section no later than the
deadline listed in the DATES section.
    There will be a thirty (30) minute period allotted for comments
from members of the public joining the meeting. To accommodate as many
speakers as possible, the time for each commenter may be limited.
Individuals wishing to reserve speaking time during the meeting must
submit a request at the time of registration, as well as the name,
address, and organizational affiliation of the proposed speaker. If the
number of registrants requesting to make statements is greater than can
be reasonably accommodated during the meeting, the NHTSA office of EMS
may conduct a lottery to determine the speakers. Speakers are requested
to submit a written copy of their prepared remarks for inclusion in the
meeting records and for circulation to NEMSAC members. All prepared
remarks submitted on time will be accepted and considered as part of
the record. Any member of the public may present a written statement to
the committee at any time.

    Authority: 42 U.S.C. 300d-4(b); 49 CFR part 1.95(i)(4).

    Issued in Washington, DC.
Nanda Narayanan Srinivasan,
Associate Administrator, Research and Program Development.
[FR Doc. 2021-00162 Filed 1-7-21; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 245 (Wednesday, December 21, 2016)]
[Notices]
[Pages 93720-93722]
[FR Doc No: 2016-30689]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79570; File No. SR-FINRA-2016-045]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to Rule 4554 Reporting Requirements for
Alternative Trading Systems

December 15, 2016.
    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 December 8, 2016, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission.
---------------------------------------------------------------------------

    \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

    FINRA is proposing to amend Rule 4554 to require alternative
trading systems (``ATSs'') to submit additional order information to
FINRA.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
    FINRA proposes to amend Rule 4554 (Alternative Trading Systems--
Recording and Reporting Requirements of Order and Execution Information
for NMS Stocks) to require ATSs to provide additional order sequence
information on reports submitted to the Order Audit Trail System
(``OATS''). In May 2016, the SEC approved Rule 4554 to further enhance
FINRA's ability to reconstruct an ATS's order book and better perform
its order-based surveillance, which includes surveillance for layering,
quote spoofing and mid-point pricing manipulation. To accomplish this,
Rule 4554 requires ATSs to report order information for each order they
receive in an NMS stock beyond that set forth in the OATS rules, such
as order re-pricing events (e.g., changes to an order that is pegged to
the National Best Bid or Offer (``NBBO'')) and order display and
reserve size information.\4\ Rule 4554 sets forth four categories of
reporting requirements: (1) Data to be reported by all ATSs at the time
of order receipt; (2) data to be reported by all ATSs at the time of
order execution; (3) data to be reported by ATSs that display
subscriber orders; and (4) data specific to ATSs that are registered as
ADF Trading Centers.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 77798 (May 10,
2016), 81 FR 30395 (May 16, 2016) (SR-FINRA-2016-010). With the
exception of the requirement for ATSs to report sequence numbers,
Rule 4554 was implemented on November 7, 2016. See Regulatory Notice
16-28 (August 2016). FINRA delayed the implementation for the
requirement to report sequence numbers until the requirement could
be extended to apply to all OATS reports. See Securities Exchange
Act Release No. 79289 (November 10, 2016), 81 FR 81202 (November 17,
2016) (Notice of Filing and Immediate Effectiveness of SR-FINRA-
2016-041).
---------------------------------------------------------------------------

    Rule 4554(b) requires that all ATSs report eight categories of
information at the time of order receipt, including the sequence number
assigned to the order event by the ATS's matching engine.\5\

After further evaluation of the need for the sequence number in other
order events, FINRA proposes to amend this requirement to require ATSs
to report a sequence number for all OATS event types, not just for
order receipt, including reports for the execution of an order or the
routing of an order away from the ATS.\6\ FINRA is proposing to extend
the requirement to report a sequence number beyond order receipt
because, without a sequence number on all order events, FINRA is unable
to properly sequence events when a single ATS MPID reports order events
in the same symbol with identical timestamps.\7\ Requiring ATSs to
report a sequence number for all OATS order events, rather than just
order receipt, will further enable FINRA to properly sequence order
events within an ATS, which will allow FINRA to more fully reconstruct
an ATS's order book and better perform order-based surveillance,
including surveillance for layering, quote spoofing and mid-point
pricing manipulation.
---------------------------------------------------------------------------

    \5\ Rule 4554(b)(8). Rule 4554(b) also requires all ATSs, at the
time of order receipt, to report: (1) Whether the ATS displays
subscriber orders outside of the ATS and, if the ATS displays
subscriber orders outside of the ATS, whether subscriber orders are
displayed to subscribers only, or are distributed for publication in
the consolidated quotation data; (2) whether the ATS is an ADF
Trading Center as defined in FINRA Rule 6220; (3) whether the order
can be routed away from the ATS for execution; (4) whether there are
any counter-party restrictions on the order; (5) a unique identifier
representing the specific order type other than market and limit
orders that have no other special handling instructions; (6) the
NBBO (or relevant reference price) in effect at the time of order
receipt and the timestamp of when the ATS captured the effective
NBBO (or relevant reference price); and (7) the market data feed the
ATS used to obtain the NBBO (or relevant reference price).
    \6\ FINRA is proposing to move the provision into a separate
paragraph to reflect this change.
    \7\ The occurrence of identical timestamps in these
circumstances is not infrequent. For example, on a recent reporting
day, over 13% of ATS order events within a single ATS MPID and
symbol contained an identical timestamp.
---------------------------------------------------------------------------

    FINRA notes that the expansion of the requirement to report a
sequence number with all order events mirrors the proposed requirement
from Regulatory Notice 14-51. As discussed in the filing for SR-FINRA-
2016-010, FINRA initially solicited comment on the proposal for ATSs to
report order information to OATS in Regulatory Notice 14-51.\8\ As part
of the proposal set forth in the Regulatory Notice, ATSs exceeding the
proposed volume threshold would have been required to report certain
order information and ``would provide, for every order, the ATS book
sequence identifier and the associated OATS identifier, which would
link information about that order to the related information and full
lifecycle reported to OATS.'' \9\ None of the commenters on that
proposal specifically addressed the provision of sequence numbers on
order reports.
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    \8\ See Securities Exchange Act Release No. 77269 (March 1,
2016), 81 FR 11851, 11854-55 (March 7, 2016).
    \9\ Regulatory Notice 14-51. The volume threshold proposed in
the Regulatory Notice was removed as part of the proposed rule
change approved by the Commission. See Securities Exchange Act
Release No. 77269 (March 1, 2016), 81 FR 11851, 11854-55 (March 7,
2016).
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    In response to a comment on the proposed rule change filed with the
Commission, FINRA clarified that it was not mandating a particular or
uniform format by which ATSs must report sequence numbers and that
reporting sequence numbers as they currently exist in an ATS will
satisfy the requirement.\10\ The same clarification is true with the
expansion of the requirement beyond reporting order receipt (i.e., an
ATS may report all sequence numbers as they currently exist in the ATS
rather than in a particular or uniform format).
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    \10\ See Securities Exchange Act Release No. 77798 (May 10,
2016), 81 FR 30395, 30397 (May 16, 2016).
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    FINRA has filed the proposed rule change for immediate
effectiveness. FINRA will announce the implementation date of the
proposed rule change no later than 30 days following Commission notice
of the filing of the proposed rule change for immediate effectiveness.
The implementation date will be no later than 145 days after the date
of the filing.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\11\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest, and Section 15A(b)(9) of the Act,\12\ which requires
that FINRA rules not impose any burden on competition that is not
necessary or appropriate. FINRA believes that this proposed rule change
is consistent with the Act because requiring sequence numbers on all
OATS reports will further enhance FINRA's ability to surveil activity
occurring within an ATS by providing FINRA with additional information
that can be integrated into FINRA's surveillance patterns to support
alert generation and analysis.
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    \11\ 15 U.S.C. 78o-3(b)(6).
    \12\ 15 U.S.C. 78o-3(b)(9).
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B. Self-Regulatory Organization's Statement on Burden on Competition
    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The proposed changes will apply
equally to all similarly situated ATSs. FINRA also notes that the
proposed rule change is designed to assist FINRA in meeting its
regulatory obligations by enhancing its ability to efficiently surveil
activity occurring within ATSs and across markets. FINRA believes that,
because ATSs are already required to include sequence numbers on new
order reports pursuant to Rule 4554 as approved by the Commission,
including sequence numbers on additional order events will not be
overly burdensome.
C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others
    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
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    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 necessary or
appropriate in the public interest, for the protection of investors, or
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_ADDRESS>Please include
File Number SR-FINRA-2016-045 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-FINRA-2016-045. 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 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 Web site 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 such filing also will be available
for inspection and copying at the principal office of FINRA. 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-FINRA-2016-045, and should
be submitted on or before January 11, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-30689 Filed 12-20-16; 8:45 am]
 BILLING CODE 8011-01-P